Domiren
Generic Name
Domperidone
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| domiren 5 mg pediatric drop | ৳ 25.00 | N/A |
Description
Overview of the medicine
Domiren 5 mg Pediatric Drop contains Domperidone, used to relieve nausea and vomiting in infants and children. It also helps with symptoms like stomach discomfort and bloating associated with delayed gastric emptying.
Uses & Indications
Dosage
Adults
Not applicable for this pediatric drop formulation. General Domperidone dosage for adults is 10-20 mg up to 3 times daily, 15-30 minutes before meals.
Elderly
Not applicable for this pediatric drop formulation. For elderly patients, the lowest effective dose of Domperidone should be used due to potential cardiac risks.
Renal_impairment
For adults with severe renal impairment (creatinine clearance <30 mL/min), the dosing frequency of Domperidone should be reduced to once or twice daily, depending on the severity. Specific pediatric guidance should be sought from a physician.
How to Take
For oral administration. Administer 15-30 minutes before meals. Measure the dose accurately using the dropper provided. For children over 1 month of age and weighing less than 35 kg, the typical dose is 0.25 mg/kg body weight, up to 3 times daily. Maximum daily dose should not exceed 1 mg/kg (up to 30 mg/day). Follow your doctor's instructions carefully regarding the duration of treatment, which should generally not exceed one week in children.
Mechanism of Action
Domperidone is a peripheral dopamine D2 receptor antagonist that blocks dopamine receptors in the chemoreceptor trigger zone (CTZ) and in the gastrointestinal tract. This increases lower esophageal sphincter pressure, enhances gastric motility and peristalsis, and accelerates gastric emptying, thus reducing nausea and vomiting.
Pharmacokinetics
Onset
Anti-emetic effects usually within 30-60 minutes.
Excretion
Primarily excreted in feces (approx. 66%) and urine (approx. 33%), mainly as metabolites.
Half life
Approximately 7-9 hours in healthy subjects, potentially longer in those with severe renal impairment.
Absorption
Rapidly absorbed after oral administration, but with low oral bioavailability (approx. 15%) due to extensive first-pass metabolism. Peak plasma concentrations are reached within 30-60 minutes.
Metabolism
Extensively metabolized in the liver by hydroxylation and N-dealkylation, primarily by CYP3A4.
Side Effects
Contraindications
- Known hypersensitivity to Domperidone or any component of the formulation
- Patients with prolactin-releasing pituitary tumor (prolactinoma)
- Patients with moderate to severe hepatic impairment
- Patients with conditions where gastrointestinal motility stimulation is dangerous (e.g., gastrointestinal hemorrhage, mechanical obstruction, perforation)
- Concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin)
- Patients with known prolonged cardiac conduction intervals, particularly QTc, or significant electrolyte disturbances, or underlying cardiac diseases (e.g., congestive heart failure)
- Children under 1 month of age
Drug Interactions
Antacids and antisecretory agents
Reduce the oral bioavailability of domperidone. Should be taken after domperidone, not simultaneously.
Dopaminergic agonists (e.g., bromocriptine, levodopa)
Domperidone may antagonize their peripheral effects, but not central effects.
QTc-prolonging drugs (e.g., antiarrhythmics, antipsychotics, some antidepressants)
Increased risk of QTc prolongation and ventricular arrhythmias. Concomitant use should be avoided.
Potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin, ritonavir)
Increased plasma levels of domperidone, increasing the risk of QTc prolongation and cardiac arrhythmias. Concomitant use is contraindicated.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, disorientation, extrapyramidal reactions (e.g., uncontrolled muscle movements), and convulsions, especially in children. ECG monitoring should be performed due to the risk of QTc prolongation. Treatment is symptomatic and supportive, including gastric lavage or activated charcoal. Anticholinergic, anti-Parkinsonian drugs may be useful for extrapyramidal reactions.
Pregnancy & Lactation
Domperidone is not generally recommended during pregnancy unless the potential benefits outweigh the risks. Limited data suggest low levels of domperidone are excreted in breast milk. While generally considered safe for the infant at typical doses, a physician's advice is crucial. Use in breastfeeding mothers should be carefully considered, particularly for promoting lactation, due to potential cardiac risks.
Side Effects
Contraindications
- Known hypersensitivity to Domperidone or any component of the formulation
- Patients with prolactin-releasing pituitary tumor (prolactinoma)
- Patients with moderate to severe hepatic impairment
- Patients with conditions where gastrointestinal motility stimulation is dangerous (e.g., gastrointestinal hemorrhage, mechanical obstruction, perforation)
- Concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin)
- Patients with known prolonged cardiac conduction intervals, particularly QTc, or significant electrolyte disturbances, or underlying cardiac diseases (e.g., congestive heart failure)
- Children under 1 month of age
Drug Interactions
Antacids and antisecretory agents
Reduce the oral bioavailability of domperidone. Should be taken after domperidone, not simultaneously.
Dopaminergic agonists (e.g., bromocriptine, levodopa)
Domperidone may antagonize their peripheral effects, but not central effects.
QTc-prolonging drugs (e.g., antiarrhythmics, antipsychotics, some antidepressants)
Increased risk of QTc prolongation and ventricular arrhythmias. Concomitant use should be avoided.
Potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin, ritonavir)
Increased plasma levels of domperidone, increasing the risk of QTc prolongation and cardiac arrhythmias. Concomitant use is contraindicated.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, disorientation, extrapyramidal reactions (e.g., uncontrolled muscle movements), and convulsions, especially in children. ECG monitoring should be performed due to the risk of QTc prolongation. Treatment is symptomatic and supportive, including gastric lavage or activated charcoal. Anticholinergic, anti-Parkinsonian drugs may be useful for extrapyramidal reactions.
Pregnancy & Lactation
Domperidone is not generally recommended during pregnancy unless the potential benefits outweigh the risks. Limited data suggest low levels of domperidone are excreted in breast milk. While generally considered safe for the infant at typical doses, a physician's advice is crucial. Use in breastfeeding mothers should be carefully considered, particularly for promoting lactation, due to potential cardiac risks.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months when stored unopened. Check product label for specific expiry date.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Off-patent
Clinical Trials
Numerous clinical trials have evaluated domperidone for its efficacy in nausea, vomiting, and dyspepsia in both adults and pediatric populations. Some studies have raised concerns regarding cardiac safety, particularly at higher doses and in vulnerable populations, leading to updated dosing recommendations.
Lab Monitoring
- ECG monitoring (especially in patients with cardiac risk factors or concomitant QTc-prolonging drugs)
- Electrolyte levels (potassium, magnesium) in susceptible patients
Doctor Notes
- Emphasize shortest duration and lowest effective dose, especially in pediatric patients, due to cardiac risks.
- Carefully assess cardiac risk factors and concomitant medications before prescribing, particularly QTc-prolonging drugs or strong CYP3A4 inhibitors.
- Educate parents/caregivers on proper dosing technique using the dropper and signs of adverse reactions.
Patient Guidelines
- Always use the provided dropper for accurate dosing. Do not exceed the prescribed dose or duration of treatment.
- Take the drop 15-30 minutes before meals.
- If you notice any unusual heart rhythms or symptoms like dizziness, fainting, or palpitations, seek immediate medical attention.
- Inform your doctor about all other medications, including over-the-counter drugs and herbal supplements, before starting Domiren.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Domperidone may cause dizziness or drowsiness in some individuals. Patients should be advised not to drive or operate machinery if they experience these effects.
Lifestyle Advice
- Avoid self-medicating with Domperidone for prolonged periods without medical supervision.
- Maintain a healthy diet and lifestyle to support overall digestive health.
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