Misoclo
Generic Name
Diclofenac Sodium + Misoprostol
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| misoclo 75 mg tablet | ৳ 11.07 | ৳ 110.70 |
Description
Overview of the medicine
Misoclo 75 mg tablet is a combination medicine containing Diclofenac Sodium, a non-steroidal anti-inflammatory drug (NSAID), and Misoprostol, a prostaglandin analogue. It is used to relieve pain and inflammation while reducing the risk of stomach ulcers that can be caused by NSAIDs.
Uses & Indications
Dosage
Adults
One tablet (Diclofenac 75 mg / Misoprostol 200 mcg) twice daily, preferably with food. Max 2 tablets per day.
Elderly
Use with caution, lowest effective dose. Monitor renal function.
Renal_impairment
Use with caution, consider dose reduction. Not recommended for severe renal impairment.
How to Take
Take orally, usually twice daily, preferably with food to minimize gastrointestinal upset. Swallow whole; do not chew, crush, or break the tablet.
Mechanism of Action
Diclofenac inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis, which leads to anti-inflammatory, analgesic, and antipyretic effects. Misoprostol is a synthetic prostaglandin E1 analogue that replaces endogenous prostaglandins, protecting the gastroduodenal mucosa by inhibiting gastric acid secretion and enhancing bicarbonate and mucus production.
Pharmacokinetics
Onset
Diclofenac: 30-60 minutes for analgesia. Misoprostol: rapid absorption, cytoprotective effects evident within 30 minutes.
Excretion
Diclofenac: Approximately 60% renally, 35% biliary. Misoprostol acid: Primarily renal.
Half life
Diclofenac: 1-2 hours. Misoprostol acid: 20-40 minutes.
Absorption
Diclofenac is well absorbed orally, peak plasma concentrations typically reached in 2-3 hours. Misoprostol is rapidly absorbed and extensively de-esterified to its active metabolite, misoprostol acid.
Metabolism
Diclofenac: Extensively metabolized in the liver via glucuronidation and hydroxylation. Misoprostol: Rapid and extensive de-esterification in the liver and other tissues to misoprostol acid, which is then further metabolized.
Side Effects
Contraindications
- Known hypersensitivity to diclofenac, misoprostol, or other NSAIDs
- Active gastrointestinal bleeding or peptic ulcer
- Severe heart failure
- Third trimester of pregnancy
- Severe renal or hepatic impairment
- Aspirin-sensitive asthma
Drug Interactions
Lithium
Increased plasma lithium levels.
Methotrexate
Increased methotrexate toxicity.
SSRIs, SNRIs
Increased risk of GI bleeding.
Corticosteroids
Increased risk of GI ulceration or bleeding.
Warfarin, other anticoagulants
Increased risk of bleeding.
Diuretics, ACE inhibitors, ARBs
Reduced antihypertensive effect; 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 may include drowsiness, lethargy, nausea, vomiting, epigastric pain, GI bleeding. Severe overdose may lead to acute renal failure, respiratory depression, convulsions. Misoprostol overdose may cause abdominal cramps, diarrhea, fever, palpitations, hypotension, bradycardia. Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered soon after ingestion.
Pregnancy & Lactation
Contraindicated in pregnancy due to misoprostol's abortifacient effects and NSAID risks (e.g., premature closure of ductus arteriosus). Not recommended during lactation as both diclofenac and misoprostol metabolites pass into breast milk.
Side Effects
Contraindications
- Known hypersensitivity to diclofenac, misoprostol, or other NSAIDs
- Active gastrointestinal bleeding or peptic ulcer
- Severe heart failure
- Third trimester of pregnancy
- Severe renal or hepatic impairment
- Aspirin-sensitive asthma
Drug Interactions
Lithium
Increased plasma lithium levels.
Methotrexate
Increased methotrexate toxicity.
SSRIs, SNRIs
Increased risk of GI bleeding.
Corticosteroids
Increased risk of GI ulceration or bleeding.
Warfarin, other anticoagulants
Increased risk of bleeding.
Diuretics, ACE inhibitors, ARBs
Reduced antihypertensive effect; 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 may include drowsiness, lethargy, nausea, vomiting, epigastric pain, GI bleeding. Severe overdose may lead to acute renal failure, respiratory depression, convulsions. Misoprostol overdose may cause abdominal cramps, diarrhea, fever, palpitations, hypotension, bradycardia. Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered soon after ingestion.
Pregnancy & Lactation
Contraindicated in pregnancy due to misoprostol's abortifacient effects and NSAID risks (e.g., premature closure of ductus arteriosus). Not recommended during lactation as both diclofenac and misoprostol metabolites pass into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy of diclofenac in pain and inflammation and misoprostol in preventing NSAID-induced ulcers. Combination products were studied for their combined benefits.
Lab Monitoring
- Complete Blood Count (CBC)
- Renal function (creatinine, BUN)
- Liver function tests (ALT, AST)
- Stool for occult blood
Doctor Notes
- Carefully assess patient's cardiovascular and GI risk factors before prescribing.
- Monitor renal and hepatic function, especially during long-term therapy.
- Ensure female patients of reproductive age are not pregnant and use effective contraception during treatment.
- Educate patients on potential GI and cardiovascular symptoms and when to seek medical attention.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not exceed the recommended dose.
- Inform your doctor about all other medications you are taking.
- Report any signs of stomach bleeding (e.g., black, tarry stools) immediately.
- Avoid during pregnancy due to high risk of birth defects or abortion.
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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
May cause dizziness or drowsiness. Exercise caution when driving or operating machinery until you know how the medicine affects you.
Lifestyle Advice
- Avoid alcohol consumption, which can increase the risk of stomach bleeding.
- Maintain a healthy diet and stay hydrated.
- Avoid smoking, as it may worsen stomach issues.
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