Misoprostol Tablets

Description

Product Description: Misoprostol Tablets contain the active ingredient misoprostol, a synthetic prostaglandin E1 analog. It is primarily used for the prevention and treatment of gastric ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs) and for medical abortion.

Indications and Usage: Misoprostol Tablets are indicated for the prevention and treatment of NSAID-induced gastric ulcers in patients at high risk for complications from gastric ulceration. It is also used in combination with mifepristone for medical abortion up to 70 days of gestation.

Dosage and Administration: The dosage and administration regimen for Misoprostol Tablets may vary depending on the specific indication. For the prevention of NSAID-induced gastric ulcers, the typical dosage is 200 mcg orally four times daily with food. For medical abortion, a typical regimen involves the administration of 800 mcg of misoprostol orally or vaginally, typically 24 to 48 hours after mifepristone administration.

Dosage Forms and Strengths: Misoprostol Tablets are available in oral tablet form, typically containing 100 or 200 mcg of misoprostol.

Contraindications: Misoprostol Tablets are contraindicated in pregnant women for the prevention of gastric ulcers and should not be used for medical abortion in women with confirmed or suspected ectopic pregnancy. It is also contraindicated in patients with a known hypersensitivity to misoprostol or any of its components.

Warnings and Precautions: Patients should be warned about the potential risks of misoprostol-induced abortion and the need for appropriate counseling and medical supervision when using Misoprostol Tablets for medical abortion. It should be used with caution in patients with a history of cardiovascular disease, inflammatory bowel disease, or renal impairment.

Adverse Reactions/Side Effects: Common adverse reactions associated with Misoprostol Tablets may include diarrhea, abdominal pain, uterine cramping, vaginal bleeding, nausea, and headache. Less common but serious side effects may include allergic reactions, uterine rupture, and hemorrhage.

Drug Interactions: Misoprostol may interact with certain medications, including antacids, magnesium-containing products, and drugs that induce or inhibit cytochrome P450 enzymes, potentially altering its efficacy or increasing the risk of adverse effects.

Use In Specific Populations Description: Misoprostol Tablets should be used with caution in pregnant women and should not be used for medical abortion beyond 70 days of gestation. It is not recommended for use during breastfeeding due to the potential risk of adverse effects on the infant.

How Supplied/Storage and Handling: Misoprostol Tablets are typically supplied in blister packs or bottles, with specific packaging details varying depending on the manufacturer. They should be stored at room temperature (20°C to 25°C) away from moisture and heat. Unused tablets should be properly disposed of according to local regulations.