Country: United States
Language: English
Source: NLM (National Library of Medicine)
Letrozole (UNII: 7LKK855W8I) (letrozole - UNII:7LKK855W8I)
Dr. Reddy's Laboratories Limited
Letrozole
Letrozole 2.5 mg
ORAL
PRESCRIPTION DRUG
Letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. . Letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. The effectiveness of letrozole tablets in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [see Clinical Studies (14.2, 14.3) ]. Letrozole tablets are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. Letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [see Clinical Studies (14.4, 14.5) ]. Letrozole tablets may cause fetal harm when administered to a pregnant woman and the clinicl ben
Letrozole tablets USP, 2.5 mg are dark yellow coloured, round, biconvex, film coated tablets with ‘LET’ debossed on one side and ‘2.5’ on other side and is supplied in Bottles of 30’s count and Unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-646-30 Unit dose Package of 100 (10 x 10) NDC 55111-646-78
Abbreviated New Drug Application
LETROZOLE- LETROZOLE TABLET, FILM COATED DR. REDDY'S LABORATORIES LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LETROZOLE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LETROZOLE LETROZOLE TABLETS USP INITIAL U.S. APPROVAL: 1997 RECENT MAJOR CHANGES Adjuvant Treatment of Early Breast Cancer (1.1, 2.2) 04/2010 INDICATIONS AND USAGE Letrozole tablets are an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer (1.1) Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy (1.2) First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer (1.3) DOSAGE AND ADMINISTRATION Letrozole tablets are taken orally without regard to meals (2): Recommended dose: 2.5.mg once daily (2.1) Patients with cirrhosis or severe hepatic impairment: 2.5 mg every other day (2.5, 5.3) DOSAGE FORMS AND STRENGTHS 2.5 milligram tablets (3) (3) CONTRAINDICATIONS Women of premenopausal endocrine status, including pregnant women (4) WARNINGS AND PRECAUTIONS Decreases in bone mineral density may occur. Consider bone mineral density monitoring (5.1) Increases in total cholesterol may occur. Consider cholesterol monitoring. (5.2) Fatigue, dizziness and somnolence may occur. Exercise caution when operating machinery (5.4) ADVERSE REACTIONS The most common adverse reactions (>20%) were hot flashes, arthralgia (6.1); flushing, asthenia, edema, arthralgia, headache, dizziness, hypercholesterolemia, sweating increased, bone pain (6.2, 6.3); and musculoskeletal (6.4). TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DR. REDDY’S LABORATORIES LIMITED INC., AT 1-888-375- 3784 OR FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 6/2010 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 ADJUVANT Read the complete document