Cytotec label

Cytotec

Cytotec Recall

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Side Effects & Adverse Reactions

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Misoprostol tablets are 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 has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months’ duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.

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History

There is currently no drug history available for this drug.

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Other Information

Misoprostol 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 (±):

image of formula

Misoprostol is a water-soluble, viscous liquid chemically described as (±) methyl 11α, 16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate.

Each misoprostol tablet for oral administration contains either 100 mcg or 200 mcg of misoprostol and has the following inactive ingredients:

Hydrogenated caster oil, hypromellose, microcrystalline cellose, and sodium starch glycolate.

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Cytotec Manufacturers

  • Apotheca, Inc
    Cytotec | Apotheca, Inc
    No Recall

    Cytotec | Apotheca, Inc

    Cytotec | Apotheca, Inc

    The recommended adult oral dose of misoprostol 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 should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol should be taken with a meal, and the last dose of the day should be at bedtime.

    Renal Impairment

    Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See CLINICAL PHARMACOLOGY).

  • Physicians Total Care, Inc.
    Cytotec | Physicians Total Care, Inc.
    No Recall

    Cytotec | Physicians Total Care, Inc.

    Cytotec | Physicians Total Care, Inc.

    The recommended adult oral dose of Cytotec 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.) Cytotec should be taken for the duration of NSAID therapy as prescribed by the physician. Cytotec should be taken with a meal, and the last dose of the day should be at bedtime.

    Renal impairment

    Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See Clinical Pharmacology.)

  • Pd-rx Pharmaceuticals, Inc.
    Cytotec | Pd-rx Pharmaceuticals, Inc.
    No Recall

    Cytotec | Pd-rx Pharmaceuticals, Inc.

    Cytotec | Pd-rx Pharmaceuticals, Inc.

    The recommended adult oral dose of Cytotec 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.) Cytotec should be taken for the duration of NSAID therapy as prescribed by the physician. Cytotec should be taken with a meal, and the last dose of the day should be at bedtime.

    Renal impairment

    Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See Clinical Pharmacology.)

  • A-s Medication Solutions Llc
    Cytotec | A-s Medication Solutions Llc
    No Recall

    Cytotec | A-s Medication Solutions Llc

    Cytotec | A-s Medication Solutions Llc

    The recommended adult oral dose of Cytotec 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.) Cytotec should be taken for the duration of NSAID therapy as prescribed by the physician. Cytotec should be taken with a meal, and the last dose of the day should be at bedtime.

    Renal impairment

    Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See Clinical Pharmacology.)

  • Cardinal Health
    Cytotec | Cardinal Health
    No Recall

    Cytotec | Cardinal Health

    Cytotec | Cardinal Health

    The recommended adult oral dose of Cytotec 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.) Cytotec should be taken for the duration of NSAID therapy as prescribed by the physician. Cytotec should be taken with a meal, and the last dose of the day should be at bedtime.

    Renal impairment

    Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See Clinical Pharmacology.)

  • G.d. Searle Llc Division Of Pfizer Inc
    Cytotec | G.d. Searle Llc Division Of Pfizer Inc
    No Recall

    Cytotec | G.d. Searle Llc Division Of Pfizer Inc

    Cytotec | G.d. Searle Llc Division Of Pfizer Inc

    The recommended adult oral dose of Cytotec 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.) Cytotec should be taken for the duration of NSAID therapy as prescribed by the physician. Cytotec should be taken with a meal, and the last dose of the day should be at bedtime.

    Renal impairment

    Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See Clinical Pharmacology.)

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