LETROZOLE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Physicians Total Care, Inc.

INN (שם בינלאומי):

LETROZOLE

הרכב:

LETROZOLE 2.5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Enter section text here Letrozole tablets 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 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 pregna

leaflet_short:

Letrozole Tablets, USP are available containing 2.5 mg of letrozole, USP. The 2.5 mg tablets are pink film-coated, round tablets debossed with M on one side of the tablet and L71 on the other side. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

LETROZOLE - LETROZOLE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LETROZOLE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LETROZOLE TABLETS. LETROZOLE TABLETS, USP
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Adjuvant Treatment of Early Breast Cancer (1.1, 2.2) 04/2010
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 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 MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2011
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Adjuvant Tre