Држава: Индонезија
Језик: Индонежански
Извор: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 10 BLISTER @ 10 KAPSUL
2022-06-03
Generic Name: Gabapentin Trade Name: Neurontin CDS Effective Date: April 17, 2020 Supersedes: March 16, 2017 Approved by BPOM: 2019-0057090 Page 1 of 17 PT PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Gabapentin Trade Name: Neurontin_ _ CDS Effective Date: April 17, 2020 Supersedes: March 16, 2017 TRADE NAME(S) OF THE MEDICINAL PRODUCT NEURONTIN QUALITATIVE AND QUANTITATIVE COMPOSITION (ACTIVE INGREDIENTS) Gabapentin is supplied in capsules containing, 300 mg, of active drug substance for oral administration. Gabapentin is a white to off-white crystalline solid. It is freely soluble in water and both basic and acidic aqueous solutions. LIST OF EXCIPIENTS Each capsule also contains lactose, cornstarch, and talc. PHARMACEUTICAL FORM Capsules CLINICAL PARTICULARS THERAPEUTIC INDICATIONS EPILEPSY 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 POSOLOGY AND METHOD OF ADMINISTRATION: _Pediatric Patients Aged 3 to 12 Years_)._ _ NEUROPATHIC PAIN Gabapentin is indicated for the treatment of neuropathic pain in adults aged 18 years and older. Safety and effectiveness in patients younger than 18 years have not been established. DISETUJUI OLEH BPOM: 18/02/2021 EREG10024112000513 Generic Name: Gabapentin Trade Name: Neurontin CDS Effective Date: April 17, 2020 Supersedes: March 16, 2017 Approved by BPOM: 2019-0057090 Page 2 of 17 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 _Adults and Pediatric Patients Older Than 12 Years of Age _ In clinical trials, the effective dosing range was 900 mg/day to 1800 mg/day. Therapy Прочитајте комплетан документ