Misoprostol (misoprostol)

Routine reduction of misoprostol dosage in patients with renal impairment or in geriatric patients does not appear to be necessary; however, if patients are unable to tolerate the usual adult dosage, dosage can be reduced.

Misoprostol usually is administered orally.

When used to reduce the risk of nonsteroidal anti-inflammatory agent (NSAIA)-induced gastric ulcers, the incidence of misoprostol-induced diarrhea may be minimized by administering the drug in divided doses after meals and at bedtime and by avoiding concomitant administration with a magnesium-containing or other laxative antacid.

When used in conjunction with mifepristone for the medical termination of pregnancy, misoprostol is administered intrabuccally 24-48 hours following mifepristone administration; patients should be instructed to place 2 misoprostol tablets in each side of the mouth between the cheek and gums for 30 minutes, then swallow any remnants with water or another liquid. Misoprostol should be administered in an appropriate setting for the patient, taking into account that expulsion of uterine contents could begin within 2 hours of misoprostol administration.

Misoprostol also has been administered intravaginally+ using tablets formulated for oral administration.

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There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

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• Pregnancy

• Inflammatory bowel disease
• Uterine rupture in pregnancy

• Dehydration
• Previous cesarean section
• Uterine scar present

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Less Frequent

• Abnormal hepatic function tests

Rare or Very Rare

• Acute myocardial infarction
• Anaphylaxis
• Anemia
• Bronchospastic pulmonary disease
• Cardiac arrhythmia
• CNS toxicity
• Gout
• Hearing loss
• Purpura
• Seizure disorder
• Tachycardia
• Thrombocytopenic disorder
• Thromboembolic disorder
• Uterine rupture in pregnancy

More Frequent

• Abdominal pain with cramps
• Diarrhea

Less Frequent

• Constipation
• Dyspepsia
• Flatulence
• Headache disorder
• Nausea
• Vomiting

Rare or Very Rare

• Abnormal vaginal bleeding
• Acute cognitive impairment
• Agitation
• Alopecia
• Arthralgia
• Back pain
• Chest pain
• Chills
• Conjunctivitis
• Cramps
• Depression
• Dizziness
• Drowsy
• Dysgeusia
• Dysmenorrhea
• Dysphagia
• Dyspnea
• Dysuria
• Earache
• Edema
• Epistaxis
• Erectile dysfunction
• Fatigue
• Fever
• General weakness
• Gingivitis
• Hematuria
• Hyperhidrosis
• Hypertension
• Hypotension
• Mastalgia
• Menstrual disorder
• Myalgia
• Pallor
• Phlebitis
• Polyuria
• Skin inflammation
• Skin rash
• Symptoms of anxiety
• Syncope
• Tinnitus
• Upper respiratory infection
• Uterine cramps
• Visual changes

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Misoprostol exhibits abortifacient activity and therefore can cause serious fetal harm when administered to pregnant women. A boxed warning about this risk is included in the prescribing information for the drug. Misoprostol should not be used in pregnant women for reducing the risk of NSAIA-induced gastric ulcers. The drug also should not be used for reducing the risk of NSAIA-induced gastric ulcers 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; such women should not receive misoprostol until pregnancy is excluded and other necessary precautions are ensured.

Misoprostol has been reported to produce uterine contractions and to stimulate uterine bleeding and total or partial expulsion of the products of conception in pregnant women. Spontaneous abortions induced by the drug may be incomplete, may require hospitalization and/or surgery, and can result in dangerous uterine bleeding, premature birth, or birth defects.

Intravaginal use of misoprostol may result in hyperstimulation of the uterus, which may progress to uterine tetany with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy), or amniotic fluid embolism. Pelvic pain, retained placenta, severe genital bleeding, shock, fetal bradycardia, and fetal and maternal death have been reported. Use of intravaginal misoprostol dosages exceeding 25 mcg may be associated with an increased risk of uterine tachysystole, uterine rupture, meconium passage, meconium staining of amniotic fluid, and cesarean delivery resulting from uterine hyperstimulation. The risk of uterine rupture increases with advancing gestational age, prior uterine surgery (including cesarean delivery), and grand multiparity; the American College of Obstetricians and Gynecologists (ACOG) states that intravaginal use of misoprostol for cervical ripening or labor induction is not recommended in patients with a previous cesarean delivery or prior major uterine surgery.

Serious, sometimes fatal, bacterial (e.g., Clostridium sordellii) infection and sepsis or prolonged heavy vaginal bleeding have been reported following spontaneous, surgical, and medical abortions, including in patients receiving mifepristone and misoprostol for termination of pregnancy; a causal relationship to the regimen has not been established.

Congenital abnormalities, sometimes associated with fetal death, have been reported subsequent to the unsuccessful use of misoprostol as an abortifacient. Some data indicate that use of misoprostol during the first trimester of pregnancy has been associated with skull defects, cranial nerve palsies, facial malformations, and limb defects; however, the precise mechanism(s) for these teratogenic effects has not been fully elucidated. Effects of misoprostol on later growth, development, and functional maturation of the child whose mother received the drug for cervical ripening or labor induction have not been established. The effects of misoprostol on the need for forceps delivery or other intervention are not known.

Currently, it is recommended that misoprostol be used for reducing the risk of NSAIA-induced gastric ulcers in women of childbearing potential only if they are at high risk of complications resulting from NSAIA-induced gastric ulceration or are at high risk of developing gastric ulceration. Such therapy should be initiated in such women only after determining that they are reliable and able to comply with effective contraceptive measures and ensuring that they have received both oral and written warnings concerning the hazards associated with misoprostol therapy, the risk of possible contraceptive failure, and the danger to other women of childbearing potential should the drug be taken by them. In addition, a reliable, blood pregnancy test must be performed within 2 weeks prior to beginning misoprostol therapy and the drug should not be provided to the patient until the pregnancy test is reported as negative, initiating therapy on the second or third day of the next normal menstrual cycle.

If misoprostol is inadvertently administered during pregnancy or if the patient becomes pregnant while receiving the drug for reducing the risk of NSAIA-induced gastric ulcer, misoprostol should be discontinued and the patient informed of the potential hazard to the fetus.

Reproduction studies in rats and rabbits using oral misoprostol dosages up to 10 and 1 mg/kg (625 and 63 times the usual human dosage), respectively, have not revealed evidence of fetotoxicity or teratogenicity. However, increased fetal resorption occurred in rabbits, suggesting possible embryotoxicity.

It is not known whether misoprostol and/or misoprostol acid cross the placenta. The drug is metabolized rapidly to the free acid following oral administration, which is biologically active and distributed into breast milk. There are no published reports of adverse effects associated with misoprostol in breast-fed infants. Caution is advised if the drug is used during breast-feeding.

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