Zitotec Tablet

Description

Misoprostol is contraindicated in anyone with a history of allergy to prostaglandins. It is also contraindicated in women of childbearing potential unless they require NSAID therapy and are using effective contraception. Pregnancy and lactation are general contraindications except for specific indicated uses under medical supervision.

Precautions

Use with caution in:

• For prevention and treatment of NSAID-induced gastric and duodenal ulcer: Misoprostol is contraindicated in pregnant women and should not be used in women of childbearing potential unless the patient requires NSAID therapy and must use an effective contraception method while taking misoprostol.
• Conditions where hypotension might precipitate severe complications (e.g., cerebrovascular or cardiovascular disease).
• Inflammatory bowel disease.
• Patients prone to dehydration.
• Elderly patients.
• Patients with renal impairment.

Pregnancy and Lactation

• Lactation: The drug is rapidly metabolized in the mother to misoprostol acid, which is biologically active and is excreted in breast milk. Although no published reports of adverse effects of misoprostol in breast-feeding infants exist, caution should be exercised when misoprostol is administered to breastfeeding women.
• Pregnancy: Generally contraindicated due to its abortifacient properties, except for specific indicated uses (e.g., termination of pregnancy, labor induction) under strict medical supervision.

Drug Interactions

• May increase effects of oxytocin.
• Increased risk of misoprostol-induced diarrhea with magnesium-containing antacids.

Adverse Effects

Side effects of Misoprostol can vary.

Very Common (>10%)

Diarrhea (14-40%), Abdominal pain (13-20%).

Common (1-10%)

Headache (2%).

Frequency Not Defined (meaning occurrence is rare or not precisely quantified)

Anaphylaxis, Anemia, Cardiac dysrhythmia, Chest pain, Flatulence, Gastrointestinal hemorrhage, Hearing loss, Myocardial infarction, Nausea, Rupture of uterus, Thromboembolic disorder.

Mechanism of Action

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).