LETROZOLE tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Chartwell RX, LLC

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Letrozole Tablets, USP are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Letrozole Tablets, USP 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 for a median of 60 months [ see Clinical Studies ( 14.2 , 14.3 ) ]. Letrozole Tablets, USP are indicated for first-line treatment of postmenopausal women with hormone receptor 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 fol

Ապրանքի ամփոփագիր:

Packaged in HDPE bottles with a safety screw cap. Letrozole Tablets, USP 2.5 mg Bottles of 30 tablets................................................NDC 62135-491-30 Bottles of 90 tablets................................................NDC 62135-491-90 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

LETROZOLE- LETROZOLE TABLET, FILM COATED
CHARTWELL RX, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
LETROZOLE TABLETS
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 Tablets, USP are 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
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
ADVERSE REACTIONS
The most common adverse reactions (greater than 20%) were hot flashes,
arthralgia; flushing, asthenia, edema, arthralgia, headache,
dizziness, hypercholesterolemia, sweat