PROSCAR 5 mg Tablet

দেশ: দক্ষিণ আফ্রিকা

ভাষা: ইংরেজি

সূত্র: South African Health Products Regulatory Authority (SAHPRA)

থেকে পাওয়া:

MSD (PTY) LTD

ফার্মাসিউটিকাল ফর্ম:

Tablet

রচনা:

Each tablet contains FINASTERIDE 5 mg

অনুমোদন তারিখ:

1994-05-10

তথ্য লিফলেট

PRODUCT NAME: PROSCAR TABLETS
CURRENT APPROVED PROFESSIONAL INFORMATION
SR-PIN: 31 OCTOBER 2018
AJ20181031(0)
Page 1 of 11
SCHEDULING STATUS
PROPRIETARY NAME AND DOSAGE FORM
PROSCAR
®
5 mg Tablet
COMPOSITION
Each PROSCAR 5 mg Tablet contains 5 mg finasteride.
PROSCAR Tablets contain sugar.
PHARMACOLOGICAL CLASSIFICATION
A.21.12 Hormone inhibitors
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Finasteride, a synthetic 4-azasteroid compound, is an inhibitor of
Type II 5-alpha reductase, an
intracellular enzyme which metabolises testosterone into the more
potent androgen
dihydrotestosterone (DHT).
In benign prostatic hyperplasia (BPH), enlargement of the prostate
gland is dependent upon
the conversion of testosterone to DHT within the prostate. Finasteride
reduces circulating and
intraprostatic DHT. Finasteride has no affinity for the androgen
receptor.
PHARMACOKINETIC PROPERTIES
S4
PRODUCT NAME: PROSCAR TABLETS
CURRENT APPROVED PROFESSIONAL INFORMATION
SR-PIN: 31 OCTOBER 2018
AJ20181031(0)
Page 2 of 11
Following an oral dose of
14
C-finasteride in man, 39 % of the dose was excreted in the urine
in the form of metabolites (virtually no unchanged drug was excreted
in the urine) and 57 %
of the total dose was excreted in the faeces. Two metabolites of
finasteride have been
identified which possess only a small fraction of the 5-alpha
reductase inhibitory activity of
finasteride.
Relative to an intravenous reference dose, the oral bioavailability of
finasteride is
approximately 80 %. The bioavailability is not affected by food.
Maximum finasteride plasma
concentrations are reached approximately 2 hours after dosing and the
absorption is
complete after 6 to 8 hours. Finasteride displays a mean plasma
elimination half-life of
approximately 6 hours (4 to 12 hours) in subjects 46 to 60 years of
age and approximately 8
hours in men 70 years of age and older. Protein binding is
approximately 93 %. Plasma
clearance and the volume of distribution of finasteride are
approximately 165 ml/min and 76
litres, respectively.
SUMM

পণ্য বৈশিষ্ট্য

PRODUCT NAME: PROSCAR TABLETS
CURRENT APPROVED PROFESSIONAL INFORMATION
SR-PIN: 31 OCTOBER 2018
AJ20181031(0)
Page 1 of 11
SCHEDULING STATUS
PROPRIETARY NAME AND DOSAGE FORM
PROSCAR
®
5 mg Tablet
COMPOSITION
Each PROSCAR 5 mg Tablet contains 5 mg finasteride.
PROSCAR Tablets contain sugar.
PHARMACOLOGICAL CLASSIFICATION
A.21.12 Hormone inhibitors
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Finasteride, a synthetic 4-azasteroid compound, is an inhibitor of
Type II 5-alpha reductase, an
intracellular enzyme which metabolises testosterone into the more
potent androgen
dihydrotestosterone (DHT).
In benign prostatic hyperplasia (BPH), enlargement of the prostate
gland is dependent upon
the conversion of testosterone to DHT within the prostate. Finasteride
reduces circulating and
intraprostatic DHT. Finasteride has no affinity for the androgen
receptor.
PHARMACOKINETIC PROPERTIES
S4
PRODUCT NAME: PROSCAR TABLETS
CURRENT APPROVED PROFESSIONAL INFORMATION
SR-PIN: 31 OCTOBER 2018
AJ20181031(0)
Page 2 of 11
Following an oral dose of
14
C-finasteride in man, 39 % of the dose was excreted in the urine
in the form of metabolites (virtually no unchanged drug was excreted
in the urine) and 57 %
of the total dose was excreted in the faeces. Two metabolites of
finasteride have been
identified which possess only a small fraction of the 5-alpha
reductase inhibitory activity of
finasteride.
Relative to an intravenous reference dose, the oral bioavailability of
finasteride is
approximately 80 %. The bioavailability is not affected by food.
Maximum finasteride plasma
concentrations are reached approximately 2 hours after dosing and the
absorption is
complete after 6 to 8 hours. Finasteride displays a mean plasma
elimination half-life of
approximately 6 hours (4 to 12 hours) in subjects 46 to 60 years of
age and approximately 8
hours in men 70 years of age and older. Protein binding is
approximately 93 %. Plasma
clearance and the volume of distribution of finasteride are
approximately 165 ml/min and 76
litres, respectively.
SUMM