AROMASIN- exemestane tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Physicians Total Care, Inc.

INN (International ime):

EXEMESTANE

Sastav:

EXEMESTANE 25 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

AROMASIN is 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 AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy. AROMASIN is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. AROMASIN Tablets are contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients.

Proizvod sažetak:

AROMASIN Tablets are round, biconvex, and off-white to slightly gray. Each tablet contains 25 mg of exemestane. The tablets are printed on one side with the number "7663" in black. AROMASIN is packaged in HDPE bottles with a child-resistant screw cap, supplied in packs of 30 tablets. 30-tablet HDPE bottle          NDC 54868-5261-0 Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature]. Rx only Distributed by Pfizer       Pharmacia & Upjohn Company                  Division of Pfizer Inc., NY, NY    10017

Status autorizacije:

New Drug Application

Svojstava lijeka

AROMASIN - EXEMESTANE TABLET
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
AROMASIN® Tablets for oral administration contain 25 mg of
exemestane, an irreversible, steroidal
aromatase inactivator. Exemestane is chemically described as
6-methylenandrosta-1,4-diene-3,17-dione.
Its molecular formula is C
H O and its structural formula is as follows:
The active ingredient is a white to slightly yellow crystalline powder
with a molecular weight of
296.41. Exemestane is freely soluble in N, N-dimethylformamide,
soluble in methanol, and practically
insoluble in water.
Each AROMASIN Tablet contains the following inactive ingredients:
mannitol, crospovidone,
polysorbate 80, hypromellose, colloidal silicon dioxide,
microcrystalline cellulose, sodium starch
glycolate, magnesium stearate, simethicone, polyethylene glycol 6000,
sucrose, magnesium carbonate,
titanium dioxide, methylparaben, and polyvinyl alcohol.
CLINICAL PHARMACOLOGY
Mechanism of Action
Breast cancer cell growth may be estrogen-dependent. Aromatase is the
principal enzyme that converts
androgens to estrogens both in pre- and postmenopausal women. While
the main source of estrogen
(primarily estradiol) is the ovary in premenopausal women, the
principal source of circulating estrogens
in postmenopausal women is from conversion of adrenal and ovarian
androgens (androstenedione and
testosterone) to estrogens (estrone and estradiol) by the aromatase
enzyme in peripheral tissues.
Estrogen deprivation through aromatase inhibition is an effective and
selective treatment for some
postmenopausal patients with hormone-dependent breast cancer.
Exemestane is an irreversible, steroidal aromatase inactivator,
structurally related to the natural
substrate androstenedione. It acts as a false substrate for the
aromatase enzyme, and is processed to an
intermediate that binds irreversibly to the active site of the enzyme
causing its inactivation, an effect
also known as "suicide inhibition." Exemestane significantly lowers
circulating estrogen concentrations
in postmenopaus