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Uses

Prevention of NSAIA-induced Ulcers

Treatment to reduce the risk of NSAIA-induced gastric ulcers in patients at high risk (e.g., concomitant debilitating disease, geriatric patients, history of upper GI ulcer) of developing complications (e.g., bleeding, perforation, death) from these ulcers.

Not recommended for use in women of childbearing potential unless the woman is at high risk of developing gastric ulcers or of complications resulting from NSAIA-induced gastric ulcers.

Gastric Ulcer

Short-term treatment of active, benign, gastric ulcer†; however, not considered a drug of choice.

Maintenance treatment following healing of active gastric ulcer to reduce ulcer recurrence†.

Duodenal Ulcer

Short-term treatment of endoscopically or radiographically confirmed active duodenal ulcer†; however, not considered a drug of choice.

Termination of Pregnancy

Use as an adjunct to mifepristone for medical termination of an intrauterine pregnancy. (See Pregnancy under Cautions.)

Labor Induction

Treatment to improve cervical inducibility (cervical “ripening”) in appropriately selected pregnant women with unfavorable cervices with a medical or obstetric need for labor induction†. However, avoid such use in women with prior uterine surgery or cesarean section because of the risk of possible uterine rupture.

Postpartum Hemorrhage

Prevention or treatment of serious postpartum hemorrhage† in the presence of uterine atony.

Dosage and Administration

Administration

Administer orally.

Also has been administered intravaginally†, using tablets formulated for oral administration.

Oral Administration

Administer in divided doses after meals and at bedtime.

Avoid concomitant administration with a magnesium-containing or other laxative antacid to minimize the incidence of misoprostol-induced diarrhea. (See GI Effects under Cautions and also see Interactions.)

Dosage

Available as mifoprostol; dosage expressed in terms of mifoprostol.

Adults

Prevention of NSAIA-Induced Ulcers

Oral

200 mcg 4 times daily. May reduce dosage to 100 mcg 4 times daily if higher dosage is not well tolerated; however, reduced dosage may be less effective. Alternatively, 200 mcg twice daily. Continue therapy for the duration of NSAIA therapy.

Gastric Ulcer

Oral

100 or 200 mcg 4 times daily for 8 weeks.†

Duodenal Ulcer

Oral

100 or 200 mcg 4 times daily or 400 mcg twice daily for 4–8 weeks.†

Termination of Pregnancy

Oral

400 mcg administered orally on day 3 (2 days after mifepristone administration) unless abortion has occurred and has been confirmed by clinical examination or ultrasonographic scan. See Mifepristone 76:00.

Induction of Labor

Intravaginal

Initially, 25 mcg (¼ of a 100-mcg oral tablet). Subsequently, 25-mcg every 3–6 hours.†

Prescribing Limits

Adults

Induction of Labor

Intravaginal

Maximum 25 mcg. Subsequently, maximum 25-mcg every 3–6 hours. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)†

Special Populations

Renal Impairment

Routine dosage reduction not required; however, dosage can be reduced if not tolerated.

Geriatric Patients

Routine dosage reduction not required; however, dosage can be reduced if not tolerated.