Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
LETROZOLE (UNII: 7LKK855W8I) (LETROZOLE - UNII:7LKK855W8I)
INDICUS PHARMA LLC
LETROZOLE
LETROZOLE 2.5 mg
ORAL
PRESCRIPTION DRUG
Letrozole tablets (letrozole) 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 cl
Packaged in HDPE bottles with a child resistant closure. 2.5 milligram tablets Bottles of 30 tablets………………………………………………NDC 24724-030-03 Bottles of 100 tablets……..………………………………………NDC 24724-030-01 Store at 25°C (77°F); [see USP Controlled Room Temperature]. Excursions permitted to 15-30°C (59-86°F)
Abbreviated New Drug Application
LETROZOLE - LETROZOLE TABLET INDICUS PHARMA LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LETROZOLE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LETROZOLE TABLETS. LETROZOLE TABLETS USP ,2.5 MG INITIAL U.S. APPROVAL: 1997 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) 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 FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 6/2011 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Adjuvant Treatment of Early Breast Cancer 1.2 Extended Adjuvant Treatment of Early Breast Cancer 1.3 First and Second-Line Treatment of Advanced Breast Cancer Læs hele dokumentet