देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
ANASTROZOLE (UNII: 2Z07MYW1AZ) (ANASTROZOLE - UNII:2Z07MYW1AZ)
BluePoint Laboratories
ANASTROZOLE
ANASTROZOLE 1 mg
ORAL
PRESCRIPTION DRUG
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 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 administere
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 68001-155-04 in bottle of 30 tablets (unit-of-use package) NDC 68001-155-08 in bottle of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Preserve in tight containers
Abbreviated New Drug Application
ANASTROZOLE- ANASTROZOLE TABLET, COATED BLUEPOINT LABORATORIES ---------- 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 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, insomni पूरा दस्तावेज़ पढ़ें