Detailed View: Safety Labeling Changes Approved By FDA Center for Drug eva luation and Research (CDER)
ARIMIDEX Rx
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ARIMIDEX
Breast cancer  Only 4 drugs may be compared at once

Generic Name and Formulations:
Anastrozole 1mg; tabs.
Company:
AstraZeneca Pharmaceuticals
 
Select therapeutic use: Breast cancer
Indications for ARIMIDEX:
In postmenopausal women: adjuvant treatment of hormone receptor-positive early breast cancer; first-line treatment of hormone receptor-positive or unknown locally advanced or metastatic breast cancer; advanced breast cancer with disease progression after tamoxifen therapy.

Adult:
1mg once daily. Advanced disease: continue until tumor progression.

Children:
Not applicable.

Contraindications:
Women who are or may become pregnant. Pregnancy (Cat.X).

Warnings/Precautions:
Pre-existing ischemic heart disease. Severe hepatic impairment. Monitor bone mineral density, cholesterol. Nursing mothers: not recommended.

Interactions:
Antagonized by tamoxifen, estrogens; do not give concomitantly.

Pharmacological Class:
Aromatase inhibitor.

Adverse Reactions:
Hot flashes, asthenia, arthritis, pain, arthralgia, pharyngitis, hypertension, depression, nausea, vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, peripheral edema, lymphedema, dyspnea, dizziness, paresthesia, vaginal bleeding, cough, hypercholesterolemia.

How Supplied:
Tabs—30