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
Rifamate Indications, Dosage, Storage, Stability - Rifampin and Isoniazid
Rifamate Indications, Dosage, Storage, Stability - Rifampin and Isoniazid
INDICATIONS
AND USES
For pulmonary tuberculosis in which organisms are susceptible, and when the
patient has been titrated on the individual components and it has therefore
been established that this fixed dosage is therapeutically effective.
This fixed-dosage combination drug is not recommended for initial therapy of
tuberculosis or for preventive therapy.
In the treatment of tuberculosis, small numbers of resistant cells, present
within large populations of susceptible cells, can rapidly become the predominating
type. Since rapid emergence of resistance can occur, culture and susceptibility
tests should be performed in the event of persistent positive cultures.
This drug is not indicated for the treatment of meningococcal infections or
asymptomatic carriers of N. meningitidis to eliminate meningococci from
the nasopharynx.
DOSAGE AND ADMINISTRATION
In general, therapy should be continued until bacterial conversion and maximal
improvement have occurred.
Adults: Two RIFAMATE (rifampin and isoniazid capsules USP) capsules
(600 mg rifampin, 300 mg isoniazid) once daily, administered one hour before
or two hours after a meal.
Concomitant administration of pyridoxine (B 6 ) is recommended in
the malnourished, in those predisposed to neuropathy (e.g., diabetic), and in
adolescents.
Susceptibility Testing
Rifampin
Rifampin susceptibility powders are available for both direct and indirect
methods of determining the susceptibility of strains of mycobacteria. The MIC's
of susceptible clinical isolates when determined in 7H10 or other non-egg-containing
media have ranged from 0.1 to 2 mcg/ml.
Quantitative methods that require measurement of zone diameters give the most
precise estimates of antibiotic susceptibility. One such procedure has been
recommended for use with discs for testing susceptibility to rifampin. Interpretations
correlate zone diameters from the disc test with MIC (minimal inhibitory concentration)
values for rifampin.
HOW SUPPLIED
Capsules (opaque red), imprinted "RIFAMATE" on both ends of the capsule, containing
300 mg rifampin and 150 mg isoniazid; bottles of 60 (NDC 0068-0509-60).
Merrell Pharmaceuticals Inc.
Subsidiary of
Hoechst Marion Roussel, Inc.
Kansas City, MO 64137 USA
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