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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MYCOBUTIN®(rifabutin)
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MYCOBUTIN® Quick Finder
Dosage and Administration
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
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 and Precautions
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
Adverse Reactions from Clinical Trials
MYCOBUTIN Capsules were generally well tolerated in the controlled clinical trials. Discontinuation of therapy...
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Overdosage
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
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
CLINICAL PHARMACOLOGY
Pharmacokinetics
Absorption
Following a single oral dose of 300 mg to nine healthy adult...
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Nonclinical Toxicology
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
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/Storage and Handling
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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