KAMAGRA 50MG TABLETS

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

SILDENAFIL CITRATE

Available from:

Gopharma Sdn. Bhd.

INN (International Name):

SILDENAFIL CITRATE

Units in package:

4Tablet Tablets

Manufactured by:

Ajanta Pharma Limited

Summary of Product characteristics

KAMAGRA 50 & 100MG TABLETS
SILDENAFIL CITRATE TABLETS
COMPOSITION:
Each film coated tablet contains:
Sildenafil citrate equivalent to Sildenafil….50/100 mg
THERAPEUTICAL CODE:
G04BE03
DOSAGE FORM:
Film Coated Tablets
PRODUCT DESCRIPTION
Green coloured diamond shaped film coated tablet engraved with
‘ap’ logo on one side and ‘KGR 50
/ KGR 100’ on the other side.
MECHANISM OF ACTION:
Kamagra
i.e.
sildenafil
citrate
is
a
new
potential
oral
therapy
for
the
treatment
of
erectile
dysfunction. It is a selective inhibitor of phosphodiesterase-5 and
classified as a vasodilator-
peripheral.
PDE-5 is an enzyme found mainly in the corpus cavernosum. Sildenafil
is a selective inhibitor of
cGMP specific phosphodiesterase-5 i.e. PDE5.The physiologic mechanism
of erection of the penis
involves release of nitric oxide (NO) in the corpus cavernosum during
sexual stimulation. NO then
activates the enzyme guanylate cyclase, which results in increased
levels of cyclic guanosine
monophosphate
(cGMP),
producing
smooth
muscle
relaxation
in
the
corpus
cavernosum
and
allowing inflow of blood. Thus sexual stimulation causes local release
of NO, inhibition of PDE5 by
sildenafil causes increase level of cGMP in the corpus cavernosum
resulting in smooth muscle
relaxation and inflow of blood to the corpus cavernosum. Sildenafil at
recommended dose has no
effect in the absence of sexual stimulation.
PHARMACOKINETICS:
Absorption: Sildenafil tablet undergoes rapid absorption after rapid
oral administration. Maximum
observed plasma concentrations are reached within 30 to 120 minutes
(median 60 minutes) of oral
dosing in the fasted state. When Sildenafil is taken with a high fat
meal, the rate of absorption is
reduced, with a mean delay in Tmax of 60 minutes and a mean reduction
in Cmax of 29%.
Distribution:
The
mean
state
volume
of
distribution
(Vss)
for
sildenafil
is
105L,
indicating
distribution into the tissues. Sildenafil and its major circulating N-
desmethyl metabolite are both
approximately
96%
bound
to
plasma
proteins.
Protein
bi