Misoclo
Generic Name
Diclofenac + Misoprostol
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| misoclo 50 mg tablet | ৳ 10.07 | ৳ 100.70 |
| misoclo 75 mg tablet | ৳ 11.07 | ৳ 110.70 |
Description
Overview of the medicine
Misoclo is a combination medicine containing Diclofenac, a non-steroidal anti-inflammatory drug (NSAID), and Misoprostol, a synthetic prostaglandin E1 analogue. It is used to treat symptoms of osteoarthritis and rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers.
Uses & Indications
Dosage
Adults
One tablet twice daily, preferably with food.
Elderly
Dosage adjustment may be necessary in elderly patients with impaired renal function. Use with caution.
Renal_impairment
Caution is advised. Lower doses or extended intervals may be needed. Contraindicated in severe renal impairment.
How to Take
Oral administration. Take with food to minimize gastrointestinal upset.
Mechanism of Action
Diclofenac inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, and antipyretic effects. Misoprostol, a prostaglandin E1 analogue, protects the gastric mucosa by increasing bicarbonate and mucus secretion, enhancing mucosal blood flow, and inhibiting gastric acid secretion. This combination mitigates the gastrointestinal side effects of diclofenac.
Pharmacokinetics
Onset
Diclofenac: ~30-60 minutes; Misoprostol: ~30 minutes for gastric protection
Excretion
Diclofenac: Primarily renal (60%) and biliary/fecal (35%). Misoprostol acid: Primarily renal.
Half life
Diclofenac: 1-2 hours; Misoprostol acid: 20-40 minutes
Absorption
Diclofenac is well absorbed orally, misoprostol is rapidly and extensively absorbed and then rapidly de-esterified to its active metabolite, misoprostol acid.
Metabolism
Diclofenac: Hepatic metabolism via CYP2C9 and other enzymes. Misoprostol: Rapid de-esterification in the body to misoprostol acid, then further metabolism.
Side Effects
Contraindications
- Hypersensitivity to diclofenac, misoprostol, or other NSAIDs
- Active gastrointestinal bleeding or ulceration
- Third trimester of pregnancy due to misoprostol's abortifacient effects
- Severe renal or hepatic impairment
- History of asthma, urticaria, or allergic reactions to aspirin or other NSAIDs
Drug Interactions
Lithium
Increased lithium plasma levels
Warfarin
Increased risk of bleeding
Diuretics
Reduced diuretic and antihypertensive effects
Cyclosporine
Increased nephrotoxicity
Methotrexate
Increased methotrexate toxicity
Storage
Store below 30°C, in a dry place, away from direct light. Keep out of reach of children.
Overdose
Symptoms may include lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding, hypotension, respiratory depression, coma. Management is supportive and symptomatic; gastric lavage or activated charcoal may be considered.
Pregnancy & Lactation
Contraindicated in pregnancy due to misoprostol's abortifacient effects. Use during lactation is not recommended as diclofenac and misoprostol metabolites are excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to diclofenac, misoprostol, or other NSAIDs
- Active gastrointestinal bleeding or ulceration
- Third trimester of pregnancy due to misoprostol's abortifacient effects
- Severe renal or hepatic impairment
- History of asthma, urticaria, or allergic reactions to aspirin or other NSAIDs
Drug Interactions
Lithium
Increased lithium plasma levels
Warfarin
Increased risk of bleeding
Diuretics
Reduced diuretic and antihypertensive effects
Cyclosporine
Increased nephrotoxicity
Methotrexate
Increased methotrexate toxicity
Storage
Store below 30°C, in a dry place, away from direct light. Keep out of reach of children.
Overdose
Symptoms may include lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding, hypotension, respiratory depression, coma. Management is supportive and symptomatic; gastric lavage or activated charcoal may be considered.
Pregnancy & Lactation
Contraindicated in pregnancy due to misoprostol's abortifacient effects. Use during lactation is not recommended as diclofenac and misoprostol metabolites are excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date
Availability
Pharmacies, hospitals
Approval Status
Approved by health authorities in various countries (e.g., FDA, DGDA)
Patent Status
Generic versions available, original patent expired
Clinical Trials
Clinical trials have demonstrated the efficacy of diclofenac in reducing arthritis symptoms and misoprostol in reducing the incidence of NSAID-induced ulcers.
Lab Monitoring
- Complete blood count (CBC)
- Liver function tests (LFTs)
- Renal function tests (RFTs)
- Stool for occult blood
Doctor Notes
- Carefully assess patient's cardiovascular and gastrointestinal risk factors before prescribing.
- Advise patients on the importance of avoiding pregnancy.
- Monitor renal and hepatic function during long-term therapy.
Patient Guidelines
- Do not take if pregnant or planning pregnancy.
- Take with food.
- Report any unusual bleeding or severe stomach pain.
- Avoid alcohol consumption.
Missed Dose Advice
If a dose is missed, take it as soon as remembered unless it is almost time for the next dose. Do not double dose.
Driving Precautions
May cause dizziness or drowsiness; exercise caution when driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet.
- Avoid smoking.
- Limit alcohol intake.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
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