FLUTAMIDE- flutamide capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Actavis Pharma, Inc.

INN (mednarodno ime):

FLUTAMIDE

Sestava:

FLUTAMIDE 125 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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. Treatment with flutamide capsules and the goserelin acetate implant should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy. 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).

Povzetek izdelek:

Flutamide Capsules, USP are available as: 125 mg:       Brown opaque cap and white opaque body filled with yellow powder.                     Imprinted in black ink with “WPI 2227 ”.                     Available in bottles of:                     180 NDC-0591-2466-18 Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: July 2014 195814-2

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

FLUTAMIDE- FLUTAMIDE CAPSULE
ACTAVIS PHARMA, INC.
----------
FLUTAMIDE CAPSULES USP
FLUTAMIDE CAPSULES, USP
RX ONLY
Revised: July 2014
195814-2
RX ONLY
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, 2-methyl-_N_-[4-nitro-3-(trifluoromethyl)phenyl]
propanamide. The compound is a buff to
Yellow powder and has the following structural formula:
Each capsule, for oral administration, contains 125 mg flutamide and
has the following inactive
ingredients: lactose monohydrate, magnesium stearate, povidone,
pregelatinized starch, and sodium
lauryl sulfate.
The ingredients in the capsule shell are black iron oxide, gelatin,
red iron oxide, yellow iron oxide, and
titanium dioxide.
The ingredients