BICALUTAMIDE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

REMEDYREPACK INC.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets 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 Us

Descriptif du produit:

Bicalutamide tablets, USP 50 mg are white to off-white, round, biconvex, film-coated tablets debossed "B 50" on one side and plain on other side and supplied in NDC: 70518-2993-00 NDC: 70518-2993-01 PACKAGING: 30 in 1 BOX PACKAGING: 1 in 1 POUCH “Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature]” Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

BICALUTAMIDE- BICALUTAMIDE TABLET
REMEDYREPACK INC.
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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
INDICATIONS AND USAGE
Bicalutamide tablets 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 tablets 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, and 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) is recommended. Evaluate
for clinical pro