DUTABIT 0.5 SOFT CAPSULES 0.5MG

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

Dutasteride

Dostępny od:

APOTHECA MARKETING PTE LTD

Kod ATC:

G04CB02

Forma farmaceutyczna:

CAPSULE, LIQUID FILLED

Skład:

Dutasteride 0.5mg

Droga podania:

ORAL

Typ recepty:

Prescription Only

Wyprodukowano przez:

AUROBINDO PHARMA LIMITED - UNIT VII

Status autoryzacji:

ACTIVE

Data autoryzacji:

2022-03-22

Charakterystyka produktu

NAME OF THE MEDICINAL PRODUCT:
Dutasteride Soft Capsules 0.5 mg
(TRADE) NAME OF PRODUCT:
DUTABIT 0.5
STRENGTH:
0.5 mg.
PHARMACEUTICAL DOSAGE FORM:
Soft Capsules.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DUTASTERIDE SOFT CAPSULES 0.5 MG: Each Capsule contains Dutasteride
Ph. Eur. 0.5 mg.
PHARMACEUTICAL FORM:
Dull yellow, opaque, oblong shaped, size '6' soft gelatin capsule
containing clear colorless to pale yellow viscous oil.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment and control of benign prostatic hyperplasia (BPH) in men
with an enlarged prostate to improve symptoms, reduce prostate
size, reduce the risk of acute urinary retention, and reduce the need
for BPH-related surgery.
In addition, Dutasteride in combination with the alpha-blocker
tamsulosin is indicated for the treatment of symptomatic BPH in men
with an enlarged prostate.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dutasteride can be administered alone or in combination with the
alpha-blocker tamsulosin (0.4 mg)
_ADULTS (INCLUDING ELDERLY):_
The recommended dose of Dutasteride is one capsule (0.5 mg) taken
orally once a day. The capsules should be swallowed whole
and not chewed or opened as contact with the capsule contents may
result in irritation of the oropharyngeal mucosa. The capsules
may be taken with or without food. Although an improvement may be
observed at an early stage, it can take up to 6 months before
a response to the treatment can be achieved. No dose adjustment is
necessary in the elderly.
_RENAL IMPAIRMENT_
The effect of renal impairment on Dutasteride pharmacokinetics has not
been studied. No adjustment in dosage is anticipated for
patients with renal impairment
_HEPATIC IMPAIRMENT_
The effect of hepatic impairment on dutasteride pharmacokinetics has
not been studied so caution should be used in patients with
mild to moderate hepatic impairment. In patients with severe hepatic
impairment, the use of dutasteride is contraindicated.
CONTRAINDICATIONS
Dutasteride is contraindicated in:
-
Women, children and adolescents.