BICALUTAMIDE tablet, film coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

BICALUTAMIDE (UNII: A0Z3NAU9DP) (BICALUTAMIDE - UNII:A0Z3NAU9DP)

MAH:

Physicians Total Care, Inc.

INN:

BICALUTAMIDE

composition:

BICALUTAMIDE 50 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Bicalutamide 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate. Bicalutamide 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. Bicalutamide tablets are contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet’s components. Hypersensitivity reactions including angioneurotic edema and urticaria have been reported [see Adverse Reactions (6.2) ]. Bicalutamide tablets have no indication for women, and should not be used in this population. Bicalutamide tablets may cause fetal harm when administered to a pregnant woman. Bicalutamide tablets are contraindicated in women, including those who are or may become pregnant. There are no studies in pregnant women using bicalutamide. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient sh

leaflet_short:

Bicalutamide tablets USP are available as follows: 50 mg - white to off-white, film-coated, round tablets, debossed with “93” on one side and “220” on the other side, in bottles of 30 NDC 54868-6133-0 . 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).

authorization_status:

Abbreviated New Drug Application

SPC

BICALUTAMIDE - BICALUTAMIDE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BICALUTAMIDE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BICALUTAMIDE TABLETS
USP.
BICALUTAMIDE TABLETS USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Bicalutamide 50 mg is an androgen receptor inhibitor indicated for use
in combination therapy with a luteinizing
hormone-releasing hormone (LHRH) analog for the treatment of Stage D
metastatic carcinoma of the prostate.
Bicalutamide 150 mg daily is not approved for use alone or with other
treatments. (1)
DOSAGE AND ADMINISTRATION
The recommended dose for bicalutamide therapy in combination with an
LHRH analog is one 50 mg tablet once daily
(morning or evening). (2)
DOSAGE FORMS AND STRENGTHS
50 mg tablets (3)
CONTRAINDICATIONS
Hypersensitivity (4.1)
Women (4.2)
Pregnancy (4.3 and 8.1)
WARNINGS AND PRECAUTIONS
Severe hepatic changes and hepatic failure have been observed rarely.
Monitor serum transaminase levels prior to
starting treatment with bicalutamide, at regular intervals for the
first four months of treatment and periodically
thereafter, and for symptoms or signs suggestive of hepatic
dysfunction. Use bicalutamide with caution in patients with
hepatic impairment. (5.1)
Gynecomastia and breast pain have been reported during treatment with
bicalutamide 150 mg when used as a single
agent. (5.2)
Bicalutamide is used in combination with a LHRH agonist. LHRH agonists
have been shown to cause a reduction in
glucose tolerance in males. Consideration should be given to
monitoring blood glucose in patients receiving
bicalutamide in combination with LHRH agonists. (5.3)
Monitoring Prostate Specific Antigen (PSA) is recommended. Evaluate
for clinical progression if PSA increases. (5.4)
ADVERSE REACTIONS
Adverse reactions that occurred in more than 10% of patients receiving
bicalutamide plus an LHRH-A were: hot flashes,
pain (including