BICALUTAMIDE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

BICALUTAMIDE

Sammensætning:

BICALUTAMIDE 50 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Bicalutamide tablets, USP 50 mg daily are 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 tablets, USP 150 mg daily are not approved for use alone or with other treatments [see Clinical Studies (14.2)]. Bicalutamide is contraindicated in: - Hypersensitivity Bicalutamide is 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. - Women Bicalutamide has no indication for women, and should not be used in this population. - Pregnancy Bicalutamide can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Risk Summary Bicalutamide is contraindicated for use in pregnant women because it can cause fetal harm. Bicalutamide is not indicated for use in females. There are no human data on t

Produkt oversigt:

White to off white, circular, biconvex, film-coated tablets debossed with “485” on one side and plain on other side. Bottles of 30 with Child Resistant Cap……….…..…. NDC 47335-485-83 Bottles of 100 with Child Resistant Cap………….…..NDC 47335-485-88 Bottles of 100…..…….…..…….…..…….…..…….…..…….NDC 47335-485-08 Bottles of 1000…..…….…..…….…..…….…..…….……….NDC 47335-485-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

BICALUTAMIDE - BICALUTAMIDE TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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 .
BICALUTAMIDE TABLETS, FOR ORAL USE
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. (1)
Bicalutamide tablet 150 mg daily is not approved for use alone or with
other treatments. (1)
(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) (2)
DOSAGE FORMS AND STRENGTHS
50 mg tablets (3) (3)
CONTRAINDICATIONS
Hypersensitivity (4)
Women (4)
Pregnancy (4,8.1)
WARNINGS AND PRECAUTIONS
Severe hepatic injury and fatal hepatic failure have been observed.
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)
Hemorrhage with Concomitant Use of Coumarin Anticoagulant. Closely
monitor the Prothrombin Time
(PT) and International Normalized Ratio (INR), and adjust the
anticoagulant dose as needed. (5.2)
Gynecomastia and breast pain have been reported during treatment with
bicalutamide 150 mg when
used as a single agent. (5.3)
Bicalutamide is used in combination with an 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.
(5.4)
Monitoring