Domfix
Generic Name
Domperidone
Manufacturer
Reputable Pharmaceuticals Inc.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| domfix 5 mg suspension | ৳ 35.00 | N/A |
Description
Overview of the medicine
Domperidone is an antiemetic that increases the movements or contractions of the stomach and bowel. It is used to treat nausea, vomiting, dyspepsia, and certain stomach problems.
Uses & Indications
Dosage
Adults
10 ml (10 mg) three times daily, 15-30 minutes before meals. Maximum daily dose 30 ml (30 mg).
Elderly
No specific dose adjustment for elderly, but caution advised due to potential cardiac risks. Use the lowest effective dose.
Children
0.25-0.5 mg/kg body weight, given three times daily, 15-30 minutes before meals. Maximum daily dose 1.25 mg/kg. For example, a 20 kg child would take 5-10 ml (5-10 mg) three times daily.
Renal_impairment
In severe renal impairment (creatinine clearance <30 ml/min), the dosing frequency should be reduced to once or twice daily, depending on severity, and the daily dose should not exceed 10 mg.
How to Take
Domfix suspension should be taken orally, 15-30 minutes before meals, to ensure optimal absorption and efficacy. Shake the bottle well before each use. Use the provided measuring cup or syringe for accurate dosing.
Mechanism of Action
Domperidone acts as a peripheral dopamine D2 receptor antagonist, primarily blocking dopamine receptors in the chemoreceptor trigger zone (CTZ) and the gastrointestinal tract. This increases lower esophageal sphincter pressure, improves gastroduodenal coordination, and accelerates gastric emptying, leading to its antiemetic and prokinetic effects.
Pharmacokinetics
Onset
Within 30-60 minutes.
Excretion
Excreted mainly via feces (66%) and urine (33%) as inactive metabolites. Less than 1% is excreted unchanged in urine.
Half life
Approximately 7-9 hours in healthy subjects, prolonged in severe renal impairment.
Absorption
Rapidly absorbed after oral administration, but extensively metabolized in the gut wall and liver (first-pass metabolism). Absolute bioavailability is approximately 15%. Peak plasma levels are reached within 1 hour.
Metabolism
Extensively metabolized in the liver by hydroxylation and N-dealkylation, primarily by cytochrome P450 3A4 (CYP3A4) enzymes.
Side Effects
Contraindications
- Known hypersensitivity to domperidone or any component of the formulation.
- Patients with moderate to severe hepatic impairment.
- Patients with known prolongation of cardiac QTc intervals, significant cardiac disease (e.g., congestive heart failure), or electrolyte disturbances.
- Concomitant use with QT-prolonging drugs or potent CYP3A4 inhibitors.
- Patients with prolactin-releasing pituitary tumour (prolactinoma).
- When stimulation of gastric motility could be harmful, e.g., in gastrointestinal haemorrhage, mechanical obstruction, or perforation.
Drug Interactions
Anticholinergics
Anticholinergic drugs may antagonize the prokinetic effect of domperidone.
QT-prolonging drugs
Coadministration with other drugs known to prolong the QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics like erythromycin, some antidepressants, antifungals like ketoconazole) is contraindicated due to increased risk of cardiac arrhythmias.
Potent CYP3A4 inhibitors
Drugs that strongly inhibit CYP3A4 (e.g., ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone) significantly increase domperidone plasma levels and should not be used concomitantly due to increased cardiac risk.
Antacids/H2 blockers/PPIs
These drugs may reduce the bioavailability of domperidone. It is recommended to take domperidone before meals and antacids/acid suppressants after meals.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, disorientation, extrapyramidal reactions (e.g., dystonia, dyskinesia), especially in children. In severe cases, cardiac arrhythmias may occur. Management involves symptomatic and supportive treatment. Gastric lavage and activated charcoal may be considered within the first hour of ingestion. Close monitoring of vital signs and ECG is recommended.
Pregnancy & Lactation
Pregnancy: Limited data suggest no increased risk of major birth defects. Use only if clearly needed and the potential benefits outweigh the potential risks to the fetus. It is classified as Pregnancy Category C. Lactation: Domperidone is excreted in breast milk in small amounts. While generally considered compatible with breastfeeding, caution is advised, and it should be used only if considered essential by the physician, monitoring the infant for potential side effects.
Side Effects
Contraindications
- Known hypersensitivity to domperidone or any component of the formulation.
- Patients with moderate to severe hepatic impairment.
- Patients with known prolongation of cardiac QTc intervals, significant cardiac disease (e.g., congestive heart failure), or electrolyte disturbances.
- Concomitant use with QT-prolonging drugs or potent CYP3A4 inhibitors.
- Patients with prolactin-releasing pituitary tumour (prolactinoma).
- When stimulation of gastric motility could be harmful, e.g., in gastrointestinal haemorrhage, mechanical obstruction, or perforation.
Drug Interactions
Anticholinergics
Anticholinergic drugs may antagonize the prokinetic effect of domperidone.
QT-prolonging drugs
Coadministration with other drugs known to prolong the QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics like erythromycin, some antidepressants, antifungals like ketoconazole) is contraindicated due to increased risk of cardiac arrhythmias.
Potent CYP3A4 inhibitors
Drugs that strongly inhibit CYP3A4 (e.g., ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone) significantly increase domperidone plasma levels and should not be used concomitantly due to increased cardiac risk.
Antacids/H2 blockers/PPIs
These drugs may reduce the bioavailability of domperidone. It is recommended to take domperidone before meals and antacids/acid suppressants after meals.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, disorientation, extrapyramidal reactions (e.g., dystonia, dyskinesia), especially in children. In severe cases, cardiac arrhythmias may occur. Management involves symptomatic and supportive treatment. Gastric lavage and activated charcoal may be considered within the first hour of ingestion. Close monitoring of vital signs and ECG is recommended.
Pregnancy & Lactation
Pregnancy: Limited data suggest no increased risk of major birth defects. Use only if clearly needed and the potential benefits outweigh the potential risks to the fetus. It is classified as Pregnancy Category C. Lactation: Domperidone is excreted in breast milk in small amounts. While generally considered compatible with breastfeeding, caution is advised, and it should be used only if considered essential by the physician, monitoring the infant for potential side effects.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 months from the manufacturing date, when stored under recommended conditions. Once opened, use within 28 days.
Availability
Pharmacies nationwide
Approval Status
Approved
Patent Status
Generic
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated domperidone's efficacy in treating nausea, vomiting, and dyspeptic symptoms. Recent trials and post-marketing surveillance have focused on cardiac safety, leading to revised dosing recommendations and contraindications to minimize the risk of QT prolongation and serious cardiac events.
Lab Monitoring
- ECG monitoring is recommended for patients with cardiac risk factors, pre-existing cardiac conditions, or those concomitantly receiving QT-prolonging drugs.
- Electrolyte levels should be monitored, especially in patients at risk of imbalance (e.g., hypokalemia, hypomagnesemia).
- Liver function tests may be considered in patients on long-term therapy or with pre-existing hepatic impairment.
Doctor Notes
- Prescribe domperidone with caution to patients with cardiac disease, a family history of sudden cardiac death, or electrolyte disturbances.
- Thoroughly review concomitant medications for potential drug interactions, especially with potent CYP3A4 inhibitors and QT-prolonging agents.
- Advise patients to report any cardiac symptoms (e.g., palpitations, syncope) immediately.
- The duration of treatment should be as short as possible, generally not exceeding one week for acute nausea/vomiting, and the lowest effective dose should be used.
Patient Guidelines
- Always take Domfix suspension 15-30 minutes before meals.
- Do not exceed the prescribed dose or duration of treatment, especially if you are elderly or have heart problems.
- Immediately report any symptoms like palpitations, dizziness, fainting, or swelling of the face/tongue.
- Avoid concurrent use with other medications unless approved by your doctor, particularly certain antibiotics or antifungals.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Domperidone may cause drowsiness, dizziness, or blurred vision in some individuals. If you experience these side effects, avoid driving or operating heavy machinery.
Lifestyle Advice
- If you experience dyspepsia, try to eat smaller, more frequent meals and avoid fatty, spicy, or acidic foods.
- For reflux symptoms, elevate the head of your bed and avoid lying down immediately after eating.
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