LETROZOLE tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

West-Ward Pharmaceuticals Corp.

INN (Alþjóðlegt nafn):

LETROZOLE

Samsetning:

LETROZOLE 2.5 mg

Gerð lyfseðils:

PRESCRIPTION DRUG

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

LETROZOLE- LETROZOLE TABLET
WEST-WARD PHARMACEUTICALS CORP.
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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
Letrozole is an aromatase inhibitor indicated for:
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•
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DOSAGE AND ADMINISTRATION
Letrozole is taken orally without regard to meals (2):
•
•
DOSAGE FORMS AND STRENGTHS
2.5 milligram tablets (3)
CONTRAINDICATIONS
Women of premenopausal endocrine status, including pregnant women (4)
WARNINGS AND PRECAUTIONS
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•
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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 1-800- 962-8364
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 6/2016
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
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
2.2 Use in Adjuvant Treatment of Early Breast Cancer
2.3 Use in Extended Adjuvant Treatment of Early Breast Cancer
2.4 Use in First and Second-Line Treatment of Advanced Breast Cancer
2.5 Use in Hepatic Impairment
2.6 Use in Renal Impairment
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)
Recommended dose: 2.5