ANASTROZOLE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Dispensing Solutions, Inc.

INN (Tarptautinis Pavadinimas):

ANASTROZOLE

Sudėtis:

ANASTROZOLE 1 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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,

Produkto santrauka:

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 30 tablets (NDC 16729-035-10) Bottles of 90 tablets (NDC 16729-035-15) Bottles of 500 tablets (NDC 16729-035-16) Bottles of 1000 tablets (NDC 16729-035-17) Store at controlled room temperature, 20 to 25°C (68 to 77°F) [see USP].

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

ANASTROZOLE- ANASTROZOLE TABLET
DISPENSING SOLUTIONS, INC.
----------
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:
19 9 5
INDICATIONS AND USAGE
Anastrozole is 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 (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 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 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 included: hot flashes, asthenia, arthritis,
pain, arthralgia, pharyngitis, hypertension, depression,
nausea and vomiting, rash, osteoporosis, fractures, back pain,
insomnia, headache, peripheral edema and lymphedema,
regardless of causality. (6.1)
In the advanced br