NUPENTIN 300 gabapentin 300 mg capsule bottle

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

gabapentin, Quantity: 300 mg

Saadav alates:

Alphapharm Pty Ltd

INN (Rahvusvaheline Nimetus):

Gabapentin

Ravimvorm:

Capsule, hard

Koostis:

Excipient Ingredients: lactose monohydrate; maize starch; purified talc; titanium dioxide; quinoline yellow; allura red AC; potable water; Gelatin; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Manustamisviis:

Oral

Ühikuid pakis:

100 capsules

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

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 antiepileptic drugs.,Gabapentin is indicated for the treatment of neuropathic pain.

Toote kokkuvõte:

Visual Identification: Size 1 capsule with yellow body and yellow cap, 'GP300' printed in black ink on the body and 'G' on the cap.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2004-07-23

Toote omadused

AUSTRALIAN PRODUCT INFORMATION
NUPENTIN
_Gabapentin capsule _
1
NAME OF THE MEDICINE
Gabapentin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gabapentin is a white to off-white crystalline solid. It is freely
soluble in water and both basic and acidic
aqueous solutions.
Each NUPENTIN capsule contains gabapentin 100 mg, 300 mg or 400 mg as
the active ingredient.
NUPENTIN also contains: lactose monohydrate and sulfites (present in
trace amounts).
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
NUPENTIN 100:
Each 100 mg capsule contains gabapentin as the active ingredient,
presented as a size 3
capsule with white body and white cap, “GP100” printed in black
ink on the body and “G” on the cap.
NUPENTIN 300:
Each 300 mg capsule contains gabapentin as the active ingredient,
presented as a
size 1 capsule with yellow body and yellow cap, “GP300” printed in
black ink on the body and “G” on the
cap.
NUPENTIN 400:
Each 400 mg capsule contains gabapentin as the active ingredient,
presented as a
size 0 capsule with orange body and orange cap, “GP400” printed in
black ink on the body and “G” on the
cap.
4
CLINICAL PARTICULARS
4.1
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
EPILEPSY DOSAGE FOR ADULTS AND CHILDREN OLDER THAN 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 mg/day
to 1800 mg/day given in divided
doses (three times a day).
Therapy may be initiated by administering 300 mg of Nupentin three
times a day on Day 1, or by titrating the
dose as described below.
Titration to an ef