Finished product reference

Rifapentine

Tablet · Oral · 150 mg

List code
52163
Pharmacologic class
Rifamycin Antimycobacterial

What it is and how it works

Mechanism of Action Rifapentine, a cyclopentyl rifamycin, is an antimycobacterial agent .

Indications

• Rifapentine tablets are a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible. • Rifapentine tablets are indicated for the treatment of latent tuberculosis infection (LTBI) caused by M. tuberculosis in combination with isoniazid in patients 2 years of age and older at high risk of progression to TB disease. • See Full Prescribing Information for Limitations of Use. ( 1.1 , 1.2 ) Active Pulmonary Tuberculosis Rifapentine tablets are indicated in adults and pediatric patients 12 years and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis. Rifapentine tablets must always be used in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible .

Dosage and administration (summary)

• Active pulmonary tuberculosis: Rifapentine tablets should be used in regimens consisting of an initial 2 month phase followed by a 4 month continuation phase. Initial phase (2 Months): 600 mg twice weekly for two months as directly observed therapy (DOT), with no less than 72 hours between doses, in combination with other antituberculosis drugs. Continuation phase (4 Months): 600 mg once weekly for 4 months as directly observed therapy with isoniazid or another appropriate antituberculosis agent. • Latent tuberculosis infection: Rifapentine tablets should be administered in combination with isoniazid once weekly for 12 weeks as directly observed therapy.

Contraindications

Known hypersensitivity to any rifamycin. Hypersensitivity Rifapentine tablets are contraindicated in patients with a history of hypersensitivity to rifamycins.

Warnings and precautions

•Hepatotoxicity: Monitor for symptoms of liver injury and discontinue rifapentine tablets if signs or symptoms or liver injury occur. •Hypersensitivity: Discontinue rifapentine tablets if signs or symptoms of hypersensitivity reaction occur. •Severe cutaneous adverse reactions: Discontinue rifapentine tablets at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. •Relapse in the treatment of active pulmonary tuberculosis: Do not use as a once-weekly continuation phase regimen with isoniazid in HIV-infected patients.

Pregnancy

Pregnancy Risk Summary Based on animal data, rifapentine tablets may cause fetal harm when administered to a pregnant woman. Available data from clinical trials, case reports, epidemiology studies and postmarketing experience with rifapentine tablets use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, …

Storage and supply

How Supplied Rifapentine tablets is supplied as 150 mg reddish brown colored, round, beveled edge, biconvex, film-coated tablets debossed with "K" and "23" on one side and plain on other side of tablets packaged in blister strips. Carton of 24 tablets (3 strips of 8 tablets) NDC 33342-599-54 Storage Store at 20° to 25°C (68° to 77°F).

Source: Rifapentine (Rifapentine) — US FDA prescribing information, 2026-06-04, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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