ANASTROZOLE tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Anastrozole (UNII: 2Z07MYW1AZ) (Anastrozole - UNII:2Z07MYW1AZ)

Tilgjengelig fra:

Synthon Pharmaceuticals, Inc.

INN (International Name):

Anastrozole

Sammensetning:

Anastrozole 1 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Anastrozole Tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. Anastrozole Tablets are indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Anastrozole Tablets are indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to Anastrozole Tablets. Anastrozole Tablets may cause fetal harm when administered to a pregnant woman and offers no clinical benefit to premenopausal women with breast cancer. Anastrozole Tablets are contraindicated in women who are or may become pregnant. There are no adequate and well-controlled studies in pregnant women using Anastrozole Tablets. If Anastrozole Tablets are used during pregnancy, or if the patient becomes

Produkt oppsummering:

The Anastrozole Tablets are white, round, biconvex, film-coated tablets with "ANA 1" debossed on one side. These tablets are supplied as follows: NDC 63672-0015-1 , Bottles of 30 tablets Storage Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ANASTROZOLE- ANASTROZOLE TABLET, FILM COATED
SYNTHON PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ANASTROZOLE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ANASTROZOLE TABLETS.
ANASTROZOLE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Contraindications - Premenopausal Women and Pregnancy (4.1, 8.1)
11/2008
Warnings and Precautions- Ischemic Cardiovascular Events (5.1, 6.1)
11/2008
INDICATIONS AND USAGE
Anastrozole Tablets are an aromatase inhibitor indicated for:
Adjuvant treatment of postmenopausal women with hormone
receptor-positive early breast cancer (1.1)
First-line treatment of postmenopausal women with hormone
receptor-positive or hormone receptor unknown locally
advanced or metastatic breast cancer (1.2)
Treatment of advanced breast cancer in postmenopausal women with
disease progression following tamoxifen therapy.
Patients with ER-negative disease and patients who did not respond to
previous tamoxifen therapy rarely responded to
Anastrozole Tablets (1.3)
DOSAGE AND ADMINISTRATION
One 1 mg tablet taken once daily (2.1)
DOSAGE FORMS AND STRENGTHS
1 mg tablets (3)
CONTRAINDICATIONS
Women of premenopausal endocrine status, including pregnant women
(4.1, 8.1)
Patients with demonstrated hypersensitivity to Anastrozole Tablets or
any excipient (4.2)
WARNINGS AND PRECAUTIONS
In women with pre-existing ischemic heart disease, an increased
incidence of ischemic cardiovascular events occurred
with Anastrozole Tablets use compared to tamoxifen use. Consider risks
and benefits. (5.1, 6.1)
Decreases in bone mineral density may occur. Consider bone mineral
density monitoring. (5.2, 6.1)
Increases in total cholesterol may occur. Consider cholesterol
monitoring. (5.3, 6.1)
ADVERSE REACTIONS
In the early breast cancer (ATAC) study, the most common (occurring
with an incidence of >10%) side effects occurring in
women taking Anastrozole Tablets included: hot flashes, asthenia,
arthriti