LEPTICA CAPSULES 150MG

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

Pregabalin

Fáanlegur frá:

GLORIOUS DEXA SINGAPORE PTE. LTD.

ATC númer:

N03AX16

Lyfjaform:

CAPSULE

Samsetning:

Pregabalin 150 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

Prescription Only

Framleitt af:

PT. Dexa Medica

Leyfisstaða:

ACTIVE

Leyfisdagur:

2021-01-05

Vara einkenni

67795-02XX-YY
Last revised: dd/mm/yyyy
LEPTICA
Capsule
COMPOSITIONS:
LEPTICA 75 MG
Each capsule contains
Pregabalin 75 mg
LEPTICA 150 MG
Each capsule contains
Pregabalin 150 mg
LIST OF EXCIPIENTS:
LEPTICA 75 MG
Spray dried lactose DCL 11, corn starch, talc, capsule shells Leptica
75 mg size 3 (cap
scarlet and body white).
LEPTICA 150 MG
Spray dried lactose DCL 11, corn starch, talc, capsule shells Leptica
150 mg size 2
(body and cap white op. (44.700))
PRODUCT DESCRIPTIONS:
LEPTICA 75 MG
Hard gelatin capsule, cap scarlet, body white, contain white
crystalline powder. Cap
printed DXM logo in black, body unmark.
LEPTICA 150 MG
Hard gelatin capsule, body and cap white op. (44.700), contain white
crystalline powder.
Cap printed DXM logo in black, body unmark.
PHARMACODYNAMICS:
ATC CODE: N03AX16
Mechanism of action
Pregabalin binds to an auxiliary subunit (
α
2-
δ
protein) of voltage-gated calcium
channels in the central nervous system.
Evidence from animal models with nerve damage has shown that
pregabalin reduces
calcium dependent release of pronociceptive neurotransmitters in the
spinal cord
possibly by disrupting calcium trafficking and/or reducing calcium
currents. Evidence
from other animal models of nerve damage suggests the antinociceptive
activities of
pregabalin
may
also
be
mediated
through
interactions
with
the
descending
noradrenergic and serotonergic pathways.
Clinical experience
_Neuropathic pain_
Efficacy has been shown in studies in diabetic neuropathy and
postherpetic neuralgia.
Efficacy has not been studied in other models of neuropathic pain.
Pregabalin has been
studied in 9 controlled clinical studies of up to 13 weeks with twice
a day dosing and up
to 8 weeks with three times a day dosing. Overall, the safety and
efficacy profiles for
twice a day and three times a day dosing regimens were similar.
In clinical trials up to 13 weeks, a reduction in pain was seen by
week 1 and was
maintained throughout the treatment period. In controlled clinical
trials, 35% of the
pregabalin treated patients and 1