LETROZOLE tablet film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

LETROZOLE (UNII: 7LKK855W8I) (LETROZOLE - UNII:7LKK855W8I)

제공처:

KAISER FOUNDATION HOSPITALS

INN (국제 이름):

LETROZOLE

구성:

LETROZOLE 2.5 mg

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

LETROZOLE- LETROZOLE TABLET, FILM COATED
KAISER FOUNDATION HOSPITALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO
USELETROZOLE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FORLETROZOLE TABLETS.
LETROZOLE TABLETS USP
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Letrozole tablet 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 mg 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 ACCORD HEALTHCARE INC.
AT 1-866-941-7875 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 2/2015
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