Donadin
Generic Name
Domperidone
Manufacturer
Acme Laboratories Ltd.
Country
Bangladesh
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Description
Overview of the medicine
Donadin (Domperidone) is a dopamine antagonist with antiemetic and prokinetic properties. It is used to treat nausea and vomiting and to relieve symptoms of dyspepsia, such as bloating and heartburn.
Uses & Indications
Dosage
Adults
10 mg orally, up to three times daily, 15-30 minutes before meals. Maximum daily dose is 30 mg.
Elderly
Similar to adults, but reduced dose or frequency may be considered due to potential for prolonged QT interval and other age-related factors.
Renal_impairment
Reduce frequency to once or twice daily, depending on the severity of impairment (e.g., once daily for severe impairment).
How to Take
Orally, typically 15-30 minutes before meals. For suppositories, rectally. Do not crush or chew tablets.
Mechanism of Action
Domperidone selectively blocks dopamine D2 receptors in the chemoreceptor trigger zone (CTZ) and peripherally in the gastrointestinal wall, promoting gastric motility and emptying, and reducing nausea and vomiting. It generally does not cross the blood-brain barrier significantly.
Pharmacokinetics
Onset
30-60 minutes
Excretion
Primarily via feces (66%) and urine (33%) over several days, mainly as metabolites.
Half life
7-9 hours (in healthy adults), prolonged in severe renal impairment.
Absorption
Rapidly absorbed after oral administration; peak plasma concentrations reached within 30-60 minutes. Bioavailability is low (15%) due to extensive first-pass metabolism.
Metabolism
Extensively metabolized in the liver by CYP3A4, N-dealkylation, and oxidative hydroxylation.
Side Effects
Contraindications
- Known hypersensitivity to domperidone or any excipients.
- Prolactin-releasing pituitary tumor (prolactinoma).
- Moderate to severe hepatic impairment.
- Known prolongation of QT interval or underlying cardiac disease (e.g., congestive heart failure, significant electrolyte disturbances).
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin).
- Conditions where stimulation of gastric motility might be harmful (e.g., gastrointestinal hemorrhage, mechanical obstruction, perforation).
Drug Interactions
Dopamine agonists (e.g., bromocriptine, cabergoline)
Domperidone may antagonize their effects.
Antacids/antisecretory agents (e.g., proton pump inhibitors)
Decrease oral bioavailability of domperidone if taken concomitantly. Domperidone should be taken before meals, while antacids/antisecretory agents after meals.
QT-prolonging drugs (e.g., some antipsychotics, antiarrhythmics)
Increased risk of QT prolongation and cardiac arrhythmias; concomitant use is generally not recommended or requires careful monitoring.
Strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin, ritonavir)
Concomitant use is contraindicated due to significantly increased plasma levels of domperidone and increased risk of QT prolongation.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include somnolence, disorientation, extrapyramidal reactions, and QT prolongation. Management is symptomatic and supportive. Gastric lavage and activated charcoal may be considered if ingestion was recent. ECG monitoring is crucial due to the risk of cardiac arrhythmias.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus, as human data are limited. Domperidone is excreted in breast milk in small amounts; potential risk of cardiac effects to the infant exists. Use with caution during lactation, or consider alternatives.
Side Effects
Contraindications
- Known hypersensitivity to domperidone or any excipients.
- Prolactin-releasing pituitary tumor (prolactinoma).
- Moderate to severe hepatic impairment.
- Known prolongation of QT interval or underlying cardiac disease (e.g., congestive heart failure, significant electrolyte disturbances).
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin).
- Conditions where stimulation of gastric motility might be harmful (e.g., gastrointestinal hemorrhage, mechanical obstruction, perforation).
Drug Interactions
Dopamine agonists (e.g., bromocriptine, cabergoline)
Domperidone may antagonize their effects.
Antacids/antisecretory agents (e.g., proton pump inhibitors)
Decrease oral bioavailability of domperidone if taken concomitantly. Domperidone should be taken before meals, while antacids/antisecretory agents after meals.
QT-prolonging drugs (e.g., some antipsychotics, antiarrhythmics)
Increased risk of QT prolongation and cardiac arrhythmias; concomitant use is generally not recommended or requires careful monitoring.
Strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin, ritonavir)
Concomitant use is contraindicated due to significantly increased plasma levels of domperidone and increased risk of QT prolongation.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include somnolence, disorientation, extrapyramidal reactions, and QT prolongation. Management is symptomatic and supportive. Gastric lavage and activated charcoal may be considered if ingestion was recent. ECG monitoring is crucial due to the risk of cardiac arrhythmias.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus, as human data are limited. Domperidone is excreted in breast milk in small amounts; potential risk of cardiac effects to the infant exists. Use with caution during lactation, or consider alternatives.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date, specific to product batch.
Availability
Pharmacies, Hospitals
Approval Status
Approved by DGDA and other regulatory bodies
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Ongoing clinical trials continue to investigate the cardiac safety profile of domperidone, particularly in vulnerable populations and at varying doses, to refine prescribing guidelines. Studies also explore its efficacy in specific types of dyspepsia and motility disorders.
Lab Monitoring
- ECG monitoring is recommended, especially in patients with cardiac risk factors, electrolyte imbalances, or those taking concomitant QT-prolonging medications.
- Renal function tests (e.g., creatinine clearance) in patients with kidney impairment.
Doctor Notes
- Emphasize the importance of using the lowest effective dose for the shortest possible duration, especially for patients with cardiac risk factors.
- Thoroughly review patient's medication list for potential drug-drug interactions, particularly with strong CYP3A4 inhibitors and QT-prolonging agents.
- Educate patients on symptoms requiring immediate medical attention, such as palpitations or fainting.
Patient Guidelines
- Take Donadin 15-30 minutes before meals for best results.
- Do not exceed the prescribed dose or duration, as higher doses and longer use increase cardiac risks.
- Inform your doctor about all other medicines you are taking, especially antibiotics, antifungals, or heart medications.
- Seek immediate medical attention if you experience palpitations, fainting, seizures, or any unusual muscle movements.
- Avoid using alcohol while on this medication.
Missed Dose Advice
Take the missed dose as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed one. Continue with your regular dosing schedule.
Driving Precautions
Donadin may cause dizziness, drowsiness, or visual disturbances. Patients should be advised to exercise caution when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- For dyspepsia, consider lifestyle changes such as eating smaller, more frequent meals, avoiding fatty/spicy foods, and elevating the head during sleep.
- Maintain a healthy diet and stay hydrated.
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