ISONIAZID tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Mylan Institutional Inc.

INN（国際名）:

ISONIAZID

構図:

ISONIAZID 300 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 therapy who have HIV infection should have a minimum of 12 months of therapy. - Close contacts of persons with newly diagnosed infectious tuberculosis (greater than or equal to 5 mm). In addition, tuberculin-negative (less than 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (greater than 5 mm), therapy should be continued. - Recent converters, as indicated by a tuberculin skin test (greater than or equal to 10 mm increase within a 2-year period for those less than 35 years old; greater than or equal to 15 mm increase for those greater than or equal to 35 years of age). All infants and children younger than 4 years of age with a greater than 10 mm skin test are included in this category. - Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (greater than or equal to 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. - Intravenous drug users known to be HIV-seronegative (greater than 10 mm). - Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (greater than or equal to 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin’s disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state [with or without weight loss], chronic peptic ulcer disease, chronic malabsorption syndromes and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. Additionally, in the absence of any of the above risk factors, persons under the age of 35 with a tuberculin skin test reaction of 10 mm or more are also appropriate candidates for preventive therapy if they are a member of any of the following high-incidence groups: - Foreign-born persons from high-prevalence countries who never received BCG vaccine. - Medically underserved low-income populations, including high-risk racial or ethnic minority populations, especially blacks, Hispanics and Native Americans. - Residents of facilities for long-term care (e.g., correctional institutions, nursing homes and mental institutions). Children who are less than 4 years old are candidates for isoniazid preventive therapy if they have greater than 10 mm induration from a PPD Mantoux tuberculin skin test. Finally, persons under the age of 35 who a) have none of the above risk factors (1 to 6); b) belong to none of the high-incidence groups; and c) have a tuberculin skin test reaction of 15 mm or more, are appropriate candidates for preventive therapy. The risk of hepatitis must be weighed against the risk of tuberculosis in positive tuberculin reactors over the age of 35. However, the use of isoniazid is recommended for those with the additional risk factors listed above (1 to 6) and on an individual basis in situations where there is likelihood of serious consequences to contacts who may become infected. Isoniazid is contraindicated in patients who develop severe hypersensitivity reactions, including drug-induced hepatitis; previous isoniazid-associated hepatic injury; severe adverse reactions to isoniazid such as drug fever, chills, arthritis; and acute liver disease of any etiology.

製品概要:

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. NDC 51079-083-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. 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 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12762 R1 10/22

認証ステータス:

Abbreviated New Drug Application

製品の特徴

ISONIAZID- ISONIAZID TABLET
MYLAN INSTITUTIONAL 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,
discontinuation