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Pharmacologic class: Prostaglandin E1 analog
Therapeutic class: Antiulcerative, cytoprotective agent
Pregnancy risk category X
FDA Box Warning
• In pregnant women, drug can cause abortion, premature birth, or birth defects. Uterine rupture has occurred when drug was given to pregnant women to induce labor or to induce abortion beyond week 8 of pregnancy.
• Don't give to pregnant women to reduce risk of nonsteroidal anti-inflammatory drug (NSAID)-induced ulcers.
• Advise patients of drug's abortifacient property and warn them not to give it to others.
• Don't use drug to reduce risk of NSAID-induced ulcers in women of childbearing potential unless patient is at high risk for complications from gastric ulcers linked to NSAIDs or at high risk for gastric ulcers. In such patients, drug may be prescribed if patient has had negative serum pregnancy test within 2 weeks before starting therapy; is able to comply with effective contraceptive measures; has received both oral and written warnings of drug's hazards, risk of possible contraception failure, and danger to other women of childbearing potential should drug be taken by mistake; and will begin drug only on second or third day of next normal menstrual period.
Reduces gastric acid secretion and increases gastric mucus and bicarbonate production, creating a protective coating on gastric mucosa
Tablets: 100 mcg, 200 mcg
Indications and dosages
➣ To prevent gastric ulcers caused by NSAIDs
Adults: 200 mcg q.i.d. with food, with last daily dose given at bedtime. If intolerance occurs, decrease to 100 mcg q.i.d.
• Duodenal ulcer
• Pregnancy termination
• Prostaglandin hypersensitivity
Use cautiously in:
• females of childbearing age
• breastfeeding patients
• children younger than age 18 (safety not established).
☞ Before starting therapy, make sure female patient understands dangers of taking drug while pregnant or breastfeeding.
• Be aware that drug should not be used in females of childbearing age, except those who need NSAIDs and are at high risk for complications from NSAID-associated gastric ulcers.
• For antiulcer use in females, start therapy on day 2 or 3 of normal menses.
GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, flatulence
GU: miscarriage, menstrual disorders, postmenopausal bleeding
Drug-drug. Magnesium-containing antacids: increased risk of diarrhea
• Assess GI status. Report significant adverse reactions.
• Monitor menstrual pattern or postmenopausal bleeding. Report significant problems.
• Instruct patient to take with food.
• Advise patient to report diarrhea, abdominal pain, and menstrual irregularities.
☞ Tell patient drug may cause spontaneous abortion. Stress importance of using reliable contraception.
• Instruct female patient using drug for ulcer treatment to start therapy on second or third day of normal menses.
• Caution patient not to take magnesium-containing antacids, which may worsen diarrhea.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs mentioned above.
misoprostol(mī′sō-prŏs′tôl′, -tōl′, -tŏl′)
misoprostolA synthetic PGE1 analogue administered vaginally with mifepristone (RU 486) as an abortifacient. It is also used to prevent NSAID-induced gastric ulcers and in patients with a history of GI bleeding. Misoprostol may be of use in reducing acute rejection of renal allografts, a phenomenon partially due to ischaemic damage of kidneys that occurs between the time of “harvesting” and re-establishment of the blood flow; misoprostol-treated group subjects suffered acute rejection one-half as often as the placebo group.
When compared to PGE2, misoprostol induces complete abortion (i.e., passage of foetus and placenta simultaneously) more often (43% vs 32% for PGE2), was more convenient (insertion of two 100-µg tablets at 12 hours vs insertion of 20 mg suppository every 3 hours, plus antidiarrhoeal, antiemetic and antipyretic medication required for PGE2 therapy), was associated with fewer side effects, including fever (11% vs 63%), vomiting (4% vs 33%) and diarrhoea (4% vs 30%), and is less expensive (USD $0.97 vs $315.30).