BICALUTAMIDE- bicalutamide tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Northstar RxLLC

INN (Rahvusvaheline Nimetus):

BICALUTAMIDE

Koostis:

BICALUTAMIDE 50 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 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 the use of bicalutamide

Toote kokkuvõte:

Bicalutamide tablets, USP are available as follows: 50 mg – White, round, film-coated, biconvex tablets marked with “B 50” on one side with “” on the other side are supplied in bottles of 30 tablets (NDC 16714-571-01), 100 tablets (NDC 16714-571-02), and 500 tablets (NDC 16714-571-03). Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Dispense in a tight, light-resistant container as defined in the USP.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

BICALUTAMIDE- BICALUTAMIDE TABLET, FILM COATED
NORTHSTAR RXLLC
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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
RECENT MAJOR CHANGES
Warnings and Precautions (5.2) 10/2017
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. (1)
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)
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 Prostate Specific Antigen (PSA) i