ISONIAZID tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

PD-Rx Pharmaceuticals, Inc.

INN (International namn):

ISONIAZID

Sammansättning:

ISONIAZID 300 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy. Isoniazid tablets, USP are 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 parenthesis): - Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 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 therap

Produktsammanfattning:

Isoniazid tablets, USP are available as follows: 300 mg: White to off-white, oval-shaped, scored, flat-faced, beveled-edge tablet, debossed with stylized b on one side and 071 over 300 on the other side. Available in bottles of 30 tablets (NDC 43063-463-30). Protect from moisture and light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured In Canada By: Patheon Inc. Whitby, ON, Canada L1N 5Z5 Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. D 10/2021

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

ISONIAZID- ISONIAZID TABLET
PD-RX PHARMACEUTICALS, INC.
----------
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 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 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,
discontinuati