GABARAN gabapentin 800 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gabapentin

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Gabapentin

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hyprolose; mannitol; crospovidone; purified talc; magnesium stearate; poloxamer; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

50 tablets, 100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

GABARAN is indicated for the maintenance 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. GABARAN is also indicated for the maintenance treatment of neuropathic pain

Product summary:

Visual Identification: White to off-white, oval shaped, biconvex, film-coated tablets imprinted with 'G 800' in black ink on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-05-02

Patient Information leaflet

Gabaran CMI V11 Jan09
Page 1 of 8
GABARAN
®
GABAPENTIN_ _600MG/800MG TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about GABARAN TABLETS
(gabapentin).
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking GABARAN against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING/TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS MEDICINE.
You may need to read it again.
WHAT GABARAN TABLET IS USED FOR
GABARAN contains gabapentin. Gabapentin belongs to a group of
medicines used for treating epilepsy (antiepileptic medicines). These
drugs are thought to work by controlling brain chemicals, which send
signals to nerves so that convulsions do not happen.
Gabapentin also has analgesic effects. It may also be used for
treating neuropathic pain (pain caused by damage to nerves).
Your doctor would have prescribed GABARAN tablets for one or more of
the following:

To treat certain types of epilepsy (partial onset seizures) in
combination with other antiepileptic medicines, when the
condition is not controlled with other anti-epileptic medicines
or there are unacceptable side effects.

To treat neuropathic pain (pain caused by damage to nerves). A
variety of conditions can cause neuropathic pain, e.g.,
shingles, diabetes, trauma.
GABARAN 600 mg and 800 mg tablets will not be used to start your
treatment. Your doctor will give you another brand of gabapentin when
you begin your treatment. You will be given GABARAN tablets once your
daily dose of gabapentin is 1800 mg (one 600 mg tablet three times a
day) or more than 1800 mg.
Your doctor may have prescribed GABARAN tablets for another reason.
Ask your doctor if you have any questions about why GABARAN tablets
have been prescribed for you.
There is no evidence that GABARAN tablets are addictive.
Gabapentin may

Summary of Product characteristics

GABARAN PI V10 JAN 2009
Page 1 of 16
GABARAN 600MG / 800MG TABLETS (GABAPENTIN TABLETS)
NAME OF THE MEDICINE
Gabapentin
_CAS Number_:_ _60142-96-3
DESCRIPTION
GABARAN tablets contain gabapentin, which is chemically designated as
1-(aminomethyl)
cyclohexaneacetic acid, with a molecular formula of C
9
H
17
NO
2
and a molecular weight of
171.24. Gabapentin is a white to off-white crystalline solid with a
pKa
1
of 3.7 and a pKa
2
of
10.7. It is freely soluble in water and both basic and acidic aqueous
solutions. The log of the
partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is
–1.25.
GABAPENTIN
STRUCTURE
GABARAN tablets contain following inactive ingredients:
hydroxypropylcellulose, mannitol,
crospovidone, purified talc, magnesium stearate, poloxamer, Opadry
20A59015, OPACODE S-1-
17823.
PHARMACOLOGY
MECHANISM OF ACTION
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
GABARAN PI V10 JAN 2009
Page 2 of 16
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 rec