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MYCOBUTIN®(rifabutin)

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MYCOBUTIN® Quick Finder

INDICATIONS AND USAGE

MYCOBUTIN Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.

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DOSAGE AND ADMINISTRATION

It is recommended that MYCOBUTIN Capsules be administered at a dose of 300 mg once daily. For those patients with propensity to nausea, vomiting, or other gastrointestinal upset, administration of...

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CONTRAINDICATIONS

MYCOBUTIN Capsules are contraindicated in patients who have had clinically significant hypersensitivity to rifabutin or to any other rifamycins.

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WARNINGS

Tuberculosis

MYCOBUTIN Capsules must not be administered for MAC prophylaxis to patients with active tuberculosis. Patients who develop complaints consistent...

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ADVERSE REACTIONS

Adverse Reactions from Clinical Trials

MYCOBUTIN Capsules were generally well tolerated in the controlled clinical trials. Discontinuation of therapy...

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OVERDOSAGE

No information is available on accidental overdosage in humans.

Treatment

While there is no experience in the treatment of overdose with...

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DESCRIPTION

MYCOBUTIN Capsules for oral administration contain 150 mg of the rifamycin antimycobacterial agent rifabutin, USP, per capsule, along with the inactive ingredients, microcrystalline cellulose, magnesium stearate,...

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CLINICAL PHARMACOLOGY

Pharmacokinetics

Absorption

Following a single oral dose of 300 mg to nine healthy adult...

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ANIMAL TOXICOLOGY

Liver abnormalities (increased bilirubin and liver weight) occurred in mice, rats and monkeys at doses (respectively) 0.5, 1, and 3 times the recommended human daily dose based on body surface area...

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CLINICAL STUDIES

Two randomized, double-blind clinical trials (Study 023 and Study 027) compared MYCOBUTIN (300 mg/day) to placebo in patients with CDC-defined AIDS and CD4 counts ≤200 cells/µL. These studies accrued patients...

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HOW SUPPLIED

MYCOBUTIN (rifabutin) Capsules, USP are supplied as hard gelatin capsules having an opaque red-brown cap and body, imprinted with MYCOBUTIN/PHARMACIA & UPJOHN in white ink, each containing 150 mg of rifabutin...

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LAB-0217-11.0
Revised 9/2021

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