Promel Plus
Generic Name
Paracetamol 500 mg + Domperidone 10 mg
Manufacturer
ACI Limited
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
promel plus 500 mg tablet | ৳ 1.90 | N/A |
Description
Overview of the medicine
Promel Plus 500 mg Tablet is a combination medicine used to relieve mild to moderate pain and fever, especially when accompanied by nausea, vomiting, or gastrointestinal discomfort. It contains Paracetamol, an analgesic and antipyretic, and Domperidone, an antiemetic and prokinetic agent.
Uses & Indications
Dosage
Adults
One tablet 2-3 times daily, or as directed by the physician. Do not exceed 4 doses in 24 hours.
Elderly
No specific dose adjustment is usually required, but caution is advised in patients with impaired renal or hepatic function.
Renal_impairment
Use with caution. Dosage interval may need to be extended in severe renal impairment (CrCl < 30 mL/min).
Hepatic_impairment
Use with caution. Avoid in severe hepatic impairment. Lower doses or extended intervals may be required.
How to Take
Take the tablet orally with water, preferably 15-30 minutes before meals. Do not crush or chew the tablet.
Mechanism of Action
Paracetamol primarily acts by inhibiting prostaglandin synthesis in the central nervous system, thereby reducing pain and fever. Domperidone selectively blocks peripheral dopamine D2 receptors in the chemoreceptor trigger zone (CTZ) and in the gastrointestinal tract, leading to antiemetic effects and increased gastric motility.
Pharmacokinetics
Onset
Pain relief: 30-60 minutes (Paracetamol); Antiemetic effect: 30-60 minutes (Domperidone).
Excretion
Paracetamol metabolites are excreted mainly in the urine. Domperidone is primarily excreted in feces (66%) and urine (33%), mainly as metabolites.
Half life
Paracetamol: 1.25-3 hours; Domperidone: 7-9 hours.
Absorption
Paracetamol is rapidly and almost completely absorbed from the GI tract. Peak plasma concentrations occur within 30-60 minutes. Domperidone is rapidly absorbed after oral administration but has low oral bioavailability (15%) due to extensive first-pass metabolism. Peak plasma concentrations occur within 30-60 minutes.
Metabolism
Paracetamol is primarily metabolized in the liver (90-95%) via conjugation with glucuronic acid and sulfate. Domperidone undergoes extensive hepatic metabolism by cytochrome P450-mediated N-dealkylation and oxidative hydroxylation.
Side Effects
Contraindications
- Hypersensitivity to Paracetamol, Domperidone, or any components of the formulation
- Moderate to severe hepatic impairment
- Moderate to severe cardiac impairment, including prolonged QTc interval
- Known electrolyte disturbances (e.g., hypokalemia, hypomagnesemia)
- Significant gastrointestinal hemorrhage, mechanical obstruction, or perforation
- Prolactin-releasing pituitary tumor (prolactinoma)
- Concomitant use with potent CYP3A4 inhibitors that prolong the QT interval (e.g., ketoconazole, erythromycin, clarithromycin, amiodarone)
Drug Interactions
Alcohol
Increases risk of hepatotoxicity with Paracetamol.
Warfarin
Prolonged use of Paracetamol may potentiate anticoagulant effect.
Cholestyramine
Reduces absorption of Paracetamol.
Anticholinergics
May antagonize the prokinetic effect of Domperidone.
Phenytoin, Carbamazepine, Barbiturates
May increase hepatotoxicity of Paracetamol.
CYP3A4 inhibitors (e.g., Ketoconazole, Erythromycin, Clarithromycin, Amiodarone)
Increase plasma levels of Domperidone and risk of QT prolongation. Concomitant use is contraindicated.
QT-prolonging drugs (e.g., certain antiarrhythmics, antipsychotics, antidepressants)
Increased risk of cardiac arrhythmias with Domperidone. Concomitant use is contraindicated.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Paracetamol overdose can cause severe hepatotoxicity, potentially leading to liver failure and death. Symptoms may include nausea, vomiting, abdominal pain, and anorexia, often delayed for 24-48 hours. Domperidone overdose can lead to drowsiness, disorientation, and extrapyramidal reactions. Treatment involves gastric lavage, activated charcoal, and supportive measures. For Paracetamol, N-acetylcysteine (NAC) is a specific antidote and should be administered promptly. Cardiac monitoring is essential for Domperidone overdose due to QT prolongation risk.
Pregnancy & Lactation
Paracetamol is generally considered safe during pregnancy when used at recommended doses. Domperidone's use in pregnancy should be avoided unless clearly necessary, as animal studies have shown potential reproductive toxicity. Domperidone is excreted in breast milk and can cause adverse effects in breastfed infants. Use during lactation is generally not recommended, or the lowest effective dose should be used for the shortest duration, with careful monitoring of the infant. Consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date
Availability
Available in pharmacies nationwide in Bangladesh
Approval Status
Approved in Bangladesh
Patent Status
Generic available, original patent expired
Clinical Trials
Clinical trials support the efficacy and safety of Paracetamol and Domperidone individually and in combination for their approved indications. Ongoing research may explore new applications or refine safety profiles.
Lab Monitoring
- Liver function tests (in prolonged use or overdose)
- Renal function tests (in patients with impairment)
- Electrolyte levels (potassium, magnesium) for Domperidone safety
- ECG monitoring (for patients at risk of QT prolongation with Domperidone)
Doctor Notes
- Emphasize strict adherence to dosage due to potential for Paracetamol hepatotoxicity and Domperidone cardiotoxicity.
- Screen patients for cardiac risk factors (e.g., pre-existing heart disease, electrolyte imbalance) before initiating Domperidone-containing products.
- Advise patients to report any palpitations, dizziness, or syncope immediately.
Patient Guidelines
- Do not exceed the recommended dose to avoid serious side effects, especially liver damage with Paracetamol.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
- Avoid alcohol consumption while taking this medicine.
- If symptoms do not improve after a few days, consult your doctor.
- Do not take for more than 3 days for fever or 10 days for pain without consulting a doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medicine may cause drowsiness or dizziness. Avoid driving or operating machinery if you experience these effects.
Lifestyle Advice
- Maintain adequate hydration.
- Get sufficient rest.
- Avoid foods that trigger nausea or discomfort.
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Global Brand Names
International brand names for this medicine
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