misoprostol (Rx)

Brand and Other Names:Cytotec
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 100mcg
  • 200mcg

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

Fat Malabsorption 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

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    Contraindicated

      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (5)

              • aluminum hydroxide/magnesium carbonate

                aluminum hydroxide/magnesium carbonate, misoprostol. unknown mechanism. Avoid or Use Alternate Drug. Antacids reduce the bioavailability of misoprostol acid. Magnesium-containing antacids may potentiate misoprostol-induced diarrhea. If an antacid is needs, use an aluminum- or calcium- containing antacids.

              • aluminum hydroxide/magnesium trisilicate

                aluminum hydroxide/magnesium trisilicate, misoprostol. unknown mechanism. Avoid or Use Alternate Drug. Antacids reduce the bioavailability of misoprostol acid. Magnesium-containing antacids may potentiate misoprostol-induced diarrhea. If an antacid is needs, use an aluminum- or calcium- containing antacids.

              • citric acid/glucono-delta-lactone/magnesium carbonate

                citric acid/glucono-delta-lactone/magnesium carbonate, misoprostol. unknown mechanism. Avoid or Use Alternate Drug. Antacids reduce the bioavailability of misoprostol acid. Magnesium-containing antacids may potentiate misoprostol-induced diarrhea. If an antacid is needs, use an aluminum- or calcium- containing antacids.

              • magnesium gluconate

                magnesium gluconate, misoprostol. unknown mechanism. Avoid or Use Alternate Drug. Antacids reduce the bioavailability of misoprostol acid. Magnesium-containing antacids may potentiate misoprostol-induced diarrhea. If an antacid is needs, use an aluminum- or calcium- containing antacids.

              • oxytocin

                misoprostol increases effects of oxytocin by pharmacodynamic synergism. Avoid or Use Alternate Drug. Misoprostol may augment the effects oxytocic agents, especially when given less than 4 hours before initiating oxytocin. .

              Monitor Closely (0)

                Minor (0)

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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; risk of uterine rupture increases with advancing gestational ages and prior uterine surgery, including cesarean delivery

                  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

                  Misoprostol may cause birth defects, abortion (sometimes incomplete), premature labor or rupture of the uterus if given to pregnant women

                  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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                  Images

                  BRAND FORM. UNIT PRICE PILL IMAGE
                  misoprostol oral
                  -
                  200 mcg tablet
                  misoprostol oral
                  -
                  100 mcg tablet
                  misoprostol oral
                  -
                  100 mcg tablet
                  misoprostol oral
                  -
                  200 mcg tablet
                  misoprostol oral
                  -
                  200 mcg tablet
                  misoprostol oral
                  -
                  100 mcg tablet
                  Cytotec oral
                  -
                  200 mcg tablet
                  Cytotec oral
                  -
                  100 mcg tablet

                  Copyright © 2010 First DataBank, Inc.

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                  Patient Handout

                  Patient Education
                  misoprostol oral

                  MISOPROSTOL - ORAL

                  (MYE-soe-PROST-ol)

                  COMMON BRAND NAME(S): Cytotec

                  WARNING: Do not take this medication if you think that you may be pregnant. It may cause abortion, premature birth, or birth defects. In rare cases, serious complications (e.g., uterine rupture) have occurred when misoprostol was used to start labor or cause an abortion. These complications have resulted in harm to the unborn baby and mother. The risk for uterine rupture increases as your pregnancy advances and if you had prior uterine surgery (including Cesarean delivery) or if you had five or more previous pregnancies.Avoid pregnancy while taking misoprostol and for at least one month or one completed menstrual cycle after you have stopped treatment. If you become pregnant while taking misoprostol, contact your doctor right away.If you are pregnant, do not take this medication to reduce the risk of stomach ulcers due to aspirin or other related drugs (non-steroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Also, if you are of childbearing age, do not use this drug to reduce the risk of ulcers from NSAIDs unless you are at high risk of having an ulcer or ulcer complications.Female patients must meet the following four requirements in order to use this drug: 1) test negative for pregnancy within two weeks before starting treatment; 2) use effective birth control to prevent pregnancy; 3) receive oral and written warnings on the dangers of using misoprostol while of childbearing age and the risks of possible birth control failure; 4) start taking misoprostol only on the second or third day of the next normal menstrual period.This medication must not be shared with others.

                  USES: This medication is used to prevent stomach ulcers while you take NSAIDs (e.g., aspirin, ibuprofen, naproxen), especially if you are at risk for developing ulcers or have a history of ulcers. Misoprostol helps to decrease your risk of serious ulcer complications such as bleeding. This medication protects your stomach lining by lowering the amount of acid that comes in contact with it.This medication is also used in combination with another drug (mifepristone) to end a pregnancy (abortion).

                  HOW TO USE: This medicine comes with a patient information leaflet. Read it carefully. If you have any questions about this drug, ask your doctor, nurse, or pharmacist.Dosage is based on your medical condition and response to therapy.If you are taking this drug to prevent stomach ulcers, take it by mouth usually four times a day, after meals and at bedtime to minimize diarrhea, or as directed by your doctor.If you are taking this medication for abortion, take it by mouth exactly as directed by your doctor.If you are using this medication to start labor, your healthcare professional will insert it into your vagina.Avoid taking antacids that contain magnesium while using misoprostol because they may make the diarrhea it causes worse. If you need an antacid, consult your doctor or pharmacist to help you choose a product.For ulcer prevention, continue to take this drug for as long as you take NSAIDs. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day.Inform your doctor if your condition persists or worsens.

                  SIDE EFFECTS: Nausea or stomach cramps may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Diarrhea is common with misoprostol and usually occurs about two weeks after you start taking it, and lasts for about a week. Be sure to keep up your intake of fluids and minerals/electrolytes to prevent dehydration. Persistent diarrhea may sometimes lead to a large loss of your body's water and minerals. Tell your doctor right away if you develop any of these serious signs of dehydration and mineral imbalance: severe dizziness, decreased urination, mental/mood changes, muscle weakness, slow/irregular heartbeat.Tell your doctor right away if any of these unlikely but serious side effects occur: menstrual problems or irregularities, unusual/heavy vaginal bleeding.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                  PRECAUTIONS: Before taking misoprostol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal disease (e.g., inflammatory bowel disease).Daily use of alcohol and tobacco may increase your risk for stomach bleeding. Limit alcohol beverages and stop smoking. Consult your doctor or pharmacist for more information.If you are taking this medication in combination with mifepristone to end a pregnancy, an incomplete abortion may rarely occur. It is very important for you to be closely monitored by your doctor and to keep your scheduled appointments to follow your progress. Be sure to have clear instructions from your doctor about who to call and what to do in case of an emergency. Expect vaginal bleeding after you take the combined medicine, however tell your doctor right away if you develop any unlikely symptoms such as severe/prolonged vaginal bleeding, signs of infection (including fever, chills), or fainting.This drug must not be used during pregnancy to prevent stomach ulcers because of possible harm to an unborn baby (see also Warnings). If you are of childbearing age, use effective birth control methods while taking misoprostol and for at least one month or one completed menstrual cycle after you stop taking it. If you become pregnant or think you may be pregnant, inform your doctor right away.This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

                  DRUG INTERACTIONS: See also the How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

                  OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, seizures, severe dizziness, slow/irregular heartbeats.

                  NOTES: Do not share this medication with others.

                  MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

                  STORAGE: Store at or below 77 degrees F (25 degrees C) in a dry place away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

                  Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                  IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                  Formulary

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                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.