A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Rifater Indications, Dosage, Storage, Stability - Rifampin, Isoniazid and Pyrazinamide
Rifater Indications, Dosage, Storage, Stability - Rifampin, Isoniazid and Pyrazinamide
INDICATIONS
AND USES
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
section).
Following the initial phase and treatment with RIFATER, treatment should be
continued with rifampin and isoniazid (eg, 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 rifampin, isoniazid, and pyrazinamide
and they should be repeated throughout therapy to monitor response to the treatment.
If test results show resistance to any of the components of RIFATER and the
patient is not responding to therapy, the drug regimen should be modified.
DOSAGE AND ADMINISTRATION
Adults: Patients should be given the following single daily dose of
RIFATER either 1 hour before or 2 hours after a meal with a full glass of water.
Patients weighing ≤44 kg - 4 tablets
Patients weighing between 45-54 kg - 5 tablets
Patients weighing ≥55 kg - 6 tablets
Pediatric Patients: The ratio of the drugs in RIFATER may not be appropriate
in pediatric patients under the age of 15 (eg, higher mg/kg doses of isoniazid
are usually given in pediatric patients than adults).
RIFATER is recommended in the initial phase of short-course therapy which is
usually continued for 2 months. The Advisory Council for the Elimination of
Tuberculosis, the American Thoracic Society, and the Centers for Disease Control
and Prevention recommend that either streptomycin or ethambutol be added as
a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide
for initial treatment of tuberculosis unless the likelihood of INH or rifampin
resistance is very low. The need for a fourth drug should be reassessed when
the results of susceptibility testing are known. If community rates of INH resistance
are currently less than 4%, an initial treatment regimen with less than four
drugs may be considered.
Following the initial phase, treatment should be continued with rifampin and
isoniazid (eg, RIFAMATE®) for at least 4 months. Treatment should be continued
for longer if the patient is still sputum or culture positive, if resistant
organisms are present, or if the patient is HIV positive.
Concomitant administration of pyridoxine (B 6 ) is recommended in
the malnourished, in those predisposed to neuropathy (eg, alcoholics and diabetics),
and in adolescents.
See CLINICAL PHARMACOLOGY : General for dosing information in patients with
renal failure.
HOW SUPPLIED
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).
Storage Conditions: Store at controlled room temperature 59-86°F (15-30°C).
Protect from excessive humidity.
REFERENCE 1. National Committee for Clinical Laboratory
Standards. 1990. Antimycobacterial Susceptibility Testing (Proposed Standard).
Document M24-P.
Merrell Pharmaceuticals Inc.
Subsidiary of Hoechst Marion Roussel, Inc.
Kansas City, MO 64137 USA
Rifater Tablets are manufactured by:
GRUPPO LEPETIT S.p.A.
20020 Lainate, Italy
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