ANASTROZOLE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Proficient Rx LP

INN (Tên quốc tế):

ANASTROZOLE

Thành phần:

ANASTROZOLE 1 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 may cause fetal harm when administered to a pregnant woman and offers no clinical benefit to premenopausal women with breast cancer. Anastrozole is contraindicated in women who are or may become pregnant. There are no adequate and well-controlled studies in pregnant women using anastrozole. If anastrozole is used during pregnancy, or if the patient becomes pregnant while taking this drug

Tóm tắt sản phẩm:

Anastrozole tablets, 1 mg are white to off-white, round biconvex, film coated tablets, with “AHI” debossing on one side and plain on other side and are supplied as follows: Bottles of 18 tablets (NDC 63187-080-18) Bottles of 20 tablets (NDC 63187-080-20) Bottles of 30 tablets (NDC 63187-080-30) Bottles of 60 tablets (NDC 63187-080-60) Bottles of 90 tablets (NDC 63187-080-90) Store at controlled room temperature, 20 to 25°C (68 to 77°F) [see USP].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

ANASTROZOLE- ANASTROZOLE TABLET
PROFICIENT RX LP
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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 TABLET FOR ORAL USE.
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Anastrozole is an aromatase inhibitor indicated for:
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DOSAGE AND ADMINISTRATION
One 1 mg tablet taken once daily (2.1)
DOSAGE FORMS AND STRENGTHS
1 mg tablets (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ACCORD HEALTHCARE INC.
AT 1-866-941-
7875 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
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 (1.3)
Women of premenopausal endocrine status, including pregnant women
(4.1, 8.1)
Patients with demonstrated hypersensitivity to anastrozole or any
excipient (4.2)
In women with pre-existing ischemic heart disease, an increased
incidence of ischemic cardiovascular
events occurred with anastrozole 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)
In the early breast cancer (ATAC) study, the most common (occurring
with an incidence of ≥10%)
side effects o