ISONIAZID tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISONIAZID (UNII: V83O1VOZ8L) (ISONIAZID - UNII:V83O1VOZ8L)

Available from:

VersaPharm Incorporated

INN (International Name):

ISONIAZID

Composition:

ISONIAZID 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Isoniazid is recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant antituberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid, or any other medication, is inadequate therapy. Isoniazid is recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parentheses): - Persons with human immunodeficiency virus (HIV) infection (≥ 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 1

Product summary:

Isoniazid Tablets, USP 100 mg: White, Round Tablets; Debossed "West-ward" on one side and "260" on the Scored side. Isoniazid Tablets, USP 300 mg: White, Round Tablets; Debossed "West-ward 261" on one side and Scored on the other side. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISONIAZID- ISONIAZID TABLET
VERSAPHARM INCORPORATED
----------
ISONIAZID TABLETS, USP
RX ONLY
WARNING
Severe and sometimes fatal hepatitis associated with isoniazid therapy
has been reported and may
occur or may develop even after many months of treatment. The risk of
developing hepatitis is age
related. Approximate case rates by age are: less than 1 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 the 174 cases of hepatitis.
Therefore, patients given isoniazid should be carefully monitored and
interviewed at monthly
intervals. For persons 35 and older, in addition to monthly symptom
reviews, hepatic enzymes
(specifically, AST and ALT (formerly SGOT and SGPT, respectively))
should be measured prior
to starting isoniazid therapy and periodically throughout treatment.
Isoniazid-associated hepatitis
usually occurs during the first three months of treatment. Usually,
enzyme levels return to normal
despite continuance of drug, but in some cases progressive liver
dysfunction occurs. Other
factors associated with an increased risk of hepatitis include daily
use of alcohol, chronic liver
disease and injection drug use. A recent report suggests an increased
risk of fatal hepatitis
associated with isoniazid among women, particularly black and Hispanic
women. The risk may
also be increased during the post-partum period. More careful
monitoring should be considered
in these groups, possibly including more frequent laboratory
monitoring. If abnormalities of liver
function exceed three to five times the upper limit of normal,
discontinuation of