ANASTROZOLE tablet, coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Zydus Pharmaceuticals USA Inc.

INN (mednarodno ime):

ANASTROZOLE

Sestava:

ANASTROZOLE 1 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 pregnan

Povzetek izdelek:

Anastrozole Tablets USP, 1 mg are white, biconvex, round coated tablets, debossed with 'A7' on one side and plain on other side and are supplied as follows: NDC 68382-209-06 in bottle of 30 tablets with child-resistant closure (unit-of-use package) NDC 68382-209-10 in bottle of 1000 tablets Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

ANASTROZOLE- ANASTROZOLE TABLET, COATED
ZYDUS PHARMACEUTICALS USA 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: 1995
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
Patients with demonstrated hypersensitivity to anastrozole 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 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 included: hot flashes,
asthenia, arthritis, pain, arthralgia,
pharyngitis, hypertension, depression, nausea and vomiting, rash,
osteoporosis, fractures, back pain,
insomnia, h