ISONIAZIDA 100 mg/5mL JARABE

국가: 페루

언어: 스페인어

출처: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)

제공처:

FARMA VITA GROUP SOCIEDAD ANONIMA CERRADA - DROGUERÍA

ATC 코드:

J04AC01

약제 형태:

JARABE

구성:

POR DOSIS -

관리 경로:

ORAL

처방전 유형:

Con receta médica

Manufactured by:

YURIA-PHARM LTD. - UCRANIA

치료 그룹:

Isoniazida

제품 요약:

Presentación: Caja de Cartón conteniendo un frasco de Tereftalato de polietileno de color marrón de 200 mL con tapón de polietileno de baja densidad incoloro y con tapa de Polietileno de alta densidad de color blanco con jeringa dosificadora de 5 mL.

승인 상태:

VIGENTE

승인 날짜:

2025-11-05

제품 특성 요약

ISONIAZID- ISONIAZID SOLUTION
CMP PHARMA, INC.
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ISONIAZID ORAL SOLUTION, USP
50 MG/5 ML
CMP Pharma, Inc.
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