Rifapentine dosage and administration

Rifapentine
FDA Package Insert (PRIFTIN®)
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

Dosage And Administration

Dosage

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

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

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 Rifapentine 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).

Dosage Forms And Strengths

Rifapentine is supplied as 150 mg round normal convex dark-pink film-coated tablets debossed "Rifapentine" on top and "150" on the bottom.

References

Adapted from the FDA Package Insert.