देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
LETROZOLE (UNII: 7LKK855W8I) (LETROZOLE - UNII:7LKK855W8I)
Sun Pharmaceutical Industries Limited
LETROZOLE
LETROZOLE 2.5 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
LETROZOLE - LETROZOLE TABLET, FILM COATED SUN PHARMACEUTICAL INDUSTRIES LIMITED ---------- 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 RECENT MAJOR CHANGES Contraindications (4) 7/2017 Warnings and Precautions, Embryo-Fetal Toxicity (5.6) 7/2017 INDICATIONS AND USAGE Letrozole is 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 Pregnancy (4) Known hypersensitivity to the active substance, or to any of the excipients (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) Embryo-Fetal toxicity: Can cause fetal harm when administered to pregnant women. Obtain a pregnancy test in females of reproductive potential. Advise females of reproductive potential to use effective contraception (5.6, 8.1, 8.3) ADVERSE REACTIONS The most common adverse reactions (greater than 20%) were hot flashes, arthralgia; flushing, asthenia, edema, arthralgia, headache, dizziness, hypercholesterolemia, sweating increased, bone pain; and musculoskeletal पूरा दस्तावेज़ पढ़ें