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misoprostol (Rx)Brand and Other Names:Cytotec

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 100mcg
  • 200mcg
more...

NSAID-Induced Ulcer

Prophylaxis

200 mcg PO q6hr with food; may be decreased to 100 mcg q6hr if higher dose is not tolerated; last dose to be administered at bedtime

Should take therapy for duration of therapy

Pregnancy Termination

See mifepristone (Mifeprex) drug monograph for FDA approved dosage regimen

Stress Ulcer Prophylaxis (Off-label)

100-200 mcg PO q4-6hr

Induction of Labor (Off-label)

25 mcg (1/4 of 100-mcg oral tablet) intravaginally initially, then repeat at intervals not to exceed q3-6hr

Not to be used in patients with previous cesarean delivery or major uterine surgery

Postpartum Hemorrhage (Off-label)

Prophylaxis: 600 mcg PO within 1 minute of delivery

Treatment: 800 mcg PO once; use caution if prophylactic dose already given and adverse effects present or observed

Use only in settings where oxytocin not available

Treatment of Incomplete Abortion (Off-label)

600 mcg buccally once

Intrauterine Fetal Death (Orphan)

Treatment of intrauterine fetal death not accompanied by complete expulsion of products of conception in second and third trimesters of pregnancy

Orphan indication sponsor

  • Gynuity Health Projects, LLC; 15 East 26th Street; New York, NY 10010

Dosing Modifications

Renal impairment: Use with caution; peak plasma concentration, half-life, and bioavailability may be increased, but it is not clear whether these increases are of clinical relevance

Dosage Forms & Strengths

tablet

  • 100mcg
  • 200mcg
more...

Fat Absorption in Cystic Fibrosis Patients (Off-label)

<8 years: Safety and efficacy not established

≥8 years: 100 mcg PO q6hr

NSAID-Induced Ulcer

To avoid possibility of diarrhea, dosing may be initiated at 100 mcg q6hr and increased by 100 mcg/day every 3 days until desired dose is achieved

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Interactions

Interaction Checker

misoprostol and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Diarrhea (14-40%)

            Abdominal pain (13-20%)

            1-10%

            Headache (2%)

            Frequency Not Defined

            Anaphylaxis

            Anemia

            Cardiac dysrhythmia

            Chest pain

            Flatulence

            Gastrointestinal hemorrhage

            Hearing loss

            Myocardial infarction

            Nausea

            Rupture of uterus

            Thromboembolic disorder

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            Warnings

            Black Box Warnings

            Bacterial infections reported after use

            Patients must seek medical attention if excessive bleeding occurs

            Administration to pregnant women can cause abortion, premature birth, or birth defects

            Uterine rupture has been reported when drug is administered to pregnant women to induce labor or induce abortion beyond 8th week of gestation

            Contraindicated in pregnant women to reduce peptic ulcer risk from nonsteroidal anti-inflammatory drugs (NSAIDs)

            Warn patients of risk for abortion, and warn them not to give drug to others

            Use in women of childbearing potential

            • Do not use for reducing risk of NSAID-induced ulcers in women of childbearing potential unless patient is at high risk for complication from gastric ulcers; may be prescribed in the following situations:
            • (1) Patient has negative serum pregnancy test result within 2 weeks before initiation of therapy
            • (2) Patient is capable of complying with effective contraceptive measures
            • (3) Patient has received both oral and written warnings about misoprostol hazards, risk of possible contraception failure, and danger to other women of childbearing potential should drug be taken by mistake
            • (4) Patient will begin misoprostol only on day 2 or 3 of next normal menstrual period

            Contraindications

            Pregnancy when used to reduce risk of NSAID-induced ulcers

            Hypersensitivity to misoprostol, prostaglandins, or prostaglandin analogues

            Cautions

            May cause diarrhea; should not be coadministered with other drugs that cause diarrhea (eg, magnesium-containing antacids)

            Adequate contraception is required in women of childbearing age

            May cause anaphylactic reaction

            May cause chills

            Unknown whether drug is safe for use in women with severe anemia

            Safety and efficacy in patients with cardiovascular disease, diabetes, renal impairment, or respiratory disease are not established

            Use with caution in women >35 years or heavy smokers (these patients were not included in clinical trials)

            Off-label use

            • For hospital use only if used off label for cervical ripening, induction of labor, or treatment of serious postpartum hemorrhage
            • Uterine activity and fetal status should be monitored by trained obstetric personnel in hospital setting
            • May be associated with meconium passage, meconium staining of amniotic fluid, and cesarean delivery
            • Maternal shock, maternal death, fetal bradycardia, and fetal death have been reported
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            Pregnancy & Lactation

            Pregnancy category: X

            Lactation: Drug is rapidly metabolized in mother to misoprostol acid, which is biologically active and is excreted in breast milk; although no published reports of adverse effects of misoprostol in breast-feeding infants exist, caution should be exercised when misoprostol is administered to breastfeeding women

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Synthetic prostaglandin E analogue parent drug that is rapidly deesterified to misoprostol acid (active metabolite) and replaces protective prostaglandins consumed with therapies that inhibit prostaglandin synthesis; inhibits gastric acid secretion and protects gastric mucosa

            Significantly reduces degree of fat malabsorption in patients with >10% fat malabsorption, possibly by stimulating duodenal bicarbonate production

            Absorption

            Bioavailability: Unquantified

            Onset: 2-3 hr (initial response for acid secretion)

            Duration: ≥3 hr (inhibition of acid secretion)

            Peak plasma time: Misoprostol acid (active metabolite), 14 min

            Distribution

            Protein bound: Misoprostol acid (active metabolite), 80-90%

            Metabolism

            Extensive and rapid 1st-pass metabolism by liver to form misoprostol acid (active metabolite)

            Metabolites: Misoprostol acid (principal and active metabolite), dinor and tetranor metabolites of misoprostol acid

            Elimination

            Half-life: Misoprostol acid (active metabolite), 20-40 min

            Dialyzable: No

            Excretion: Urine (80%)

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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