Generic name: rifapentine
Dosage form: tablet, film coated
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PRIFTIN has been studied for the treatment of tuberculosis caused by drug-susceptible organisms as part of regimens consisting of an initial 2 month phase followed by a 4 month continuation phase.
These recommendations apply only to the treatment of patients with drug-susceptible organisms.
Initial Phase (2 Months) of short course treatment for pulmonary tuberculosis:
PRIFTIN should be administered at a dose of 600 mg (4 × 150 mg tablets) twice weekly for two months by direct observation of therapy, with an interval of no less than 3 consecutive days (72 hours) between doses, in combination with other antituberculosis drugs as part of an appropriate regimen which includes daily companion drugs such as ethambutol, pyrazinamide, and streptomycin.
The determination of the companion drugs to be used should be made by the treating physician and depends on the results of susceptibility testing as well as the phase of treatment. PRIFTIN has been studied as part of the initial regimen with isoniazid, pyrazinamide and ethambutol [see Clinical Studies (14)].
Continuation Phase (4 Months) of short course treatment for pulmonary tuberculosis:
Following the Initial Phase (2 months), Continuation Phase (4 months) treatment may consist of PRIFTIN 600 mg once weekly for 4 months in combination with isoniazid or an appropriate antituberculosis agent for susceptible organisms by direct observation therapy.
PRIFTIN was studied as a component of a 4 month continuation phase in conjunction with INH 900 mg once a week in two clinical studies [see Clinical Studies (14)].
The prescribing physician is directed to current guidelines for further direction on other possible components of the Continuation Phase regimen as well as for directions on extending this phase.
Take PRIFTIN with meals. Administration of rifapentine with a meal increases oral bioavailability and may reduce the incidence of gastrointestinal upset, nausea, and/or vomiting. [see Clinical Pharmacology (12.3)].
In patients with conditions which predispose them to neuropathy (e.g., nutritional deficiency, HIV infection, renal failure, alcoholism, as well as pregnant and breastfeeding women), concomitant administration of pyridoxine (Vitamin B6) is recommended in order to avoid INH-associated peripheral neuropathy (see American Thoracic Society/Centers for Disease Control/Infectious Disease Society of America Guideline for the Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children).