ISONARIF- rifampin and isoniazid capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

RIFAMPIN (UNII: VJT6J7R4TR) (RIFAMPIN - UNII:VJT6J7R4TR), ISONIAZID (UNII: V83O1VOZ8L) (ISONIAZID - UNII:V83O1VOZ8L)

Sẵn có từ:

VersaPharm Incorporated

INN (Tên quốc tế):

RIFAMPIN

Thành phần:

RIFAMPIN 300 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

For pulmonary tuberculosis in which organisms are susceptible, and when the patient has been titrated on theindividual components and it has therefore been established that this fixed dosage is therapeutically effective. This fixed-dosage combination drug is not recommended for initial therapy of tuberculosis or for preventive therapy. In the treatment of tuberculosis, small numbers of resistant cells, present within large populations of susceptiblecells, can rapidly become the predominating type. Since rapid emergence of resistance can occur, culture andsusceptibility tests should be performed in the event of persistent positive cultures. This drug is not indicated for the treatment of meningococcal infections or asymptomatic carriers of N. meningitides to eliminate meningococci from the nasopharynx. Previous isoniazid-associated hepatic injury; severe adverse reactions to isoniazid, such as drug fever, chills, andarthritis; acute liver disease of any etiology. A history of previous hypersensitivity reactio

Tóm tắt sản phẩm:

Rifampin and Isoniazid Capsules USP, 300 mg/150 mg are supplied as red powder filled No. 0 Scarlet Opaque HardGelatin Capsules; printed "IsonaRif™" on one end and “VP/017” on the other end in white ink; bottles of 60 capsules (NDC#61748-017-60). Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep tightly closed. Store in a dry place. Avoid excessive heat. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Manufactured for: VersaPharm Incorporated Marietta, GA 30062 Manufactured by: West-ward Pharmaceutical Corp Eatontown, NJ 07724 Rev. Feb. 2007

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

ISONARIF- RIFAMPIN AND ISONIAZID CAPSULE
VERSAPHARM INCORPORATED
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ISONARIF™ (RIFAMPIN AND ISONIAZID CAPSULES USP) 300 MG/150 MG
RX ONLY
WARNING
Severe and sometimes fatal hepatitis associated with isoniazid therapy
may occur and may develop
even after many months of treatment. The risk of developing hepatitis
is age related. Approximate
case rates by age are: 0 per 1,000 for persons under 20 years of age,
3 per 1,000 for persons in
the 20-34 year age group, 12 per 1,000 for persons in the 35-49 year
age group, 23 per 1,000 for
persons in the 50-64 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. Serum transaminase concentration becomes elevated in about
10-20 percent of patients,
usually during the first few months of therapy, but it can occur at
any time. Usually enzyme levels
return to normal despite continuance of drug, but in some cases
progressive liver dysfunction
occurs. Patients should be instructed to report immediately any of the
prodromal symptoms of
hepatitis, such as fatigue, weakness, malaise, anorexia, nausea, or
vomiting. If these symptoms
appear or if signs suggestive of hepatic damage are detected,
isoniazid should be discontinued
promptly, since continued use of the drug in these cases has been
reported to cause a more severe
form of liver damage.
Patients with tuberculosis should be given appropriate treatment with
alternative drugs. If
isoniazid must be reinstituted, it should be reinstituted only after
symptoms and laboratory
abnormalities have cleared. The drug should be restarted in very small
and gradually increasing
doses and should be withdrawn immediately