Ranbaxy-Gabapentin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Gabapentin 600mg

Available from:

Douglas Pharmaceuticals Limited

INN (International Name):

Gabapentin 600 mg

Dosage:

600 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Gabapentin 600mg Excipient: Crospovidone Hyprolose Magnesium stearate Mannitol Opacode black S-1-17734 Opadry clear 20A59015 Poloxamer 407 Purified talc Purified water  

Units in package:

Blister pack, PVC blister pack with Alu foil backing, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sun Pharmaceutical Industries Ltd

Therapeutic indications:

Indicated for the treatment of partial seizures with or without secondarily generalised tonic-clonic seizures, in adults and children age three years and above who have not achieved adequate control with standard anti-epileptic medicines.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC blister pack with Alu foil backing - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC blister pack with Alu foil backing - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC blister pack with Alu foil backing - 500 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE with neck finish, screw closure, induction seal liner - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE with neck finish, screw closure, induction seal liner - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE with neck finish, screw closure, induction seal liner - 500 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2006-07-06

Summary of Product characteristics

_ _
DATA SHEET 
RANBAXY-GABAPENTIN 
GABAPENTIN CAPSULES 100 MG, 300 MG AND 400 MG 
GABAPENTIN TABLETS 600 MG AND 800 MG 

PRESENTATION 
Gabapentin  _(CAS 60142-96-3) _is described as
1-(aminomethyl)-cyclohexane 
acetic acid with an empirical formula of C9H17NO2 and a molecular
weight of 
171.24. The molecular structure of gabapentin is: 

Gabapentin is a white to off-white crystalline solid. It is freely
soluble in water 
and both basic and acidic aqueous solutions. 

RANBAXY-GABAPENTIN 100 MG CAPSULES: White, opaque coloured body 
and cap, size ‘4’ hard gelatin capsules imprinted with G 100 on
both cap and 
body in black edible ink containing white to off-white crystalline
powder. Each 
capsule contains 100 mg of gabapentin. 
RANBAXY-GABAPENTIN 300 MG CAPSULES: Ivory, opaque coloured body 
and cap, size ‘0’ hard gelatin capsules imprinted with G 300 on
both cap and 
body in black edible ink containing white to off-white crystalline
powder. Each 
capsule contains 300 mg of gabapentin. 
RANBAXY-GABAPENTIN 400 MG CAPSULES: Orange, opaque coloured 
body and cap, size ‘0 el’ hard gelatin capsules imprinted with G
400 on both 
cap and body in black edible ink containing white to off-white
crystalline 
powder. Each capsule contains 400 mg of gabapentin. 
RANBAXY-GABAPENTIN  600 mg tablets: White to off-white, oval
shaped, 
biconvex film coated tablets imprinted with “G600”in black ink on
one side and 
plain on the other. 
RANBAXY-GABAPENTIN  800 mg tablets: White to off-white, oval
shaped, 
biconvex film coated tablets imprinted with “G800”in black ink on
one side and 
plain on the other. 
Do not halve tablets. Dose equivalence when tablets are divided has
not been 
established. 

_ _
USES 
_ACTIONS _
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 severa