ISONIAZID solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

CMP Pharma, Inc.

INN (Isem Internazzjonali):

ISONIAZID

Kompożizzjoni:

ISONIAZID 50 mg in 5 mL

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Isoniazid Oral Solution USP 50 mg/5 mL is supplied in bottles of 473 mL, NDC 46287-009-01. Store at 20°–25°C (68°–77°F); excursion permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers with child-resistant closures.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

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