GABAPENTIN MLABS gabapentin 100 mg capsule blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

gabapentin, Quantity: 100 mg

Disponible depuis:

Micro Labs Pty Ltd

DCI (Dénomination commune internationale):

Gabapentin

forme pharmaceutique:

Capsule, hard

Composition:

Excipient Ingredients: maize starch; purified talc; titanium dioxide; purified water; Gelatin; sodium lauryl sulfate

Mode d'administration:

Oral

Unités en paquet:

PVC/ PVDC-Aluminium blister pack of 100 capsules (10x10C in carton)

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

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.

Descriptif du produit:

Visual Identification: White-White colour size'3' hard gelatin capsule contains free flowing white crystalline powder.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statut de autorisation:

Licence status A

Date de l'autorisation:

2017-04-28

Résumé des caractéristiques du produit

AUSTRALIAN PRODUCT INFORMATION – GABAPENTIN MLABS
(GABAPENTIN)
1. NAME OF THE MEDICINE
Gabapentin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Gabapentin MLabs 100 mg capsules contains 100 mg, of gabapentin.
Gabapentin MLabs 300 mg capsules contains 300 mg, of gabapentin
Gabapentin MLabs 400 mg capsules contains 400 mg, of gabapentin
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
GABAPENTIN CAPSULES, 100MG:
Size ‘3’ hard gelatin capsule with white body and white cap,
containing 100 mg of gabapentin.
GABAPENTIN CAPSULES, 300MG:
Size ‘1’ hard gelatin capsule with yellow body and yellow
cap, containing 300 mg of gabapentin.
GABAPENTIN CAPSULES, 400MG:
Size ‘0’ hard gelatin capsule with orange body and orange
cap, containing 400 mg of gabapentin.
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
DOSAGE
_EPILEPSY DOSAGE FOR ADULTS AND CHILDREN OLDER THAN 12 YEARS OF AGE _
Initiation of treatment should be as add-on therapy. Gabapentin MLabs
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 Gabapentin MLabs
three times a day on
Day 1, as 300 mg capsules, or by titrating the dose as described
below.
Titration to an effective dose can take place rapidly, over a few
days, giving 300 mg
Gabapentin MLabs on Day 1, 300 mg Gabapentin MLabs twice a day on Day
2, 300 mg
Gabapentin MLabs three times a day on Day 3, as 300 mg capsules.
Titration may be
preferable for patients with renal impairment, patients with
encephalopathy, patients o