Treatment of active (clinical) tuberculosis (TB) in conjunction with other antituberculosis agents.
First-line agent for treatment of all forms of TB caused by Mycobacterium tuberculosis known or presumed to be susceptible to the drug.
Usually used in the initial intensive phase of treatment in a 4-drug regimen of isoniazid, rifampin, pyrazinamide, and ethambutol. Also used in multiple-drug regimens for the management of patients with treatment failure or drug-resistant pulmonary TB.
Fixed combination preparation containing rifampin, isoniazid, and pyrazinamide (Rifater®) used for treatment of pulmonary TB; designated an orphan drug by US FDA for short-term treatment of TB. Used only in the initial intensive treatment phase since pyrazinamide is not usually indicated for the continuation phase.
For initial treatment of active TB caused by drug-susceptible M. tuberculosis, recommended multiple-drug regimens consist of an initial intensive phase (2 months) and a continuation phase (4 or 7 months). Although the usual duration of treatment for drug-susceptible pulmonary and extrapulmonary TB (except disseminated infections and TB meningitis) is 6–9 months, ATS, CDC, and IDSA state that completion of treatment is determined more accurately by the total number of doses and should not be based solely on the duration of therapy. A longer duration of treatment (e.g., 12–24 months) usually is necessary for infections caused by drug-resistant M. tuberculosis.
Patients with treatment failure or drug-resistant M. tuberculosis, including multidrug-resistant (MDR) TB (resistant to both isoniazid and rifampin) or extensively drug-resistant (XDR) TB (resistant to both isoniazid and rifampin and also resistant to a fluoroquinolone and at least one parenteral second-line antimycobacterial such as capreomycin, kanamycin, or amikacin), should be referred to or managed in consultation with experts in the treatment of TB as identified by local or state health departments or CDC.
Latent Tuberculosis Infection
Although a 2-drug regimen of rifampin and pyrazinamide was previously used for treatment of latent tuberculosis infection† (LTBI), these regimens have been associated with an increased risk of hepatotoxicity and are no longer recommended by the ATS, CDC, and IDSA. (See Hepatic Effects under Cautions.)
Dosage and Administration
Administration
Oral Administration
Administer orally.
Rifater®: Administer orally with a full glass of water 1 hour before or 2 hours after a meal.
Dosage
Should not be used alone for treatment of TB; must be given in conjunction with other antituberculosis agents.
Can be used in daily or intermittent (2 or 3 times weekly) multiple-drug TB regimens.
Dosage of Rifater® expressed as number of tablets.
Pediatric Patients
Tuberculosis
Treatment of Active (Clinical) Tuberculosis
Oral
15–30 mg/kg (up to 3 g) once daily or 50–75 mg/kg twice weekly recommended by manufacturer.
Children <15 years of age or weighing ≤40 kg: 15–30 mg/kg (up to 2 g) once daily recommended by ATS, CDC, and IDSA; 20–40 mg/kg (up to 2 g) once daily recommended by AAP and others. If an intermittent regimen is used, 50–70 mg/kg (up to 2 g) twice weekly recommended by ATS, CDC, IDSA, and AAP.
Adolescents ≥15 years of age weighing 40–55 kg: 1 g once daily, 2 g twice weekly, or 1.5 g 3 times weekly recommended by ATS, CDC, IDSA.
Adolescents ≥15 years of age weighing 56–75 kg: 1.5 g once daily, 3 g twice weekly, or 2.5 g 3 times weekly recommended by ATS, CDC, IDSA.
Adolescents ≥15 years of age weighing 76–90 kg: 2 g once daily, 4 g twice weekly, or 3 g 3 times weekly recommended by ATS, CDC, IDSA.
Rifater® in adolescents ≥15 years of age: 4 tablets once daily in those weighing ≤44 kg, 5 tablets once daily in those weighing 45–54 kg, or 6 tablets once daily in those weighing ≥55 kg.
Adults
Tuberculosis
Treatment of Active (Clinical) Tuberculosis
Oral
15–30 mg/kg (up to 3 g) once daily or 50–75 mg/kg twice weekly recommended by manufacturer.
Adults weighing 40–55 kg: 1 g once daily, 2 g twice weekly, or 1.5 g 3 times weekly recommended by ATS, CDC, IDSA.
Adults weighing 56–75 kg: 1.5 g once daily, 3 g twice weekly, or 2.5 g 3 times weekly recommended by ATS, CDC, IDSA.
Adults weighing 76–90 kg: 2 g once daily, 4 g twice weekly, or 3 g 3 times weekly recommended by ATS, CDC, IDSA .
Rifater®: 4 tablets once daily in adults weighing ≤44 kg, 5 tablets once daily in adults weighing 45–54 kg, or 6 tablets once daily in adults weighing ≥55 kg.
Prescribing Limits
Pediatric Patients
Treatment of Active (Clinical) Tuberculosis
Oral
Maximum 3 g per dose in once-daily regimens recommended by manufacturer.
Children <15 years of age or weighing ≤40 kg: ATS, CDC, IDSA, and AAP recommend maximum 2 g per dose in once-daily or twice-weekly regimens.
Adults
Treatment of Active (Clinical) Tuberculosis
Oral
Maximum 3 g per dose in once-daily regimens recommended by the manufacturer.
ATS, CDC, and IDSA recommend maximum 2 g per dose when used in once-daily regimens, maximum 3 g per dose when used in 3-times weekly regimens, and maximum 4 g per dose when used in twice-weekly regimens.
Special Populations
Renal Impairment
Treatment of Active (Clinical) Tuberculosis
Oral
End-stage renal disease (i.e., Clcr <30 mL/minute, on hemodialysis): 25–35 mg/kg 3 times weekly after dialysis.
Geriatric Patients
Select dosage with caution; start at the low end of the dosage range.
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