ISONIAZID tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

STAT RX USA LLC

INN (Medzinárodný Name):

ISONIAZID

Zloženie:

ISONIAZID 300 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Isoniazid is recommended for all forms of tuberculos 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 tuberculos 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 parenthesis): 1. 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 mini

Prehľad produktov:

Isoniazid Tablets, USP are available as: 100 mg: White to off-white, round, scored, flat-faced, beveled-edge tablet. Debossed with stylized b on one side and 066 over 100 on the other side. Available in bottles of: 100 Tablets NDC 0555-0066-02 1000 Tablets NDC 0555-0066-05 300 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 0555-0071-01 100 Tablets NDC 0555-0071-02 1000 Tablets NDC 0555-0071-05 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. Rx only Manufactured By: BARR LABORATORIES, INC. Pomona, NY 10970 Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Iss. 8/2009

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

ISONIAZID - ISONIAZID TABLET
STAT RX USA LLC
----------
RX only
Iss. 8/2009
11001498
0066
0071
Warning
Severe and sometimes fatal hepatitis associated with isoniazid therapy
has been re-
ported 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 in- volving 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 abnor-
malities of liver function exceed three to five times the upper limit
of normal, discontin-