ALPENTIN CAPSULE 300MG

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

Gabapentin

Boleh didapati daripada:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Kod ATC:

N03AX12

Borang farmaseutikal:

CAPSULE

Komposisi:

Gabapentin 300 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

PT Actavis Indonesia

Status kebenaran:

ACTIVE

Tarikh kebenaran:

2023-02-15

Ciri produk

1.
NAME OF THE MEDICINAL PRODUCT
ALPENTIN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alpentin 100 mg: Each capsule contains Gabapentin 100 mg
Alpentin 300 mg: Each capsule contains Gabapentin 300 mg.
Gabapentin is a white to off-white crystalline solid. It is freely
soluble in water and both basic
and acidic aqueous solutions.
3.
DESCRIPTION
100mg: Orange-white hard gelatine capsule No. 3, containing white
powder.
300mg: Brownish-yellow/brownish-yellow hard-gelatine capsule, size No.
1, containing white
or off white powder.
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
Ep
Epilepsy
ilepsy
Gabapentin is indicated as adjunctive therapy in the treatment of
partial seizures with and
without secondary generalization in adults and children aged 3 years
and older. Safety and
effectiveness for adjunctive therapy in pediatric patients younger
than 3 years have not been
established (see Section 4.2 – Posology and method of
administration: _Pediatric pati_
_Pediatric patients_
_ents _
_aged 3 to 12 years_
_aged 3 to 12 years_).
).
Ne
Neuropathic pain
uropathic pain
Gabapentin is indicated for the treatment of neuropathic pain which
include diabetic pain,
post-herpetic neuralgia and trigeminal neuralgia. Safety and
effectiveness in patients younger
than 18 years have not been established.
4.2 Posology and method of administration
General
Gabapentin is given orally with or without food.
When in the judgment of the clinician, there is a need for dose
reduction, discontinuation, or
substitution with an alternative medication, this should be done
gradually over a minimum
of 1 week.
Epilepsy
_Adu_
_Adults and pediatric patients old_
_lts and pediatric patients older than 12 years of age_
_er than 12 years of age_
In clinical trials, the effective dosing range was 900 mg/day to 1800
mg/day. Therapy may be
initiated by administering 300 mg three times a day on Day 1, or by
titrating the dose (Table
1). Thereafter, the dose can be increased in three equally divided
doses up to a maximum dose
of 1800 mg/day. Doses up to 2400