MIPENTINE gabapentin 600 mg film coated tablets blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

gabapentin, Quantity: 600 mg

Dostępny od:

Micro Labs Pty Ltd

Forma farmaceutyczna:

Tablet, film coated

Skład:

Excipient Ingredients: hyprolose; magnesium stearate; purified talc

Droga podania:

Oral

Sztuk w opakowaniu:

10, 20, 30, 45, 50, 60, 84, 90 or 100 tablets.

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

MIPENTINE is indicated for the treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,MIPENTINE is indicated for the treatment of neuropathic pain.

Podsumowanie produktu:

Visual Identification: White to off white, oval, biconvex, film coated tablets approx.18.00 mm long and 9.20 mm wide, engraved with '600' on one face and plain on the other; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status autoryzacji:

Registered

Data autoryzacji:

2017-12-05

Charakterystyka produktu

PRODUCT INFORMATION
MIPENTINE
600 MG /800 MG TABLETS
NAME OF THE MEDICINE
Mipentine (gabapentin) 600 mg and 800 mg Tablets
Mipentine contains the active ingredient gabapentin. The structural
formula of
gabapentin is shown below:
Chemical name
: 1-(aminomethyl) cyclohexaneacetic acid
Molecular formu1a
: C
9
H
17
NO
2
Molecular weight
: 171.24
CAS Registry Number
: 60142-96-3
DESCRIPTION
Gabapentin is a white to off-white crystalline powder. It is freely
soluble in water and both
basic and acidic aqueous solutions.
It has values for LogP of -1.10, and values for pKa of
3.68 and 10.70.
Mipentine tablets also contain the following inactive ingredients:
hyprolose, magnesium
stearate and Opadry white YS-1-18111 (ARPING No.
3289).
PHARMACOLOGY
PHARMACODYNAMICS
The mechanism by which gabapentin exerts its anticonvulsant action is
unknown.
Gabapentin is structurally related to the neurotransmitter GABA
(gamma-aminobutyric acid)
but its mechanism of action is different from that of several other
drugs that interact with
GABA synapses including valproate, barbiturates, benzodiazepines, GABA
transaminase
inhibitors, GABA uptake inhibitors, GABA agonists, and GABA prodrugs.
_In vitro _
studies
with radiolabelled gabapentin have characterised a novel peptide
binding site in rat brain
tissues including neocortex and hippocampus that may relate to
anticonvulsant activity of
gabapentin and its structural derivatives. However, the identification
and function of the
gabapentin
binding
site
remains
to
be
elucidated.
Gabapentin
at
relevant
clinical
concentrations does not bind to other common drug or neurotransmitter
receptors of the brain
including GABA
A
, GABA
B
, benzodiazepine, glutamate, glycine or
_N_
-methyl-d-aspartate
receptors.
Gabapentin does not interact with sodium channels
_in vitro_
and so differs from phenytoin and
carbamazepine. Several test systems ordinarily used to assess activity
at the NMDA receptor
complex have been examined. Results are contradictory. Accordingly no
general statement
about the effects, if any