No

Prostaglandin

Prevention of NSAID-induced gastric ulcers

X

Pregnancy; hypersensitivity to misoprostol or any component

Safety and efficacy have not been established in children <18 years of age; use with caution in patients with renal impairment and the elderly; not to be used in pregnant women or women of childbearing potential unless woman is capable of complying with effective contraceptive measures; therapy is normally begun on the second or third day of next normal menstrual period

>10%: Gastrointestinal: Diarrhea, abdominal pain

1% to 10%:

Central nervous system: Headache

Gastrointestinal: Constipation, flatulence

<1%: Nausea, vomiting, uterine stimulation, vaginal bleeding

Symptoms of overdose include sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, hypotension, bradycardia

Antacids and food diminish absorption; antacids may enhance diarrhea

Misoprostol is a synthetic prostaglandin E₁ analog that replaces the protective prostaglandins consumed with prostaglandin-inhibiting therapies eg, nonsteroidal anti-inflammatory drugs

Absorption: Oral: Rapid

Metabolism: Rapidly de-esterified to misoprostol acid

Half-life (parent and metabolite combined): 1.5 hours

Time to peak serum concentration (active metabolite): Within 15-30 minutes

Elimination: In urine (64% to 73% in 24 hours) and feces (15% in 24 hours)

Adults: Oral: 200 mcg 4 times/day with food; if not tolerated, may decrease dose to 100 mcg 4 times/day with food or 200 mcg twice daily with food

Incidence of diarrhea may be lessened by having patient take dose right after meals and at bedtime

None reported

None reported

No information available to require special precautions

No effects or complications reported

Take as directed; continue taking your NSAIDs while taking this medication. Take with meals or after meals to prevent nausea, diarrhea, and flatulence. Avoid using antacids. You may experience increased menstrual pain, or cramping; request analgesics. Report abnormal menstrual periods, spotting (may occur even in postmenstrual women), or severe menstrual bleeding. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not get pregnant during or for 1 month following therapy. Male: Do not cause a female to become pregnant. Male/female: Consult prescriber for instruction on appropriate contraceptive measures. This drug may cause severe fetal defects. Do not breast-feed.

Incidence of diarrhea may be lessened by having patient take dose right after meals

Tablet: 100 mcg, 200 mcg

Cleghorn GJ, Shepherd RW, and Holt TL, "The Use of a Synthetic Prostaglandin E1 Analogue (Misoprostol) as an Adjunct to Pancreatic Enzyme Replacement in Cystic Fibrosis," Scand J Gastroenterol Suppl, 1988, 143:142-7.

Robinson PJ, Smith AL, and Sly PD, "Duodenal pH in Cystic Fibrosis and Its Relationship to Fat Malabsorption," Dig Dis Sci, 1990, 35(10):1299-304.

Walt RP, "Misoprostol for the Treatment of Peptic Ulcer and Anti-inflammatory Drug-Induced Gastroduodenal Ulceration," N Engl J Med, 1992, 327(22):1575-80.