خواص دارویی و گیاهی
Domperidone, sold under the brand name Motilium among others, is a peripherally selective dopamine D2 receptor antagonist that was developed by Janssen Pharmaceutica and is used as an antiemetic, gastroprokinetic agent, and galactagogue.[1][6][7] It may be administered orally or rectally, and is available in the form of tablets, orally disintegrating tablets (based on Zydis technology),[8] suspension, and suppositories.[9] The drug is used to relieve nausea and vomiting; to increase the transit of food through the stomach (by increasing gastrointestinal peristalsis); and to promote lactation (breast milk production) by release of prolactin.[1][7]
It was reported in 2007 that domperidone is available in 58 countries, including Canada,[10] but the uses or indications of domperidone vary between nations. In Italy it is used in the treatment of gastroesophageal reflux disease and in Canada, the drug is indicated in upper gastrointestinal motility disorders and to prevent gastrointestinal symptoms associated with the use of dopamine agonist antiparkinsonian agents.[11] In the United Kingdom, domperidone is only indicated for the treatment of nausea and vomiting and the treatment duration is usually limited to 1 week.
In the United States, domperidone is not currently a legally marketed human drug and it is not approved for sale in the U.S. On 7 June 2004, FDA issued a public warning that distributing any domperidone-containing products is illegal.[12]
There is some evidence that domperidone has antiemetic activity.[13] It is recommended in the Canadian Headache Society’s guidelines for treatment of nausea associated with acute migraine.[14]
قرص domperidone چیست
Gastroparesis is a medical condition characterised by delayed emptying of the stomach when there is no mechanical gastric outlet obstruction. Its cause is most commonly idiopathic, a diabetic complication or a result of abdominal surgery. The condition causes nausea, vomiting, fullness after eating, early satiety (feeling full before the meal is finished), abdominal pain and bloating.
Domperidone may be useful in diabetic and idiopathic gastroparesis.[15][16]
However, increased rate of gastric emptying induced by drugs like domperidone does not always correlate (equate) well with relief of symptoms.[17]
Parkinson’s disease is a chronic neurological condition where a decrease in dopamine in the brain leads to rigidity (stiffness of movement), tremor and other symptoms and signs. Poor gastrointestinal function, nausea and vomiting is a major problem for people with Parkinson’s disease because most medications used to treat Parkinson’s disease are given by mouth. These medications, such as levodopa, can cause nausea as a side effect. Furthermore, anti-nausea drugs, such as metoclopramide, which do cross the blood–brain barrier may worsen the extra-pyramidal symptoms of Parkinson’s disease.
Domperidone can be used to relieve gastrointestinal symptoms in Parkinson’s disease; it blocks peripheral D2 receptors but does not cross the blood–brain barrier in normal doses (the barrier between the blood circulation of the brain and the rest of the body) so has no effect on the extrapyramidal symptoms of the disease.[18] In addition to this, domperidone may enhance the bioavailability (effect) of levodopa (one of the main treatments in Parkinson’s disease).[19]
Although these features make domperidone a useful drug in Parkinson’s disease, caution is needed due to the cardiotoxic side effects of domperidone especially when given intravenously, in elderly people and in high doses (> 30 mg per day).[20] A clinical sign of domperidone’s potential toxicity to the heart is the prolongation (lengthening) of the QT interval (a segment of the heart’s electrical pattern).[21]
Domperidone may be used in functional dyspepsia in both adults and children.[22][23]
The hormone prolactin stimulates lactation (production of breast milk). Dopamine, released by the hypothalamus stops the release of prolactin from the pituitary gland. Domperidone, by acting as an anti-dopaminergic agent, results in increased prolactin secretion, and thus promotes lactation (that is, it is a galactogogue). Domperidone moderately increases the volume of expressed breast milk in mothers of preterm babies where breast milk expression was inadequate, and appears to be safe for short-term use for this purpose.[24][25][26] In the United States, domperidone is not approved for this or any other use.[27][28]
A study called the EMPOWER trial was designed to assess the effectiveness and safety of domperidone in assisting mothers of preterm babies to supply breast milk for their infants.[29] The study randomized 90 mothers of preterm babies to receive either domperidone 10 mg orally three times daily for 28 days (Group A) or placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days (Group B). Mean milk volumes at the beginning of the intervention were similar between the 2 groups. After the first 14 days, 78% of mothers receiving domperidone (Group A) achieved a 50% increase in milk volume, while 58% of mothers receiving placebo (Group B) achieved a 50% increase in milk volume.[30]
To induce lactation, domperidone is used at a dosage of 10 to 20 mg 3 or 4 times per day by mouth.[31] Effects may be seen within 24 hours or may not be seen for 3 or 4 days.[31] The maximum effect occurs after 2 or 3 weeks of treatment, and the treatment period generally lasts for 3 to 8 weeks.[31] A 2012 review shows that no studies support prophylactic use of a galactagogue medication at any gestation including Domperidone.[32]
Domperidone has been found effective in the treatment of pediatric reflux.[33] However some specialists consider its risks prohibitory of the treatment of infantile reflux.[34]
Side effects associated with domperidone include dry mouth, abdominal cramps, diarrhea, nausea, rash, itching, hives, and hyperprolactinemia (the symptoms of which may include breast enlargement, galactorrhea, breast pain/tenderness, gynecomastia, hypogonadism, and menstrual irregularities).[31] Due to blockade of D2 receptors in the central nervous system, D2 receptor antagonists like metoclopramide can also produce a variety of additional side effects including drowsiness, akathisia, restlessness, insomnia, lassitude, fatigue, extrapyramidal symptoms, dystonia, Parkinsonian symptoms, tardive dyskinesia, and depression.[1][7] However, this is not the case with domperidone, because, unlike other D2 receptor antagonists, it minimally crosses the blood-brain-barrier, and for this reason, is rarely associated with such side effects.[1][7]
Due to D2 receptor blockade, domperidone causes hyperprolactinemia.[36] Hyperprolactinemia can suppress the secretion of gonadotropin-releasing hormone (GnRH) from the hypothalamus, in turn suppressing the secretion of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) and resulting in hypogonadism (low sex hormone (e.g., testosterone, estradiol) levels).[37] As such, male patients may experience low libido, erectile dysfunction, and impaired spermatogenesis.[37] Also in accordance with hyperprolactinemia, 10–15% of female patients have been reported to experience mammoplasia (breast enlargement), mastodynia (breast pain/tenderness), galactorrhea (inappropriate or excessive milk production/secretion), and amenorrhea (cessation of menstrual cycles) with domperidone treatment.[36] Gynecomastia has been reported in males treated with domperidone,[38] and galactorrhea could occur in males as well.[37]
Domperidone use is associated with an increased risk of sudden cardiac death (by 70%)[39] most likely through its prolonging effect of the cardiac QT interval and ventricular arrhythmias.[40][41] The cause is thought to be blockade of hERG voltage-gated potassium channels.[42][43] The risks are dose-dependent, and appear to be greatest with high/very high doses via intravenous administration and in the elderly, as well as with drugs that interact with domperidone and increase its circulating concentrations (namely CYP3A4 inhibitors).[44][45] Conflicting reports exist, however.[46] In neonates and infants, QT prolongation is controversial and uncertain.[47][48]
UK drug regulatory authorities (MHRA) have issued the following restriction on domperidone in 2014 due to increased risk of adverse cardiac effects:
Domperidone (Motilium) is associated with a small increased risk of serious cardiac side effects. Its use is now restricted to the relief of nausea and vomiting and the dosage and duration of use have been reduced. It should no longer be used for the treatment of bloating and heartburn. Domperidone is now contraindicated in those with underlying cardiac conditions and other risk factors. Patients with these conditions and patients receiving long-term treatment with domperidone should be reassessed at a routine appointment, in light of the new advice.
However, a 2015 Australian review concluded the following:[45]
Based on the results of the two TQT (the regulatory agency gold standard for assessment of QT prolongation) domperidone does not appear to be strongly associated with QT prolongation at oral doses of 20 mg QID in healthy volunteers. Further, there are limited case reports supporting an association with cardiac dysfunction, and the frequently cited case-control studies have significant flaws. While there remains an ill-defined risk at higher systemic concentrations, especially in patients with a higher baseline risk of QT prolongation, our review does not support the view that domperidone presents intolerable risk.
In Britain a legal case involved the death of two children of a mother whose three children had all had hypernatraemia. She was charged with poisoning the children with salt. One of the children, who was born at 28 weeks gestation with respiratory complications and had a fundoplication for gastroesophageal reflux and failure to thrive was prescribed domperidone. An advocate for the mother suggested the child may have suffered neuroleptic malignant syndrome as a side effect of domperidone due to the drug crossing the child’s immature blood-brain-barrier.[49]
Domperidone is almost exclusively metabolized by CYP3A4, and for this reason, inhibitors and inducers of this enzyme may alter the metabolism and concentrations of domperidone. Moreover, domperidone has been identified as a modest mechanism-based (irreversible) inhibitor of CYP3A4 (Ki = 12 μM), and it has been estimated that it may increase the serum concentrations of CYP3A4 substrates by approximately 50%.[50]
Itraconazole and ketoconazole, both used to treat fungal infections, are potent CYP3A4 inhibitors and increase the plasma concentration of domperidone.[51][52] In healthy volunteers, ketoconazole increased the Cmax and AUC concentrations of domperidone by 3- to 10-fold.[53] This was accompanied by a QT interval prolongation of about 10–20 milliseconds when domperidone 10 mg four times daily and ketoconazole 200 mg twice daily were administered, whereas domperidone by itself at the dosage assessed produced no such effect.[53] As such, domperidone with ketoconazole or other CYP3A4 inhibitors is a potentially dangerous combination.[53]
Erythromycin and certain other macrolide antibiotics are CYP3A4 inhibitors and inhibit the metabolism of domperidone (in vitro), thus increasing the concentration of domperidone and potential side effects of the drug. This is of concern as both drugs may be used to treat gastroparesis.[54]
There is evidence that domperidone should not be taken with grapefruit juice, which is a known CYP3A4 inhibitor.[55]
Domperidone is a peripherally selective dopamine D2 and D3 receptor antagonist.[7] It has no clinically significant interaction with the D1 receptor, unlike metoclopramide.[7] The medication provides relief from nausea by blocking D2 receptors in the chemoreceptor trigger zone (a location in the nervous system that mediates nausea) at the floor of the fourth ventricle (a location near the brain). It increases motility in the upper gastrointestinal tract to a moderate degree and increases[56] lower esophageal sphincter pressure by blocking dopamine receptors in the gastric antrum and the duodenum. It blocks dopamine receptors in the anterior pituitary gland increasing release of prolactin which in turn increases lactation.[57][58] Domperidone may be more useful in some patients and cause harm in others by way of the genetics of the person, such as polymorphisms in the drug transporter gene ABCB1 (which encodes P-glycoprotein), the voltage-gated potassium channel KCNH2 gene (hERG/Kv11.1), and the α1D—adrenoceptor ADRA1D gene.[59]
A single 20 mg oral dose of domperidone has been found to increase mean serum prolactin levels (measured 90 minutes post-administration) in non-lactating women from 8.1 ng/mL to 110.9 ng/mL (a 13.7-fold increase).[7][60][61][62] This was similar to the increase in prolactin levels produced by a single 20 mg oral dose of metoclopramide (7.4 ng/mL to 124.1 ng/mL; 16.7-fold increase).[61][62] After two weeks of chronic administration (30 mg/day in both cases), the increase in prolactin levels produced by domperidone was reduced (53.2 ng/mL; 6.6-fold above baseline), but the increase in prolactin levels produced by metoclopramide, conversely, was heightened (179.6 ng/mL; 24.3-fold above baseline).[7][62] This indicates that acute and chronic administration of both domperidone and metoclopramide is effective in increasing prolactin levels, but that there are differential effects on the secretion of prolactin with chronic treatment.[61][62] The mechanism of the difference is unknown.[62] The increase in prolactin levels observed with the two drugs was, as expected, much greater in women than in men.[61][62] This appears to be due to the higher estrogen levels in women, as estrogen stimulates prolactin secretion.[63]
For comparison, normal prolactin levels in women are less than 20 ng/mL, prolactin levels peak at 100 to 300 ng/mL at parturition in pregnant women, and in lactating women, prolactin levels have been found to be 90 ng/mL at 10 days postpartum and 44 ng/mL at 180 days postpartum.[64][65]
Along with prolactin, domperidone has, to a lesser extent, been found to increase the secretion of thyroid-stimulating hormone (TSH), even in patients with hypothyroidism.[61] A single 4 mg intravenous dose of domperidone produced peak TSH levels of 1.9-fold above baseline and peak prolactin levels of 23-fold above baseline (which occurred at 30 minutes post-administration) in women with hypothyroidism.[61] Levels of TSH and prolactin decreased to 1.6-fold and 17-fold above baseline, respectively, at 120 minutes post-administration.[61]
With oral administration, domperidone is extensively metabolized in the liver (almost exclusively by CYP3A4/5, though minor contributions by CYP1A2, CYP2D6, and CYP2C8 have also been reported)[66] and in the intestines.[4] Due to the marked first-pass effect via this route, the oral bioavailability of domperidone is low (13–17%);[1] conversely, its bioavailability is high via intramuscular injection (90%).[1] The terminal half-life of domperidone is 7.5 hours in healthy individuals, but can be prolonged to 20 hours in people with severe renal dysfunction.[1] All of the metabolites of domperidone are inactive as D2 receptor ligands.[1][4] The drug is a substrate for the P-glycoprotein (ABCB1) transporter, and animal studies suggest that this is the reason for the low central nervous system penetration of domperidone.[67]
Domperidone is a benzimidazole derivative and is structurally related to butyrophenone neuroleptics like haloperidol.[68][69]
Domperidone is the generic name of the drug and its INN, USAN, BAN, and JAN.[75][6][76]
In 2007, it was reported that domperidone was available in 58 countries.[1] It is available over-the-counter to treat gastroesophageal reflux and functional dyspepsia in many countries, such as Ireland, the Netherlands, Italy, South Africa, Mexico, Chile, and China.[77]
Domperidone is not generally approved for use in the United States. There is an exception for use in people with treatment-refractory gastrointestinal symptoms under an FDA Investigational New Drug application.[1]
Domperidone has been studied as a potential hormonal contraceptive to prevent pregnancy in women.[81]
A prolactin modulator is a drug which modulates the secretion of the pituitary hormone prolactin from the anterior pituitary gland. Prolactin inhibitors suppress and prolactin releasers induce the secretion of prolactin, respectively.[1][2]
Prolactin inhibitors are mainly used to treat hyperprolactinemia.[1] Agonists of the dopamine D2 receptor such as bromocriptine and cabergoline are able to powerfully suppress pituitary prolactin secretion and thereby decrease circulating prolactin levels, and so are most commonly used as prolactin inhibitors.[1] Antiestrogens such as aromatase inhibitors and GnRH analogues are also able to inhibit the secretion of prolactin, though not nearly as robustly as D2 receptor agonists, and as such, they are not usually used as prolactin inhibitors.
Whereas D2 receptor agonists suppress prolactin secretion, dopamine D2 receptor antagonists like domperidone and metoclopramide have the opposite effect, powerfully inducing the pituitary secretion of prolactin, and are sometimes used as prolactin releasers, for instance to correct hypoprolactinemia in the treatment of lactation failure.[2] When such drugs are used not for the purpose of inducing prolactin secretion, increased prolactin levels may be unwanted, and can result in various side effects including mammoplasia (breast enlargement), mastodynia (breast pain/tenderness), galactorrhea (inappropriate or excessive milk production/secretion), gynecomastia (breast development in males), hypogonadism (low sex hormone levels), amenorrhea (cessation of menstrual cycles), reversible infertility, and sexual dysfunction.
D2 receptor agonists that are described as prolactin inhibitors include bromocriptine, cabergoline, lergotrile, lisuride, metergoline, quinagolide, and terguride.[3]
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 domperidone 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 domperidone 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.
دومپریدون (به انگلیسی: Domperidone) که با نامهای تجاری موتیلیوم و موتینرم (Motilium, Motinorm) هم شناخته میشود، دارویی است ضددوپامینرژیک که معمولاً یا برای درمان تهوع و استفراغ بکار میرود، یا برای تحرک و منظم کردن حرکت دستگاه گوارش (داروی پروکینتیک) یا برای تحریک نمودن شیردهی بکار میرود. و برای ضد استفراغ کاربرد زیادی دارد.
شواهد موجود نشان میدهد که دومپریدون اثر ضد استفراغ دارد.[۲] برای درمان تهوع و استفراغ، همانطوریکه از متوکلوپرامید، سیکلیزین (که یک آنتیهیستامین است) و اندانسترون (که یک مسدودکننده زیرگروه سوم گیرنده پنج هیدروکسی تریپتامین(سروتونین) ۵HT۳ است) استفاده میشود، دومپریدون هم مورد استفاده قرار میگیرد. در بعضی کشورها، به عنوان اولین دارو در درمان استفراغ تجویز میشود، البته در آمریکا هنوز مجوز مصرف نگرفتهاست.
بر خلاف متوکلوپرامید که در بیماران مبتلا به پارکینسون منع مصرف دارد[۳]، از دومپریدون میتوان در درمان استفراغ بیمار پارکینسونی هم استفاده کرد[۴] چونکه دومپریدون از سد خونی-مغزی نمیگذرد.
در درمان گاستروپارزی (نوعی فلج حرکت و تخلیه معده)[۵] و ریفلاکس نوزادان از دومپریدون استفاده شدهاست.
قرص domperidone چیست
در کانادا، استفاده از این دارو برای درمان علامتی اختلالات حرکتی دستگاه گوارش فوقانی که بعلت گاستریت مزمن، گاستریت تحتحاد و گاستروپارزی دیابتی ایجاد شدهاند، به رسمیت شناخته شده.[۶]
در انسانها، هورمون پرولاکتین شیردهی را تحریک میکند و دوپامین ترشح شده از هیپوتالاموس، اثر جلوگیریکننده از رها شدن پرولاکتین را داراست. چون دومپریدون اثر ضد دوپامینی دارد، باعث افزایش ترشح پرولاکتین و به دنبال آن افزایش ترشح شیر از غدد پستانی میشود. البته این اثر دومپریدون باعث نشدهاست که در هیچ کشوری به عنوان داروی افزاینده شیردهی به رسمیت شناخته شود و بکار بردن این چنینی دومپریدون نوعی استفادهٔ بدون منبع در پزشکی تجربی محسوب میشود.[۷][۸]
با توجه به اینکه این دارو در شیر مادر ترشح میشود و مطالعهٔ قطعیی در مورد اثر آن روی کودکان شیرخوار منتشر نشدهاست، استفاده از آن به عنوان افزاینده شیر، مورد تأیید نیست. حتی در مقالهای ادعا شده که خطر تشنج در نوزادانی که مادرانشان دومپریدون خوراکی استفاده کرده بودند، افزایش مییابد.[۹]
در بعضی موارد نادر، دیده شدهاست که تزریق وریدی دومپریدون منجر به نامنظمی قلب و ایست قلبی شدهاست. چنین عوارضی باعث شده که در بعضی از کشورها نوع تزریق وریدی آن را جمعآوری نمایند.[۱۰]
در استرالیا ادعا شده در بیمارانی که بیش از ۳۰ میلیگرم در روز دمپریدون مصرف میکنند یا سنشان بالای ۶۰ سال است، خطر مرگ ناشی از ایست قلبی یا آریتمیهای بطنی نسبت به افراد معمولی بالاتر است.[۱۱]
دومپریدون (به انگلیسی: Domperidone) که با نامهای تجاری موتیلیوم و موتینرم (Motilium, Motinorm) هم شناخته میشود، دارویی است ضددوپامینرژیک که معمولاً یا برای درمان تهوع و استفراغ بکار میرود، یا برای تحرک و منظم کردن حرکت دستگاه گوارش (داروی پروکینتیک) یا برای تحریک نمودن شیردهی بکار میرود. و برای ضد استفراغ کاربرد زیادی دارد.
شواهد موجود نشان میدهد که دومپریدون اثر ضد استفراغ دارد.[۲] برای درمان تهوع و استفراغ، همانطوریکه از متوکلوپرامید، سیکلیزین (که یک آنتیهیستامین است) و اندانسترون (که یک مسدودکننده زیرگروه سوم گیرنده پنج هیدروکسی تریپتامین(سروتونین) ۵HT۳ است) استفاده میشود، دومپریدون هم مورد استفاده قرار میگیرد. در بعضی کشورها، به عنوان اولین دارو در درمان استفراغ تجویز میشود، البته در آمریکا هنوز مجوز مصرف نگرفتهاست.
بر خلاف متوکلوپرامید که در بیماران مبتلا به پارکینسون منع مصرف دارد[۳]، از دومپریدون میتوان در درمان استفراغ بیمار پارکینسونی هم استفاده کرد[۴] چونکه دومپریدون از سد خونی-مغزی نمیگذرد.
در درمان گاستروپارزی (نوعی فلج حرکت و تخلیه معده)[۵] و ریفلاکس نوزادان از دومپریدون استفاده شدهاست.
قرص domperidone چیست
در کانادا، استفاده از این دارو برای درمان علامتی اختلالات حرکتی دستگاه گوارش فوقانی که بعلت گاستریت مزمن، گاستریت تحتحاد و گاستروپارزی دیابتی ایجاد شدهاند، به رسمیت شناخته شده.[۶]
در انسانها، هورمون پرولاکتین شیردهی را تحریک میکند و دوپامین ترشح شده از هیپوتالاموس، اثر جلوگیریکننده از رها شدن پرولاکتین را داراست. چون دومپریدون اثر ضد دوپامینی دارد، باعث افزایش ترشح پرولاکتین و به دنبال آن افزایش ترشح شیر از غدد پستانی میشود. البته این اثر دومپریدون باعث نشدهاست که در هیچ کشوری به عنوان داروی افزاینده شیردهی به رسمیت شناخته شود و بکار بردن این چنینی دومپریدون نوعی استفادهٔ بدون منبع در پزشکی تجربی محسوب میشود.[۷][۸]
با توجه به اینکه این دارو در شیر مادر ترشح میشود و مطالعهٔ قطعیی در مورد اثر آن روی کودکان شیرخوار منتشر نشدهاست، استفاده از آن به عنوان افزاینده شیر، مورد تأیید نیست. حتی در مقالهای ادعا شده که خطر تشنج در نوزادانی که مادرانشان دومپریدون خوراکی استفاده کرده بودند، افزایش مییابد.[۹]
در بعضی موارد نادر، دیده شدهاست که تزریق وریدی دومپریدون منجر به نامنظمی قلب و ایست قلبی شدهاست. چنین عوارضی باعث شده که در بعضی از کشورها نوع تزریق وریدی آن را جمعآوری نمایند.[۱۰]
در استرالیا ادعا شده در بیمارانی که بیش از ۳۰ میلیگرم در روز دمپریدون مصرف میکنند یا سنشان بالای ۶۰ سال است، خطر مرگ ناشی از ایست قلبی یا آریتمیهای بطنی نسبت به افراد معمولی بالاتر است.[۱۱]
دومپریدون (به انگلیسی: Domperidone) که با نامهای تجاری موتیلیوم و موتینرم (Motilium, Motinorm) هم شناخته میشود، دارویی است ضددوپامینرژیک که معمولاً یا برای درمان تهوع و استفراغ بکار میرود، یا برای تحرک و منظم کردن حرکت دستگاه گوارش (داروی پروکینتیک) یا برای تحریک نمودن شیردهی بکار میرود. و برای ضد استفراغ کاربرد زیادی دارد.
شواهد موجود نشان میدهد که دومپریدون اثر ضد استفراغ دارد.[۲] برای درمان تهوع و استفراغ، همانطوریکه از متوکلوپرامید، سیکلیزین (که یک آنتیهیستامین است) و اندانسترون (که یک مسدودکننده زیرگروه سوم گیرنده پنج هیدروکسی تریپتامین(سروتونین) ۵HT۳ است) استفاده میشود، دومپریدون هم مورد استفاده قرار میگیرد. در بعضی کشورها، به عنوان اولین دارو در درمان استفراغ تجویز میشود، البته در آمریکا هنوز مجوز مصرف نگرفتهاست.
بر خلاف متوکلوپرامید که در بیماران مبتلا به پارکینسون منع مصرف دارد[۳]، از دومپریدون میتوان در درمان استفراغ بیمار پارکینسونی هم استفاده کرد[۴] چونکه دومپریدون از سد خونی-مغزی نمیگذرد.
در درمان گاستروپارزی (نوعی فلج حرکت و تخلیه معده)[۵] و ریفلاکس نوزادان از دومپریدون استفاده شدهاست.
قرص domperidone چیست
در کانادا، استفاده از این دارو برای درمان علامتی اختلالات حرکتی دستگاه گوارش فوقانی که بعلت گاستریت مزمن، گاستریت تحتحاد و گاستروپارزی دیابتی ایجاد شدهاند، به رسمیت شناخته شده.[۶]
در انسانها، هورمون پرولاکتین شیردهی را تحریک میکند و دوپامین ترشح شده از هیپوتالاموس، اثر جلوگیریکننده از رها شدن پرولاکتین را داراست. چون دومپریدون اثر ضد دوپامینی دارد، باعث افزایش ترشح پرولاکتین و به دنبال آن افزایش ترشح شیر از غدد پستانی میشود. البته این اثر دومپریدون باعث نشدهاست که در هیچ کشوری به عنوان داروی افزاینده شیردهی به رسمیت شناخته شود و بکار بردن این چنینی دومپریدون نوعی استفادهٔ بدون منبع در پزشکی تجربی محسوب میشود.[۷][۸]
با توجه به اینکه این دارو در شیر مادر ترشح میشود و مطالعهٔ قطعیی در مورد اثر آن روی کودکان شیرخوار منتشر نشدهاست، استفاده از آن به عنوان افزاینده شیر، مورد تأیید نیست. حتی در مقالهای ادعا شده که خطر تشنج در نوزادانی که مادرانشان دومپریدون خوراکی استفاده کرده بودند، افزایش مییابد.[۹]
در بعضی موارد نادر، دیده شدهاست که تزریق وریدی دومپریدون منجر به نامنظمی قلب و ایست قلبی شدهاست. چنین عوارضی باعث شده که در بعضی از کشورها نوع تزریق وریدی آن را جمعآوری نمایند.[۱۰]
در استرالیا ادعا شده در بیمارانی که بیش از ۳۰ میلیگرم در روز دمپریدون مصرف میکنند یا سنشان بالای ۶۰ سال است، خطر مرگ ناشی از ایست قلبی یا آریتمیهای بطنی نسبت به افراد معمولی بالاتر است.[۱۱]
دومپریدون (به انگلیسی: Domperidone) که با نامهای تجاری موتیلیوم و موتینرم (Motilium, Motinorm) هم شناخته میشود، دارویی است ضددوپامینرژیک که معمولاً یا برای درمان تهوع و استفراغ بکار میرود، یا برای تحرک و منظم کردن حرکت دستگاه گوارش (داروی پروکینتیک) یا برای تحریک نمودن شیردهی بکار میرود. و برای ضد استفراغ کاربرد زیادی دارد.
شواهد موجود نشان میدهد که دومپریدون اثر ضد استفراغ دارد.[۲] برای درمان تهوع و استفراغ، همانطوریکه از متوکلوپرامید، سیکلیزین (که یک آنتیهیستامین است) و اندانسترون (که یک مسدودکننده زیرگروه سوم گیرنده پنج هیدروکسی تریپتامین(سروتونین) ۵HT۳ است) استفاده میشود، دومپریدون هم مورد استفاده قرار میگیرد. در بعضی کشورها، به عنوان اولین دارو در درمان استفراغ تجویز میشود، البته در آمریکا هنوز مجوز مصرف نگرفتهاست.
بر خلاف متوکلوپرامید که در بیماران مبتلا به پارکینسون منع مصرف دارد[۳]، از دومپریدون میتوان در درمان استفراغ بیمار پارکینسونی هم استفاده کرد[۴] چونکه دومپریدون از سد خونی-مغزی نمیگذرد.
در درمان گاستروپارزی (نوعی فلج حرکت و تخلیه معده)[۵] و ریفلاکس نوزادان از دومپریدون استفاده شدهاست.
قرص domperidone چیست
در کانادا، استفاده از این دارو برای درمان علامتی اختلالات حرکتی دستگاه گوارش فوقانی که بعلت گاستریت مزمن، گاستریت تحتحاد و گاستروپارزی دیابتی ایجاد شدهاند، به رسمیت شناخته شده.[۶]
در انسانها، هورمون پرولاکتین شیردهی را تحریک میکند و دوپامین ترشح شده از هیپوتالاموس، اثر جلوگیریکننده از رها شدن پرولاکتین را داراست. چون دومپریدون اثر ضد دوپامینی دارد، باعث افزایش ترشح پرولاکتین و به دنبال آن افزایش ترشح شیر از غدد پستانی میشود. البته این اثر دومپریدون باعث نشدهاست که در هیچ کشوری به عنوان داروی افزاینده شیردهی به رسمیت شناخته شود و بکار بردن این چنینی دومپریدون نوعی استفادهٔ بدون منبع در پزشکی تجربی محسوب میشود.[۷][۸]
با توجه به اینکه این دارو در شیر مادر ترشح میشود و مطالعهٔ قطعیی در مورد اثر آن روی کودکان شیرخوار منتشر نشدهاست، استفاده از آن به عنوان افزاینده شیر، مورد تأیید نیست. حتی در مقالهای ادعا شده که خطر تشنج در نوزادانی که مادرانشان دومپریدون خوراکی استفاده کرده بودند، افزایش مییابد.[۹]
در بعضی موارد نادر، دیده شدهاست که تزریق وریدی دومپریدون منجر به نامنظمی قلب و ایست قلبی شدهاست. چنین عوارضی باعث شده که در بعضی از کشورها نوع تزریق وریدی آن را جمعآوری نمایند.[۱۰]
در استرالیا ادعا شده در بیمارانی که بیش از ۳۰ میلیگرم در روز دمپریدون مصرف میکنند یا سنشان بالای ۶۰ سال است، خطر مرگ ناشی از ایست قلبی یا آریتمیهای بطنی نسبت به افراد معمولی بالاتر است.[۱۱]
دومپریدون (به انگلیسی: Domperidone) که با نامهای تجاری موتیلیوم و موتینرم (Motilium, Motinorm) هم شناخته میشود، دارویی است ضددوپامینرژیک که معمولاً یا برای درمان تهوع و استفراغ بکار میرود، یا برای تحرک و منظم کردن حرکت دستگاه گوارش (داروی پروکینتیک) یا برای تحریک نمودن شیردهی بکار میرود. و برای ضد استفراغ کاربرد زیادی دارد.
شواهد موجود نشان میدهد که دومپریدون اثر ضد استفراغ دارد.[۲] برای درمان تهوع و استفراغ، همانطوریکه از متوکلوپرامید، سیکلیزین (که یک آنتیهیستامین است) و اندانسترون (که یک مسدودکننده زیرگروه سوم گیرنده پنج هیدروکسی تریپتامین(سروتونین) ۵HT۳ است) استفاده میشود، دومپریدون هم مورد استفاده قرار میگیرد. در بعضی کشورها، به عنوان اولین دارو در درمان استفراغ تجویز میشود، البته در آمریکا هنوز مجوز مصرف نگرفتهاست.
بر خلاف متوکلوپرامید که در بیماران مبتلا به پارکینسون منع مصرف دارد[۳]، از دومپریدون میتوان در درمان استفراغ بیمار پارکینسونی هم استفاده کرد[۴] چونکه دومپریدون از سد خونی-مغزی نمیگذرد.
در درمان گاستروپارزی (نوعی فلج حرکت و تخلیه معده)[۵] و ریفلاکس نوزادان از دومپریدون استفاده شدهاست.
قرص domperidone چیست
در کانادا، استفاده از این دارو برای درمان علامتی اختلالات حرکتی دستگاه گوارش فوقانی که بعلت گاستریت مزمن، گاستریت تحتحاد و گاستروپارزی دیابتی ایجاد شدهاند، به رسمیت شناخته شده.[۶]
در انسانها، هورمون پرولاکتین شیردهی را تحریک میکند و دوپامین ترشح شده از هیپوتالاموس، اثر جلوگیریکننده از رها شدن پرولاکتین را داراست. چون دومپریدون اثر ضد دوپامینی دارد، باعث افزایش ترشح پرولاکتین و به دنبال آن افزایش ترشح شیر از غدد پستانی میشود. البته این اثر دومپریدون باعث نشدهاست که در هیچ کشوری به عنوان داروی افزاینده شیردهی به رسمیت شناخته شود و بکار بردن این چنینی دومپریدون نوعی استفادهٔ بدون منبع در پزشکی تجربی محسوب میشود.[۷][۸]
با توجه به اینکه این دارو در شیر مادر ترشح میشود و مطالعهٔ قطعیی در مورد اثر آن روی کودکان شیرخوار منتشر نشدهاست، استفاده از آن به عنوان افزاینده شیر، مورد تأیید نیست. حتی در مقالهای ادعا شده که خطر تشنج در نوزادانی که مادرانشان دومپریدون خوراکی استفاده کرده بودند، افزایش مییابد.[۹]
در بعضی موارد نادر، دیده شدهاست که تزریق وریدی دومپریدون منجر به نامنظمی قلب و ایست قلبی شدهاست. چنین عوارضی باعث شده که در بعضی از کشورها نوع تزریق وریدی آن را جمعآوری نمایند.[۱۰]
در استرالیا ادعا شده در بیمارانی که بیش از ۳۰ میلیگرم در روز دمپریدون مصرف میکنند یا سنشان بالای ۶۰ سال است، خطر مرگ ناشی از ایست قلبی یا آریتمیهای بطنی نسبت به افراد معمولی بالاتر است.[۱۱]
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Active substance(s): DOMPERIDONE MALEATE
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
قرص domperidone چیست
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This leaflet is about the use of domperidone for gastro-oesophageal reflux.
This leaflet has been written specifically for parents and carers about the use of this medicine in children. The information may differ from that provided by the manufacturer. Please read this leaflet carefully. Keep it somewhere safe so that you can read it again.
Important information about domperidone:
In April 2014, MHRA released advice that domperidone should no longer be prescribed to treat conditions such as gastro-oesophageal reflux and heartburn. This is because there is a small chance that using domperidone over long periods of time can increase the risk of your child developing serious problems with their heart.
If you are reading this leaflet because your child has just been prescribed or is still using domperidone for reflux, discuss what to do with your doctor. Do not stop giving your child their medicine. If your child does have problems with their heart or you are concerned, contact your doctor, pharmacist or your local NHS services as soon as you can.
You can read the press release from MHRA about domperidone here: http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON409258
DomperidoneCommon brand: Motilium®
Domperidone helps to keep the entrance to the stomach properly closed, so that the stomach contents do not leak back up into the food pipe (oesophagus). Your child is therefore less likely to be sick (vomit) or have reflux after a meal or feed.قرص domperidone چیست
Your doctor will work out the amount of domperidone (the dose) that is right for your child. The dose will be shown on the medicine label.
It is important that you follow your doctor’s instructions about how much to give.
Tablets should be swallowed with a glass of water, milk or juice. Your child should not chew the tablets.
Liquid medicine: Shake the medicine well. Measure out the right amount using a medicine spoon or oral syringe. You can get these from your pharmacist. Do not use a kitchen teaspoon as it will not give the right amount.
Domperidone works quickly to prevent vomiting with each feed or meal.
If your child is sick again, seek advice from your GP, pharmacist or hospital. They will decide what to do based on your child’s condition and the specific medicine involved
If you forget to give the medicine before a meal but remember during the meal, give the missed dose. If you remember after this, do not give the missed dose.
Never give a double dose of domperidone.
You are unlikely to do harm if you give an extra dose of domperidone by mistake.
If you are concerned that you may have given too much, or if your child is dizzy, faints, has a dry mouth or seems unusually floppy, they may have had too much domperidone. Contact your doctor or local NHS services (111 in parts of England and Scotland; 0845 4647 in Wales).
Take the medicine container or packaging with you, even if it is empty. This will be useful to the doctor.Have the medicine packet with you when you telephone for advice.
We use medicines to make our children better, but sometimes they have other effects that we don’t want (side-effects).
Domperidone is generally a safe medicine and causes few side effects. The side-effects will stop when they stop taking the medicine.
If your child has tremor (shakiness), moves strangely or slowly, or their speech is slurred, contact your doctor straight away.
There may, sometimes, be other side-effects that are not listed above. If you notice anything unusual and are concerned, contact your doctor. You can report any suspected side-effects to a UK safety scheme at http://www.mhra.gov.uk/yellowcard.
In April 2014, MHRA released advice that domperidone should no longer be prescribed to treat conditions such as gastro-oesophageal reflux and heartburn. This is because there is a small chance that using domperidone over long periods of time can increase the risk of your child developing serious problems with their heart.
If you are reading this leaflet because your child has just been prescribed or is still using domperidone for reflux, discuss what to do with your doctor. Do not stop giving your child their medicine. If your child does have problems with their heart or you are concerned, contact your doctor, pharmacist or your local NHS services as soon as you can.
If you think someone else may have taken the medicine by accident, contact your doctor straight away.
Your child’s doctor, pharmacist or health visitor will be able to give you more information about domperidone and other medicines used to treat gastro-oesophageal reflux.
Version 2.1, February 2014 (June 2014). © NPPG, RCPCH and WellChild 2010, all rights reserved. Reviewed by: February 2017.
The primary source for the information in this leaflet is the British National Formulary for Children. For details on any other sources used for this leaflet, please contact us through our website, www.medicinesforchildren.org.uk
We take great care to make sure that the information in this leaflet is correct and up-to-date. However, medicines can be used in different ways for different patients. It is important that you ask the advice of your doctor or pharmacist if you are not sure about something. This leaflet is about the use of these medicines in the UK, and may not apply to other countries. The Royal College of Paediatrics and Child Health (RCPCH), the Neonatal and Paediatric Pharmacists Group (NPPG), WellChild and the contributors and editors cannot be held responsible for the accuracy of information, omissions of information, or any actions that may be taken as a consequence of reading this leaflet.
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A specific blocker of dopamine receptors. It speeds gastrointestinal peristalsis, causes prolactin release, and is used as antiemetic and tool in the study of dopaminergic mechanisms.
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.
A governmentally-recognized ID which uniquely identifies the product within its regulatory market.قرص domperidone چیست
For management of dyspepsia, heartburn, epigastric pain, nausea, and vomiting.
Domperidone is a specific blocker of dopamine receptors. It speeds gastrointestinal peristalsis, causes prolactin release, and is used as antiemetic and tool in the study of dopaminergic mechanisms.
Domperidone acts as a gastrointestinal emptying (delayed) adjunct and peristaltic stimulant. The gastroprokinetic properties of domperidone are related to its peripheral dopamine receptor blocking properties. Domperidone facilitates gastric emptying and decreases small bowel transit time by increasing esophageal and gastric peristalsis and by lowering esophageal sphincter pressure. Antiemetic: The antiemetic properties of domperidone are related to its dopamine receptor blocking activity at both the chemoreceptor trigger zone and at the gastric level. It has strong affinities for the D2 and D3 dopamine receptors, which are found in the chemoreceptor trigger zone, located just outside the blood brain barrier, which – among others – regulates nausea and vomiting
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.
91%-93%
7 hours
Side effects include galactorrhea, gynecomastia, or menstrual irregularities.
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.
Vanderberk, J., Kennis, L.E.J., Van der Aa, M.J.M.C. and Van Heertum, A.H.M.T.; U.S. Patents 4,066,772; January 3,1978; 4.1 10,333; August 29,1978; 4,126,687; November 21, 1978; 4,126,688; November 21,1978; 4,160,836; July 10,1979 and 4,175,129; November 20,1979; all assigned to Janssen Pharmaceutica NV (Belgium).
There is additional data available for commercial users including Adverse Effects, Contraindications, and Blackbox Warnings. Contact us to learn more about these and other features.
Drug created on June 13, 2005 07:24 / Updated on July 06, 2019 02:02
