Misofenac
Generic Name
Diclofenac Sodium 50 mg + Misoprostol 200 mcg Tablet
Manufacturer
General Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| misofenac 50 mg tablet | ৳ 10.07 | ৳ 100.70 |
Description
Overview of the medicine
Misofenac is a combination medicine containing Diclofenac Sodium, a non-steroidal anti-inflammatory drug (NSAID), and Misoprostol, a synthetic prostaglandin E1 analogue. It is used to treat pain and inflammation in conditions like osteoarthritis and rheumatoid arthritis, while misoprostol protects the stomach lining from NSAID-induced ulcers.
Uses & Indications
Dosage
Adults
One tablet (Diclofenac 50 mg/Misoprostol 200 mcg) two to three times daily, taken with food. The lowest effective dose for the shortest duration should be used.
Elderly
No specific dose adjustment is generally required, but caution should be exercised due to increased risk of adverse effects.
Renal_impairment
Use with caution in mild to moderate renal impairment; avoid in severe renal impairment.
How to Take
Take orally, with food, to minimize gastrointestinal discomfort. Do not crush, chew, or break the tablet.
Mechanism of Action
Diclofenac inhibits cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing prostaglandin synthesis, which mediates inflammation, pain, and fever. Misoprostol replaces endogenous prostaglandins in the gastric mucosa, enhancing mucosal blood flow, bicarbonate and mucus secretion, and inhibiting gastric acid secretion, thus protecting the stomach from NSAID-induced damage.
Pharmacokinetics
Onset
Diclofenac: ~30-60 minutes for analgesia. Misoprostol: Rapid onset of gastroprotection.
Excretion
Diclofenac: Primarily renal (60%), biliary (35%). Misoprostol acid: Primarily renal.
Half life
Diclofenac: ~1-2 hours. Misoprostol acid: ~20-40 minutes.
Absorption
Diclofenac: Rapidly and completely absorbed. Misoprostol: Rapidly absorbed and de-esterified to its active metabolite, misoprostol acid.
Metabolism
Diclofenac: Extensively metabolized by CYP2C9 and other enzymes. Misoprostol: Extensively metabolized by fatty acid oxidation to misoprostol acid.
Side Effects
Contraindications
- Known hypersensitivity to diclofenac, misoprostol, other prostaglandins, or any component of the formulation.
- Patients with active gastrointestinal bleeding or ulceration.
- During pregnancy and in women of childbearing potential not using effective contraception.
- Patients with severe renal or hepatic impairment.
- Patients with severe heart failure.
- In the setting of coronary artery bypass graft (CABG) surgery.
Drug Interactions
Methotrexate
Increased methotrexate toxicity.
Lithium/Digoxin
Increased plasma levels of lithium and digoxin.
Cyclosporine/Tacrolimus
Increased nephrotoxicity.
Anticoagulants/Antiplatelets
Increased risk of bleeding.
Other NSAIDs/Corticosteroids
Increased risk of gastrointestinal adverse effects.
Diuretics/ACE inhibitors/Beta-blockers
Reduced antihypertensive effect and increased risk of renal impairment.
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 severe gastrointestinal discomfort, drowsiness, lethargy, tremor, convulsions, shortness of breath, abdominal pain, diarrhea, fever, palpitations, hypotension, and bradycardia. Management is primarily supportive and symptomatic. Gastric lavage and activated charcoal may be considered soon after ingestion.
Pregnancy & Lactation
This medicine is absolutely contraindicated during pregnancy (Pregnancy Category X) due to the abortifacient and teratogenic effects of misoprostol. Women of childbearing potential must use effective contraception. It is not recommended during lactation as diclofenac and misoprostol metabolites are excreted in breast milk.
Side Effects
Contraindications
- Known hypersensitivity to diclofenac, misoprostol, other prostaglandins, or any component of the formulation.
- Patients with active gastrointestinal bleeding or ulceration.
- During pregnancy and in women of childbearing potential not using effective contraception.
- Patients with severe renal or hepatic impairment.
- Patients with severe heart failure.
- In the setting of coronary artery bypass graft (CABG) surgery.
Drug Interactions
Methotrexate
Increased methotrexate toxicity.
Lithium/Digoxin
Increased plasma levels of lithium and digoxin.
Cyclosporine/Tacrolimus
Increased nephrotoxicity.
Anticoagulants/Antiplatelets
Increased risk of bleeding.
Other NSAIDs/Corticosteroids
Increased risk of gastrointestinal adverse effects.
Diuretics/ACE inhibitors/Beta-blockers
Reduced antihypertensive effect and increased risk of renal impairment.
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 severe gastrointestinal discomfort, drowsiness, lethargy, tremor, convulsions, shortness of breath, abdominal pain, diarrhea, fever, palpitations, hypotension, and bradycardia. Management is primarily supportive and symptomatic. Gastric lavage and activated charcoal may be considered soon after ingestion.
Pregnancy & Lactation
This medicine is absolutely contraindicated during pregnancy (Pregnancy Category X) due to the abortifacient and teratogenic effects of misoprostol. Women of childbearing potential must use effective contraception. It is not recommended during lactation as diclofenac and misoprostol metabolites are excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
Approved (Combination available globally)
Patent Status
Off-patent
Clinical Trials
Clinical trials have demonstrated that the combination of diclofenac and misoprostol significantly reduces the incidence of serious NSAID-induced upper gastrointestinal adverse events (e.g., ulcers, bleeding) compared to diclofenac alone, while maintaining efficacy in treating arthritis symptoms.
Lab Monitoring
- Monitor complete blood count (CBC) periodically for anemia or bleeding.
- Monitor renal function (serum creatinine, BUN) due to potential NSAID-induced nephrotoxicity.
- Monitor liver function (ALT, AST) periodically for hepatotoxicity.
- Periodically test for occult blood in stool.
Doctor Notes
- Strictly contraindicated in pregnancy; confirm negative pregnancy test before initiation in women of childbearing potential and ensure effective contraception.
- Carefully assess cardiovascular and gastrointestinal risk factors before prescribing.
- Monitor renal function, liver enzymes, and CBC periodically during prolonged therapy.
- Advise patients on symptoms of GI bleeding and cardiovascular events.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Always take with food to reduce stomach upset.
- Do not take if you are pregnant or planning to become pregnant, as it can cause serious harm to the unborn baby.
- Use effective contraception if you are a woman of childbearing potential.
- Report any signs of stomach bleeding (e.g., black, tarry stools; vomit that looks like coffee grounds), chest pain, or difficulty breathing immediately.
- Do not exceed the recommended dose.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
This medicine may cause dizziness or drowsiness. If you experience these symptoms, avoid driving or operating machinery.
Lifestyle Advice
- Avoid alcohol consumption while taking this medicine, as it may increase the risk of gastrointestinal bleeding.
- Limit or avoid smoking, as it can worsen gastrointestinal irritation and ulcer risk.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.