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Priftin

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Priftin

Priftin

INDICATIONS

PRIFTIN (rifapentine) ® is indicated for the treatment of pulmonary tuberculosis caused by Mycobacterium tuberculosis. PRIFTIN (rifapentine) must always be used in combination with one or more antituberculosis drugs to which the isolate is susceptible depending on the phase of treatment [See DOSAGE AND ADMINISTRATION and Clinical Studies].

Limitations of Use

PRIFTIN (rifapentine) should not be used as a once weekly Continuation Phase regimen in combination with isoniazid in HIV seropositive patients with pulmonary tuberculosis because of a higher rate of failure and/or relapse documented with the presence of rifampin-resistant organisms [see WARNINGS AND PRECAUTIONS and Clinical Studies].

PRIFTIN (rifapentine) has not been studied as part of the Initial Phase treatment regimen in HIV seropositive patients with pulmonary tuberculosis.

PRIFTIN (rifapentine) should not be used as monotherapy in either the initial or the continuation phases of antituberculous treatment.

DOSAGE AND ADMINISTRATION

Dosage

PRIFTIN (rifapentine) 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 (rifapentine) should be administered at a dose of 600 mg (4 x 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 (rifapentine) has been studied as part of the initial regimen with isoniazid, pyrazinamide and ethambutol [see Clinical Studies].

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 (rifapentine) 600 mg once weekly for 4 months in combination with isoniazid or an appropriate antituberculosis agent for susceptible organisms by direct observation therapy.

PRIFTIN (rifapentine) 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].

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.

Administration

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].

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).

HOW SUPPLIED

Dosage Forms And Strengths

PRIFTIN (rifapentine) is supplied as 150 mg round normal convex dark-pink film-coated tablets debossed "Priftin (rifapentine) " on top and "150" on the bottom.

PRIFTIN (rifapentine) is supplied as 150 mg round normal convex dark-pink film-coated tablets debossed "Priftin (rifapentine) " on top and "150" on the bottom, packaged in aluminum formable foil blister strips placed in cartons of 32 tablets (4 strips of 8). Each strip of 8 tablets is inserted into an aluminum foil laminated pouch. (NDC 0088-2100-03).

Storage

Store at 25°C (77°F); excursions permitted 15-30°C (59-86°F) (see USP Controlled Room Temperature). Protect from excessive heat and humidity.

Release Date: May 11, 2010. sanofi-aventis U.S. LLC Bridgewater, NJ 08807.

Last reviewed on RxList: 8/27/2010
This monograph has been modified to include the generic and brand name in many instances.

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