FLUTAMIDE capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

FLUTAMIDE (UNII: 76W6J0943E) (FLUTAMIDE - UNII:76W6J0943E)

Sẵn có từ:

Par Pharmaceutical, Inc.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Flutamide capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B2 -C and Stage D2 metastatic carcinoma of the prostate. Stage B2 -C Prostatic Carcinoma Treatment with flutamide capsules and the goserelin acetate implant should start eight weeks prior to initiating radiation therapy and continue during radiation therapy. Stage D2 Metastatic Carcinoma To achieve benefit from treatment, flutamide capsules should be initiated with the LHRH-agonist and continued until progression. Flutamide capsules are contraindicated in patients who are hypersensitive to flutamide or any component of this preparation. Flutamide capsules are contraindicated in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment).

Tóm tắt sản phẩm:

Flutamide capsules USP, 125 mg, are available as opaque, beige/beige capsules, imprinted “par/753”on the cap and body. They are available in bottle of 180 (NDC 49884-753-13). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

FLUTAMIDE- FLUTAMIDE CAPSULE
PAR PHARMACEUTICAL, INC.
----------
FLUTAMIDE CAPSULES
WARNINGS
Hepatic Injury
There have been postmarketing reports of hospitalization and rarely
death due to
liver failure in patients taking flutamide. Evidence of hepatic injury
included elevated
serum transaminase levels, jaundice, hepatic encephalopathy and death
related to
acute hepatic failure. The hepatic injury was reversible after
discontinuation of
therapy in some patients. Approximately half of the reported cases
occurred within
the initial 3 months of treatment with flutamide.
Serum transaminase levels should be measured prior to starting
treatment with
flutamide. Flutamide is not recommended in patients whose ALT values
exceed
twice the upper limit of normal. Serum transaminase levels should then
be
measured monthly for the first 4 months of therapy, and periodically
thereafter.
Liver function tests also should be obtained at the first signs and
symptoms
suggestive of liver dysfunction, e.g., nausea, vomiting, abdominal
pain, fatigue,
anorexia, “flu-like” symptoms, hyperbilirubinuria, jaundice or
right upper quadrant
tenderness. If at any time, a patient has jaundice, or their ALT rises
above 2 times
the upper limit of normal, flutamide should be immediately
discontinued with close
follow-up of liver function tests until resolution.
DESCRIPTION
Flutamide capsules contain flutamide, an acetanilid, nonsteroidal,
orally active
antiandrogen having the chemical name,
α,α,α-trifluoro-2-methyl-4'-nitrom-
propionotoluidide.
Each capsule contains 125 mg flutamide. The compound is a buff to
yellow powder with
a molecular weight of 276.22 and the following structural formula:
C
H
F N O
In addition, each capsule contains the following inactive ingredients:
corn starch, lactose
monohydrate, magnesium stearate, povidone, and sodium lauryl sulfate.
Gelatin capsule
shells may contain gelatin, silicon dioxide, sodium lauryl sulfate,
titanium dioxide,
FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide, and black ink
containing
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