misoprostol

misoprostol /mi·so·pro·stol/ (mi″so-pros´tol) a synthetic prostaglandin E analogue used to treat gastric irritation resulting from long-term therapy with nonsteroidal antiinflammatory drugs; also used in conjunction with mifepristone (q.v.) for termination of pregnancy.

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misoprostol

(mī´sōprôs´til),
n brand name: Cytotec;
drug class: gastric mucosa protectant;
action: a prostaglandin E₁ analog that inhibits gastric acid secretion;
uses: prevention of nonsteroidal antiinflammatory drug-induced gastric ulcers.

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misoprostol

a synthetic analog of prostaglandin E and inhibitor of gastric secretion; used in the treatment of gastrointestinal ulceration, particularly those associated with the use of nonsteroidal anti-inflammatory drugs.

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misoprostol

Apo-Misoprostol (CA), Cytotec

Pharmacologic class: Prostaglandin E₁ analog

Therapeutic class: Antiulcerative, cytoprotective agent

Pregnancy risk category X

FDA Boxed 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.

Action

Reduces gastric acid secretion and increases gastric mucus and bicarbonate production, creating a protective coating on gastric mucosa

Availability

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.

Off-label uses

• Duodenal ulcer
• Pregnancy termination

Contraindications

• Prostaglandin hypersensitivity
• Pregnancy

Precautions

Use cautiously in:
• females of childbearing age
• breastfeeding patients
• children younger than age 18 (safety not established).

Administration

☞ 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.

Route	Onset	Peak	Duration
P.O.	Rapid	14-20 min	3-6 hr

Adverse reactions

CNS: headache

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, flatulence

GU: miscarriage, menstrual disorders, postmenopausal bleeding

Interactions

Drug-drug. Magnesium-containing antacids: increased risk of diarrhea

Patient monitoring

• Assess GI status. Report significant adverse reactions.
• Monitor menstrual pattern or postmenopausal bleeding. Report significant problems.

Patient teaching

• 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.

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misoprostol

Obstetrics A synthetic PGE₁ analogue administered vaginally with mifepristone–RU 486 as an abortifacient, also used to manage peptic and duodenal ulcers. See Abortion, Gemeprost, Mifepristone, Sulprostone.