BICALUTAMIDE tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Kremers Urban

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Bicalutamide Tablet 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 Tablet 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 Tablets. If this drug is used during pregnancy, or if the patient becomes pregnant while taking th

Termék összefoglaló:

White, circular, biconvex, film-coated tablets (identified on one side with "KU" and on the reverse with the "132") are supplied in bottles of 30 tablets (62175-132-32). Store at controlled room temperature, 20°-25°C (68°-77°F)

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

BICALUTAMIDE- BICALUTAMIDE TABLET, FILM COATED
KREMERS URBAN
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BICALUTAMIDE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR BICALUTAMIDE TABLETS.
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Bicalutamide Tablet 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 Tablet 150 mg daily is not approved for use alone or with
other treatments (1)
DOSAGE AND ADMINISTRATION
The recommended dose for Bicalutamide Tablets 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 Tablets, at regular intervals for
the first four months of treatment and periodically
thereafter, and for symptoms or signs suggestive of hepatic
dysfunction. Use Bicalutamide Tablets with caution in
patients with hepatic impairment. (5.1)
Gynecomastia and breast pain have been reported during treatment with
Bicalutamide Tablets 150 mg when used as a
single agent. (5.2.)
Bicalutamide Tablets are 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 Tablets 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 Tablets plus an LHRH-A were: hot
flashes, pai