خواص دارویی و گیاهی
نشانگذاری
عجب سازنده ی این علامت عرب دولاب است
[[رده:نمادهای
نوشتار]]
Please read this leaflet carefully before you start to take your medicine.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.
The name of your medicine is Domperidone 1mg Tablets.
Domperidone is an anti-emetic which can stop you feeling sick.
The active ingredient is domperidone maleate.
Each tablet contains 1mg domperidone as domperidone maleate.
Domperidone is used to treat:
Important information about one of the ingredients in your medicine
These tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
DO NOT TAKE Domperidone 1mg Tablets if you:
Before you use Domperidone 1mg Tablets tell your doctor if you:
Driving and using machinery
It is unlikely that these tablets will affect your ability to drive or operate machinery.
Taking other medicines
Please inform your doctor or pharmacist if you are taking, or have recently taken any other medicine, even those not prescribed by a doctor, including any of the following:
If taken with other medicines the effect of Domperidone 1mg Tablets or the effects of the other medicine may be altered.
These tablets have been prescribed for you by a doctor. Take them exactly as he or she has told you. Please read the label carefully.
Domperidone should be used at the lowest effective dose in adults and children.
The tablets should be swallowed whole with a sufficient quantity of liquid (e.g. one glass of water).
Adults and adolescents (weighing 35kg or more i.e. approximately 5 stone)
The usual dose for the treatment is 1 to 2 tablets taken 3 to 4 times a day before meals. Do not take more than 8 tablets (8mg) in 24 hours.
Infants and Children
Children weighing less than 35kg (5 stone) should not take these tablets. The usual dose for the treatment is .25 .5mg per kg bodyweight taken 3 to 4 times a day before meals. Your pharmacist may be able to help you if you are not sure.
People with kidney problems
Your doctor may tell you to take a lower dose or take the medicine less often.
Your doctor may advise you to take your medicine in a different way, so you should always follow your doctor s advice about how and when to take your medicine and always read the label. If you feel that the effect of Domperidone 1mg Tablets is too strong or too weak, talk to your doctor or pharmacist.
If your complaint shows no improvement after 28 days while taking Domperidone 1mg Tablets, consult your doctor to see if you need to go on taking this medicine.
If you take more Domperidone 1mg Tablets than you should
If you take more tablets than you should, tell your doctor immediately or go to the nearest hospital.
You may be given active charcoal, which can prevent the absorption of domperidone, if taken soon after having taken the overdose. Symptoms of overdose are drowsiness, disorientation, irregular eye movements and strange movements of the body, especially in children.
If you forget to take your tablets
Take your tablets as soon as you remember. If it is almost time for your next dose, wait until that is due and continue as normal. Do not take a double dose to make up for the forgotten dose.
Like all medicines, Domperidone 1mg Tablets can have side
effects.
If any of the following side effects occur, STOP TAKING your
Domperidone 1mg Tablets and tell your doctor immediately
or go to your nearest hospital as it may be an allergic reaction:
If you experience any of the following, STOP TAKING
Domperidone 1mg Tablets and talk to your doctor:
Rare side effects
In rare cases domperidone may:
Very rare side effects
Frequency unknown
Domperidone may be associated with an increased risk of heart
rhythm disorder and cardiac arrest. This risk may be more likely in
those over 6 years old or taking doses higher than 3mg per day.
Domperidone should be used at the lowest effective dose in adults and children.
If you notice any side effects not mentioned in this leaflet, or if any of the side effects listed become serious or last longer than a few days please inform your doctor or pharmacist.
Do not use your Domperidone 1mg Tablets after the expiry date printed on the package. If you have any tablets that are out of date, please them to your pharmacist for disposal.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Store the tablets in the original package.
Domperidone 1mg Tablets are white coloured, round, biconvex tablets. The active ingredient is domperidone maleate. Each tablet also contains several inactive ingredients. These include lactose monohydrate, maize starch, microcrystalline cellulose, povidone, magnesium stearate, colloidal anhydrous silica and sodium laurilsulfate.
Domperidone 1mg Tablets are supplied in cartons of 1, 3 or 1 tablets.
The marketing authorisation holder:
Athlone Pharmaceuticals Limited, Ballymurray, Co.Roscommon, Ireland.
Distributor:
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT.
Product Licence Number: PL3464/93
This leaflet was last revised in April 212.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
More drug information updates
The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices.
Subscribe to receive email notifications whenever new articles are published.
Drugs.com provides accurate and independent information on more than 24, preion drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include Micromedex® (updated Sep 4th, 218), Cerner Multum™ (updated Sep 4th, 218), Wolters Kluwer™ (updated Sep 3rd, 218) and others. To view content sources and ibutions, please refer to our editorial policy.
We comply with the HONcode standard for trustworthy health information – verify here
© 2-218 Drugs.com. All rights reserved.
دومپریدوندومپریدون داروی پرکاربردی است که جهت برطرف کردن حالت تهوع یا استفراغ مصرف می شود.
احساس تهوع اگرچه یک علامت شایع می باشد اما می تواند ناشی از عوامل مختلفی باشد. داروهای ضدتهوع مانند دومپریدون را تنها زمانی می توانید مصرف کنید که علت تهوع شما مشخص شده باشد.
دومپریدون با کمک به تسریع حرکت غذا در دستگاه گوارش ، تهوع را مهار می نماید.
پیش از مصرف دومپریدون- در صورت بارداری یا شیردهی به پزشک اطلاع دهید .
– در صورت سابقه ی مشکلات کبدی ، ضربان قلب نظم ، گوارشی (انسداد یا خونریزی دستگاه گوارشی)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 دومپریدون -اگرچه باید دومپریدون را دقیقاً طبق دستور پزشک مصرف نمایید، اما معمولاً مقدار مصرف روزانه ی آن برای بزرگسالان و افراد بالای ۱۶سال، یک قرص، سه مرتبه در روز می باشد.
-از مصرف بیش از سه قرص در ۲۴ساعت خودداری نمایید .
-در صورتی که این دارو برای کودک شما تجویز شده است، مقدار مصرف آن باید توسط پزشک محاسبه گردد.
-بهتر است دومپریدون را نیم ساعت پیش از غذا مصرف کنید.با این حال مصرف پس از غذا نیز موثر می باشد اما زمان بیشتری طول می کشد تا اثر نماید.
-درمان با این دارو عموماً کوتاه مدت می باشد و از هفت روز طول نمی کشد.عوارض شایع دومپریدون_خشکی دهان نیز از علائم مربوط به مصرف این دارو میباشد که با آدامس یا آبنبات فاقد شکر می توان آن را برطرف نمود .
-ضربان قلب بالا و از هوش رفتن در برخی افراد مصرف کننده ی این دارو مشاهده می شود. در صورت وقوع این علائم به پزشک خود مراجعه نمایید.
-در صورت احساس اضطراب، خواب آلودگی، ضعف، سردرد و اسهال با پزشک خود مشورت نمایید تا راهکار مناسب را دریافت نمایید.
-در صورت ورم و دردناکی سینه ها، قاعدگی نظم، ترشح شیر غیر معمول از سینه ها، لکه های قرمز و خارش پوستی پزشک خود را مطلع سازید.
پاسخ به سوالات پزشکی و جنسی شما ، در مجله دلگرم کلیک کنید
POM: Preion only medicine
This information is intended for use by health professionals
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
Domperidone 1mg Tablets
Each tablet contains Domperidone maleate equivalent to 1mg domperidone base.
For a full list of excipients see section 6.1.
Tablets
Domperidone 1mg Tablet is presented as a white round biconvex tablet with “Dm 1 inion on one side.
Domepridone is indicated for the relief of the symptoms of nausea and vomiting.
Domeperidone should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.
Domperidone 1mg Tablets are for oral administration.
It is recommended to take oral domperidone tablets before meals. If taken after meals, absorption of the drug is somewhat delayed.
Patients should try to take each dose at scheduled time. If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed. The dose should not be doubled to make up for a missed dose.
Usually, the maximum treatment duration should not exceed one week.
Adults and adolescents (12 years of age and older and weighing 35 kg or more)
One 1mg tablet up to three times per day with maximum dose of 3 mg per day.
Neonates, infants, children (less than 12 years of age) and adolescents weighing less than 35 kg
Hepatic Impairment
Domperidone is contraindicated in moderate or severe hepatic impairment (see section 4.3). Dose modification in mild hepatic impairment is however not needed (see section 5.2).
Renal Impairment
Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of Domperidone tablets should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced. Such patients on prolonged therapy should be reviewed regularly (see sections 4.4 and 5.2)
Domperidone is contraindicated in the following situations:
• In patients with moderate or severe hepatic impairment (see section 5.2).
• In patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure (see section 4.4)
• Co-administration with QT-prolonging drugs, at the exception of apomorphine (see section 4.4 and 4.5).
• Co-administration with potent CY3A4 inhibitors (regardless of their QT prolonging effects) (see section 4.5)
• Known hypersensitivity to domperidone or any of the excipients.
• Prolactin-releasing pituitary tumour (prolactinoma.)
• Renal impairment
Domperidone should not be used when stimulation of gastric motility could be harmful: gastro-intestinal haemorrhage, mechanical obstruction or perforation.
Precautions for use
Domperidone tablets contain lactose and may be unsuitable for patients with lactose intolerance, galactosaemia or glucose/galactose malabsorption.
Use in infants
Neurological side effects are rare (see “Undesirable effects” section). Since metabolic s and the blood-brain barrier are not fully developed in the first months of life the risk of neurological side effects is higher in young children.
Overdosing may cause extrapyramidal symptoms in children, but other causes should be taken into consideration.
Renal Impairment
The elimination half-life of domperidone is prolonged in severe renal impairment. For repeated administration, the dosing frequency of domperidone should be reduced to once or twice daily depending on the severity of the impairment. The dose may also need to be reduced.
Cardiovascular effects
Domperidone has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking domperidone. These reports included patients with confounding risk factors, electrolyte abnormalities and concomitant treatment which may have been contributing factors (see section 4.8).
Epidemiological studies showed that domperidone was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death (see section 4.8). A higher risk was observed in patients older than 6 years, patients taking daily doses greater than 3 mg, and patients concurrently taking QT-prolonging drugs or CYP3A4 inhibitors.
Domperidone should be used at the lowest effective dose in adults and children.
Domperidone is contraindicated in patients with known existing prolongation of cardiac conduction intervals, particularly QTc, in patients with significant electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia), or bradycardia, or in patient with underlying cardiac diseases such as congestive heart failure due to increased risk of ventricular arrhythmia (see section 4.3). Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) or bradycardia are known to be conditions increasing the proarrythmic risk.
Domperidone is contra-indicated with QT prolonging drugs including apomorphine, unless the benefit of the co-administration with apomorphine outweighs the risks, and only if the recommended precautions for co-administration mentioned in the apomorphine SmPC are strictly fulfilled. Please refer to the apomorphine SmPC
Treatment with domperidone should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patient should consult their physician.
Patient should be advised to promptly report any cardiac symptoms.
The main metabolic pathway of domperidone is through CYP3A4. In vitro data suggest that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of domperidone.
Increased risk of occurrence of QT-interval prolongation, due to pharmacodynamic and/or pharmacokinetic interactions.
Concomitant use of the following substances is contraindicated
QTc-prolonging medicinal products
• anti-arrhythmics class IA (e.g., disopyramide, hydroquinidine, quinidine)
• anti-arrhythmics class III (e.g., amiodarone, dofetilide, dronedarone, ibutilide, sotalol)
• certain antipsychotics (e.g., haloperidol, pimozide, sertindole)
• certain antidepressants (e.g., citalopram, escitalopram)
• certain antibiotics (e.g. , erythromycin, levofloxacin, moxifloxacin, spiramycin)
• certain antifungal agents (e.g., pentamidine)
• certain antimalarial agents (in particular halofantrine, lumefantrine)
• certain gastro-intestinal medicines (e.g., cisapride, dolasetron, prucalopride)
• certain antihistaminics (e.g., mequitazine, mizolastine)
• certain medicines used in cancer (e.g., toremifene, vandetanib, vincamine)
• certain other medicines (e.g., bepridil, diphemanil, methadone) (see section 4.3).
• apomorphine, unless the benefit of the co-administration outweighs the risks, and only if the recommended precautions for co-administration are strictly fulfilled. Please refer to the apomorphine SmPC.
Potent CYP3A4 inhibitors (regardless of their QT prolonging effects), i.e :
• protease inhibitors
• systemic azole antifungals
• some macrolides (erythromycin, clarithromycin and telithromycin) (see section 4.3).
Concomitant use of the following substances is not recommended
Moderate CYP3A4 inhibitors i.e. diltiazem, verapamil and some macrolides.
(see section 4.3)
Concomitant use of the following substances requires caution in use
Caution with bradycardia and hypokalaemia-inducing drugs, as well as with the following macrolides involved in QT-interval prolongation: azithromycin and roxithromycin (clarithromycin is contraindicated as it is a potent CYP3A4 inhibitor).
The above list of substances is representative and not exhaustive.
Separate in vivo pharmacokinetic/pharmacodynamic interaction studies with oral ketoconazole or oral erythromycin in healthy subjects confirmed a marked inhibition of domperidone’s CYP3A4 mediated first pass metabolism by these drugs.
With the combination of oral domperidone 1mg four times daily and ketoconazole 2mg twice daily, a mean QTc prolongation of 9.8 msec was seen over the observation period, with changes at individual time points ranging from 1.2 to 17.5 msec. With the combination of domperidone 1mg four times daily and oral erythromycin 5mg three times daily, mean QTc over the observation period was prolonged by 9.9 msec, with changes at individual time points ranging from 1.6 to 14.3 msec. Both the Cmax and AUC of domperidone at steady state were increased approximately three-fold in each of these interaction studies. In these studies domperidone monotherapy at 1mg given orally four times daily resulted in increases in mean QTc of 1.6 msec (ketoconazole study) and 2.5 msec (erythromycin study), while Ketoconazole monotherapy (2mg twice daily) led to increases in QTc of 3.8 and 4.9 msec, respectively, over the observation period.
Pregnancy-
There are limited post-marketing data on the use of domperidone in pregnant women. A study in rats has shown reproductive toxicity at a high, maternally toxic dose. The potential risk for humans is unknown. Therefore, domperidone should only be used during pregnancy when justified by the anticipated therapeutic benefit.
Breast-feeding
Domperidone is excreted in human milk and breast-fed infants receive less than .1% of the maternal weight-adjusted dose. Occurrence of adverse effects, in particular cardiac effects cannot be excluded after exposure via breast milk. A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from domperidone therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the women. Caution should be exercised in case of QTc prolongation risk factor in breast-fed infants.
Domperidone has no or negligible influence on the ability to drive or use machines.
The following frequencies are used for the deion of the occurrence of adverse reactions:
Very common (≥1/1) common (≥1/1 to <1/1) uncommon (≥1/1, to <1/1) rare (≥1/1, to <1/1,) very rare (<1/1,), unknown (cannot be estimated from the available data).
Where frequency cannot be estimated from clinical trials data, it is recorded as “Not known.
System Organ Class
Adverse Drug Reaction
Frequency
Common
Uncommon
Psychiatric disorders
Loss of libido
Anxiety
Nervous system disorders
Somnolence
Headache
Gastrointestinal disorders
Dry mouth
Diarrhoea
Skin and subcutaneous tissue disorder
Rash
Pruritus
Reproductive system and breast disorders
Galactorrhoea
Breast pain
Breast tenderness
General disorders and administration site conditions
Asthenia
Postmarketing experience
In addition to the adverse effects reported during clinical studies and listed above, the following adverse drug reactions have been reported.
Immune System Disorder:
Not know: anaphylactic reactions including anaphylactic shock, angioedema, allergic reaction
Psychiatric System Disorder:
Not known: agitation, nervousness
Nervous system disorders:
Not known extrapyramidal disorder, convulsions,
Eye disorders:Not known: Oculogyric crisis
Skin and subcutaneous tissue disorders:
Not known: urticaria, angioedema
Reproductive system and breast disorders:
Not known:, gynaecomastia, amenorrhoea.
Cardiac disorders:
Not known ventricular arrhythmias, QTc prolongation, Torsade de pointes, sudden cardiac death (See sections 4.4).
Investigations:
Not known: liver test abnormal, blood prolactin increased
As the hypophysis is outside the blood brain barrier, domperidone may cause an increase in prolactin levels. In rare cases this hyperprolactinaemia may lead to neuro-endocrinological side effects such as galactorrhoea, gynaecomastia and amenorrhoea.
Extrapyramidal side effects are very rare in neonates and infants, and exceptional in adults. These side effects reverse spontaneously and completely as soon as the treatment is stopped.
Other central nervous system-related effects of convulsion, agitation and somnolence also are very rare and primarily reported in infants and children.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms
Overdose has been reported primarily in infants and children. Symptoms of overdosage may include agitation, altered consciousness, convulsions, disorientation, somnolence and extrapyramidal reactions.
Treatment
There is no specific antidote to domperidone, but in the event of overdose, standard symptomatic treatment should be given immediately. Gastric lavage as well as the administration of activated charcoal, may be useful. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Close medical supervision and supportive therapy is recommended.
Anticholinergic, anti-parkinson drugs may be helpful in controlling the extrapyramidal reactions.
Pharmacotherapeutic Group: Propulsives, ATC code: A3F A3
Domperidone is a dopamine antagonist with anti-emetic properties domperidone does not readily cross the bloodbrain barrier. In domperidone users, especially in adults, extrapyramidal side effects are very rare, but domperidone promotes the release of prolactin from the pituitary. Its anti-emetic effect may be due to a combination of peripheral (gastrokinetic) effects and antagonism of dopamine receptors in the chemoreceptor trigger zone, which lies outside the blood-brain barrier in the area postrema. Animal studies, together with the low concentrations found in the brain, indicate a predominantly peripheral effect of domperidone on dopamine receptors. Studies in man have shown oral domperidone to increase lower oesophageal pressure, improve antroduodenal motility and accelerate gastric emptying. There is no effect on gastric secretion.
In accordance with ICH-E14 guidelines, a thorough QT study was performed. This study included a placebo, an active comparator and a positive control and was conducted in healthy subjects with up to 8 mg per day 1 or 2 mg administered 4 times a day of domperidone. This study found a maximal difference of QTc between domperidone and placebo in LS-means in the change from baseline_of 3.4 msec for 2 mg domperidone administered 4 times a day on Day 4. The 2-sided 9% CI (1. to 5.9 msec) did not exceed 1 msec. No clinically relevant QTc effect were observed in this study when domperidone was administered at up to 8 mg/day (i.e., more than twice the maximum recommended dosing).
However, two previous drug-drug interaction studies showed some evidence of QTc prolongation when domperidone was administered as monotherapy (1 mg 4 times a day). The largest time-matched mean difference of QTcF between domperidone and placebo was 5.4 msec (95 % CI: -1.7 to 12.4) and 7.5msec (95 % CI: .6 to 14.4), respectively.
Absorption
Domperidone is rapidly absorbed after oral administration with peak plasma concentrations occurring at approximately 1 hr after dosing.. The Cmax and AUC values of domperidone increased proportionally with dose in the 1 mg to 2 mg dose range. A 2- to 3-fold accumulation of domperidone AUC was observed with repeated four times daily (every 5 hr) dosing of domperidone for 4 days.
The low absolute bioavailability of oral domperidone (approximately 15%) is due to an extensive first-pass metabolism in the gut wall and liver. Although domperidone’s bioavailability is enhanced in normal subjects when taken after a meal, patients with gastrointestinal complaints should take domperidone 15-3 minutes before a meal. Reduced gastric acidity impairs the absorption of domperidone. Oral bioavailability is decreased by prior concomitant administration of cimetidine and sodium bicarbonate. The time of peak absorption is slightly delayed and the AUC somewhat increased when the oral drug is taken after a meal.
Distribution
Oral domperidone does not appear to accumulate or induce its own metabolism a peak plasma level after 9 minutes of 21ng/ml after two weeks oral administration of 3 mg per day was almost the same as that of 18 ng/ml after the first dose. Domperidone is 91-93% bound to plasma proteins. Distribution studies with radiolabelled drug in animals have shown wide tissue distribution, but low brain concentration. Small amounts of drug cross the placenta in rats.
Metabolism
Domperidone undergoes rapid and extensive hepatic metabolism by hydroxylation and N-dealkylation. In vitro metabolism experiments with diagnostic inhibitors revealed that CYP3A4 is a major form of cytochrome P-45 involved in the N-dealkylation of domperidone, whereas CYP3A4, CYP1A2 and CYP2E1 are involved in domperidone aromatic hydroxylation.
Excretion
Urinary and faecal excretions amount to 31 and 66% of the oral dose respectively, The proportion of the drug excreted unchanged is small (1% of faecal excretion and approximately 1% of urinary excretion). The plasma half life after a single oral dose is 7-9 hours in healthy subjects but is prolonged in patients with severe renal insufficiency.
Hepatic impairment
In subjects with moderate hepatic impairment (Pugh score 7 to 9, Child-Pugh rating B), the AUC and Cmax of domperidone is 2.9- and 1.5- fold higher, respectively, than in healthy subjects.
The unbound fraction is increased by 25%, and the terminal elimination half-life is prolonged from 15 to 23 hours. Subjects with mild hepatic impairment have a somewhat lower systemic exposure than healthy subjects based on Cmax and AUC, with no change in protein binding or terminal half-life. Subjects with severe hepatic impairment were not studied. Domperidone is contraindicated in patients with moderate or severe hepatic impairment (see section 4.3).
Renal impairment
In subjects with renal insufficiency (creatinine clearance<3 ml/min/1.73m2) the elimination half-life of domperidone was increased from 7.4 to 2.8 hours, but plasma drug levels were lower than in healthy volunteers.
Since very little unchanged drug (approximately 1%) is excreted via the kidneys, it is unlikely that the dose of a single administration needs to be adjusted in patients with renal insufficiency.
However, on repeated administration, the dosing frequency should be reduced to once or twice daily depending on severity of the impairment, and the dose may need to be reduced.
Electrophysiological in vitro and in vivo studies indicate an overall moderate risk of domperidone to prolong the QT interval in humans. In in vitro experiments on isolated cells transfected with hERG and on isolated guinea pig myocytes exposure ratios ranged between 26 – 47-fold, based on IC5 values inhibiting currents through IKr ion channels in comparison to the free plasma concentrations in humans after administration of the maximum daily dose of 1 mg administered 3 times a day. safety margins for prolongation of action potential duration in in vitro experiments on isolated cardiac tissues exceeded the free plasma concentrations in humans at maximum daily dose (1 mg administered 3 times a day) by 45-fold.
Safety margins in in vitro proarrhythmic models (isolated Langendorff perfused heart) exceeded the free plasma concentrations in humans at maximum daily dose (1 mg administered 3 times a day) by 9- up to 45-fold. In in vivo models the no effect levels for QTc prolongation in dogs and induction of arrhythmias in a rabbit model sensitized for torsade de pointes exceeded the free plasma concentrations in humans at maximum daily dose (1 mg administered 3 times a day) by more than 22-fold and 435-fold, respectively. In the anesthetized guinea pig model following slow intravenous infusions, there were no effects on QTc at total plasma concentrations of 45.4ng/ml, which are 3-fold higher than the total plasma levels in humans at maximum daily dose (1 mg administered 3 times a day). The relevance of the latter study for humans following exposure to rally administered domperidone is uncertain.
In the presence of inhibition of the metabolism via CYP3A4 free plasma concentrations of domperidone can rise up to 3- fold.
At a high, maternally toxic dose (more than 4 times the recommended human dose), teratogenic effects were seen in the rat. No teratogenicity was observed in mice and rabbits.
Microcrystalline cellulose
Lactose monohydrate
Maize starch
Povidone K3
Sodium lauryl sulphate
Silica colloidal, anhydrous
Magnesium stearate
Not Applicable
24 months.
Do not store above 25°C. Store in the original package.
The tablets are packed in blisters constituted from a PVC and aluminium foil in packs of 3 and 1.
None
Milpharm Limited,
Ares,
Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD,
United Kingdom
PL 16363/16
3 February 23
14/11/217
Odyssey Business Park, Ares Block, West End Road, South Ruislip, Middlesex, HA4 6QD
+ 44 ()28 845 8811
medinfo@aurobindo.com
+44 ()28 845 8795
http://www.aurobindo.com
+44 ()28 845 8735
+44 ()28 845 8811
To bookmark a medicine you must sign up and log in.
To email a medicine you must sign up and log in.
To view the changes to a medicine you must sign up and log in.
This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies.
Continue
Loading
Loading
Loading
Working
Loading
Loading
Working
Loading
Loading
Loading
Antiemetic, domperidone, vomiting
Loading
Loading
Loading
Loading
Loading
Working
Loading playlists
1