EXEMESTANE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

EXEMESTANE (UNII: NY22HMQ4BX) (EXEMESTANE - UNII:NY22HMQ4BX)

זמין מ:

Zydus Lifesciences Limited

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Exemestane tablets are indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14.1)]. Exemestane tablets are indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14.2) ]. Exemestane tablets are contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients. Risk Summary Based on findings in animal studies and its mechanism of action, exemetane can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . Limited human data from case reports are insufficient to inform a drug-associated risk. In animal reproduction studies, administration of exemestane to pregnant rats and rabbits caused increased

leaflet_short:

Exemestane Tablets, 25 mg are white to off-white, round-shaped, film-coated tablets debossed with '383' on one side and plain on other side and are supplied as follows: NDC 70771-1374-3 in bottle of 30 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

עלון מידע

EXEMESTANE- EXEMESTANE TABLET
Cadila Healthcare Limited
----------
FDA- Approved Patient Labeling
Patient Information
Exemestane (EX-e-MES-tane) Tablets
1 What are exemestane tablets?
Exemestane tablets are used in women who are past menopause for the
treatment of:
•
Early breast cancer (cancer that has not spread outside the breast) in
women who:
•
have cancer that needs the female hormone estrogen to grow and
•
have had other treatments for breast cancer and
•
have taken tamoxifen for 2 to 3 years and
•
are switching to exemestane to complete 5 years in a row of hormonal
therapy.
•
Advanced breast cancer (cancer that has spread), after treatment with
tamoxifen and it did not work
or is no longer working.
It is not known if exemestane tablets are safe and effective in
children.
2 Who should not take exemestane tablets?
Do not take exemestane tablets if: you are allergic to exemestane or
any of the ingredients in exemestane
tablets. See end of this leaflet for complete list of ingredients in
exemestane tablets.
Before you take exemestane tablets, tell your doctor about all your
medical conditions including if you:
•
are still having menstrual periods (are not past menopause).
Exemestane is only for women who are
past menopause.
•
Have liver or kidney problems.
•
have weak or brittle bones (osteoporosis)
•
are pregnant or plan to become pregnant. Taking exemestane during
pregnancy or within 1 month of
becoming pregnant can harm your unborn baby.
•
Females who are able to become pregnant should have a pregnancy test
within 7 days before starting
treatment with exemestane.
•
Females who are able to become pregnant should use effective birth
control (contraceptive) during
treatment with exemestane and for 1 month after your last dose of
exemestane. Tell your doctor right
away if you become pregnant or think you may be pregnant.
•
are breastfeeding or plan to breastfeed. It is not known if exemestane
passes into your breast milk. Do
not breast-feed during treatment with exemestane and for 1 m

מאפייני מוצר

EXEMESTANE - EXEMESTANE TABLET
ZYDUS LIFESCIENCES LIMITED
----------
EXEMESTANE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1374-3 in bottle of 30 tablets
Exemestane Tablets, 25 mg
R only
30 tablets
EXEMESTANE
exemestane tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1374
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
EXEMESTANE (UNII: NY22HMQ4BX) (EXEMESTANE - UNII:NY22HMQ4BX)
EXEMESTANE
25 mg
x
Zydus Lifesciences Limited
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
6mm
FLAVOR
IMPRINT CODE
383
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1374-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
10/08/2018
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA202602
10/08/2018
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (863362789)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
863362789
ANALYSIS(70771-1374) , MANUFACTURE(70771-1374)
Revised: 8/2022