ANASTROZOLE tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

ANASTROZOLE (UNII: 2Z07MYW1AZ) (ANASTROZOLE - UNII:2Z07MYW1AZ)

Доступна з:

Teva Pharmaceuticals USA, Inc.

ІПН (Міжнародна Ім'я):

ANASTROZOLE

Склад:

ANASTROZOLE 1 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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. Hypersensitivity Anastrozole tablets are contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients. Observed reactions include anaphylaxis, angioedema, and urticaria [see Adverse Reactions (6.2) ]. Risk Summary Based on findings from animal studies and its mechanism of action, anastrozole tablets may cause fetal harm when administered to a pregnant

Огляд продуктів:

Anastrozole Tablets, USP are available as follows: 1 mg – White to off-white, film-coated, round-shaped tablets, debossed with “TEVA” on one side of the tablet and with “A10” on the other, in bottles of 30 (NDC 0093-7536-56). Storage Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

ANASTROZOLE- ANASTROZOLE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, 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
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
Patients with demonstrated hypersensitivity to anastrozole tablets or
any excipient (4)
WARNINGS AND PRECAUTIONS
In women with pre-existing ischemic heart disease, an increased
incidence of ischemic cardiovascular
events occurred with anastrozole tablet 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)
Embryo-Fetal Toxicity: Anastrozole tablets may cause fetal harm.
Advise patients of the potential risk to
a fetus and to use effective contraception. (5.4, 8.1)
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, arthritis, pain,
arthralgia, pharyngitis, hypertension, depression, nausea and
vomiting, ras