Misoprostol

Misoprostol is a prescription drug used to reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, such as the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer.

• Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs.
• Misoprostol should be taken for the duration of NSAID therapy.
• Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.

Misoprostol is available under the following different brand names: Cytotec.

Dosages of Misoprostol:

Adult and Pediatric Dosage

Tablet

• 100 mcg
• 200 mcg

Dosage Considerations – Should be Given as Follows:

NSAID-Induced Ulcer

Adult

Prophylaxis

• 200 mcg orally every 6 hours with food; may be decreased to 100 mcg every 6 hours if higher dose is not tolerated; last dose to be administered at bedtime
• Should take therapy for duration of therapy

Geriatric

• To avoid possibility of diarrhea, dosing may be initiated at 100 mcg every 6 hours and increased by 100 mcg/day every 3 days until desired dose is achieved

Pregnancy Termination

• See mifepristone (Mifeprex) drug monograph for FDA approved dosage regimen

Stress Ulcer Prophylaxis (off-label)

• 100-200 mcg orally every 4-6 hours

Induction of Labor (off-label)

• 25 mcg (1/4 of 100 mcg oral tablet) intravaginally initially, then repeat at intervals not to exceed every 3-6 hours

Not to be used in patients with previous cesarean delivery or major uterine surgery

Postpartum Hemorrhage (off-label)

• Prophylaxis: 600 mcg orally within 1 minute of delivery
• Treatment: 800 mcg orally once; use caution if prophylactic dose already given and adverse effects present or observed
• Use only in settings where oxytocin not available

Treatment of Incomplete Abortion (off-label)

• 600 mcg buccally (dissolved in the mouth) once

Fat Absorption in Cystic Fibrosis Patients (off-label)

Pediatric

• Children under 8 years: safety and efficacy not established
• Children 8 years and older: 100 mcg orally every 6 hours

Dosage Modifications

Renal impairment

• Use with caution; peak plasma concentration, half-life, and bioavailability may be increased, but it is not clear whether these increases are of clinical relevance