Cytotec

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

• Cytotec^®

GENERIC AVAILABLE: Yes

Misoprostol should never be used during pregnancy since it can cause abortion, premature birth, or birth defects. Uterine rupture has been reported when misoprostol was administered to pregnant women to induce labor or to induce abortion beyond the eighth week of pregnancy.

It is not known if misoprostol is excreted in human milk; however it should not be administered to nursing mothers because it could cause significant diarrhea in nursing infants.

Misoprostol is the generic form of the brand-name drug Cytotec, which is used to prevent ulcers in people who take certain arthritis or pain medicines.

Drugs that can cause stomach damage include aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Anaprox, Naprosen), celecoxib (Celebrex), diclofenac (Voltarin, Cataflam), indomethacin (Indocin), and meloxicam (Mobic).

Misoprostol is a synthetic prostaglandin. It works by protecting the stomach lining and decreasing stomach acid secretion.

The Food and Drug Administration (FDA) approved the medication in 1988. The drug was originally manufactured by G.D. Searle & Company, and generic forms of misoprostol are now made by several drug manufacturers.

Misoprostol and Abortion

Misoprostol is sometimes used off-label to end an early pregnancy. (Off-label use means that the FDA has not approved the drug for this purpose.)

The drug is most effective when it's used in combination with methotrexate or mifepristone. Misoprostol can be given orally, buccally (dissolved between the gums and cheek), or vaginally for this purpose.

The FDA has reported that a few women have died from severe infection after having an abortion using mifepristone and vaginal misoprostol.

You should call your doctor immediately if you experience any signs of infection, which may include weakness, pain, muscle aches, nausea, and diarrhea. This rare infection may not cause a fever.

Misoprostol is also sometimes used off-label to induce labor or decrease blood loss after delivery of a baby. However, the FDA has issued an alert about the potential dangers of using misoprostol for these purposes. The risks include a torn uterus, the need for a hysterectomy, and death of the mother and baby.

Pregnancy and Misoprostol

Misoprostolis a Pregnancy Category X drug, which means it is likely to harm an unborn baby, causing birth defects and premature birth. The drug can also harm the pregnant woman, causing uterine rupture, uterine bleeding, miscarriage, or an incomplete miscarriage. You should use an effective form of birth control while taking misoprostol and for at least one month after you stop using it.

Women shouldn't take their first dose of misoprostol until the second or third day of their menstrual period to ensure that they aren't pregnant.

It's not known whether this drug passes into breast milk or if it could harm a breastfeeding baby. You should talk to your doctor about these risks.

Misoprostol Warnings

Before taking misoprostol, you should tell your doctor if you have:

• Inflammatory bowel disease (IBD)
• Irritable bowel syndrome (IBS)
• Any other intestinal problems
• Heart disease

You should also alert your physician if you suspect you are dehydrated before taking this medicine.

This drug must be taken regularly for you to benefit. Don't stop taking misoprostol without first talking to your doctor.

Call your doctor if you experience severe nausea, stomach pain, or diarrhea lasting several days while on misoprostol.

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 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

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

Your pharmacist has more information about misoprostol written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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You should not use this medicine if you are allergic to misoprostol or other prostaglandins, or if you are pregnant.

To make sure misoprostol is safe for you, tell your doctor if you have:

• inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other intestinal problems;

• heart disease; or

• if you are dehydrated.

FDA pregnancy category X. Misoprostol can cause birth defects, premature birth, uterine rupture, miscarriage, or incomplete miscarriage and dangerous uterine bleeding. Do not use misoprostol if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine, and for at least 1 month after your treatment ends.

If you are able to become pregnant, you will need to have a negative pregnancy test before you start taking misoprostol. Treatment with this medicine should begin on the second or third day of your menstrual period.

Stop taking this medicine and tell your doctor right away if you become pregnant during treatment.

It is not known whether misoprostol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

Drugs Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interaction unlikely.1 3 5 41 126 127

Specific Drugs and Foods

In the U.S.

• Cytotec

Available Dosage Forms:

• Tablet

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Prostaglandin

Misoprostol is used to decrease the chance of having stomach ulcers in patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin. This medicine works by helping the stomach protect itself against acid damage, and decreases the amount of acid produced by the stomach.

This medicine is available only with your doctor's prescription.

• If you have an allergy to misoprostol or any other part of Cytotec.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are getting oxytocin.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Cytotec with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use Cytotec as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take this medicine with food.
• Do not take antacids that have magnesium with Cytotec (misoprostol).

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Cytotec or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Cytotec. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Cytotec oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog.

Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by (±):

Misoprostol is a water-soluble, viscous liquid.

Inactive ingredients of tablets are hydrogenated castor oil, hypromellose, microcrystalline cellulose, and sodium starch glycolate.

See boxed WARNINGS.

For hospital use only if misoprostol were to be used for cervical ripening, induction of labor, or for the treatment of serious post-partum hemorrhage, which are outside of the approved indication.

Cytotec 100-mcg tablets are white, round, with SEARLE debossed on one side and 1451 on the other side; supplied as:

Cytotec 200-mcg tablets are white, hexagonal, with SEARLE debossed above and 1461 debossed below the line on one side and a double stomach debossed on the other side; supplied as:

Store at or below 25°C (77°F), in a dry area.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

LAB-0170-6.0
January 2017

Use is contraindicated. AU TGA pregnancy category: X US FDA pregnancy category: Not assigned. Risk summary: This drug may endanger pregnancy by producing uterine contractions, bleeding, and expulsion of the products of conception. Comments: -Patients of childbearing potential should be apprised of the potential harm to the fetus. -Pregnancy should be excluded prior to initiation. -Use of adequate methods of contraception should be encouraged. -If the patient becomes pregnant while taking this drug, treatment should be discontinued. -When used for medical termination of pregnancy, contraception should be resumed immediately after the termination of pregnancy is confirmed.

Animal studies have revealed evidence of embryotoxicity when this drug was administered during organogenesis; animal models have revealed skeletal abnormalities and cleft palate at maternally toxic doses. There are no controlled data in human pregnancy. There are reports of uterine contractions, abortions, skull defects, cranial nerve palsies, facial malformations, and limb defects when this drug was used during the first trimester. Abortion, miscarriages (including incomplete miscarriage), Moebius syndrome, amniotic band syndrome, premature birth, fetal death, and uterine rupture have occurred later in gestation. Male animal models have revealed a potential dose-associated risks of pre- and post-implantation losses and a decrease in the number of live pups born at the highest dose. AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.