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Misoprostol

Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients a.

Prescription medicine Oral Safety alerts on record

How to use Misoprostol

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Serious warning: MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE. UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL TABLETS WERE ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION. THE RISK OF UTERINE RUPTURE INCREASES WITH ADVANCING GESTATIONAL AGES AND WITH PRIOR UTERINE SURGERY, INCLUDING CESAREAN DELIVERY (see also PRECAUTIONS and LABOR AND DELIVERY ). …
Who it is for

Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol Tablet has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol Tablets should be taken for the duration of NSAID therapy. Misoprostol Tablets has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. …

How to take it and how often
  • The recommended adult oral dose of Misoprostol Tablets for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food
  • If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology : Clinical studies .) Misoprostol Tablets should be taken for the duration of NSAID therapy as prescribed by the physician
  • Misoprostol Tablets should be taken with a meal, and the last dose of the day should be at bedtime
Children
  • Safety and effectiveness of Misoprostol Tablets
  • In pediatric patients have not been established
While you are taking it
  • Women of childbearing potential using Misoprostol Tablets to decrease the risk of NSAID-induced ulcers should be told that they must not be pregnant when Misoprostol Tablets therapy is initiated, and that they must use an effective contraception method while taking Misoprostol Tablets
  • See boxed WARNINGS
  • Misoprostol Tablets is intended for administration along with nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, to decrease the chance of developing an NSAID-induced gastric ulcer
  • Misoprostol Tablets should be taken only according to the directions given by a physician. …
Talk to a doctor first if
  • See boxed WARNINGS
  • Misoprostol Tablets should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Misoprostol Tablets should not be taken by anyone with a history of allergy to prostaglandins
Medicines it may not mix with

See Clinical Pharmacology . Misoprostol Tablets has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol Tablets does not exert clinically significant effects on the absorption, blood levels, and antiplatelet effects of therapeutic doses of aspirin. Misoprostol Tablets has no clinically significant effect on the kinetics of diclofenac or ibuprofen. Prostaglandins such as Misoprostol Tablets may augment the activity of oxytocic agents, especially when given less than 4 hours prior to initiating oxytocin treatment. Concomitantuse is not recommended.

Warnings

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.

Possible side effects

The following have been reported as adverse events in subjects receiving Misoprostol Tablets: Gastrointestinal: In subjects receiving Misoprostol Tablets 400 or 800 mcg daily in clinical trials, the most frequent gastrointestinal adverse events were diarrhea and abdominal pain. The incidence of diarrhea at 800 mcg in controlled trials in patients on NSAIDs ranged from 14 to 40% and in all studies (over 5,000 patients) averaged 13%. Abdominal pain occurred in 13 to 20% of patients in NSAID trials and about 7% in all studies, but there was no consistent difference from placebo. …

If you take too much

The toxic dose of Misoprostol Tablets in humans has not been determined. Cumulative total daily doses of 1600 mcg have been tolerated, with only symptoms of gastrointestinal discomfort being reported. In animals, the acute toxic effects are diarrhea, gastrointestinal lesions, focal cardiac necrosis, hepatic necrosis, renal tubular necrosis, testicular atrophy, respiratory difficulties, and depression of the central nervous system. Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, or bradycardia. …

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2020-12-21.

Brands around the world

Products with Misoprostol as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

Diclofenac Sodium MisoprostolDICLOFENAC SODIUM 50 mg/1, MISOPROSTOL 200 ug/1 · Tablet, Delayed Release · Bryant Ranch Prepack
NDC 72162-2518Label
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM 50 mg/1, MISOPROSTOL 200 ug/1 · Tablet, Delayed Release · Nivagen Pharmaceuticals, Inc.
NDC 75834-264Label
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM 75 mg/1, MISOPROSTOL 200 ug/1 · Tablet, Delayed Release · Bryant Ranch Prepack
NDC 72162-2519Label
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM 75 mg/1, MISOPROSTOL 200 ug/1 · Tablet, Delayed Release · Nivagen Pharmaceuticals, Inc.
NDC 75834-265Label
MisoprostolMISOPROSTOL 100 ug/1 · Tablet · Bryant Ranch Prepack
NDC 71335-2455Label

Nigeria (NAFDAC)

NAFDACMisoprostol 200 mcg Tablet C4-1588NAFDACOvoid Tablets B4-8154NAFDACEprotec Tablet A11-100340NAFDACMiso-Fem Tablet B4-3625NAFDACMisofree Tablet C4-1140NAFDACEvabon Tablets_ A4-101738NAFDACCytofix Tablets A4-7182NAFDACMariprist Tablet B4-6871NAFDACNisetotec Tablet A4-8429NAFDACMisofree Tablets C4-1140NAFDACOsteotec Tablets A4-100764NAFDACBosstotec Tablets A4-101217

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff LaU.S. FDA Class II
20 Apr 2018 · Exela Pharma Sciences LLC · TerminatedLabeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDCU.S. FDA Class III
9 Sep 2016 · Pfizer Inc. · TerminatedFailed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Misoprostol 1% active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, U.S. FDA Class II
14 Nov 2014 · Attix Pharmaceuticals · TerminatedPenicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the poten
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC: 0591-0398-60, U.S. FDA Class II
26 Sep 2014 · Actavis Laboratories, FL, Inc. · TerminatedFailed Tablet/Capsule Specifications: Presence of split or broken tablets.

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Misoprostol

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3 free checks left today Official sources: U.S. FDA · EMA (EU) · NAFDAC · WHO alerts

Questions about Misoprostol

What is Misoprostol used for?

Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol Tablet has not been shown to r (From the official U.S. FDA label.)

How do I take Misoprostol?

Follow your prescription or the leaflet in your pack. The official label says: The recommended adult oral dose of Misoprostol Tablets for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology : Clinical studies .) Misoprostol Tablets should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol Tabl…

Do I need a prescription for Misoprostol?

Usually yes. Misoprostol is a prescription medicine in most countries. Rules differ by country.

What brands contain Misoprostol?

Misoprostol is sold under names such as Cytotec, Arthrotec, Misoprostol. Brand names differ between countries.

How can I check that my Misoprostol is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.