GABAPENTIN MLPL gabapentin 400 mg capsule blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

gabapentin, Quantity: 400 mg

Disponível em:

Micro Labs Pty Ltd

DCI (Denominação Comum Internacional):

Gabapentin

Forma farmacêutica:

Capsule, hard

Composição:

Excipient Ingredients: purified talc; maize starch; titanium dioxide; purified water; iron oxide yellow; iron oxide red; Gelatin; sodium lauryl sulfate

Via de administração:

Oral

Unidades em pacote:

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

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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.

Resumo do produto:

Visual Identification: Orange-Orange colour size '0' 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

Status de autorização:

Licence status A

Data de autorização:

2017-04-28

Características técnicas

AUSTRALIAN PRODUCT INFORMATION – GABAPENTIN MLPL
(GABAPENTIN)
1. NAME OF THE MEDICINE
Gabapentin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Gabapentin MLPL 100 mg capsules contains 100 mg, of gabapentin.
Gabapentin MLPL 300 mg capsules contains 300 mg, of gabapentin
Gabapentin MLPL 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 MLPL
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 MLPL
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 MLPL on Day 1, 300 mg Gabapentin MLPL twice a day on Day 2,
300 mg
Gabapentin MLPL three times a day on Day 3, as 300 mg capsules.
Titration may be
preferable for patients with renal impairment, patients with
encephalopathy, patients on more
th