Rifamate (Rifampin / Isoniazid) - Indications and Dosage

INDICATIONS AND USAGE

For pulmonary tuberculosis in which organisms are susceptible, and when the patient has been titrated on the individual components and it has therefore been established that this fixed dosage is therapeutically effective.

This fixed-dosage combination drug is not recommended for initial therapy of tuberculosis or for preventive therapy.

In the treatment of tuberculosis, small numbers of resistant cells, present within large populations of susceptible cells, can rapidly become the predominating type. Since rapid emergence of resistance can occur, culture and susceptibility tests should be performed in the event of persistent positive cultures.

This drug is not indicated for the treatment of meningococcal infections or asymptomatic carriers of N. meningitidis to eliminate meningococci from the nasopharynx.

DOSAGE AND ADMINISTRATION

In general, therapy should be continued until bacterial conversion and maximal improvement have occurred.

Adults: Two RIFAMATE (rifampin and isoniazid capsules USP) capsules (600 mg rifampin, 300 mg isoniazid) once daily, administered one hour before or two hours after a meal.

Concomitant administration of pyridoxine (B₆) is recommended in the malnourished, in those predisposed to neuropathy (e.g., diabetic), and in adolescents.

Susceptibility Testing

Rifampin

Rifampin susceptibility powders are available for both direct and indirect methods of determining the susceptibility of strains of mycobacteria. The MIC's of susceptible clinical isolates when determined in 7H10 or other non-egg-containing media have ranged from 0.1 to 2 mcg/ml.

Quantitative methods that require measurement of zone diameters give the most precise estimates of antibiotic susceptibility. One such procedure has been recommended for use with discs for testing susceptibility to rifampin. Interpretations correlate zone diameters from the disc test with MIC (minimal inhibitory concentration) values for rifampin.

HOW SUPPLIED

Capsules (opaque red), imprinted "RIFAMATE" on both ends of the capsule, containing 300 mg rifampin and 150 mg isoniazid; bottles of 60 (NDC 0068-0509-60).

Storage: Keep tightly closed. Store in a dry place. Avoid excessive heat.

Manufactured for:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

Rev. March 2007

©2007 sanofi-aventis U.S. LLC