ISONIAZID solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

A-S Medication Solutions

INN (Международно Name):

ISONIAZID

Композиция:

ISONIAZID 50 mg in 5 mL

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Isoniazid oral solution is 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 oral solution 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): - 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

Каталог на резюме:

Product: 50090-1490 NDC: 50090-1490-0 473 mL in a BOTTLE

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

ISONIAZID- ISONIAZID SOLUTION
A-S MEDICATION SOLUTIONS
----------
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 upp