AROMASIN

Pays: Indonésie

Langue: indonésien

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingrédients actifs:

EXEMESTANE

Disponible depuis:

PFIZER INDONESIA - Indonesia

DCI (Dénomination commune internationale):

EXEMESTANE

Dosage:

25 MG

forme pharmaceutique:

TABLET SALUT GULA

Unités en paquet:

DUS, 2 BLISTER @ 15 TABLET SALUT GULA

Fabriqué par:

PFIZER ITALIA S.R.L - Italy

Date de l'autorisation:

2021-05-26

Résumé des caractéristiques du produit

Generic Name: Exemestane tablets
Trade Name: Aromasin
CDS Effective Date: June 03, 2021
Supersedes: September 07, 2017
Approved by BPOM:
2021-0068641, 2021-0068642
Page 1 of 10
PT. PFIZER INDONESIA
Local Product Document
Generic Name: Exemestane tablets
Trade Name: Aromasin
®
CDS Effective Date: June 03, 2021
Supersedes: September 07, 2017
DESCRIPTION
Aromasin

tablets for oral administration contain 25 mg of exemestane, in
irreversible, steroidal
aromatase
inactivator.
Exemestane
is
chemically
described
as
6-methylenandrosta-1,4-diene-3,17-dione. Its molecular formula is C
20
H
24
O
2
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.
CLINICAL PARTICULARS
THERAPEUTIC INDICATION
Exemestane is indicated for the treatment of advanced breast cancer in
women with natural or
induced post-menopausal status whose disease has progressed following
anti-oestrogen therapy.
Patient selection should be based on positive oestrogen and/or
progesterone receptor status,
because efficacy has not been demonstrated when it is absent.
Exemestane
is
indicated
for
the
adjuvant
treatment
of
post-menopausal
women
with
estrogen-receptor positive early breast cancer, following 2-3 years of
initial adjuvant tamoxifen
therapy.
POSOLOGY AND METHOD OF ADMINISTRATION
Adult and Elderly Patients
The recommended dose of exemestane is one 25 mg tablet to be taken
once daily, preferably
after a meal.
In patients with advanced breast cancer, treatment with exemestane
should continue until tumor
progression is evident.
In patients with early breast cancer, treatment with exemestane should
continue until completion
of five years of adjuvant endocrine therapy, or until local or distant
recurrence or new
contralateral breast cancer.
Hepatic or Renal Insufficiency
No dose adjustments are required for patients with hepatic or renal
insufficiency.
C