ANASTROZOLE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Accord Healthcare Inc.

INN (Algemene Internationale Benaming):

ANASTROZOLE

Samenstelling:

ANASTROZOLE 1 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 is 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 may cause fetal harm when administered to a pregnant woman

Product samenvatting:

Anastrozole tablets, USP 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 with a child-resistant closure (NDC 16729-035-10) Bottles of 90 tablets with a child-resistant closure (NDC 16729-035-15) Bottles of 500 tablets (NDC 16729-035-16) Bottles of 1000 tablets (NDC 16729-035-17) Storage Store at controlled room temperature, 20 to 25°C (68 to 77°F) [see USP]. Preserve in tight container.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ANASTROZOLE- ANASTROZOLE TABLET
ACCORD HEALTHCARE 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 TABLET, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions, Embryo-Fetal Toxicity ( 5.4) 12/2018
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 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,