خواص دارویی و گیاهی
Ondansetron, marketed under the brand name Zofran, is a medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, or surgery.[1] It is also useful in gastroenteritis.[2][3] It has little effect on vomiting caused by motion sickness.[4] It can be given by mouth, or by injection into a muscle or into a vein.[1]
Common side effects include diarrhea, constipation, headache, sleepiness, and itchiness.[1] Serious side effects include QT prolongation and severe allergic reaction.[1] It appears to be safe during pregnancy but has not been well studied in this group.[1] It is a serotonin 5-HT3 receptor antagonist.[1] It does not have any effect on dopamine receptors or muscarinic receptors.[5]
Ondansetron was patented in 1984 and approved for medical use in 1990.[6] It is on the World Health Organization’s List of Essential Medicines, the most effective and safe medicines needed in a health system.[7] It is available as a generic medication.[1] The wholesale cost of the injectable form in the developing world is about US$0.10 to US$0.76 per dose.[8] In the United States it costs about US$1.37 per tablet.[1] In 2016 it was the 91st most prescribed medication in the United States with more than 8 million prescriptions.[9]
Although an effective antiemetic agent, the high cost of brand-name ondansetron initially limited its use to controlling postoperative nausea and vomiting and chemotherapy-induced nausea and vomiting.[10]
The 5-HT3 receptor antagonists are the primary medications used to treat and prevent chemotherapy-induced nausea and vomiting and radiotherapy-induced nausea and vomiting.
قرص ondansetron چیست
A number of medications including ondansetron appear to be effective in controlling postoperative nausea and vomiting. It is more effective than metoclopramide, and less sedating than cyclizine or droperidol.
Ondansetron is used off-label to treat morning sickness and hyperemesis gravidarum of pregnancy. It is typically used after trials of other drugs have failed.[11]
There appears to be a low risk of harm to the baby with use during pregnancy, though there may be an increase in heart problems among the babies.[12][13]
Ondansetron is in pregnancy category B in the US.[14] It is not known if ondansetron is excreted in breast milk.[14]
Ondansetron is one of several antiemetic agents used during the vomiting phase of cyclic vomiting syndrome.[15]
Trials in emergency department settings support the use of ondansetron to reduce vomiting associated with gastroenteritis and dehydration.[16] A retrospective review found it was used commonly for this purpose, being administered in over 58% of cases. Its use reduced hospital admissions, but was also associated with higher rates of return visits to the emergency department. Furthermore, people who had initially received ondansetron were more likely to be admitted on the return visit than people who had not received the drug. However, this effect may simply be due to the agent being used more frequently in people who present with more severe illness. Its use was not found to mask serious diagnoses.[17]
Ondansetron has rarely been studied in people under 4 years of age. As such, little data is available to guide dosage recommendations.[14]
It is not necessary to adjust the dosage for people under 75 years of age. The use of ondansetron has not been studied in people older than 75 years of age, and it is not known if dosage should be adjusted for this group.[14]
The maximum recommended dose for people with severe liver function impairment is 8 mg/day. In these people, ondansetron is cleared from the body at half to one-third the rate as in healthy people. The concentration of ondansetron in body tissues as opposed to plasma is also higher than in healthy people.[14]
Headache is the most common adverse effect.[18] A review of use for post-operative nausea and vomiting found that for every 36 people treated, one would experience headache, which could be severe.[19]
Constipation, diarrhea, and dizziness are other commonly reported side effects.[1] It is broken down by the hepatic cytochrome P450 system and it has little effect on the metabolism of other drugs broken down by this system. Anecdotally, ototoxicity has also been reported if injected too quickly.[1]
Use of ondansetron has been associated with prolongation of the QT interval, which can lead to a potentially fatal heart rhythm known as torsades de pointes. Although this may happen in any person with any formulation, the risk is most salient with the injectable (intravenous) form of the drug and increases with dose. The risk is also higher in people taking other medicines that prolong the QT interval, as well as in people with congenital long QT syndrome, congestive heart failure, and/or bradyarrhythmias. As such, single doses of injectable ondansetron should not exceed 16 mg at one time. (Oral dosing recommendations remain intact, including the recommendation of a single 24-mg oral dose when indicated.) Electrolyte imbalances should be corrected before the use of injectable ondansetron. People are cautioned to seek immediate medical care if symptoms such as irregular heartbeat/palpitations, shortness of breath, dizziness, or fainting occur while taking ondansetron.[20]
No specific treatment is available for ondansetron overdose; people are managed with supportive measures. An antidote to ondansetron is not known.[14]
Ondansetron is a highly specific and selective serotonin 5-HT3 receptor antagonist, with low affinity for dopamine receptors. The 5-HT3 receptors are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema in the medulla. Serotonin is released by the enterochromaffin cells of the small intestine in response to chemotherapeutic agents and may stimulate vagal afferents (via 5-HT3 receptors) to initiate the vomiting reflex. It is thought that ondansetron’s antiemetic action is mediated mostly via antagonism of vagal afferents with a minor contribution from antagonism of central receptors.[21]
Ondansetron (marketed under the brand name Zofran) was developed in the mid-1980s by GlaxoSmithKline in London. It was granted US patent protection in September 1987,[22] received a use patent June 1988,[23] and was approved by the US FDA in January 1991. It was granted another divisional patent in November 1996.[24] Finally, owing to GlaxoSmithKline’s research on pediatric use, ondansetron’s patent protection was extended until December 2006.[25] By this final year of its patent (2006), Zofran had become the 20th highest-selling brand-name drug in the United States, with sales of US$1.3 billion in the first 9 months of 2006 (80% from the US).[26] The first generic versions were approved by the US FDA in December 2006, with marketing approval granted to Teva Pharmaceuticals USA and SICOR Pharmaceuticals.[27]
In 1997, ondansetron was the subject of a meta-analysis case study published in the British Medical Journal. Researchers examined 84 trials, with 11,980 people receiving ondansetron, published between 1991 and September 1996. Intravenous ondansetron 4 mg versus placebo was investigated in 16 reports and three further reports which had been duplicated a total of six times. The number needed to treat (NNT) to prevent vomiting within 24 hours was 9.5, with 95% confidence interval 6.9 to 15, in the 16 nonduplicated reports. In the three duplicated reports, the NNT was significantly lower at 3.9 (3.3 to 4.8). When all 25 reports were combined, the apparent NNT improved to 4.9 (4.4 to 5.6). Inclusion of duplicate reports led to a 23% overestimation of ondansetron’s antiemetic efficacy.[28]
In addition, the authors found the covert duplication of reports on ondansetron was not easy to detect, because of lack of cross-referencing between papers, and reports containing duplicate findings were cited in eight reviews of the drug.[28] Their analysis was a subject of an editorial in the Journal of the American Medical Association in 1999.[29]
Ondansetron is a generic drug and is available in many countries under many brand names.[30]
A 2006 double-blind, randomized controlled trial indicated ondansetron may have value in the treatment of schizophrenia, as an adjunct to haloperidol. The study found the combination to significantly improve negative schizophrenia symptoms, and people taking both drugs experienced fewer of the adverse effects commonly associated with haloperidol.[31] An earlier, smaller, open-label trial had found ondansetron to be useful in treating antipsychotic-induced tardive dyskinesia in people with schizophrenia, and the study patients also showed significant improvement in the disease’s symptoms.[32][33]
Early studies have also examined ondansetron as a possible treatment for psychosis resulting from advanced Parkinson’s disease.[34] Its apparent benefits despite a lack of any significant antagonistic properties at dopamine receptors or the 5-HT2A receptor raises interesting questions about the etiology of psychosis.
There is tentative evidence that it may be useful in decreasing the desired effects of alcohol.[35] There is also some tentative evidence in those who are addicted to stimulants.[36]
Two small, placebo-controlled trials have been conducted to assess the efficacy of ondansetron for postanesthetic shivering, a common occurrence after surgery. Ondansetron was found to be as effective as pethidine (meperidine, Demerol) when given as a single intravenous dose before anesthesia.[37]
Ondansetron, marketed under the brand name Zofran, is a medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, or surgery.[1] It is also useful in gastroenteritis.[2][3] It has little effect on vomiting caused by motion sickness.[4] It can be given by mouth, or by injection into a muscle or into a vein.[1]
Common side effects include diarrhea, constipation, headache, sleepiness, and itchiness.[1] Serious side effects include QT prolongation and severe allergic reaction.[1] It appears to be safe during pregnancy but has not been well studied in this group.[1] It is a serotonin 5-HT3 receptor antagonist.[1] It does not have any effect on dopamine receptors or muscarinic receptors.[5]
Ondansetron was patented in 1984 and approved for medical use in 1990.[6] It is on the World Health Organization’s List of Essential Medicines, the most effective and safe medicines needed in a health system.[7] It is available as a generic medication.[1] The wholesale cost of the injectable form in the developing world is about US$0.10 to US$0.76 per dose.[8] In the United States it costs about US$1.37 per tablet.[1] In 2016 it was the 91st most prescribed medication in the United States with more than 8 million prescriptions.[9]
Although an effective antiemetic agent, the high cost of brand-name ondansetron initially limited its use to controlling postoperative nausea and vomiting and chemotherapy-induced nausea and vomiting.[10]
The 5-HT3 receptor antagonists are the primary medications used to treat and prevent chemotherapy-induced nausea and vomiting and radiotherapy-induced nausea and vomiting.
قرص ondansetron چیست
A number of medications including ondansetron appear to be effective in controlling postoperative nausea and vomiting. It is more effective than metoclopramide, and less sedating than cyclizine or droperidol.
Ondansetron is used off-label to treat morning sickness and hyperemesis gravidarum of pregnancy. It is typically used after trials of other drugs have failed.[11]
There appears to be a low risk of harm to the baby with use during pregnancy, though there may be an increase in heart problems among the babies.[12][13]
Ondansetron is in pregnancy category B in the US.[14] It is not known if ondansetron is excreted in breast milk.[14]
Ondansetron is one of several antiemetic agents used during the vomiting phase of cyclic vomiting syndrome.[15]
Trials in emergency department settings support the use of ondansetron to reduce vomiting associated with gastroenteritis and dehydration.[16] A retrospective review found it was used commonly for this purpose, being administered in over 58% of cases. Its use reduced hospital admissions, but was also associated with higher rates of return visits to the emergency department. Furthermore, people who had initially received ondansetron were more likely to be admitted on the return visit than people who had not received the drug. However, this effect may simply be due to the agent being used more frequently in people who present with more severe illness. Its use was not found to mask serious diagnoses.[17]
Ondansetron has rarely been studied in people under 4 years of age. As such, little data is available to guide dosage recommendations.[14]
It is not necessary to adjust the dosage for people under 75 years of age. The use of ondansetron has not been studied in people older than 75 years of age, and it is not known if dosage should be adjusted for this group.[14]
The maximum recommended dose for people with severe liver function impairment is 8 mg/day. In these people, ondansetron is cleared from the body at half to one-third the rate as in healthy people. The concentration of ondansetron in body tissues as opposed to plasma is also higher than in healthy people.[14]
Headache is the most common adverse effect.[18] A review of use for post-operative nausea and vomiting found that for every 36 people treated, one would experience headache, which could be severe.[19]
Constipation, diarrhea, and dizziness are other commonly reported side effects.[1] It is broken down by the hepatic cytochrome P450 system and it has little effect on the metabolism of other drugs broken down by this system. Anecdotally, ototoxicity has also been reported if injected too quickly.[1]
Use of ondansetron has been associated with prolongation of the QT interval, which can lead to a potentially fatal heart rhythm known as torsades de pointes. Although this may happen in any person with any formulation, the risk is most salient with the injectable (intravenous) form of the drug and increases with dose. The risk is also higher in people taking other medicines that prolong the QT interval, as well as in people with congenital long QT syndrome, congestive heart failure, and/or bradyarrhythmias. As such, single doses of injectable ondansetron should not exceed 16 mg at one time. (Oral dosing recommendations remain intact, including the recommendation of a single 24-mg oral dose when indicated.) Electrolyte imbalances should be corrected before the use of injectable ondansetron. People are cautioned to seek immediate medical care if symptoms such as irregular heartbeat/palpitations, shortness of breath, dizziness, or fainting occur while taking ondansetron.[20]
No specific treatment is available for ondansetron overdose; people are managed with supportive measures. An antidote to ondansetron is not known.[14]
Ondansetron is a highly specific and selective serotonin 5-HT3 receptor antagonist, with low affinity for dopamine receptors. The 5-HT3 receptors are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema in the medulla. Serotonin is released by the enterochromaffin cells of the small intestine in response to chemotherapeutic agents and may stimulate vagal afferents (via 5-HT3 receptors) to initiate the vomiting reflex. It is thought that ondansetron’s antiemetic action is mediated mostly via antagonism of vagal afferents with a minor contribution from antagonism of central receptors.[21]
Ondansetron (marketed under the brand name Zofran) was developed in the mid-1980s by GlaxoSmithKline in London. It was granted US patent protection in September 1987,[22] received a use patent June 1988,[23] and was approved by the US FDA in January 1991. It was granted another divisional patent in November 1996.[24] Finally, owing to GlaxoSmithKline’s research on pediatric use, ondansetron’s patent protection was extended until December 2006.[25] By this final year of its patent (2006), Zofran had become the 20th highest-selling brand-name drug in the United States, with sales of US$1.3 billion in the first 9 months of 2006 (80% from the US).[26] The first generic versions were approved by the US FDA in December 2006, with marketing approval granted to Teva Pharmaceuticals USA and SICOR Pharmaceuticals.[27]
In 1997, ondansetron was the subject of a meta-analysis case study published in the British Medical Journal. Researchers examined 84 trials, with 11,980 people receiving ondansetron, published between 1991 and September 1996. Intravenous ondansetron 4 mg versus placebo was investigated in 16 reports and three further reports which had been duplicated a total of six times. The number needed to treat (NNT) to prevent vomiting within 24 hours was 9.5, with 95% confidence interval 6.9 to 15, in the 16 nonduplicated reports. In the three duplicated reports, the NNT was significantly lower at 3.9 (3.3 to 4.8). When all 25 reports were combined, the apparent NNT improved to 4.9 (4.4 to 5.6). Inclusion of duplicate reports led to a 23% overestimation of ondansetron’s antiemetic efficacy.[28]
In addition, the authors found the covert duplication of reports on ondansetron was not easy to detect, because of lack of cross-referencing between papers, and reports containing duplicate findings were cited in eight reviews of the drug.[28] Their analysis was a subject of an editorial in the Journal of the American Medical Association in 1999.[29]
Ondansetron is a generic drug and is available in many countries under many brand names.[30]
A 2006 double-blind, randomized controlled trial indicated ondansetron may have value in the treatment of schizophrenia, as an adjunct to haloperidol. The study found the combination to significantly improve negative schizophrenia symptoms, and people taking both drugs experienced fewer of the adverse effects commonly associated with haloperidol.[31] An earlier, smaller, open-label trial had found ondansetron to be useful in treating antipsychotic-induced tardive dyskinesia in people with schizophrenia, and the study patients also showed significant improvement in the disease’s symptoms.[32][33]
Early studies have also examined ondansetron as a possible treatment for psychosis resulting from advanced Parkinson’s disease.[34] Its apparent benefits despite a lack of any significant antagonistic properties at dopamine receptors or the 5-HT2A receptor raises interesting questions about the etiology of psychosis.
There is tentative evidence that it may be useful in decreasing the desired effects of alcohol.[35] There is also some tentative evidence in those who are addicted to stimulants.[36]
Two small, placebo-controlled trials have been conducted to assess the efficacy of ondansetron for postanesthetic shivering, a common occurrence after surgery. Ondansetron was found to be as effective as pethidine (meperidine, Demerol) when given as a single intravenous dose before anesthesia.[37]
Ondansetron, marketed under the brand name Zofran, is a medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, or surgery.[1] It is also useful in gastroenteritis.[2][3] It has little effect on vomiting caused by motion sickness.[4] It can be given by mouth, or by injection into a muscle or into a vein.[1]
Common side effects include diarrhea, constipation, headache, sleepiness, and itchiness.[1] Serious side effects include QT prolongation and severe allergic reaction.[1] It appears to be safe during pregnancy but has not been well studied in this group.[1] It is a serotonin 5-HT3 receptor antagonist.[1] It does not have any effect on dopamine receptors or muscarinic receptors.[5]
Ondansetron was patented in 1984 and approved for medical use in 1990.[6] It is on the World Health Organization’s List of Essential Medicines, the most effective and safe medicines needed in a health system.[7] It is available as a generic medication.[1] The wholesale cost of the injectable form in the developing world is about US$0.10 to US$0.76 per dose.[8] In the United States it costs about US$1.37 per tablet.[1] In 2016 it was the 91st most prescribed medication in the United States with more than 8 million prescriptions.[9]
Although an effective antiemetic agent, the high cost of brand-name ondansetron initially limited its use to controlling postoperative nausea and vomiting and chemotherapy-induced nausea and vomiting.[10]
The 5-HT3 receptor antagonists are the primary medications used to treat and prevent chemotherapy-induced nausea and vomiting and radiotherapy-induced nausea and vomiting.
قرص ondansetron چیست
A number of medications including ondansetron appear to be effective in controlling postoperative nausea and vomiting. It is more effective than metoclopramide, and less sedating than cyclizine or droperidol.
Ondansetron is used off-label to treat morning sickness and hyperemesis gravidarum of pregnancy. It is typically used after trials of other drugs have failed.[11]
There appears to be a low risk of harm to the baby with use during pregnancy, though there may be an increase in heart problems among the babies.[12][13]
Ondansetron is in pregnancy category B in the US.[14] It is not known if ondansetron is excreted in breast milk.[14]
Ondansetron is one of several antiemetic agents used during the vomiting phase of cyclic vomiting syndrome.[15]
Trials in emergency department settings support the use of ondansetron to reduce vomiting associated with gastroenteritis and dehydration.[16] A retrospective review found it was used commonly for this purpose, being administered in over 58% of cases. Its use reduced hospital admissions, but was also associated with higher rates of return visits to the emergency department. Furthermore, people who had initially received ondansetron were more likely to be admitted on the return visit than people who had not received the drug. However, this effect may simply be due to the agent being used more frequently in people who present with more severe illness. Its use was not found to mask serious diagnoses.[17]
Ondansetron has rarely been studied in people under 4 years of age. As such, little data is available to guide dosage recommendations.[14]
It is not necessary to adjust the dosage for people under 75 years of age. The use of ondansetron has not been studied in people older than 75 years of age, and it is not known if dosage should be adjusted for this group.[14]
The maximum recommended dose for people with severe liver function impairment is 8 mg/day. In these people, ondansetron is cleared from the body at half to one-third the rate as in healthy people. The concentration of ondansetron in body tissues as opposed to plasma is also higher than in healthy people.[14]
Headache is the most common adverse effect.[18] A review of use for post-operative nausea and vomiting found that for every 36 people treated, one would experience headache, which could be severe.[19]
Constipation, diarrhea, and dizziness are other commonly reported side effects.[1] It is broken down by the hepatic cytochrome P450 system and it has little effect on the metabolism of other drugs broken down by this system. Anecdotally, ototoxicity has also been reported if injected too quickly.[1]
Use of ondansetron has been associated with prolongation of the QT interval, which can lead to a potentially fatal heart rhythm known as torsades de pointes. Although this may happen in any person with any formulation, the risk is most salient with the injectable (intravenous) form of the drug and increases with dose. The risk is also higher in people taking other medicines that prolong the QT interval, as well as in people with congenital long QT syndrome, congestive heart failure, and/or bradyarrhythmias. As such, single doses of injectable ondansetron should not exceed 16 mg at one time. (Oral dosing recommendations remain intact, including the recommendation of a single 24-mg oral dose when indicated.) Electrolyte imbalances should be corrected before the use of injectable ondansetron. People are cautioned to seek immediate medical care if symptoms such as irregular heartbeat/palpitations, shortness of breath, dizziness, or fainting occur while taking ondansetron.[20]
No specific treatment is available for ondansetron overdose; people are managed with supportive measures. An antidote to ondansetron is not known.[14]
Ondansetron is a highly specific and selective serotonin 5-HT3 receptor antagonist, with low affinity for dopamine receptors. The 5-HT3 receptors are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema in the medulla. Serotonin is released by the enterochromaffin cells of the small intestine in response to chemotherapeutic agents and may stimulate vagal afferents (via 5-HT3 receptors) to initiate the vomiting reflex. It is thought that ondansetron’s antiemetic action is mediated mostly via antagonism of vagal afferents with a minor contribution from antagonism of central receptors.[21]
Ondansetron (marketed under the brand name Zofran) was developed in the mid-1980s by GlaxoSmithKline in London. It was granted US patent protection in September 1987,[22] received a use patent June 1988,[23] and was approved by the US FDA in January 1991. It was granted another divisional patent in November 1996.[24] Finally, owing to GlaxoSmithKline’s research on pediatric use, ondansetron’s patent protection was extended until December 2006.[25] By this final year of its patent (2006), Zofran had become the 20th highest-selling brand-name drug in the United States, with sales of US$1.3 billion in the first 9 months of 2006 (80% from the US).[26] The first generic versions were approved by the US FDA in December 2006, with marketing approval granted to Teva Pharmaceuticals USA and SICOR Pharmaceuticals.[27]
In 1997, ondansetron was the subject of a meta-analysis case study published in the British Medical Journal. Researchers examined 84 trials, with 11,980 people receiving ondansetron, published between 1991 and September 1996. Intravenous ondansetron 4 mg versus placebo was investigated in 16 reports and three further reports which had been duplicated a total of six times. The number needed to treat (NNT) to prevent vomiting within 24 hours was 9.5, with 95% confidence interval 6.9 to 15, in the 16 nonduplicated reports. In the three duplicated reports, the NNT was significantly lower at 3.9 (3.3 to 4.8). When all 25 reports were combined, the apparent NNT improved to 4.9 (4.4 to 5.6). Inclusion of duplicate reports led to a 23% overestimation of ondansetron’s antiemetic efficacy.[28]
In addition, the authors found the covert duplication of reports on ondansetron was not easy to detect, because of lack of cross-referencing between papers, and reports containing duplicate findings were cited in eight reviews of the drug.[28] Their analysis was a subject of an editorial in the Journal of the American Medical Association in 1999.[29]
Ondansetron is a generic drug and is available in many countries under many brand names.[30]
A 2006 double-blind, randomized controlled trial indicated ondansetron may have value in the treatment of schizophrenia, as an adjunct to haloperidol. The study found the combination to significantly improve negative schizophrenia symptoms, and people taking both drugs experienced fewer of the adverse effects commonly associated with haloperidol.[31] An earlier, smaller, open-label trial had found ondansetron to be useful in treating antipsychotic-induced tardive dyskinesia in people with schizophrenia, and the study patients also showed significant improvement in the disease’s symptoms.[32][33]
Early studies have also examined ondansetron as a possible treatment for psychosis resulting from advanced Parkinson’s disease.[34] Its apparent benefits despite a lack of any significant antagonistic properties at dopamine receptors or the 5-HT2A receptor raises interesting questions about the etiology of psychosis.
There is tentative evidence that it may be useful in decreasing the desired effects of alcohol.[35] There is also some tentative evidence in those who are addicted to stimulants.[36]
Two small, placebo-controlled trials have been conducted to assess the efficacy of ondansetron for postanesthetic shivering, a common occurrence after surgery. Ondansetron was found to be as effective as pethidine (meperidine, Demerol) when given as a single intravenous dose before anesthesia.[37]
Ondansetron, marketed under the brand name Zofran, is a medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, or surgery.[1] It is also useful in gastroenteritis.[2][3] It has little effect on vomiting caused by motion sickness.[4] It can be given by mouth, or by injection into a muscle or into a vein.[1]
Common side effects include diarrhea, constipation, headache, sleepiness, and itchiness.[1] Serious side effects include QT prolongation and severe allergic reaction.[1] It appears to be safe during pregnancy but has not been well studied in this group.[1] It is a serotonin 5-HT3 receptor antagonist.[1] It does not have any effect on dopamine receptors or muscarinic receptors.[5]
Ondansetron was patented in 1984 and approved for medical use in 1990.[6] It is on the World Health Organization’s List of Essential Medicines, the most effective and safe medicines needed in a health system.[7] It is available as a generic medication.[1] The wholesale cost of the injectable form in the developing world is about US$0.10 to US$0.76 per dose.[8] In the United States it costs about US$1.37 per tablet.[1] In 2016 it was the 91st most prescribed medication in the United States with more than 8 million prescriptions.[9]
Although an effective antiemetic agent, the high cost of brand-name ondansetron initially limited its use to controlling postoperative nausea and vomiting and chemotherapy-induced nausea and vomiting.[10]
The 5-HT3 receptor antagonists are the primary medications used to treat and prevent chemotherapy-induced nausea and vomiting and radiotherapy-induced nausea and vomiting.
قرص ondansetron چیست
A number of medications including ondansetron appear to be effective in controlling postoperative nausea and vomiting. It is more effective than metoclopramide, and less sedating than cyclizine or droperidol.
Ondansetron is used off-label to treat morning sickness and hyperemesis gravidarum of pregnancy. It is typically used after trials of other drugs have failed.[11]
There appears to be a low risk of harm to the baby with use during pregnancy, though there may be an increase in heart problems among the babies.[12][13]
Ondansetron is in pregnancy category B in the US.[14] It is not known if ondansetron is excreted in breast milk.[14]
Ondansetron is one of several antiemetic agents used during the vomiting phase of cyclic vomiting syndrome.[15]
Trials in emergency department settings support the use of ondansetron to reduce vomiting associated with gastroenteritis and dehydration.[16] A retrospective review found it was used commonly for this purpose, being administered in over 58% of cases. Its use reduced hospital admissions, but was also associated with higher rates of return visits to the emergency department. Furthermore, people who had initially received ondansetron were more likely to be admitted on the return visit than people who had not received the drug. However, this effect may simply be due to the agent being used more frequently in people who present with more severe illness. Its use was not found to mask serious diagnoses.[17]
Ondansetron has rarely been studied in people under 4 years of age. As such, little data is available to guide dosage recommendations.[14]
It is not necessary to adjust the dosage for people under 75 years of age. The use of ondansetron has not been studied in people older than 75 years of age, and it is not known if dosage should be adjusted for this group.[14]
The maximum recommended dose for people with severe liver function impairment is 8 mg/day. In these people, ondansetron is cleared from the body at half to one-third the rate as in healthy people. The concentration of ondansetron in body tissues as opposed to plasma is also higher than in healthy people.[14]
Headache is the most common adverse effect.[18] A review of use for post-operative nausea and vomiting found that for every 36 people treated, one would experience headache, which could be severe.[19]
Constipation, diarrhea, and dizziness are other commonly reported side effects.[1] It is broken down by the hepatic cytochrome P450 system and it has little effect on the metabolism of other drugs broken down by this system. Anecdotally, ototoxicity has also been reported if injected too quickly.[1]
Use of ondansetron has been associated with prolongation of the QT interval, which can lead to a potentially fatal heart rhythm known as torsades de pointes. Although this may happen in any person with any formulation, the risk is most salient with the injectable (intravenous) form of the drug and increases with dose. The risk is also higher in people taking other medicines that prolong the QT interval, as well as in people with congenital long QT syndrome, congestive heart failure, and/or bradyarrhythmias. As such, single doses of injectable ondansetron should not exceed 16 mg at one time. (Oral dosing recommendations remain intact, including the recommendation of a single 24-mg oral dose when indicated.) Electrolyte imbalances should be corrected before the use of injectable ondansetron. People are cautioned to seek immediate medical care if symptoms such as irregular heartbeat/palpitations, shortness of breath, dizziness, or fainting occur while taking ondansetron.[20]
No specific treatment is available for ondansetron overdose; people are managed with supportive measures. An antidote to ondansetron is not known.[14]
Ondansetron is a highly specific and selective serotonin 5-HT3 receptor antagonist, with low affinity for dopamine receptors. The 5-HT3 receptors are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema in the medulla. Serotonin is released by the enterochromaffin cells of the small intestine in response to chemotherapeutic agents and may stimulate vagal afferents (via 5-HT3 receptors) to initiate the vomiting reflex. It is thought that ondansetron’s antiemetic action is mediated mostly via antagonism of vagal afferents with a minor contribution from antagonism of central receptors.[21]
Ondansetron (marketed under the brand name Zofran) was developed in the mid-1980s by GlaxoSmithKline in London. It was granted US patent protection in September 1987,[22] received a use patent June 1988,[23] and was approved by the US FDA in January 1991. It was granted another divisional patent in November 1996.[24] Finally, owing to GlaxoSmithKline’s research on pediatric use, ondansetron’s patent protection was extended until December 2006.[25] By this final year of its patent (2006), Zofran had become the 20th highest-selling brand-name drug in the United States, with sales of US$1.3 billion in the first 9 months of 2006 (80% from the US).[26] The first generic versions were approved by the US FDA in December 2006, with marketing approval granted to Teva Pharmaceuticals USA and SICOR Pharmaceuticals.[27]
In 1997, ondansetron was the subject of a meta-analysis case study published in the British Medical Journal. Researchers examined 84 trials, with 11,980 people receiving ondansetron, published between 1991 and September 1996. Intravenous ondansetron 4 mg versus placebo was investigated in 16 reports and three further reports which had been duplicated a total of six times. The number needed to treat (NNT) to prevent vomiting within 24 hours was 9.5, with 95% confidence interval 6.9 to 15, in the 16 nonduplicated reports. In the three duplicated reports, the NNT was significantly lower at 3.9 (3.3 to 4.8). When all 25 reports were combined, the apparent NNT improved to 4.9 (4.4 to 5.6). Inclusion of duplicate reports led to a 23% overestimation of ondansetron’s antiemetic efficacy.[28]
In addition, the authors found the covert duplication of reports on ondansetron was not easy to detect, because of lack of cross-referencing between papers, and reports containing duplicate findings were cited in eight reviews of the drug.[28] Their analysis was a subject of an editorial in the Journal of the American Medical Association in 1999.[29]
Ondansetron is a generic drug and is available in many countries under many brand names.[30]
A 2006 double-blind, randomized controlled trial indicated ondansetron may have value in the treatment of schizophrenia, as an adjunct to haloperidol. The study found the combination to significantly improve negative schizophrenia symptoms, and people taking both drugs experienced fewer of the adverse effects commonly associated with haloperidol.[31] An earlier, smaller, open-label trial had found ondansetron to be useful in treating antipsychotic-induced tardive dyskinesia in people with schizophrenia, and the study patients also showed significant improvement in the disease’s symptoms.[32][33]
Early studies have also examined ondansetron as a possible treatment for psychosis resulting from advanced Parkinson’s disease.[34] Its apparent benefits despite a lack of any significant antagonistic properties at dopamine receptors or the 5-HT2A receptor raises interesting questions about the etiology of psychosis.
There is tentative evidence that it may be useful in decreasing the desired effects of alcohol.[35] There is also some tentative evidence in those who are addicted to stimulants.[36]
Two small, placebo-controlled trials have been conducted to assess the efficacy of ondansetron for postanesthetic shivering, a common occurrence after surgery. Ondansetron was found to be as effective as pethidine (meperidine, Demerol) when given as a single intravenous dose before anesthesia.[37]
Ondansetron, marketed under the brand name Zofran, is a medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, or surgery.[1] It is also useful in gastroenteritis.[2][3] It has little effect on vomiting caused by motion sickness.[4] It can be given by mouth, or by injection into a muscle or into a vein.[1]
Common side effects include diarrhea, constipation, headache, sleepiness, and itchiness.[1] Serious side effects include QT prolongation and severe allergic reaction.[1] It appears to be safe during pregnancy but has not been well studied in this group.[1] It is a serotonin 5-HT3 receptor antagonist.[1] It does not have any effect on dopamine receptors or muscarinic receptors.[5]
Ondansetron was patented in 1984 and approved for medical use in 1990.[6] It is on the World Health Organization’s List of Essential Medicines, the most effective and safe medicines needed in a health system.[7] It is available as a generic medication.[1] The wholesale cost of the injectable form in the developing world is about US$0.10 to US$0.76 per dose.[8] In the United States it costs about US$1.37 per tablet.[1] In 2016 it was the 91st most prescribed medication in the United States with more than 8 million prescriptions.[9]
Although an effective antiemetic agent, the high cost of brand-name ondansetron initially limited its use to controlling postoperative nausea and vomiting and chemotherapy-induced nausea and vomiting.[10]
The 5-HT3 receptor antagonists are the primary medications used to treat and prevent chemotherapy-induced nausea and vomiting and radiotherapy-induced nausea and vomiting.
قرص ondansetron چیست
A number of medications including ondansetron appear to be effective in controlling postoperative nausea and vomiting. It is more effective than metoclopramide, and less sedating than cyclizine or droperidol.
Ondansetron is used off-label to treat morning sickness and hyperemesis gravidarum of pregnancy. It is typically used after trials of other drugs have failed.[11]
There appears to be a low risk of harm to the baby with use during pregnancy, though there may be an increase in heart problems among the babies.[12][13]
Ondansetron is in pregnancy category B in the US.[14] It is not known if ondansetron is excreted in breast milk.[14]
Ondansetron is one of several antiemetic agents used during the vomiting phase of cyclic vomiting syndrome.[15]
Trials in emergency department settings support the use of ondansetron to reduce vomiting associated with gastroenteritis and dehydration.[16] A retrospective review found it was used commonly for this purpose, being administered in over 58% of cases. Its use reduced hospital admissions, but was also associated with higher rates of return visits to the emergency department. Furthermore, people who had initially received ondansetron were more likely to be admitted on the return visit than people who had not received the drug. However, this effect may simply be due to the agent being used more frequently in people who present with more severe illness. Its use was not found to mask serious diagnoses.[17]
Ondansetron has rarely been studied in people under 4 years of age. As such, little data is available to guide dosage recommendations.[14]
It is not necessary to adjust the dosage for people under 75 years of age. The use of ondansetron has not been studied in people older than 75 years of age, and it is not known if dosage should be adjusted for this group.[14]
The maximum recommended dose for people with severe liver function impairment is 8 mg/day. In these people, ondansetron is cleared from the body at half to one-third the rate as in healthy people. The concentration of ondansetron in body tissues as opposed to plasma is also higher than in healthy people.[14]
Headache is the most common adverse effect.[18] A review of use for post-operative nausea and vomiting found that for every 36 people treated, one would experience headache, which could be severe.[19]
Constipation, diarrhea, and dizziness are other commonly reported side effects.[1] It is broken down by the hepatic cytochrome P450 system and it has little effect on the metabolism of other drugs broken down by this system. Anecdotally, ototoxicity has also been reported if injected too quickly.[1]
Use of ondansetron has been associated with prolongation of the QT interval, which can lead to a potentially fatal heart rhythm known as torsades de pointes. Although this may happen in any person with any formulation, the risk is most salient with the injectable (intravenous) form of the drug and increases with dose. The risk is also higher in people taking other medicines that prolong the QT interval, as well as in people with congenital long QT syndrome, congestive heart failure, and/or bradyarrhythmias. As such, single doses of injectable ondansetron should not exceed 16 mg at one time. (Oral dosing recommendations remain intact, including the recommendation of a single 24-mg oral dose when indicated.) Electrolyte imbalances should be corrected before the use of injectable ondansetron. People are cautioned to seek immediate medical care if symptoms such as irregular heartbeat/palpitations, shortness of breath, dizziness, or fainting occur while taking ondansetron.[20]
No specific treatment is available for ondansetron overdose; people are managed with supportive measures. An antidote to ondansetron is not known.[14]
Ondansetron is a highly specific and selective serotonin 5-HT3 receptor antagonist, with low affinity for dopamine receptors. The 5-HT3 receptors are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema in the medulla. Serotonin is released by the enterochromaffin cells of the small intestine in response to chemotherapeutic agents and may stimulate vagal afferents (via 5-HT3 receptors) to initiate the vomiting reflex. It is thought that ondansetron’s antiemetic action is mediated mostly via antagonism of vagal afferents with a minor contribution from antagonism of central receptors.[21]
Ondansetron (marketed under the brand name Zofran) was developed in the mid-1980s by GlaxoSmithKline in London. It was granted US patent protection in September 1987,[22] received a use patent June 1988,[23] and was approved by the US FDA in January 1991. It was granted another divisional patent in November 1996.[24] Finally, owing to GlaxoSmithKline’s research on pediatric use, ondansetron’s patent protection was extended until December 2006.[25] By this final year of its patent (2006), Zofran had become the 20th highest-selling brand-name drug in the United States, with sales of US$1.3 billion in the first 9 months of 2006 (80% from the US).[26] The first generic versions were approved by the US FDA in December 2006, with marketing approval granted to Teva Pharmaceuticals USA and SICOR Pharmaceuticals.[27]
In 1997, ondansetron was the subject of a meta-analysis case study published in the British Medical Journal. Researchers examined 84 trials, with 11,980 people receiving ondansetron, published between 1991 and September 1996. Intravenous ondansetron 4 mg versus placebo was investigated in 16 reports and three further reports which had been duplicated a total of six times. The number needed to treat (NNT) to prevent vomiting within 24 hours was 9.5, with 95% confidence interval 6.9 to 15, in the 16 nonduplicated reports. In the three duplicated reports, the NNT was significantly lower at 3.9 (3.3 to 4.8). When all 25 reports were combined, the apparent NNT improved to 4.9 (4.4 to 5.6). Inclusion of duplicate reports led to a 23% overestimation of ondansetron’s antiemetic efficacy.[28]
In addition, the authors found the covert duplication of reports on ondansetron was not easy to detect, because of lack of cross-referencing between papers, and reports containing duplicate findings were cited in eight reviews of the drug.[28] Their analysis was a subject of an editorial in the Journal of the American Medical Association in 1999.[29]
Ondansetron is a generic drug and is available in many countries under many brand names.[30]
A 2006 double-blind, randomized controlled trial indicated ondansetron may have value in the treatment of schizophrenia, as an adjunct to haloperidol. The study found the combination to significantly improve negative schizophrenia symptoms, and people taking both drugs experienced fewer of the adverse effects commonly associated with haloperidol.[31] An earlier, smaller, open-label trial had found ondansetron to be useful in treating antipsychotic-induced tardive dyskinesia in people with schizophrenia, and the study patients also showed significant improvement in the disease’s symptoms.[32][33]
Early studies have also examined ondansetron as a possible treatment for psychosis resulting from advanced Parkinson’s disease.[34] Its apparent benefits despite a lack of any significant antagonistic properties at dopamine receptors or the 5-HT2A receptor raises interesting questions about the etiology of psychosis.
There is tentative evidence that it may be useful in decreasing the desired effects of alcohol.[35] There is also some tentative evidence in those who are addicted to stimulants.[36]
Two small, placebo-controlled trials have been conducted to assess the efficacy of ondansetron for postanesthetic shivering, a common occurrence after surgery. Ondansetron was found to be as effective as pethidine (meperidine, Demerol) when given as a single intravenous dose before anesthesia.[37]
The pregnancy category of a medication is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites in breast milk.
Every drug has specific information listed in its product literature. The British National Formulary used to provide a table of drugs to be avoided or used with caution in pregnancy, and did so using a limited number of key phrases, but now Appendix 4 (which was the Pregnancy table) has been removed. Appendix 4 is now titled “Intravenous Additives”.[1] However, information that was previously available in the former Appendix 4 (pregnancy) and Appendix 5 (breast feeding) is now available in the individual drug monographs.[2]
American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a “pregnancy category”. These rules are enforced by the Food and Drug Administration.
To supplement this information, FDA publishes additional rules regarding pregnancy and lactation labeling.[3]
The FDA does not regulate labeling for all hazardous and non-hazardous substances. Many substances, including alcohol, are widely known to cause serious hazards to pregnant women and their fetus, including fetal alcohol syndrome. Many other pollutants and hazardous materials are similarly known to cause reproductive harm. However, some of these substances are not subject to drug labeling laws, and are therefore not assigned a “Pregnancy Category” per 21 CFR 201.57.
قرص ondansetron چیست
One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high-quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be considered Pregnancy Category A in other countries are allocated to Category C by the FDA.
On December 13, 2014, the FDA published the Pregnancy and Lactation Labeling Final Rule (PLLR), which changed the labeling requirements for the pregnancy and lactation sections for prescription drugs and biological agents.[3] The final rule removed the pregnancy letter categories, and created descriptive subsections for pregnancy exposure and risk, lactation, and effects to reproductive potential for females and males. Labeling changes from this rule began on June 30, 2015, with all submissions for prescription drugs and biological agents using the labeling changes immediately. Previously approved drugs from June 30, 2001 will switch to the new labeling gradually. The rule does not affect the labeling of over-the-counter drugs.
Australia has a slightly different pregnancy category system[4] from the United States – notably the subdivision of Category B. (For drugs in B1, B2 and B3 categories, human data are lacking or inadequate. Subcategorisation is based on animal data, and allocation of a B category does not imply greater safety than C category).[5] The system, as outlined below, was developed by medical and scientific experts based on available evidence of risks associated with taking particular medicines while pregnant. Being general in nature it is not presented as medical advice to health professionals or the public.
Some prescribing guides, such as the Australian Medicines Handbook, are shifting away from using pregnancy categories since, inherent in these categories, there is an implied assumption that the alphabetical code is one of safety when this is not always the case. Categorisation does not indicate which stages of fetal development might be affected and does not convey information about the balance between risks and benefits in a particular situation. Additionally, categories are not necessarily maintained or updated with availability of new data.[6]
The data presented is for comparative and illustrative purposes only, and may have been superseded by updated data.
The pregnancy category of a medication is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites in breast milk.
Every drug has specific information listed in its product literature. The British National Formulary used to provide a table of drugs to be avoided or used with caution in pregnancy, and did so using a limited number of key phrases, but now Appendix 4 (which was the Pregnancy table) has been removed. Appendix 4 is now titled “Intravenous Additives”.[1] However, information that was previously available in the former Appendix 4 (pregnancy) and Appendix 5 (breast feeding) is now available in the individual drug monographs.[2]
American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a “pregnancy category”. These rules are enforced by the Food and Drug Administration.
To supplement this information, FDA publishes additional rules regarding pregnancy and lactation labeling.[3]
The FDA does not regulate labeling for all hazardous and non-hazardous substances. Many substances, including alcohol, are widely known to cause serious hazards to pregnant women and their fetus, including fetal alcohol syndrome. Many other pollutants and hazardous materials are similarly known to cause reproductive harm. However, some of these substances are not subject to drug labeling laws, and are therefore not assigned a “Pregnancy Category” per 21 CFR 201.57.
قرص ondansetron چیست
One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high-quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be considered Pregnancy Category A in other countries are allocated to Category C by the FDA.
On December 13, 2014, the FDA published the Pregnancy and Lactation Labeling Final Rule (PLLR), which changed the labeling requirements for the pregnancy and lactation sections for prescription drugs and biological agents.[3] The final rule removed the pregnancy letter categories, and created descriptive subsections for pregnancy exposure and risk, lactation, and effects to reproductive potential for females and males. Labeling changes from this rule began on June 30, 2015, with all submissions for prescription drugs and biological agents using the labeling changes immediately. Previously approved drugs from June 30, 2001 will switch to the new labeling gradually. The rule does not affect the labeling of over-the-counter drugs.
Australia has a slightly different pregnancy category system[4] from the United States – notably the subdivision of Category B. (For drugs in B1, B2 and B3 categories, human data are lacking or inadequate. Subcategorisation is based on animal data, and allocation of a B category does not imply greater safety than C category).[5] The system, as outlined below, was developed by medical and scientific experts based on available evidence of risks associated with taking particular medicines while pregnant. Being general in nature it is not presented as medical advice to health professionals or the public.
Some prescribing guides, such as the Australian Medicines Handbook, are shifting away from using pregnancy categories since, inherent in these categories, there is an implied assumption that the alphabetical code is one of safety when this is not always the case. Categorisation does not indicate which stages of fetal development might be affected and does not convey information about the balance between risks and benefits in a particular situation. Additionally, categories are not necessarily maintained or updated with availability of new data.[6]
The data presented is for comparative and illustrative purposes only, and may have been superseded by updated data.
A suppository is a solid dosage form that is inserted into the rectum (rectal suppository), vagina (vaginal suppository), or urethra (urethral suppository), where it dissolves or melts and exerts local or systemic effects. Suppositories are used to deliver medications that act both systemically and locally.
Several different ingredients can be used to form the base of a suppository: cocoa butter or a similar substitute, polyethylene glycol, hydrogels, and glycerinated gelatin. The type of material used depends on the type of suppository, the type of drug, and the conditions in which the suppository will be stored.[1]
In 1991, Abd-El-Maeboud and his colleagues conducted a study on suppository insertion in The Lancet,[2] explaining that the “torpedo” shape helps the device to travel internally, increasing its efficacy. The findings of this single study have been challenged as there is insufficient evidence on which to base clinical practice.[3]
Alprostadil pellets are urethral suppositories used for the treatment of severe erectile dysfunction. They are marketed under the name Muse in the United States of America.[4] Its use has diminished since the development of oral impotence medications.
Intravenous therapy (IV) is a therapy that delivers liquid substances directly into a vein (intra- + ven- + -ous). The intravenous route of administration can be used for injections (with a syringe at higher pressures) or infusions (typically using only the pressure supplied by gravity). Intravenous infusions are commonly referred to as drips. The intravenous route is the fastest way to deliver medications and fluid replacement throughout the body, because the circulation carries them. Intravenous therapy may be used for fluid replacement (such as correcting dehydration), to correct electrolyte imbalances, to deliver medications, and for blood transfusions.
Intravenous systems can be categorized by which type of vein the inserted tube, called the catheter, empties into.
A peripheral intravenous (PIV) line is used on peripheral veins (the veins in the arms, hands, legs and feet). This is the most common type of IV therapy used.
Central IV lines have their catheters that are advanced through a vein and empty into a large central vein (a vein within the torso), usually the superior vena cava, inferior vena cava or even the right atrium of the heart.
Indications for a central line over the more common peripheral IV line commonly includes poor peripheral venous access for a PIV. Another common indication is when patients would require infusions over a prolonged period of time, such as antibiotic therapy over a few weeks for osteomyelitis. Another indication is when the substances to be administered could irritate the blood vessel lining such as total parenteral nutrition, whose high glucose content can damage blood vessels, and some chemotherapy regimens. There is less damage to the blood vessels because central veins have a larger diameter than peripheral veins, have faster blood flow, and would get diluted as it is quickly distributed to the rest of the body. Vasopressors (such as norepinephrine, vasopressin, epinephrine, phenylephrine, among others) are typically infused through central lines to minimize the risk of extravasation.
قرص ondansetron چیست
Other advantages are that multiple medications can be delivered at once, even if they would not be chemically compatible within a single tube as there is room for multiple parallel compartments (lumina) within the catheter. It is commonly believed that fluid can be pushed faster through a central line; however, the diameter of each lumen is often smaller than that of a large-bore peripheral cannula. Caregivers can also measure central venous pressure and other physiological variables through the central line. They are also longer and, as reflected by Poiseuille’s law, require higher pressure to achieve the same flow, all other variables being equal.
Central IV lines carry risks of bleeding, infection, gangrene, thromboembolism and gas embolism (see Risks below). They are often more difficult to insert correctly as the veins are not usually palpable and rely on an experienced clinician knowing the appropriate landmarks and/or using an ultrasound probe to safely locate and enter the vein. Surrounding structures such as the pleura and carotid artery are also at risk of damage with the potential for pneumothorax or even cannulation of the artery.
There are several types of central IV access, depending on the route that the catheter takes from the outside of the body to the vein.
The PICC line is inserted through a sheath into a peripheral vein sometimes using the Seldinger technique or modified Seldinger technique, under ultrasound guidance, usually in the arm, and then carefully advanced upward until the catheter is in the superior vena cava or the right atrium. This is usually done by measuring the distance to an external landmark, such as the suprasternal notch, to estimate the optimal length. An X-ray must be used to verify that the tip is in the right place when fluoroscopy was not used during the insertion. More modern technology utilizes EKG technology to determine when the tip is in the correct location.
A PICC may have a single (single-lumen) tube and connector, two (double-lumen) or three (triple-lumen) compartments, each with its own external connector. Power-injectable PICCs are now available as well. From the outside, a single-lumen PICC resembles a peripheral IV line, except that the tubing is slightly wider.
The insertion site requires better protection than that of a peripheral IV line, due to the higher risk of serious infection if bacteria travel up the catheter. However, a PICC poses less of a systemic infection risk than other central IV lines, because the insertion site is usually cooler and drier than the sites typically used for other central lines. This helps to slow the growth of bacteria which could reach the bloodstream by traveling under the skin along the outside of the catheter.
The chief advantage of a PICC over other types of central lines is that it is safer to insert with a relatively low risk of uncontrollable bleeding and essentially no risks of damage to the lungs or major blood vessels. Although special training is required, a PICC does not require the skill level of a physician or surgeon. It is also externally unobtrusive, and with proper hygiene and care can be left in place for months to years if needed for patients who require extended treatment.
The chief disadvantage is that it must be inserted and then travel through a relatively small peripheral vein which can take a less predictable course on the way to the superior vena cava and is therefore somewhat more time consuming and more technically difficult to place in some patients. As a PICC travels through the axilla, it can also become kinked, causing poor function.
While some central lines have their catheter pass through the skin and then directly into the vein, other central lines called “tunneled catheters” insert through the skin and then pass or “tunnel” a significant distance before inserting into the vein. This reduces the risk of infection, since bacteria from the skin surface are not able to travel directly into the vein. These catheters are often made of materials that resist infection and clotting. These include the Hickman line or Broviac catheter.
A port (often referred to by brand names such as Port-a-Cath or MediPort) is a central venous line that does not have an external connector; instead, it has a small reservoir that is covered with silicone rubber and is implanted under the skin. Medication is administered intermittently by placing a small needle through the skin, piercing the silicone, into the reservoir. When the needle is withdrawn, the reservoir cover reseals itself. The cover can accept hundreds of needle sticks during its lifetime. It is possible to leave the ports in the patient’s body for years; if this is done, the port must be accessed monthly and flushed with an anti-coagulant, or the patient risks it getting plugged up. If it is plugged, it becomes a hazard as a thrombus will eventually form with an accompanying risk of embolisation. Removal of a port is usually a simple outpatient procedure; however, installation is more complex and a good implant is fairly dependent on the skill of the radiologist. Ports cause less inconvenience and have a lower risk of infection than PICCs, and are therefore commonly used for patients on long-term intermittent treatment.
A third type is a midline catheter which is inserted into a peripheral vein and advances through the vein, similar to a peripheral IV line, but falls short of emptying into a central vein.
A continuous infusion is primarily used to correct fluid and electrolyte imbalances. This is as opposed to intermittent infusion, when a patient requires medications only at certain times, such as secondary IV and IV push.
The tubing from the bag of fluid being administered that connects to directly to the patient is called the primary tubing. Any additional IVs to be administered are connected to the primary tubing and are called secondary IV, or IV piggyback;[1] this is done instead of placing multiple catheters in the patient. When administering a secondary IV medication, the primary bag is held lower than the secondary bag so that the secondary medication can flow into the primary tubing, rather than fluid from the primary bag flowing into the secondary tubing. The fluid from the primary bag is needed to help flush any remaining medication from the secondary IV from the tubing into the patient.
Some medications are also given by IV “push” or bolus. A syringe containing the medication is connected to an access port in the primary tubing and the medication is administered through the port. The syringe plunger is pressed slowly, if it might irritate the vein or cause a too-rapid effect. Certain medications, such as potassium, are never to be administered by IV push because the spike in medication in the blood from the IV push could be fatal. Once a medicine has been injected into the fluid stream of the IV tubing, there must be some means of ensuring that it gets from the tubing to the patient. Usually this is accomplished by allowing the fluid stream to flow normally and thereby carry the medicine into the bloodstream; however, a second fluid injection is sometimes used, a “flush”, following the injection to push the medicine into the bloodstream more quickly.
Substances that may be infused intravenously include volume expanders, blood-based products, blood substitutes, medications and nutrition.
There are two main types of volume expander: crystalloids and colloids. Crystalloids are aqueous solutions of mineral salts or other water-soluble molecules. Colloids contain larger insoluble molecules, such as gelatin. Blood is a colloid.
The best way to determine if a person will benefit from fluids is by doing a passive leg raise followed by measuring the output from the heart.[4]
Medications may be mixed into the fluids mentioned above. Compared with other routes of administration, such as oral medications, the intravenous route is the fastest way to deliver fluids and medications throughout the body. The bioavailability of the IV medication is 100%, unlike oral medications where much of the medication is lost in digestion before entering circulation. Certain types of medications can only be given intravenously, such as when there is insufficient uptake by other routes of administration such as enterally. Examples include intravenous immunoglobulin and propofol.
A blood product (or blood-based product) is any component of blood which is collected from a donor for use in a blood transfusion. Blood transfusions can be life-saving in some situations, such as massive blood loss due to trauma, or can be used to replace blood lost during surgery. Blood transfusions may also be used to treat a severe anaemia or thrombocytopenia caused by a blood disease. People with hemophilia usually need a replacement of clotting factor, which is a small part of whole blood. People with sickle-cell disease may require frequent blood transfusions. Early blood transfusions consisted of whole blood, but modern medical practice commonly uses only components of the blood, such as fresh frozen plasma or cryoprecipitate.
Blood substitutes (also called ‘artificial blood’ or ‘blood surrogates’) are artificial substances aiming to provide an alternative to blood-based products acquired from donors. The main blood substitutes used today are volume expanders such as crystalloids and colloids mentioned above. Also, ‘oxygen-carrying substitutes’ are emerging.
Buffer solutions are used to correct acidosis or alkalosis. Lactated Ringer’s solution also has some buffering effect. A solution more specifically used for buffering purpose is intravenous sodium bicarbonate.
Parenteral nutrition is feeding a person intravenously, bypassing the usual process of eating and digestion. The person receives nutritional formulas containing salts, glucose, amino acids, lipids and added vitamins.
A standard IV infusion set consists of a pre-filled, sterile container (glass bottle, plastic bottle or plastic bag) of fluids with an attachment that allows the fluid to flow one drop at a time, making it easy to see the flow rate (and also reducing air bubbles); a long sterile tube with a clamp to regulate or stop the flow; a connector to attach to the access device; and Y-sets to allow “piggybacking” of another infusion set onto the same line, e.g., adding a dose of antibiotics to a continuous fluid drip.
An infusion pump allows precise control over the flow rate and total amount delivered.
The volume to be infused (VTBI) of the mainline IV bag is usually programmed for about 50 milliliters less than the stated volume of that IV bag to avoid letting the IV line or tubing run dry. The VTBI for a secondary bag or piggybag should usually be programmed for 30 to 50 milliliters more than is stated to be in that medication IV bag, to make sure that in addition to the bag being emptied, the entire medication dose is flushed through the IV tubing from the mainline bag. Because of its design, the short, secondary IV line cannot run dry. Thus, the registered nurse programs the IV pump for a 50 milliliter bag of IV antibiotics volume to be infused (VTBI) for at least 80 milliliters. The 100 milliliter bag of antibiotics usually needs a VTBI of about 140 milliliters.
In cases where a change in the flow rate would not have serious consequences, or if pumps are not available, the drip is often left to flow simply by placing the bag above the level of the patient and using the clamp to regulate the rate; this is a gravity drip.
The simplest form of intravenous access is by passing a hollow needle through the skin directly into the vein. This needle can be connected directly to a syringe (used either to withdraw blood or deliver its contents into the bloodstream) or may be connected to a length of tubing and thence whichever collection or infusion system is desired.
The most convenient site is often the arm, especially the veins on the back of the hand, or the median cubital vein at the elbow, but any identifiable vein can be used. Often it is necessary to use a tourniquet which restricts the venous drainage of the limb and makes the vein bulge. Once the needle is in place, it is common to draw back slightly on the syringe to aspirate blood, thus verifying that the needle is really in a vein. The tourniquet should be removed before injecting to prevent extravasation of the medication.
Many systems of administration employ a drip chamber, which prevents air from entering the blood stream (air embolism), and allows an estimation of flow rate.
A peripheral cannula is the most common intravenous access method utilized in both hospitals and pre-hospital services. A peripheral IV line (PVC or PIV) consists of a short catheter (a few centimeters long) inserted through the skin into a peripheral vein (any vein not situated in the chest or abdomen). This is usually in the form of a cannula-over-needle device, in which a flexible plastic cannula comes mounted over a metal trocar. Once the tip of the needle and cannula are introduced into the vein via venipuncture, the cannula is advanced inside the vein over the trocar to the appropriate position and secured, the trocar is then withdrawn and discarded. Blood samples may be drawn directly after the initial IV cannula insertion.
Any accessible vein can be used although arm and hand veins are used most commonly, with leg and foot veins used to a much lesser extent. In infants, the scalp veins are sometimes used.
The caliber of needles and catheters can be given in Birmingham gauge or French gauge. A Birmingham gauge of 14 is a very large cannula (used in resuscitation settings) and 24-26 is the smallest. The most common sizes are 16-gauge (midsize line used for blood donation and transfusion), 18- and 20-gauge (all-purpose line for infusions and blood draws), and 22-gauge (all-purpose pediatric line). 12- and 14-gauge peripheral lines are capable of delivering large volumes of fluid very fast, accounting for their popularity in emergency medicine. These lines are frequently called “large bores” or “trauma lines”.
To make the procedure more tolerable for children, medical staff may apply a topical local anaesthetic (such as EMLA or Ametop) to the skin of the chosen venipuncture area about 45 minutes beforehand.
The part of the catheter that remains outside the skin is called the connecting hub; it can be connected to a syringe or an intravenous infusion line, or capped with a heplock or saline lock, a needleless connection filled with a small amount of heparin or saline solution to prevent clotting, between uses of the catheter. Ported cannulae have an injection port on the top that is often used to administer medicine.
In cases of shock, a central venous catheter, a peripherally inserted central catheter (PICC), venous cutdown or intraosseous infusion may be necessary.
If the cannula is not sited correctly, or the vein is particularly fragile and ruptures, blood may extravasate into the surrounding tissues, this situation is known as a blown vein or “tissuing”. Using this cannula to administer medications causes extravasation of the drug which can lead to edema, causing pain and tissue damage, and even necrosis depending on the medication. The person attempting to obtain the access must find a new access site proximal to the “blown” area to prevent extravasation of medications through the damaged vein. For this reason it is advisable to site the first cannula at the most distal appropriate vein.
If a patient needs frequent venous access, the veins may scar and narrow, making any future access extremely difficult or impossible.
قرص ondansetron چیست
A peripheral IV cannot be left in the vein indefinitely out of concern for the risk of infection and phlebitis, among other potential complications. However, recent studies have found that there is no increased risk of complications in patients whose IVs were replaced only when clinically indicated versus patients whose IVs were replaced routinely.[6][needs update] Thus, it is becoming more common to replace IVs only when clinically indicated. There is no need to replace peripheral IVs more frequently than 72–96 hours as long as the IV was placed aseptically.[7]
Catheter shearing is a very infrequent complication, but a very real danger. Shearing occurs when part of the catheter is cut by the sharp bevelled edge of the trochar. The sheared section may completely separate from the main body of the catheter, and become free floating in the blood stream. The majority of the time, it is due to poor technique, but infrequently a poorly manufactured catheter may break from the hub or shear. Infection, and a foreign body embolus are the two threats to the patient.[citation needed]
A rapid infuser can be used if the patient requires a high flow rate and the IV access device is of a large enough diameter to accommodate it. This is either an inflatable cuff placed around the fluid bag to force the fluid into the patient or a similar electrical device that may also heat the fluid being infused.
An injection inherently causes pain when the skin is broken and is medically invasive. In cases in which a choice between intravenous therapy and oral treatment may be made to achieve the same outcome, such as in the case of mild or moderate dehydration treatment (assuming oral rehydration therapy is an option), then one should avoid using intravenous therapy in place of the less invasive oral option.[8] Children in emergency departments being treated for dehydration in particular have better outcomes with oral treatment because it does not cause the pain or risk the complications of an injection.[8]
Cold spray can decrease the pain of putting in an IV.[9]
Any break in the skin carries a risk of infection. Although IV insertion is an aseptic procedure, skin-dwelling organisms such as Coagulase-negative staphylococcus or Candida albicans may enter through the insertion site around the catheter, or bacteria may be accidentally introduced inside the catheter from contaminated equipment. Moisture introduced to unprotected IV sites through washing or bathing substantially increases the infection risks.
Infection of IV sites is usually local, causing easily visible swelling, redness, and fever. If bacteria do not remain in one area but spread through the bloodstream, the infection is called sepsis and can be rapid and life-threatening. An infected central IV poses a higher risk of sepsis, as it can deliver bacteria directly into the central circulation.
Phlebitis is inflammation of a vein that may be caused by infection, the mere presence of a foreign body (the IV catheter) or the fluids or medication being given. Symptoms are warmth, swelling, pain, and redness around the vein. The IV device must be removed and if necessary re-inserted into another extremity.
Due to frequent injections and recurring phlebitis, scar tissue can build up along the vein. The peripheral veins of intravenous drug addicts, and of cancer patients undergoing chemotherapy, become sclerotic and difficult to access over time, sometimes forming a hard, painful “venous cord”.
Infiltration occurs when an IV fluid or medication accidentally enters the surrounding tissue rather than the vein. It may occur when the vein itself ruptures (the elderly are particularly prone to fragile veins due to a paucity of supporting tissues), when the vein is damaged during insertion of the intravascular access device, when the device is not sited correctly, from increased vein porosity or when the entry point of the device into the vein becomes the path of least resistance (e.g. if a cannula is in a vein for some time, the vein may scar and close and the only way for fluid to leave is along the outside of the cannula where it enters the vein). Infiltration is an inadvertent administration of a nonvesicant solution/drug into the tissue, which happens so often when the tourniquet isn’t removed in a timely fashion. Infiltration is characterized by coolness and pallor to the skin as well as localized swelling or edema. It is treated by removing the intravenous access device and elevating the affected limb so that the collected fluids can drain away. Sometimes injections of hyaluronidase can be used to speed the dispersal of the fluid/drug. Infiltration is one of the most common adverse effects of IV therapy[10] and is usually not serious unless the infiltrated fluid is a medication damaging to the surrounding tissue, most commonly a vesicant or chemotherapeutic agent, in which case it is called extravasation and extensive necrosis can occur.[11][12]
This occurs when fluids are given at a higher rate or in a larger volume than the system can absorb or excrete. Possible consequences include hypertension, heart failure, and pulmonary edema.
The human body is at risk of accidentally induced hypothermia when large amounts of cold fluids are infused. Rapid temperature changes in the heart may precipitate ventricular fibrillation.
Administering a too-diluted or too-concentrated solution can disrupt the patient’s balance of sodium, potassium, magnesium, chloride, and other electrolytes. Hospital patients usually receive blood tests to monitor these levels. It is essential to correct these imbalances if they occur, as they can lead to the clinical symptoms of electrolyte imbalance, which, if left untreated, can lead to acidosis/alkalosis, and ultimately death.
A blood clot or other solid mass, as well as an air bubble, can be delivered into the circulation through an IV and end up blocking a vessel; this is called embolism. It is nearly impossible to inject air through a peripheral IV at a dangerous rate. The risk is greater with a central IV.
Air bubbles of less than 30 microliters are thought to dissolve into the circulation harmlessly. A larger amount of air, if delivered all at once, can cause life-threatening damage, or, if extremely large (3-8 milliliters per kilogram of body weight), can stop the heart.
One reason veins are preferred over arteries for intravascular administration is because the flow will pass through the lungs before passing through the body. Air bubbles can leave the blood through the lungs. A patient with a right-to-left shunt is vulnerable to embolism from smaller amounts of air. Fatality by air embolism is rare, although this may be in part because it is so difficult to determine when this is the cause of death.
Intravenous glucose is used in some Asian countries such as Korea as a pick-me-up, for “energy,” but is not a part of routine medical care in the United States where a glucose solution is a prescription drug. Asian immigrants to the United States are at risk if they seek intravenous glucose treatment. It may be had at store-front clinics catering to Asian immigrants, but, despite having no more effect than drinking sugared water, poses medical risks such as the possibility of infection. It is commonly called “ringer.”[13]
IV rehydration was formerly a common technique for athletes.[14] The World Anti-Doping Agency (WADA) prohibits intravenous injection of more than 100mL per 12 hours, except under a medical exemption.[14] The United States Anti-Doping Agency notes that, as well as the dangers inherent in IV therapy, “IVs can be used to change blood test results (such as hematocrit where EPO or blood doping is being used), mask urine test results (by dilution) or by administering prohibited substances in a way that will more quickly be cleared from the body in order to beat an anti-doping test”.[14] Sportspeople suspended after attending boutique IV clinics include footballer Samir Nasri in 2017[15] and swimmer Ryan Lochte in 2018.[16]
Intravenous technology stems from studies on cholera treatment in 1831 by Dr Thomas Latta of Leith.[17]
Intravenous therapy was further developed in the 1930s by Hirschfeld, Hyman and Wanger[18][19] but was not widely available until the 1950s.[20]
In the 1960s, John Myers developed the “Myers’ cocktail”, a non-prescription IV solution of vitamins and minerals marketed as a hangover cure and general wellness remedy.[21] The first “boutique IV” clinic, offering similar treatments, opened in Tokyo in 2008.[21] These clinics, whose target market was described by Elle as “health nuts who moonlight as heavy drinkers”, have been publicized in the 2010s by glamorous celebrity customers.[21]
Intramuscular injection, often abbreviated IM, is the injection of a substance directly into muscle. In medicine, it is one of several alternative methods for the administration of medications (see route of administration). Muscles have larger and more numerous blood vessels than subcutaneous tissue and injections here usually have faster rates of absorption than subcutaneous injections or intradermal injections.[1] Depending on the injection site, an administration is limited to between 2 and 5 milliliters of fluid.
Examples of medications that are sometimes administered intramuscularly are:
In addition, some vaccines are administered intramuscularly:
Platelet-rich plasma injections can be administered intramuscularly.
Certain substances (e.g. ketamine) are injected intramuscularly for recreational purposes.
قرص ondansetron چیست
Possible sites for IM injection include: deltoid, dorsogluteal, rectus femoris, vastus lateralis and ventrogluteal muscles.[2] Sites that are bruised, tender, red, swollen, inflamed or scarred are avoided.[1]
The deltoid muscle site (upper arm) is recommended for use with injections of small volume, usually equal or less than 2 ml, including vaccinations.[2] This site is not recommended for repeated injections, due to its small area, it is difficult to rotate the injection site.[2] To locate the site, palpate the lower edge of the acromion process. Inject in the upside down triangle that forms with its base at the acromion process and its midpoint in line with the axilla.[1]
The ventrogluteal site (hip) is recommended for injections requiring a larger volume to be administered, greater than 1 ml, and for medications known to be irritating, viscous or oily. It is also given for narcotic, antibiotic, sedative and anti-emetic medications.[2] To locate the ventrogluteal site, place the palm of your hand over the greater trochanter, with the fingers facing the patient’s head. The right hand is used for the left hip and left hand is used for the right hip. Place the index finger on the anterior superior iliac spine and run the middle finger back along the iliac crest. The injection is given in the center of the triangle that is formed.[1]
The vastus lateralis site is the recommended site for infants less than 7 months old and those unable to walk, with loss of muscular tone.[2] To locate the site, divide the front thigh into thirds vertically and horizontally to make nine squares and inject in the outer middle square.[1]
It is also recommended for epinephrine autoinjectors, in such cases in the middle of the outer side of the thigh, corresponding to the location of the vastus lateralis muscle.[3]
The dorsogluteal (buttock) site is not recommended for use in any patient population due to its location near major blood vessels and nerves, as well as having inconsistent depth of adipose tissue, with very few injections in this area injected to the correct depth to administer as a true intramuscular injection.[2][4] Use of this site is associated with skin and tissue trauma, muscle fibrosis and contracture, haematoma, nerve palsy and paralysis, as well as infectious processes such as abscess and gangrene.[2] Despite the goal of healthcare in many countries to follow evidence based practices, this site is commonly preferred by healthcare professionals against research recommendation, often due to a lack of knowledge surrounding alternative sites for injection.[5] The injection site is located by dividing the buttock into four with a plus (+) shaped cross, and administering the injection in the upper outer quadrant. This is the only intramuscular injection site for which research recommends aspiration (drawing back) of the syringe prior to injection, due to higher likelihood of accidental intravenous administration in this area.[2]
The selected site is cleansed with an antimicrobial and is allowed to dry. It is injected with the dominant hand using a quick, darting motion perpendicular to the patient’s body at an angle between 72 and 90 degrees, as a faster injection is less painful. The needle is then stabilized with the nondominant hand while the dominant hand slides to the plunger to slowly instill the medication, as a rapid injection causes more discomfort. The CDC does not recommend the outdated practice of aspirating for blood to rule out injecting into a blood vessel. The needle is withdrawn at the same angle inserted. Using the “Z track” or zigzag technique is recommended, where the skin is pulled and held down to one side with the nondominant hand about an inch and after the needle is withdrawn the displaced skin is allowed to return to its normal position. This is to ensure that the medication does not leak back along the needle track. Gentle pressure is applied with a gauze but the site is not massaged to prevent forcing the medication into subcutaneous tissue.[6]
اندانسترون (به انگلیسی: Ondansetron)
نامهای تجارتی : Demitron – Zofran
رده درمانی: ضد استفراغ .
رده فارماکولوژیک: آنتاگونیست گیرنده سروتونین
قرص ondansetron چیست
اشکال دارویی: قرص روکش دار ۴ میلی گرمی، محلول خوراکی ۴ میلی گرم در ۵ سی سی، آمپول ۲ میلی گرم در سی سی، ۲ سی سی، و ۴ سی سی.
اندانسترون اثرات ضد استفراغ خود را، با اثرات آنتاگونیستی گیرندههای سروتونین، در انتهای اعصاب واگ (عصب واگ) و گیرندههای مرکزی آن در مرکز استفراغ اعمال میکند و بدین طریق با مهار کردن رفلکس استفراغ، از تهوع و استفراغ جلوگیری میکند.
دربالغین و کودکان بزرگتر از ۴ سال : ۳۰ دقیقه قبل از شروع شیمی درمانی، ۰٫۱۵ میلی گرم به ازای هر کیلوگرم وزن بدن، از راه وریدی و در خلال ۱۵ دقیقه انفوزیون میشود و سپس ۰٫۱۵ میلی گرم به ازای هر کیلوگرم وزن بدن، ۴ و ۸ ساعت بعد از دوز اول تجویز میشود. همچنین میتوان دارو را به صورت دوز واحد و به میزان، ۳۲ میلی گرم، ۳۰ دقیقه قبل از شیمی درمانی تجویز نمود.
روش دیگر: در بالغین و کودکان بزرگتر از ۱۲ سال : ۸ میلی گرم از راه خوراکی دو بار در روز تجویز میشود . دارو باید ۳۰ دقیقه قبل از شروع شیمی درمانی و سپس ۸ ساعت بعد از دوز اول تکرار شود و سپس ۸ میلی گرم هر ۱۲ ساعت تا دو روز بعد از اتمام شیمی درمانی تجویز میشود.
در کودکان سنین ۴ تا ۱۲ سال : ۴ میلی گرم از راه خوراکی، سه بار در روز تجویز میشود. ترتیب تجویز دارو، مشابه بالغین است.
دربالغین : ۸ میلی گرم، از راه خوراکی، سه بار در روز تجویز میشود.
در بالغین : ۱۶ میلی گرم، از راه خوراکی یک ساعت قبل از بیهوشی یا ۴ میلی گرم از راه وریدی بلافاصله قبل بیهوشی یا به فاصله کوتاهی بعد از عمل تجویز میشود.
نکته: در نارسایی کبد باید اندانسترون را، با احتیاط تجویز کرد.
Ondansetron is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron is in a class of medications called serotonin 5-HT3 receptor antagonists. It works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.
Ondansetron comes as a tablet, a rapidly disintegrating (dissolving) tablet, and an oral solution (liquid) to take by mouth. The first dose of ondansetron is usually taken 30 minutes before the start of chemotherapy, 1 to 2 hours before the start of radiation therapy, or 1 hour before surgery. Additional doses are sometimes taken one to three times a day during chemotherapy or radiation therapy and for 1 to 2 days after the end of treatment. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ondansetron exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
If you are taking the rapidly disintegrating tablet, remove the tablet from the package just before you take your dose. To open the package, do not try to push the tablet through the foil backing of the blister. Instead, use dry hands to peel back the foil backing. Gently remove the tablet and immediately place the tablet on the top of your tongue. The tablet will dissolve in a few seconds and can be swallowed with saliva.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Unless your doctor tells you otherwise, continue your usual diet.
قرص ondansetron چیست
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Ondansetron may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets and rapidly disintegrating tablets away from light, at room temperature or in the refrigerator. Store the solution in the bottle upright at room temperature and away from light, excess heat, and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Patient Medication Information™. © Copyright, 2019. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
مجری طرح پایلوت : انجمن داروسازان اصفهان
تحت نظارت معاونت غذا و دارو
مسئولیت صحت اطلاعات بر عهده داروخانه می باشد
*دریافت دارو فقط بصورت حضوری در محل داروخانه و با نسخه کامل امکان پذیر است*
اندانسترون
اندانسترون یک داروی ضد تهوع می باشد . این دارو به عنوان مهار کننده ی گیرنده ی سروتونین شناخته می شود.
قرص ondansetron چیست
(فراورده های دمیترون محصول شرکت تهران شیمی)
این دارو با اثر بر روی ماده ای شیمیایی به نام سروتونین که بطور طبیعی در بدن وجود دارد ، تهوع را مهار می کند .
شیمی درمانی ، اشعه درمانی و جراحی شرایطی هستند که منجر به افزایش ترشح سروتونین در بدن می شوند . سروتونین آزاد شده در بدن با اتصال به گیرنده های نوع سوم هیستامین در مغز منجر به وقوع تهوع می شوند . اندانسترون با مسدود کردن این گیرنده ها دسترسی آن ها به سروتونین را مهار می نماید و بدین ترتیب تهوع کنترل می گردد.
پیش از مصرف اندانسترون
– در صورت بارداری یا شیردهی به پزشک اطلاع دهید .
– در صورت سابقه ی مشکلات کبدی ، ضربان قلب نامنظم و حساسیت دارویی پزشک خود را مطلع نمایید .
-از آنجا که این دارو می تواند در عملکرد داروهای دیگر در بدن اختلال ایجاد کند لازم است پیش از شروع مصرف لیستی از کلیه ی داروهای مصرفی خود در اختیار پزشک یا داروسازتان قرار دهید.
نحوه ی مصرف صحیح اندانسترون
– اندانسترون را دقیقا طبق دستور پزشک مصرف نمایید . معمولا در صورتی که این دارو جهت تهوع ناشی از شیمی درمانی یا اشعه درمانی تجویز شده باشد ، یک نوبت آن باید نیم تا یک ساعت قبل از شروع درمان مصرف شود و ممکن است لازم باشد مصرف این دارو را چند روز ( تا ۵ روز یا بیشتر ) ادامه دهید .
– این دارو به صورت قرص و محلول خوراکی ۴ میلی گرمی و آمپول تزریقی ۲میلی گرمی موجود است. قرص و محلول خوراکی معمولاً هر ۱۲ ساعت یک بار تجویز می شوند .
– در صورتی که اندانسترون را جهت تهوع ناشی از عمل جراحی مصرف می نمایید ، اولین دوز آن باید کمی پیش از شروع جراحی مصرف گردد .
توصیه های دارویی اندانسترون
– اثر اندانسترون یک ساعت پس از مصرف یا بیشتر شروع می شود . در صورتی که با مصرف یک قرص تا یک ساعت تهوع شما برطرف نگردید ، می توانید یک قرص دیگر نیز مصرف نمایید .
– حتی در صورتی که میل به غذا و نوشیدنی ندارید، سعی کنید آب به مقدار کافی مصرف کنید تا بدنتان دچار کم آبی نشود. همچنین علاوه بر سه وعده غذایی اصلی، سعی کنید میان وعده های کوچک و ساده ای نیز برای خود در نظر بگیرید.
– در مصرف طولانی مدت این دارو در صورتی که سابقه ی بیماری های قلب و عروق دارید حتما تحت نظر پزشک خود باشید و آزمایشات و معاینات دوره ای را انجام دهید .
عوارض شایع اندانسترون
_برای سردرد احتمالی ناشی از مصرف این دارو از داروساز خود درمورد داروی ضد درد مناسب سوال بفرمایید.
- در صورت بروز یبوست، یک رژیم غذایی متعادل سرشار از فیبر و مصرف مایعات و آب کافی توصیه می شود. با این حال در صورتی که یبوست طولانی شد به پزشک خود مراجعه نمایید .
– احساس گرما و بر افروختگی با مصرف اندانسترون ممکن است در شما ایجاد شود لذا در این مدت از لباس های سبک و خنک استفاده نمایید .
مشاهده و خرید داروهای گوارشی با منشاء گیاهی از داروخانه اینترنتی دارویاب
چنانچه در خصوص “اندانسترون” سوالی دارید، عارضه خاصی مشاهده نموده اید و یا مطلب ویژه ای به نظرتان می رسد با دیگران به اشتراک بگذارید
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Pronunciation: on DAN se tron
Brand: Zofran, Zofran ODT, Zuplenz
4 mg, round, white, imprinted with M, 315
قرص ondansetron چیست
8 mg, round, orange, imprinted with M, 344
4 mg, round, white, imprinted with M, 732
8 mg, round, white, imprinted with M, 734
4 mg, round, white, imprinted with GG, 927
8 mg, round, yellow, imprinted with GG, 928
4 mg, round, white, imprinted with R, 153
8 mg, round, yellow, imprinted with R, 154
4 mg, round, white, imprinted with 5, E
4 mg, oval, white, imprinted with 130
8 mg, oval, yellow, imprinted with 131
8 mg, oval, white, imprinted with 241
8 mg, oval, yellow, imprinted with 8, NO
4 mg, round, white, strawberry, imprinted with 5, E
8 mg, round, white, strawberry, imprinted with 7, E
4 mg, oval, white, imprinted with 4, NO
4 mg, round, white, imprinted with G, 4
8 mg, round, white, imprinted with G, 8
4 mg, round, white, imprinted with 93, 7301
4 mg, round, white, imprinted with 93, 233
8 mg, round, white, imprinted with 93, 7302
8 mg, round, yellow, imprinted with 93, 7236
4 mg, round, white, imprinted with 5, E
4 mg, oval, white, strawberry, imprinted with 240
4 mg, oval, white, imprinted with Zofran, 4
8 mg, oval, yellow, imprinted with Zofran, 8
You should not use ondansetron if you are also using apomorphine (Apokyn).
Ondansetron blocks the actions of chemicals in the body that can trigger nausea and vomiting.
Ondansetron is used to prevent nausea and vomiting that may be caused by surgery, cancer chemotherapy, or radiation treatment.
Ondansetron may be used for purposes not listed in this medication guide.
You should not use ondansetron if:
To make sure ondansetron is safe for you, tell your doctor if you have:
Ondansetron is not expected to harm an unborn baby. Tell your doctor if you are pregnant.
It is not known whether ondansetron passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Ondansetron is not approved for use by anyone younger than 4 years old.
Ondansetron orally disintegrating tablets may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).
قرص ondansetron چیست
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Ondansetron can be taken with or without food.
The first dose of ondansetron is usually taken before the start of your surgery, chemotherapy, or radiation treatment. Follow your doctor’s dosing instructions very carefully.
Take the ondansetron regular tablet with a full glass of water.
To take the orally disintegrating tablet (Zofran ODT):
To use ondansetron oral soluble film (strip) (Zuplenz):
Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
Store at room temperature away from moisture, heat, and light. Store liquid medicine in an upright position.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include sudden loss of vision, severe constipation, feeling light-headed, or fainting.
Ondansetron may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Get emergency medical help if you have signs of an allergic reaction: rash, hives; fever, chills, difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Ondansetron can cause a serious heart problem, especially if you use certain medicines at the same time, including antibiotics, antidepressants, heart rhythm medicine, antipsychotic medicines, and medicines to treat cancer, malaria, HIV or AIDS. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ondansetron.
Taking ondansetron while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called “serotonin syndrome,” which can be fatal. Tell your doctor if you also use:
This list is not complete and many other drugs can interact with ondansetron. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Your pharmacist can provide more information about ondansetron.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2019 Cerner Multum, Inc. Version: 13.01. Revision date: 10/21/2016.
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NOTICE: This health information was not created by the University of Michigan Health System (UMHS) and may not necessarily reflect specific UMHS practices. For medical advice relating to your personal condition, please consult your doctor. Complete disclaimer
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A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties. [PubChem]
Having been developed in the 1980s by GlaxoSmithKline and approved by the US FDA since January 1991, ondansetron has demonstrated a long history of use and efficacy. Commonly formulated as oral tablets, orally disintegrating tablets (ODT), and injections, and available as generic products as well, ondansetron continues to see contemporary innovations in its formulation and use, including the development of orally soluble films that are both discreet in administration and less of a burden in comparison to having patients attempt to swallow pills during emesis 7.
A unique ID assigned by the FDA when a product is submitted for approval by the labeller.
A governmentally-recognized ID which uniquely identifies the product within its regulatory market.
A unique ID assigned by the FDA when a product is submitted for approval by the labeller.
قرص ondansetron چیست
A governmentally-recognized ID which uniquely identifies the product within its regulatory market.
In the adult patient population:
i) orally administered ondansetron tablets and orally disintegrating tablets (ODT) are indicated for:
– the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and radiotherapy, and
– the prevention and treatment of postoperative nausea and vomiting
ii) intravenously administered ondansetron injection formulations are indicated for:
– the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and
– the prevention and treatment of postoperative nausea and vomiting
In the pediatric (4-18 years of age) patient population:
i) ondansetron was effective and well tolerated when given to children 4-12 years of age for the treatment of post-chemotherapy induced nausea and vomiting,
ii) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for the treatment of children 3 years of age or younger,
iii) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of post-radiotherapy induced nausea and vomiting, and
iV) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of postoperative nausea and vomiting
In the geriatric (>65 years of age) patient population:
i) efficacy and tolerance of ondansetron were similar to that observed in younger adults for the treatment of post-chemotherapy and radiotherapy-induced nausea and vomiting, and
ii) clinical experience in the use of ondansetron in the prevention and treatment of postoperative nausea and vomiting is limited and is not indicated for use in the geriatric patient population
Ondansetron is a highly specific and selective serotonin 5-HT3 receptor antagonist, not shown to have activity at other known serotonin receptors and with low affinity for dopamine receptors Label, 3,4. The serotonin 5-HT3 receptors are located on the nerve terminals of the vagus in the periphery, and centrally in the chemoreceptor trigger zone of the area postrema Label, 3,4. The temporal relationship between the emetogenic action of emetogenic drugs and the release of serotonin, as well as the efficacy of antiemetic agents, suggest that chemotherapeutic agents release serotonin from the enterochromaffin cells of the small intestine by causing degenerative changes in the GI tract Label, 3,4. The serotonin then stimulates the vagal and splanchnic nerve receptors that project to the medullary vomiting center, as well as the 5-HT3 receptors in the area postrema, thus initiating the vomiting reflex, causing nausea and vomiting Label, 3,4.
Moreover, the effect of ondansetron on the QTc interval was evaluated in a double-blind, randomized, placebo and positive (moxifloxacin) controlled, crossover study in 58 healthy adult men and women 9,10. Ondansetron was tested at single doses of 8 mg and 32 mg infused intravenously over 15 minutes 9,10. At the highest tested dose of 32 mg, prolongation of the Fridericia-corrected QTc interval (QT/RR0.33=QTcF) was observed from 15 min to 4 h after the start of the 15 min infusion, with a maximum mean (upper limit of 90% CI) difference in QTcF from placebo after baseline-correction of 19.6 (21.5) msec at 20 min 9,10. At the lower tested dose of 8 mg, QTc prolongation was observed from 15 min to 1 h after the start of the 15-minute infusion, with a maximum mean (upper limit of 90% CI) difference in QTcF from placebo after baseline-correction of 5.8 (7.8) msec at 15 min 9,10. The magnitude of QTc prolongation with ondansetron is expected to be greater if the infusion rate is faster than 15 minutes 9,10. The 32 mg intravenous dose of ondansetron must not be administered 9,10. No treatment-related effects on the QRS duration or the PR interval were observed at either the 8 or 32 mg dose 9,10.
An ECG assessment study has not been performed for orally administered ondansetron 9,10. On the basis of pharmacokinetic-pharmacodynamic modelling, an 8 mg oral dose of ondansetron is predicted to cause a mean QTcF increase of 0.7 ms (90% CI -2.1, 3.3) at steady-state, assuming a mean maximal plasma concentration of 24.7 ng/mL (95% CI 21.1, 29.0) 9,10. The magnitude of QTc prolongation at the recommended 5 mg/m2 dose in pediatrics has not been studied, but pharmacokinetic-pharmacodynamic modeling predicts a mean increase of 6.6 ms (90% CI 2.8, 10.7) at maximal plasma concentrations 9,10.
In healthy subjects, single intravenous doses of 0.15 mg/kg of ondansetron had no effect on esophageal motility, gastric motility, lower esophageal sphincter pressure, or small intestinal transit time 8. Multiday administration of ondansetron has been shown to slow colonic transit in healthy subjects 8. Ondansetron has no effect on plasma prolactin concentrations 8.
Ondansetron is a selective antagonist of the serotonin receptor subtype, 5-HT3 8,9,10.
Cytotoxic chemotherapy and radiotherapy are associated with the release of serotonin (5-HT) from enterochromaffin cells of the small intestine, presumably initiating a vomiting reflex through stimulation of 5-HT3 receptors located on vagal afferents 8,9,10. Ondansetron may block the initiation of this reflex. Activation of vagal afferents may also cause a central release of serotonin from the chemoreceptor trigger zone of the area postrema, located on the floor of the fourth ventricle 8,9,10. Thus, the antiemetic effect of ondansetron is probably due to the selective antagonism of 5-HT3 receptors on neurons located in either the peripheral or central nervous systems, or both 8,9,10.
Although the mechanisms of action of ondansetron in treating postoperative nausea and vomiting and cytotoxic induced nausea and vomiting may share similar pathways, the role of ondansetron in opiate-induced emesis has not yet been formally established 9,10.
Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.
Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.
Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.
Ondansetron is absorbed from the gastrointestinal tract and undergoes some limited first-pass metabolism 8. Mean bioavailability in healthy subjects, following administration of a single 8-mg tablet, was recorded as being approximately 56% to 60% 8,9,10. Bioavailability is also slightly enhanced by the presence of food 8.
Ondansetron systemic exposure does not increase proportionately to dose 8. The AUC from a 16-mg tablet was 24% greater than predicted from an 8-mg tablet dose 8. This may reflect some reduction of first-pass metabolism at higher oral doses 8.
The volume of distribution of ondansetron has been recorded as being approximately 160L 5.
The plasma protein binding associated with ondansetron was documented as approximately 73% 9,10.
In vitro metabolism studies have shown that ondansetron is a substrate for human hepatic cytochrome P450 enzymes, including CYP1A2, CYP2D6 and CYP3A4 8,9,10. In terms of overall ondansetron turnover, CYP3A4 played the predominant role 8,9,10. Because of the multiplicity of metabolic enzymes capable of metabolizing ondansetron, it is likely that inhibition or loss of one enzyme (e.g. CYP2D6 enzyme deficiency) will be compensated by others and may result in little change in overall rates of ondansetron clearance 8,9,10.
Following oral or IV administration, ondansetron is extensively metabolised and excreted in the urine and faeces 8,9,10. In humans, less than 10% of the dose is excreted unchanged in the urine 8,9,10. The major urinary metabolites are glucuronide conjugates (45%), sulphate conjugates (20%) and hydroxylation products (10%) 8,9,10. The primary metabolic pathway is subsequently hydroxylation on the indole ring followed by subsequent glucuronide or sulfate conjugation 8,9,10. Although some nonconjugated metabolites have pharmacologic activity, these are not found in plasma at concentrations likely to significantly contribute to the biological activity of ondansetron 8,9,10.
Following oral or IV administration, ondansetron is extensively metabolised and excreted in the urine and faeces 9,10.
The half-life of ondansetron after either an 8 mg oral dose or intravenous dose was approximately 3-4 hours and could be extended to 6-8 hours in the elderly 9,10.
The clearance values determined for ondansetron in various patient age groups were recorded as approximately 0.38 L/h/kg in normal adult volunteers aged 19-40 yrs, 0.32 L/h/kg in normal adult volunteers aged 61-74 yrs, 0.26 L/h/kg in normal adult volunteers aged >=75 yrs Label.
At present, there is little information concerning overdosage with ondansetron 8,9,10. Nevertheless, there have been certain cases of somewhat idiosyncratic adverse effects associated with particular dosages of ondansetron used 8,9,10.
“Sudden blindness” (amaurosis) of 2 to 3 minutes duration plus severe constipation occurred in one patient that was administered 72 mg of ondansetron intravenously as a single dose 8,9,10. Hypotension (and faintness) occurred in another patient that took 48 mg of oral ondansetron 8,9,10. Following infusion of 32 mg over only a 4-minute period, a vasovagal episode with transient second-degree heart block was observed 8,9,10. Neuromuscular abnormalities, autonomic instability, somnolence, and a brief generalized tonic-clonic seizure (which resolved after a dose of benzodiazepine) were observed in a 12-month-old infant who ingested seven or eight 8-mg ondansetron tablets (approximately forty times the recommended 0.1-0.15 mg/kg dose for a pediatric patient) 8,9,10. In all instances, however, the events resolved completely 8,9,10.
The safety of ondansetron for use in human pregnancy has not been established 9,10. Ondansetron is not teratogenic in animals 9,10. However, as animal studies are not always predictive of human response, the use of ondansetron in pregnancy is not recommended 9,10.
Ondansetron is excreted in the milk of lactating rats 9,10. It is not known if it is excreted in human milk, however, nursing is not recommended during treatment with ondansetron 9,10.
Insufficient information is available to provide dosage recommendations for children 3 years of age or younger 9,10.
Extended description of the mechanism of action and particular properties of each drug interaction.
A severity rating for each drug interaction, from minor to major.
A rating for the strength of the evidence supporting each drug interaction.
An effect category for each drug interaction. Know how this interaction affects the subject drug.
Peter Bod, Kalman Harsanyi, Ferenc Trischler, Eva Fekecs, Attila Csehi, Bela Hegedus, Eva Mersich nee Donat, Gyorgyi Szabo nee Komlosi, Erika Horvath nee Sziki, “Process for preparing ondansetron.” U.S. Patent US5478949, issued September, 1990.
قرص ondansetron چیست
The date on which a patent was filed with the relevant government.
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Drug created on June 13, 2005 07:24 / Updated on July 13, 2019 01:02
