DUODART

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE

Tersedia dari:

GLAXO WELLCOME INDONESIA - Indonesia

INN (Nama Internasional):

DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE

Dosis:

0.5 MG /0.4 MG

Bentuk farmasi:

KAPSUL

Unit dalam paket:

DUS, BOTOL @ 30 KAPSUL

Diproduksi oleh:

CATALENT GERMANY SCHORNDORF GMBH - Federal Republic of Germany

Tanggal Otorisasi:

2021-10-13

Karakteristik produk

_Page 1 of 15 _
DUODART

DUTASTERIDE-TAMSULOSIN HYDROCHLORIDE
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule for oral use contains 0.5 mg dutasteride and 0.4 mg
tamsulosin hydrochloride (_see List _
_of Excipients_).
_ _
2.
PHARMACEUTICAL FORM
Capsules: oblong hard-shell capsules with a brown body and an orange
cap with GS 7CZ printed on in
black ink.
_ _
3.
CLINICAL PARTICULARS
3.1 INDICATIONS
_DUODART_
is indicated for
the
treatment of moderate to severe symptomatic benign prostatic
hyperplasia (BPH) in men with enlarged prostate.
3.2 DOSAGE AND ADMINISTRATION
ADULT MALES (INCLUDING ELDERLY)
The recommended dose of _DUODART _is one capsule (0.5 mg/ 0.4 mg)
taken orally approximately 30
minutes after the same meal each day. Capsules should be swallowed
whole and not chewed or
opened. Contact with the contents of the dutasteride capsule contained
within the hard-shell capsule
may result in irritation of the oropharyngeal mucosa.
RENAL IMPAIRMENT
The effect of renal impairment on dutasteride-tamsulosin
pharmacokinetics has not been studied.
However,
no
adjustment
in
dosage
is
anticipated
for
patients
with
renal
impairment
(_see _
_Pharmacokinetics_).
HEPATIC IMPAIRMENT
The effect of hepatic impairment on dutasteride-tamsulosin
pharmacokinetics has not been studied
(_see Warnings and Precautions and Pharmacokinetics_). In patients
with severe hepatic impairment,
the use of _DUODART_ is contraindicated.
3.3 CONTRAINDICATIONS
_DUODART_ is contraindicated in :
-
patients with known hypersensitivity to dutasteride, other 5
-alpha-reductase inhibitors, tamsulosin
hydrochloride or any component of the preparation (_see List of
Excipients_)
-
women and children and adolescent
-
patients with severe hepatic impairment
-
patient with a history of orthostatic hypotension
3.4 WARNINGS AND PRECAUTIONS
Dutasteride is absorbed through the skin, therefore women and children
must avoid contact with
leaking capsules (_see Pregnancy and Lactation_). If contact is made
with leaking capsules the contact
area should be was