দেশ: সিঙ্গাপুর
ভাষা: ইংরেজি
সূত্র: HSA (Health Sciences Authority)
Gabapentin
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
N03AX12
CAPSULE
Gabapentin 300 mg
ORAL
Prescription Only
PT Actavis Indonesia
ACTIVE
2023-02-15
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 সম্পূর্ণ নথি পড়ুন