LETROZOLE tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries Limited

INN (International Name):

LETROZOLE

Composition:

LETROZOLE 2.5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LETROZOLE - LETROZOLE TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES LIMITED
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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
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