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Pronunciation:

(mye soe PROST ole)

U.S. Brand Names:

Cytotec®

Generic Available:

Yes

Canadian Brand Names:

Apo-Misoprostol®; Cytotec®; Novo-Misoprostol

Use:

Prevention of NSAID-induced gastric ulcers; medical termination of pregnancy of 49 days (in conjunction with mifepristone)

Use - Unlabeled/Investigational:

Cervical ripening and labor induction; NSAID-induced nephropathy; fat malabsorption in cystic fibrosis

Pregnancy Risk Factor:

Pregnancy Implications:

Misoprostol is an abortifacient. During pregnancy, use to prevent NSAID-induced ulcers is contraindicated. Reports of fetal death, congenital anomalies, uterine perforation, and abortion have been received after the use of misoprostol in pregnancy.

Lactation:

Excretion in breast milk unknown/contraindicated

Contraindications:

Hypersensitivity to misoprostol, prostaglandins, or any component of the formulation; pregnancy (when used to reduce NSAID-induced ulcers)

Warnings/Precautions:

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 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. Uterine perforation and/or rupture have been reported in association with intravaginal use to induce labor or with combined oral/intravaginal use to induce abortion. The manufacturer states that Cytotec® should not be used as a cervical-ripening agent for induction of labor. However, The American College of Obstetricians and Gynecologists (ACOG) continues to support this off-label use.

Adverse Reactions:

>10%: Gastrointestinal: Diarrhea, abdominal pain

1% to 10%:

Central nervous system: Headache

Gastrointestinal: Constipation, flatulence, nausea, dyspepsia, vomiting

<1%: Cramps, uterine stimulation, vaginal bleeding

Postmarketing and/or case reports: Abnormal taste, abnormal vision, alkaline phosphatase increased, alopecia, anaphylaxis, anemia, amylase increase, anxiety, appetite changes, arrhythmia, arterial thrombosis, arthralgia, back pain, breast pain, bronchospasm, cardiac enzymes increased, chest pain, confusion, deafness, depression, dermatitis, diaphoresis, drowsiness, dysphagia, dyspnea, earache, edema, epistaxis, ESR increased, fetal or infant death (when used during pregnancy), fever, GI bleeding, GI inflammation, gingivitis, glycosuria, gout, hyper-/hypotension, impotence, loss of libido, MI, muscle cramps, myalgia, neuropathy, neurosis, nitrogen increased, pallor, phlebitis, pulmonary embolism, purpura, rash, reflux, rigors, stiffness, syncope, thirst, thrombocytopenia, tinnitus, uterine rupture, weakness, weight changes

Overdosage/Toxicology:

Symptoms of overdose include sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, hypotension, and bradycardia. Treatment is symptom-directed and supportive.

Drug Interactions:

Oxytocin: Misoprostol may increase the effect of oxytocin; wait 6-12 hours after misoprostol administration before initiating oxytocin.

Ethanol/Nutrition/Herb Interactions:

Food: Misoprostol peak serum concentrations may be decreased if taken with food (not clinically significant).

Stability:

Store at or below 25°C (77°F).

Mechanism of Action:

Misoprostol is a synthetic prostaglandin E1 analog that replaces the protective prostaglandins consumed with prostaglandin-inhibiting therapies (eg, NSAIDs); has been shown to induce uterine contractions

Pharmacodynamics/Kinetics:

Absorption: Rapid

Metabolism: Hepatic; rapidly de-esterified to misoprostol acid (active)

Half-life elimination: Metabolite: 20-40 minutes

Time to peak, serum: Active metabolite: Fasting: 15-30 minutes

Excretion: Urine (64% to 73%) and feces (15%) within 24 hours

Dosage:

Oral:

Children 8-16 years: Fat absorption in cystic fibrosis (unlabeled use): 100 mcg 4 times/day

Adults:

Prevention of NSAID-induced gastric ulcers: 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; last dose of the day should be taken at bedtime

Medical termination of pregnancy: Refer to Mifepristone monograph.

Intravaginal: Adults: Labor induction or cervical ripening (unlabeled use): 25 mcg (¹/4 of 100 mcg tablet); may repeat at intervals no more frequent than every 3-6 hours. Do not use in patients with previous cesarean delivery or prior major uterine surgery.

Administration:

Incidence of diarrhea may be lessened by having patient take dose right after meals. Therapy is usually begun on the second or third day of the next normal menstrual period.

Dietary Considerations:

Should be taken with food; incidence of diarrhea may be lessened by having patient take dose right after meals.

Patient Education:

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: When used to prevent NSAID-induced ulcers: 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, miscarriage, or abortion; do not share medication with others. Do not breast-feed.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

Tablet: 100 mcg, 200 mcg

International Brand Names:

Apo-Misoprostol® (CA); Cityl® (CO); Cyprostol® (AT); Cytolog® (IN); Cytotec® (AR, AU, BE, BR, CA, CH, CO, CY, CZ, DE, DK, EG, ES, FI, FR, GB, HK, ID, IE, IL, IT, JO, KW, LB, LU, MT, MX, NL, NO, NZ, PL, PT, SE, SY, TH, TR, ZA); Gastrul® (ID); Glefos® (ES); Misodex® (IT); Misoprostol® (RU); Misotrol® (CL); Novo-Misoprostol (CA)

References

"Induction of Labor," American College of Obstetricians and Gynecologists, ACOG Practice Guidelines Bulletin 10, Washington, DC; ACOG, 1999.

"Induction of Labor With Misoprostol," American College of Obstetricians and Gynecologists, ACOG Committee Opinion 228, Washington, DC; ACOG, 1999.

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.

Wing, DA, "Labor Induction With Misoprostol,"Am J Obstet Gynecol, 1999, 181(2):339-45.

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