ANASTROZOLE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

West-Ward Pharmaceuticals Corp.

INN (International Name):

ANASTROZOLE

Sammensætning:

ANASTROZOLE 1 mg

Recept type:

PRESCRIPTION DRUG

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

ANASTROZOLE- ANASTROZOLE TABLET
WEST-WARD PHARMACEUTICALS CORP.
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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 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
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, rash, osteoporosis, fractures, back
pain, insomnia, headache, peripheral edema and
lymphedema, regardless of causality. (6.1)
In the advanced breast cancer studies, the most common (occurring with
an incidence of >10%) side effects occurring in
women taking anastrozole tablets included: hot flashes, nausea,
asthenia, pain, headache, back pain, bone pain, increased
cough, dyspnea, pharyngitis and peripheral edema. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ROXANE LABORATORIES,
INC. AT 1-800-962-8364 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 PATIENT COUNSELING
INFORMATION.
REVISED: 5/2017
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