GABACOR Capsule, hard Ref.[50338] Active ingredients: Gabapentin

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2021  Publisher: Pharmacor Pty Ltd., Suite 803, Level 8, Tower A, The Zenith, 821 Pacific Highway, Chatswood, NSW, 2067, Australia, www.pharmacor.com.au

Product name and form

GABACOR – Gabapentin.

Pharmaceutical Form

Capsules, hard.

GABACOR 100 mg capsules: Size “4” white hard gelatin capsule imprinted “216” on body with blue ink.

GABACOR 300 mg capsules: Size “1” yellow hard gelatin capsule imprinted “215” on body with blue ink.

GABACOR 400 mg capsules: Size “0” orange hard gelatin capsule imprinted “214” on body with blue ink.

Qualitative and quantitative composition

GABACOR contains the active ingredient gabapentin.

GABACOR 100 mg capsules: Each capsule contains gabapentin 100 mg.

GABACOR 300 mg capsules: Each capsule contains gabapentin 300 mg.

GABACOR 400 mg capsules: Each capsule contains gabapentin 400 mg.

Excipient with known effect: lactose.

For the full list of excipients, see section 6.1 – LIST OF EXCIPIENTS.

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

Chemical structure

Chemical name: 1-(aminomethyl) cyclohexaneacetic acid
Molecular formula: C9H17NO2
Molecular weight: 171.24
CAS Registry Number: 60142-96-3.

Active Ingredient Description
Gabapentin

Gabapentin readily enters the brain and prevents seizures in a number of animal models of epilepsy. Gabapentin binds with high affinity to the α2δ (alpha-2-delta) subunit of voltage-gated calcium channels and it is proposed that binding to the α2δ subunit may be involved in gabapentin’s anti-seizure effects in animals.
List of Excipients

GABACOR capsules also contain the following inactive ingredients:

  • maize starch,
  • lactose,
  • Purified talc,
  • gelatin,
  • sodium lauryl sulfate,
  • titanium dioxide,

The 300 mg capsule also contains iron oxide yellow and the 400 mg capsule also contains iron oxide yellow and iron oxide red.

Pack sizes and marketing

GABACOR 100 mg capsules are available in blister packs of 100 capsules.
GABACOR 300 mg capsules are available in blister packs of 4, 20 & 100 capsules.
GABACOR 400 mg capsules are available in blister packs of 100 capsules.

Marketing authorization holder

Pharmacor Pty Ltd., Suite 803, Level 8, Tower A, The Zenith, 821 Pacific Highway, Chatswood, NSW, 2067, Australia, www.pharmacor.com.au

Marketing authorization dates and numbers

06/02/2014

Drugs

Drug Countries
GABACOR Australia, South Africa
 
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