خواص قرص domperidone - کامل (هلپ کده)

خواص دارویی و گیاهی

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عجب سازنده ی این علامت عرب دولاب است
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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

قرص دومپریدون اغلب برای درمان ناراحتی های گوارشی و میگرن مورد استفاده قرار می گیرد. در این مطلب به طور کامل و جامع موارد مصرف، منع مصرف و عوارض جانبی این قرص را مورد بررسی قرار داه ایم. این دارو همچنین ممکن است با برخی داروها تداخلات دارویی داشته باشد.

قرص دومپریدون 1 میلی گرم ضد تهوع و استفراغ می باشد که مصرف آن باعث می شود احساس ناراحتی و مریضی شما متوقف گردد. ماده فعال موجود در این قرص دومپریدون مالیت است. در این مطلب اطلاعاتی جامع در مورد این قرص در اختیار شما عزیزان قرار گرفته است. در صورت داشتن سوالات لطفا با پزشک متخصص خود مشورت کنید.

قبل از شروع مصرف هر دارو بهتر است اطلاعاتی جامع و کامل در مورد نحوه مصرف آن و احتیاطی که در هنگام مصرف آن باید کرد اطلاعاتی داشته باشیم. یکی از قرص هایی که اغلب برای تهوع و استفراغ، سوء هاضمه و گاستروپارزی دیابتی و میگرن مورد استفاده قرار می گیرد دومپریدون می باشد. در این مطلب اطلاعات دارویی این قرص را با هم مطالعه خواهیم کرد. تا پایان مطلب همراه ما باشید.

این دارو اغلب برای حالت تهوع و استفراغ و شکایت از ناراحتی های معده که اغلب در اثر تخلیه دیر هنگام شکم صورت می گیرد مورد استفاده قرار می گیرد. ناراحتی معده ممکن است همچنین عواملی مثل احساس پر بودن شکم در طول خوردن غذا یا بلافاصله پس از آن، نفخ، آروغ، تهوع، سوزش معده و دل درد را به همراه داشته باشد.

این دارو را پزشک شما تجویز کرده است پس مطابق دستور پزشک آن را مصرف کنید. دوز مصرفی قرص دومپریدون در افراد بزرگسال و کودکان متفاوت می باشد. قرص را باید به یکباره و همراه مقدار کافی مایعات( یک لیوان آب) بخورید. افراد با ناراحتی های کلیوی باید از دوزهای کمتری استفاده کنند. اگر احساس کردید قدرت داروی دومپریدون زیاد یا کم می باشد با دکتر یا پزشک متخصص خود مشورت کنید. دوز معمول آن به سن، جنس، شرایط پزشکی، واکنش به درمان و استفاده از داروهایی معینی که با این دارو تداخل دارند وابسته می باشد. افراد بزرگسال نباید بیش از سه قرص در روز مصرف کنند. اگر بعد از 28 روز پس از گذشت مصرف این قرص همچنان از ناراحتی و بیماری خود رنج می برید با پزشک خود در مورد ادامه طول درمان مشورت کنید. اگر بیش از دوز معمول از این دارو استفاده کردید فورا پزشک خود را در جریان قرار دهید یا به نزدیک ترین بیمارستان مراجعه کنید. علایم مصرف از دوز معمول خواب آلودگی، گیجی، حرکات چشم نظم و حرکات عجیب بدن بویژه در کودکان است. و اگر استفاده از دوز معمول خود را فراموش کردید اگر تقریبا به زمان بعدی مصرف نزدیک می باشد منتظر باشید تا زمان بعدی مصرف فرا برسد و به استفاده دوزها به طور معمول ادامه دهید. برای جبران دوز فراموش شده هرگز دو وعده را با هم مصرف نکنید. حداکثر دوره درمان نباید به طور معمول از یک هفته باشد.

این قرص ها حاوی لاکتوز مونوهیدرات هستند. اگر به دومپریدون یا هر یک از عناصر موجود در این دارو حساسیت دارید یا مشکلات جدی روده ای مثل خونریزی معده داخلی دارید یا مانعی در شکم یا روده شما وجود دارد یا از تومور غده هیپوفیز رنج می برید نباید از این قرص استفاده کنید. و اگر مبتلا به اختلالات کبد، کلیه می باشید یا اگر حامله هستید و یا قصد بارداری دارید و یا در دوران شیردهی می باشید. اگر از ناراحتی های قلبی رنج می برید قبل از مصرف دارو حتما با پزشک خود مشورت کنید. زیرا این دارو ضربان قلب شما را تحت تاثیر قرار می دهد به ویژه در افرادی که بیش از شصت سال سن دارند و بیش از 3 میلی گیرم روزانه استفاده می کنند.

اگر هر یک از داروهای زیر را مصرف می کنید یا قبلا از آن ها استفاده کرده اید قبل از مصرف قرص دومپریدون با پزشک خود مشورت کنید.

مصرف این دارو را بلافاصله پس از مشاهده این علایم متوقف کنید و با پزشک خود تماس بگیرید.

امیدواریم هنگام مصرف قرص دومپریدون به عوارض و موارد احتیاط در مصرف آن توجه نمایید. به یاد داشته باشید این مقاله صرفا جهت افزایش آگاهی شما ترجمه و گردآوری شده است و لازم است مصرف داروی دومپریدون تحت نظر پزشک صورت گیرد.

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دکتر ابوالفضل زارعی، جراح پلاستیک و زیبایی بینی، صورت، پلک

بالون معده با دکتر فرزاد فرامرزی – فوق تخصص گوارش, کبد و آندوسکوپی

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 &lt1/1) uncommon (≥1/1, to &lt1/1) rare (≥1/1, to &lt1/1,) very rare (&lt1/1,), 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&lt3 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

https://www.aurobindo.com

+44 ()28 845 8735

+44 ()28 845 8811

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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. [PubChem]

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

Fast

91%-93%

7 hours

Side effects include galactorrhea, gynecomastia, or menstrual irregularities.

Vanderberk, J., Kennis, L.E.J., Van der Aa, M.J.M.C. and Van Heertum, A.H.M.T. U.S. Patents 4,66,772 January 3,1978 4.1 1,333 August 29,1978 4,126,687 November 21, 1978 4,126,688 November 21,1978 4,16,836 July 1,1979 and 4,175,129 November 2,1979 all assigned to Janssen Pharmaceutica NV (Belgium).