Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
RIFAPENTINE
AVENTIS PHARMA - Indonesia
RIFAPENTINE
150 MG
TABLET SALUT SELAPUT
DUS, 3 BLISTER @ 8 TABLET SALUT SELAPUT
SANOFI AVENTIS - Italy
2018-11-13
PRIFTIN 150MG FILM-COATED TABLETS 1. DESCRIPTION 1.1 ACTIVE INGREDIENTS Rifapentine: 150 mg per Priftin tablet 1.2 THERAPEUTIC OR PHARMACOLOGICAL CLASS Antibiotic 1.3 PHARMACEUTICAL FORM(S) Tablet 1.4 COMPOSITION Active ingredient: Rifapentine Excipients: calcium stearate, disodium EDTA, FD&C Blue No. 2 aluminum lake, hydroxypropyl cellulose, hypromellose USP, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, propylene glycol, sodium ascorbate, sodium lauryl sulfate, sodium starch glycolate, synthetic red iron oxide, and titanium dioxide. 2. INDICATIONS 2.1 LATENT TUBERCULOSIS INFECTION Priftin is indicated for the treatment of latent tuberculosis infection caused by Mycobacterium tuberculosis in adults and children 2 years and older who are at high risk of progression to tuberculosis disease (including those in close contact with active tuberculosis patients with culture-confirmed TB disease and who have a positive TST, recent conversion to a positive tuberculin skin test, HIV-infected patients, or those with pulmonary fibrosis on radiograph). Active tuberculosis disease should be ruled out before initiating treatment for latent tuberculosis infection. Priftin must always be used in combination with isoniazid as a 12-week once-weekly regimen for the treatment of latent tuberculosis infection. 3. DOSAGE AND ADMINISTRATION 3.1 DOSAGE IN LATENT TUBERCULOSIS INFECTION Priftin should be administered once-weekly in combination with isoniazid for 12 weeks as directly observed therapy. Adults and children 12 years and older: The recommended dose of Priftin should be determined based DISETUJUI OLEH BPOM : 24/12/2021 ID : EREG100022VR12100503 on weight of the patient up to a maximum of 900 mg once-weekly (see Table 1). The recommended dose of isoniazid is 15 mg/kg (rounded to the nearest 50 mg or 100 mg) up to a maximum of 900 mg once-weekly for 12 weeks. Children 2-11 years: The recommended dose of Priftin should be determined based on weight of the patient up to a maximum of 900 mg once- weekly (se Baca dokumen lengkapnya