LETROZOLE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Arab Pharmaceutical Manufacturing Co. PSC Ltd

INN (International Name):

LETROZOLE

Sammensætning:

LETROZOLE 2.5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

 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

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

LETROZOLE- LETROZOLE TABLET, FILM COATED
ARAB PHARMACEUTICAL MANUFACTURING CO. PSC LTD
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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
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