Maa: Peru
Kieli: espanja
Lähde: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)
FARMA VITA GROUP SOCIEDAD ANONIMA CERRADA - DROGUERÍA
J04AC01
JARABE
POR DOSIS -
ORAL
Con receta médica
YURIA-PHARM LTD. - UCRANIA
Isoniazida
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.
VIGENTE
2025-11-05
ISONIAZID- ISONIAZID SOLUTION CMP PHARMA, INC. ---------- 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 Lue koko asiakirja