NEURONTIN

Country: Индонезија

Језик: Индонежански

Извор: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Активни састојак:

GABAPENTIN

Доступно од:

PFIZER INDONESIA - Indonesia

INN (Међународно име):

GABAPENTIN

Дозирање:

300 MG

Фармацеутски облик:

KAPSUL

Јединице у пакету:

DUS, 10 BLISTER @ 10 KAPSUL

Произведен од:

PFIZER MANUFACTURING DEUTSCHLAND Gmbh - Germany

Датум одобрења:

2018-01-18

Карактеристике производа

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