RIFATER® (rifampin, isoniazid and pyrazinamide USP) Tablets

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

rifampin (UNII: VJT6J7R4TR) (rifampin - UNII:VJT6J7R4TR), isoniazid (UNII: V83O1VOZ8L) (isoniazid - UNII:V83O1VOZ8L), pyrazinamide (UNII: 2KNI5N06TI) (pyrazinamide - UNII:2KNI5N06TI)

Available from:

sanofi-aventis U.S. LLC

INN (International Name):

rifampin

Composition:

rifampin 120 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

RIFATER is indicated in the initial phase of the short-course treatment of pulmonary tuberculosis. During this phase, which should last 2 months, RIFATER should be administered on a daily, continuous basis (see DOSAGE AND ADMINISTRATION). Following the initial phase and treatment with RIFATER, treatment should be continued with rifampin and isoniazid (e.g., RIFAMATE) for at least 4 months. Treatment should be continued for a longer period of time if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive. In the treatment of tuberculosis, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. Bacteriologic smears or cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to r

Product summary:

RIFATER tablets are light beige, smooth, round, and shiny sugar-coated tablets imprinted with "RIFATER" in black ink and contain 120 mg rifampin, 50 mg isoniazid, and 300 mg pyrazinamide, and are supplied as: Bottles of 60 tablets (NDC 0088-0576-41). Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from excessive humidity.

Authorization status:

New Drug Application

Summary of Product characteristics

RIFATER- RIFAMPIN, ISONIAZID AND PYRAZINAMIDE TABLET, SUGAR COATED
SANOFI-AVENTIS U.S. LLC
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RIFATER
(RIFAMPIN, ISONIAZID AND PYRAZINAMIDE USP)
TABLETS
WARNING
Severe and sometimes fatal hepatitis associated with isoniazid, a
component of RIFATER, therapy
may occur and may develop even after many months of treatment. The
risk of developing hepatitis
is age related. Approximate case rates by age are: 0 per 1,000 for
persons under 20 years of age,
3 per 1,000 for persons in the 20 to 34 year age group, 12 per 1,000
for persons in the 35 to 49
year age group, 23 per 1,000 for persons in the 50 to 64 year age
group, and 8 per 1,000 for
persons over 65 years of age. The risk of hepatitis is increased with
daily consumption of
alcohol. Precise data to provide a fatality rate for isoniazid-related
hepatitis is not available;
however, in a U.S. Public Health Service Surveillance Study of 13,838
persons taking isoniazid,
there were 8 deaths among 174 cases of hepatitis.
Therefore, patients given RIFATER, which contains isoniazid, should be
carefully monitored and
interviewed at monthly intervals. Serum transaminase concentration
becomes elevated in about
10% to 20% of patients, usually during the first few months of
therapy, but it can occur at any
time. Usually enzyme levels return to normal despite continuance of
drug, but in some cases
progressive liver dysfunction occurs. Patients should be instructed to
report immediately any of
the prodromal symptoms of hepatitis, such as fatigue, weakness,
malaise, anorexia, nausea, or
vomiting. If these symptoms appear or if signs suggestive of hepatic
damage are detected,
RIFATER, should be discontinued promptly since continued use of the
drug in these cases has
been reported to cause a more severe form of liver damage.
Patients with tuberculosis should be given appropriate treatment with
alternative drugs. If
isoniazid, a component of RIFATER, must be reinstituted, it should be
reinstituted only after
symptoms and laboratory abnormalities have cleared. RIFATER should no