Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUTASTERIDE; TAMSULOSIN
GLAXO WELLCOME INDONESIA - Indonesia
DUTASTERIDE; TAMSULOSIN
0,5 MG/0,4 MG
KAPSUL
DUS, BOTOL @ 30 KAPSUL
CATALENT - Germany
2017-01-31
_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 Baca dokumen lengkapnya