Misofenac
Generic Name
Diclofenac Sodium + Misoprostol
Manufacturer
General Pharmaceutical Company
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 combines an NSAID (Diclofenac) with a gastroprotective agent (Misoprostol) to provide relief from pain and inflammation associated with conditions like osteoarthritis and rheumatoid arthritis, while simultaneously reducing the risk of stomach ulcers often caused by NSAIDs.
Uses & Indications
Dosage
Adults
One tablet (Diclofenac Sodium 50 mg + Misoprostol 200 mcg) two to three times daily with food. Or one tablet (Diclofenac Sodium 75 mg + Misoprostol 200 mcg) twice daily with food.
Elderly
Use with caution. Start with a lower dose and monitor renal function, as elderly patients may be more sensitive to NSAID side effects.
Renal_impairment
Use with caution. Dosage adjustment may be necessary in patients with mild to moderate renal impairment. Contraindicated in severe renal impairment.
How to Take
Take orally with food. Do not crush, chew, or break the tablet. Swallow whole.
Mechanism of Action
Diclofenac inhibits prostaglandin synthesis by blocking cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing pain and inflammation. Misoprostol is a synthetic prostaglandin E1 analogue that replaces protective prostaglandins depleted by NSAIDs, enhancing gastric mucus and bicarbonate secretion, and reducing gastric acid output.
Pharmacokinetics
Onset
Analgesic effect of Diclofenac within 30-60 minutes; gastric protective effects of Misoprostol within 30 minutes.
Excretion
Diclofenac is primarily excreted renally (about 60%) and biliary (about 35%). Misoprostol acid is primarily excreted renally (about 80%).
Half life
Diclofenac: 1-2 hours; Misoprostol acid: 20-40 minutes.
Absorption
Diclofenac is rapidly and completely absorbed. Misoprostol is rapidly absorbed and de-esterified to its active metabolite, misoprostol acid.
Metabolism
Diclofenac undergoes hepatic metabolism via CYP2C9. Misoprostol is extensively de-esterified in the liver and other tissues.
Side Effects
Contraindications
- Known hypersensitivity to diclofenac, misoprostol, aspirin, or other NSAIDs.
- Active gastrointestinal bleeding or ulceration.
- Pregnancy, due to the abortifacient properties of misoprostol.
- Severe renal or hepatic impairment.
- Severe heart failure.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Drug Interactions
Lithium
Increased plasma levels of lithium.
Methotrexate
Increased plasma levels and toxicity of methotrexate.
Diuretics and ACE inhibitors
Reduced antihypertensive effect and increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Selective Serotonin Reuptake Inhibitors (SSRIs)
Increased risk of GI bleeding.
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 drowsiness, lethargy, nausea, vomiting, epigastric pain, and gastrointestinal bleeding. In rare cases, hypertension, acute renal failure, respiratory depression, and coma may occur. Management is symptomatic and supportive. There is no specific antidote.
Pregnancy & Lactation
Misofenac is contraindicated in pregnant women due to the abortifacient and teratogenic effects of Misoprostol. It is also not recommended during breastfeeding as both diclofenac and misoprostol metabolites can pass into breast milk.
Side Effects
Contraindications
- Known hypersensitivity to diclofenac, misoprostol, aspirin, or other NSAIDs.
- Active gastrointestinal bleeding or ulceration.
- Pregnancy, due to the abortifacient properties of misoprostol.
- Severe renal or hepatic impairment.
- Severe heart failure.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Drug Interactions
Lithium
Increased plasma levels of lithium.
Methotrexate
Increased plasma levels and toxicity of methotrexate.
Diuretics and ACE inhibitors
Reduced antihypertensive effect and increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Selective Serotonin Reuptake Inhibitors (SSRIs)
Increased risk of GI bleeding.
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 drowsiness, lethargy, nausea, vomiting, epigastric pain, and gastrointestinal bleeding. In rare cases, hypertension, acute renal failure, respiratory depression, and coma may occur. Management is symptomatic and supportive. There is no specific antidote.
Pregnancy & Lactation
Misofenac is contraindicated in pregnant women due to the abortifacient and teratogenic effects of Misoprostol. It is also not recommended during breastfeeding as both diclofenac and misoprostol metabolites can pass into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved
Patent Status
Generics available
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established the efficacy and safety of the diclofenac/misoprostol combination for reducing NSAID-induced gastrointestinal toxicity while providing effective pain and inflammation relief.
Lab Monitoring
- Regular monitoring of renal function (creatinine, BUN).
- Liver function tests (ALT, AST).
- Complete blood count (CBC) to check for anemia or other blood dyscrasias.
- Blood pressure monitoring.
Doctor Notes
- Careful patient selection is crucial, especially regarding pregnancy status and cardiovascular/gastrointestinal risk factors.
- Educate patients on potential side effects and the importance of adherence.
- Regular monitoring of renal function and blood pressure is recommended for long-term therapy.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Do not stop taking it without consulting your doctor, even if you feel better.
- Report any unusual bleeding, severe stomach pain, or dark stools immediately.
- Avoid alcohol and other NSAIDs unless advised by your 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.
Driving Precautions
This medicine may cause dizziness or drowsiness in some individuals. If you experience such effects, avoid driving or operating machinery.
Lifestyle Advice
- Avoid smoking as it can worsen stomach irritation.
- Maintain a balanced diet and stay hydrated.
- Limit alcohol intake, as it can increase the risk of gastrointestinal side effects.
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