LETROZOLE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

INDICUS PHARMA LLC

INN (nemzetközi neve):

LETROZOLE

Összetétel:

LETROZOLE 2.5 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Letrozole tablets (letrozole) are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal 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 [see Clinical Studies (14.2, 14.3) ]. Letrozole tablets are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. Letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [see Clinical Studies(14.4, 14.5) ]. Letrozole tablets may cause fetal harm when administered to a pregnant woman and the cl

Termék összefoglaló:

Packaged in HDPE bottles with a child resistant closure. 2.5 milligram tablets Bottles of 30 tablets………………………………………………NDC 24724-030-03 Bottles of 100 tablets……..………………………………………NDC 24724-030-01 Store at 25°C (77°F); [see USP Controlled Room Temperature]. Excursions permitted to 15-30°C (59-86°F)

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

LETROZOLE - LETROZOLE TABLET
INDICUS PHARMA LLC
----------
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
USP ,2.5 MG INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Letrozole tablets 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 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 FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 6/2011
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