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:

Bryant Ranch Prepack

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 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 

leaflet_short:

Letrozole Tablets, USP 2.5 mg tablets – yellow round, biconvex, film coated tablets imprinted with 'LT' on one side and plain on other side. NDC: 63629-7819-4: 40 Tablets in a BOTTLE NDC: 63629-7819-1: 30 Tablets in a BOTTLE NDC: 63629-7819-2: 10 Tablets in a BOTTLE NDC: 63629-7819-3: 90 Tablets in a BOTTLE Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

LETROZOLE- LETROZOLE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
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
Letrozole tablet 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
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 ( 6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ACCORD HEALTHCARE INC.
AT 1-866-941-
7875 OR FDA AT 1-800-FDA-10