Misoprostol Tablets 200 mcg



Misoprostol, a synthetic prostaglandin E1 analogue, exerts its antisecretory activity by directly acting on specific prostaglandin receptors found on the surface of gastric parietal cells. It exerts its protective effects on the mucosa by replacing the prostaglandins consumed during prostaglandin-inhibiting therapies e.g. NSAIDs.

Misoprostol promotes peptic ulcer healing and symptomatic relief. This agent inhibits gastric acid secretion, and protects the gastroduodenal mucosa by increasing bicarbonate and mucus secretion.

Misoprostol also binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue and it cause cervical ripening and dilation.


  • For obstetric and gynaecological uses.
  • Prevention and treatment of post partum haemorrhage.
  • NSAID-associated ulceration
  • Benign gastric and duodenal ulceration
  • Prophylaxis of NSAID-induced ulcers


For prevention of PPH: three tablets (600mcg) are taken orally immediately AFTER DELIVERY OF THE BABY OR BABIES.

For treatment of PPH: five tablets (1000mcg) are taken rectally immediately AFTER DELIVERY OF THE BABY OR BABIES.

NSAID-associated ulceration

Adult: 800 mcg daily in 2-4 divided doses for at least 4 weeks, up to 8 weeks if needed.

Elderly: Reduce dose if patients are unable to tolerate usual adult dose.

Benign gastric and duodenal ulceration

Adult: 800 mcg daily in 2-4 divided doses for at least 4 weeks, up to 8 weeks if needed.

Elderly: Reduce dose if patients are unable to tolerate usual adult dose.

Prophylaxis of NSAID-induced ulcers

Adult: 200 mcg 2-4 times daily. Patient not tolerating high dose: Reduce dose to 100 mcg 2-4 times daily.

Elderly: Reduce dose if patients are unable to tolerate usual adult dose.


If overdose is suspected, contact a poison control center or emergency room immediately.

Symptoms of overdose may include: severe drowsiness, seizures, severe dizziness, slow/irregular heartbeats.



Misoprostol may cause mild to moderate diarrhea, stomach cramps, and/or nausea. These problems usually occur during the first few weeks of treatment and stop after about a week.

Less common side effects include: headache, flatulence, dyspepsia, rupture of uterus, chest pain, anemia, anaphylaxis


  • Conditions where hypotension might precipitate severe complications e.g. cerebrovascular or CV disease, hence caution should be employed when administering Misoprostol to patients with pre-existing cardiovascular disease.
  • Inflammatory bowel disease.
  • Patients prone to dehydration.
  • Renal impairment.
  • Misoprostol Tablets may terminate pregnancies (sometimes incompletely), cause premature labor, or birth defects if given to pregnant women.
  • Women of childbearing age using Misoprostol Tablets to decrease the risk of NSAID-induced ulcers should be told that they must not be pregnant when Misoprostol Tablets therapy is initiated, and that they must use an effective contraception method while taking Misoprostol Tablets.


May increase effects of oxytocin. Increased risk of Misoprostol-induced diarrhoea with magnesium-containing antacids.

In extensive clinical studies no drug interactions have been attributed to Misoprostol. Additional evidence shows no clinically important pharmacokinetic or pharmacodynamic interaction with non-steroidal anti-inflammatory drugs including aspirin, diclofenac, ibuprofen, aspirin, naproxen or indomethacin.

Magnesium-containing antacids should be avoided during treatment with Misoprostol as this may worsen the Misoprostol-induced diarrhea. Concomitant administration of NSAIDs and Misoprostol in rare cases can cause a transaminase increase and peripheral edema.

Misoprostol is predominantly metabolized via fatty acid oxidizing systems and has shown no adverse effect on the hepatic (chytochrome P450) enzyme. A modest increase in Propranolol concentrations (mean approximately 20% in AUC, 30% in Cmax) has been observed with multiple dosing of Misoprostol.


Allergy to prostaglandins

Pregnancy: Contraindicated in pregnancy

Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Lactation: Contraindicated in lactation

Children: Safety and efficacy not established in children younger than 18 years of age.

Geriatric: Reduce dosage if usual dose is not tolerated.

Other Contraindications: Women of childbearing potential, Pregnancy and lactation.

PRESENTATIONS: 10 x 1 x 3 and 10 x 10 Tablets Alu-Alu Packs.



Store in a cool, dry place at a temperature below 30°c.

Keep all medicines away from children