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RIFAMATE
Tuberculosis
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Drug Name:

RIFAMATE Rx

Generic Name and Formulations:
Rifampin 300mg, isoniazid 150mg; caps.

Company:
Sanofi U.S.

Therapeutic Use:

Indications for RIFAMATE:

Susceptible pulmonary tuberculosis. Not for initial therapy.

Adult:

Take 1 hour before or 2 hours after a meal. 2 caps once daily. Malnourished, predisposed to neuropathy (eg, diabetes), adolescents: concomitant Vit. B6 recommended.

Children:

<15yrs: not established.

Contraindications:

Concomitant ritonavir-boosted saquinavir, atazanavir, darunavir, fosamprenavir, saquinavir, tipranavir. Previous isoniazid-associated severe hepatic damage. Severe adverse reactions to isoniazid (eg, drug fever, chills, arthritis). Acute liver disease of any etiology. Acute gout.

Boxed Warning:

Severe and sometimes fatal hepatitis may occur.

Warnings/Precautions:

Increased risk of severe or fatal hepatitis; monitor, discontinue if signs of hepatic damage detected. Acute hepatic disease: do not treat. Chronic liver disease. Perform LFTs prior to therapy, then periodically. Severe renal dysfunction. Not recommended for intermittent therapy (risk of renal hypersensitivity reactions; rare). Monitor for skin or hypersensitivity reactions (eg, SJS, TEN, DRESS); discontinue if occur. History of diabetes. May stain body secretions and contact lenses. Perform eye exams if visual symptoms occur. Neonates/newborns of rifamate-treated mothers (monitor for untoward effects). Pregnancy (teratogenic potential). Nursing mothers.

Pharmacological Class:

Rifamycin + isonicotinic acid.

Interactions:

See Contraindications. Concomitant hepatotoxic agents: may cause fatal liver dysfunction. Concomitant alcohol may be associated with higher incidence of isoniazid hepatitis. Avoid tyramine- and histamine-containing foods, halothane. Monitor prothrombin time with concomitant anticoagulants. May potentiate phenytoin (adjust dose). May antagonize oral contraceptives, methadone, oral hypoglycemics, digoxin, quinidine, disopyramide, dapsone, corticosteroids. May inhibit assays for serum folate and Vit. B12 (consider alternative methods).

Adverse Reactions:

Headache, drowsiness, fatigue, ataxia, dizziness, inability to concentrate, mental confusion, visual disturbances, muscular weakness, pain in extremities, generalized numbness, peripheral neuropathy (esp. in slow inactivators), GI disturbances, abnormal LFTs, hepatitis (may be severe or fatal), bilirubinemia, jaundice, elevated BUN and serum uric acid, blood dyscrasias, pruritus, rash, fever, menstrual disturbances, pyridoxine deficiency, hyperglycemia, rheumatic syndrome, hypersensitivity reactions.

How Supplied:

Caps—60

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