APO-GABAPENTIN gabapentin 800mg tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gabapentin, Quantity: 800 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Gabapentin

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: copovidone; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; hyprolose

Administration route:

Oral

Units in package:

500 tablets, 100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Gabapentin 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. Gabapentin is indicated for the treatment of neuropathic pain.

Product summary:

Visual Identification: White, oval biconvex tablets. Engraved "GAB" over partial bisect, "800" on one side, "APO" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2007-09-06

Summary of Product characteristics

1
AUSTRALIAN PI – APO-GABAPENTIN (GABAPENTIN)
1
NAME OF THE MEDICINE
Gabapentin.
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Gabapentin is a white to off-white crystalline solid. It is freely
soluble in water and in both
basic and acidic aqueous solutions.
Each tablet contains 600mg or 800mg gabapentin, as the active
ingredient.
In addition each tablet also contains the following inactive
ingredients: copovidone,
magnesium stearate and Opadry complete film coating system 20F180004
White.
Opadry complete film coating system 20F180004 White contains the
following inactive
ingredients: hypromellose, hyprolose, Macrogol 8000 and titanium
dioxide.
600 MG TABLETS:
White, oval biconvex tablets. Engraved “GAB” over partial bisect
“600” on one side, “APO”
on the other side.
800 MG TABLETS
White, oval biconvex tablets. Engraved “GAB” over partial bisect
“800” on one side, “APO”
on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

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 antiepileptic
drugs.

The treatment of neuropathic pain.
4.2
DOSE AND METHOD OF ADMINISTRATION
EPILEPSY
Dosage for Adults and Children Over 12 Years of Age
Initiation of treatment should be as add-on therapy. Gabapentin can be
given orally with or
without food.
In controlled clinical trials, the effective dose range was 900 to
1800mg/day given in
divided doses (three times a day).
Gabapentin therapy may be initiated by administering 300mg three times
a day on Day 1
(as 300mg capsules or half 600mg tablets) or by titrating the dose as
described below.
Titration to an effective dose can take place rapidly, over a few
days, giving 300mg on
Day 1, 300mg twice a day on Day 2, 300mg three times a day on Day 3
(using 300mg
capsule or half 600mg tablets). Titration may be preferable for
patients with renal
impairm