Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
LETROZOLE (UNII: 7LKK855W8I) (LETROZOLE - UNII:7LKK855W8I)
Arab Pharmaceutical Manufacturing Co. PSC Ltd
LETROZOLE
LETROZOLE 2.5 mg
ORAL
PRESCRIPTION DRUG
Letrozole Tablets, USP are indicated for the adjuvant treatment of postmenopausal women with hormonereceptor positive early breast cancer. Letrozole Tablets, USP are indicated for the extended adjuvant treatment of early breast cancer inpostmenopausal 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 [s e e C lini c al Studi e s ( 14.2 , 14.3 ) ] . Letrozole Tablets, USP are indicated for first-line treatment of postmenopausal women with hormonereceptor positive or unknown, locally advanced or metastatic breast cancer. Letrozole Tablets USP, are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [s e e C lini c al Studi e s ( 14.4 , 14.5 ) ] . Letrozole Tablets may cause fetal harm when adminis
Packaged in HDPE bottles with a safety screw cap. 2.5 milligram tablets bottles of 30 tablets Bottles of 30 tablets ..............................................NDC 24535-0801-1 Store at 20 to25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight light resistant containers defined in the USP using child-resistant closure
Abbreviated New Drug Application
LETROZOLE- LETROZOLE TABLET, FILM COATED ARAB PHARMACEUTICAL MANUFACTURING CO. PSC LTD ---------- 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 , FOR ORAL USE. INITIAL U.S. APPROVAL: 1997 INDICATIONS AND USAGE Letrazole Tablets, USP 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 film –coated 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 WEST-WARD PHARMACEUTICALS CORP. AT 1-877-233-2001 OR THE FDA AT 1-800-FDA-1088, OR WWW.FDA.GOV/MEDWATCH SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 4/2016 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 ADJUVANT TREATMENT OF EARLY BREAST CANC Lestu allt skjalið