Misotab
Generic Name
Misoprostol
Manufacturer
Renata Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| misotab 200 mcg tablet | ৳ 15.00 | ৳ 150.00 |
Description
Overview of the medicine
Misoprostol is a synthetic prostaglandin E1 analogue used for the prevention of NSAID-induced gastric ulcers, medical abortion, induction of labor, and management of postpartum hemorrhage.
Uses & Indications
Dosage
Adults
NSAID-induced ulcer prevention: 200 mcg orally 4 times daily with food. Medical abortion: Varies by regimen (e.g., 800 mcg vaginally after mifepristone, or 400 mcg sublingually/buccally every 3-12 hours for multiple doses). Labor induction: 25 mcg vaginally every 3-6 hours. Postpartum hemorrhage: 600-1000 mcg orally/sublingually/rectally once.
Elderly
No specific dosage adjustment recommended for the elderly, but caution is advised due to increased sensitivity and potential for impaired renal function.
Renal_impairment
Reduce the dose by 50% if creatinine clearance is less than 30 mL/min, particularly for ulcer prevention.
How to Take
For ulcer prevention, take orally with food to minimize diarrhea. For other indications, follow specific instructions regarding the route (vaginal, sublingual, buccal, or rectal) and timing.
Mechanism of Action
Misoprostol enhances the production of gastric mucus and bicarbonate, inhibits gastric acid secretion, and causes uterine contractions by binding to prostaglandin E2 receptors.
Pharmacokinetics
Onset
Gastric acid inhibition: 30 minutes. Uterine contractions: 10-20 minutes after oral or vaginal administration.
Excretion
Primarily excreted in the urine (approximately 80%) and to a lesser extent in the feces.
Half life
The plasma elimination half-life of misoprostol acid is approximately 20-40 minutes.
Absorption
Rapidly absorbed from the gastrointestinal tract and rapidly de-esterified to its active metabolite, misoprostol acid. Peak plasma concentration of misoprostol acid occurs in about 15-30 minutes.
Metabolism
Undergoes rapid and extensive first-pass metabolism to misoprostol acid, which is further metabolized by fatty acid oxidation.
Side Effects
Contraindications
- Hypersensitivity to misoprostol or other prostaglandins.
- Pregnancy, unless for medical abortion, labor induction, or other specific obstetric indications under strict medical supervision.
- Known allergy to any component of the tablet.
Drug Interactions
Oxytocin
Increased risk of uterine hyperstimulation when used concurrently for labor induction.
Other uterotonic agents
Potentiates the effect, increasing risk of uterine overstimulation.
Antacids (especially magnesium-containing)
May exacerbate diarrhea, a common side effect of misoprostol.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, and bradycardia. Management is symptomatic and supportive.
Pregnancy & Lactation
Misoprostol is contraindicated for the prevention of NSAID-induced ulcers in pregnant women due to its abortifacient properties. For obstetric indications (abortion, labor induction), it is used under strict medical supervision. Misoprostol acid is excreted in breast milk; therefore, caution is advised during breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to misoprostol or other prostaglandins.
- Pregnancy, unless for medical abortion, labor induction, or other specific obstetric indications under strict medical supervision.
- Known allergy to any component of the tablet.
Drug Interactions
Oxytocin
Increased risk of uterine hyperstimulation when used concurrently for labor induction.
Other uterotonic agents
Potentiates the effect, increasing risk of uterine overstimulation.
Antacids (especially magnesium-containing)
May exacerbate diarrhea, a common side effect of misoprostol.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, and bradycardia. Management is symptomatic and supportive.
Pregnancy & Lactation
Misoprostol is contraindicated for the prevention of NSAID-induced ulcers in pregnant women due to its abortifacient properties. For obstetric indications (abortion, labor induction), it is used under strict medical supervision. Misoprostol acid is excreted in breast milk; therefore, caution is advised during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date.
Availability
Pharmacies, Hospitals, Clinics
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety of misoprostol for NSAID-induced ulcer prevention, medical abortion, and labor induction. Ongoing research explores new applications and optimal dosing regimens.
Lab Monitoring
- No routine laboratory monitoring is typically required. For long-term use in high-risk patients, liver and renal function may be monitored.
Doctor Notes
- Crucial to confirm absence of unintended pregnancy before initiating misoprostol for ulcer prevention in women of childbearing potential.
- For obstetric uses, administer in a hospital setting with facilities for emergency intervention due to risk of uterine hyperstimulation or rupture.
- Educate patients on proper administration technique for different routes (oral, vaginal, sublingual) and expected side effects.
Patient Guidelines
- For ulcer prevention, take Misotab with meals and at bedtime to reduce the risk of diarrhea.
- Do not share this medicine with others, especially pregnant women.
- Understand all potential risks and side effects, particularly if used for obstetric purposes.
- Report any severe or persistent diarrhea, abdominal pain, or abnormal bleeding to your doctor immediately.
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 take a double dose to make up for a missed one.
Driving Precautions
Misotab may cause dizziness or lightheadedness. Exercise caution when driving or operating machinery until you know how the medicine affects you.
Lifestyle Advice
- Avoid alcohol and smoking as they can exacerbate gastrointestinal irritation and peptic ulcer disease.
- Maintain good hydration, especially if experiencing diarrhea.
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