Misoprostol

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Generic Name: Misoprostol Brand Name(s): Generics only. No brands available.

Uses

What is Misoprostol used for?

Misoprostol 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 should I take Misoprostol?

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.

How do I store Misoprostol?

Misoprostol is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Misoprostol in the bathroom or the freezer. There may be different brands of Misoprostol that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Misoprostol down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Misoprostol?

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), risk factors for uterine rupture when this drug is used vaginally (e.g. prior Cesarean delivery, uterine surgery, five or more previous pregnancies).

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 (e.g. 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.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Misoprostol during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Misoprostol. Misoprostol is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Misoprostol?

Nausea or stomach cramps may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Misoprostol?

Misoprostol may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Misoprostol?

Misoprostol may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Misoprostol?

Misoprostol may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Misoprostol.

What is the dose of Misoprostol for an adult?

Usual Adult Dose for Duodenal Ulcer

200 mcg orally 4 times a day after meals and at bedtime

-Maintenance dose: 100 to 200 mcg orally 4 times a day

Comment: Treatment should be taken for the duration of non-steroidal anti-inflammatory drug (NSAID) therapy.

Use: Reducing the risk of NSAID-induced gastric ulcers in patients at high risk of complications from gastric ulcers (e.g., patients who are elderly, with concomitant debilitating disease) or at high risk of developing gastric ulceration (e.g., history of gastric ulcer)

Usual Adult Dose for Gastric Ulcer

200 mcg orally 4 times a day after meals and at bedtime

-Maintenance dose: 100 to 200 mcg orally 4 times a day

Comment: Treatment should be taken for the duration of non-steroidal anti-inflammatory drug (NSAID) therapy.

Use: Reducing the risk of NSAID-induced gastric ulcers in patients at high risk of complications from gastric ulcers (e.g., patients who are elderly, with concomitant debilitating disease) or at high risk of developing gastric ulceration (e.g., history of gastric ulcer)

Usual Adult Dose for NSAID-Induced Ulcer Prophylaxis

200 mcg orally 4 times a day after meals and at bedtime

-Maintenance dose: 100 to 200 mcg orally 4 times a day

Comment: Treatment should be taken for the duration of non-steroidal anti-inflammatory drug (NSAID) therapy.

Use: Reducing the risk of NSAID-induced gastric ulcers in patients at high risk of complications from gastric ulcers (e.g., patients who are elderly, with concomitant debilitating disease) or at high risk of developing gastric ulceration (e.g., history of gastric ulcer)

Usual Adult Dose for Cervical Ripening

American College of Obstetricians and Gynecologists (ACOG) Recommendations:

25 mcg vaginally every 3 to 6 hours

-Some patients may require doses of 50 mcg every 6 hours

Comments:

-The manufacturer states that use outside of the approved indication should be reserved for hospital use only.

-Some experts state that this drug is a more efficient method of labor (compared to oxytocin) in patients before 28 weeks’ gestation.

-Higher doses may be associated with a higher risk of adverse events (e.g., uterine tachysystole with fetal heart rate decelerations).

-Use should be avoided during the third trimester or in patients with a history of cesarean delivery or major uterine surgery.

Use: Cervical ripening and labor induction in women with premature rupture of membranes

Usual Adult Dose for Labor Induction

American College of Obstetricians and Gynecologists (ACOG) Recommendations:

25 mcg vaginally every 3 to 6 hours

-Some patients may require doses of 50 mcg every 6 hours

Comments:

-The manufacturer states that use outside of the approved indication should be reserved for hospital use only.

-Some experts state that this drug is a more efficient method of labor (compared to oxytocin) in patients before 28 weeks’ gestation.

-Higher doses may be associated with a higher risk of adverse events (e.g., uterine tachysystole with fetal heart rate decelerations).

-Use should be avoided during the third trimester or in patients with a history of cesarean delivery or major uterine surgery.

Use: Cervical ripening and labor induction in women with premature rupture of membranes

Usual Adult Dose for Postpartum Bleeding

ACOG Recommendations:

800 to 1000 mcg rectally once

Use: Management of postpartum hemorrhage

International Federation of Gynecology Obstetrics (FIGO) Recommendations:

600 mcg orally OR 800 mcg sublingually once immediately after delivery

Comments:

-The manufacturer states that use outside of the approved indication should be reserved for hospital use only.

-Prior to administration of treatment, abdominal palpitation is recommended to confirm that there are no additional babies in utero.

-The dose is not based upon the patient’s weight.

-The addition of this drug to oxytocin was not shown to provide additional benefit, but may increase the risk of adverse events.

Use: Prevention of postpartum hemorrhage in settings where oxytocin is not available

Usual Adult Dose for Abortion

ACOG Recommendations:

First Trimester of Pregnancy:

-Early Pregnancy Loss: 800 mcg intravaginally once; a second dose may be given if there is no response to the first dose no sooner than 3 hours after the first dose, and usually within 7 days

-Incomplete Abortion: 600 mcg orally once

-Missed Abortion: 800 mcg intravaginally OR 600 mcg sublingually once; the dose may be repeated every 3 hours for 2 additional doses

Comments:

-Pain medications should be provided.

-Patients that are Rh(D) negative and unsensitized: Rh(D)-immune globulin should be given within 72 hours of administration of the initial dose.

-Follow-up treatment should be made within 7 to 14 days to ensure complete expulsion has occurred.

-If treatment fails, patients may opt for expectant management or suction curettage.

Use: Treatment of early pregnancy loss, incomplete abortion, or missed abortion

Renal Dose Adjustments

Dosage adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended.

Other Comments

Administration advice:

-Doses should be taken with food, with the last dose taken before bedtime.

-When this drug is used for medical termination of pregnancy, intrauterine devices in situ should be removed before use.

Storage requirements:

-Protect from moisture; store below 30C.

General:

-Treatment has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs.

-Meconium passage, meconium staining of amniotic fluid, cesarean delivery, maternal shock, maternal death, fetal bradycardia, and fetal death have occurred after the use of tablet formulations for labor and delivery.

-Controlled studies over 3 months have shown a reduction in the risk of gastric ulcers; however, this drug did not have an effect on NSAID-associated gastrointestinal pain/discomfort compared to placebo.

-New pregnancies can occur between expulsion and menses resumption; contraception should be resumed immediately.

Monitoring:

-Genitourinary: Vaginal bleeding

-Metabolic: Signs/symptoms of dehydration

-Other: Incomplete abortion, retained placenta

Patient advice:

-Patients should not give this drug to anyone else.

-Patients undergoing medical termination of pregnancy should avoid traveling far from the prescribing center until complete expulsion is documented.

-Patients should seek immediate medical treatment if signs/symptoms of infection or excessive vaginal bleeding occur during use.

-Patients of childbearing potential should be told to use effective contraception during treatment. Patients should discontinue treatment and should speak to a healthcare provider immediately if pregnancy occurs.

-Patients should be instructed to read the included leaflet each time the prescription is filled.

What is the dose of Misoprostol for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Misoprostol available?

Misoprostol is available in the following dosage forms and strengths:

  • Oral tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Misoprostol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: March 29, 2018 | Last Modified: March 29, 2018

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