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 Online, Description, Chemistry, Ingredients - Rifampin and Isoniazid
Rifamate Online, Description, Chemistry, Ingredients - Rifampin and Isoniazid
DESCRIPTION
WARNING
Severe and sometimes fatal hepatitis associated with isoniazid 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 20-34 year age group, 12 per 1,000 for persons in the 35-49 year
age group, 23 per 1,000 for persons in the 50-64 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 isoniazid should be carefully monitored and
interviewed at monthly intervals. Serum transaminase concentration becomes
elevated in about 10-20 percent 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, isoniazid 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 must be reinstituted, it should be reinstituted
only after symptoms and laboratory abnormalities have cleared. The drug
should be restarted in very small and gradually increasing doses and should
be withdrawn immediately if there is any indication of recurrent liver
involvement. Treatment should be deferred in persons with acute hepatic
diseases.
|
RIFAMATE is a combination capsule containing 300 mg rifampin and 150 mg isoniazid.
The capsules also contain as inactive ingredients: colloidal silicon dioxide,
FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, sodium
starch glycolate, and titanium dioxide.
Rifampin is a semisynthetic antibiotic derivative of rifamycin B. The chemical
name for rifampin is 3-(4-methyl-1-piperazinyliminomethyl) rifamycin SV.
Isoniazid is the hydrazide of isonicotinic acid. It exists as colorless or
white crystals or as a white, crystalline powder that is water soluble, odorless,
and slowly affected by exposure to air and light.
top
