- Approval Id
- 0fb2b59e248e2297
- Drug Name
- NEURAN CAPSULE 300MG
- Product Name
- NEURAN CAPSULE 300MG
- Approval Number
- SIN15230P
- Approval Date
- 2017-05-02
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- CAPSULE
- Dosage
- **DOSAGE AND ADMINISTRATION**
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 900mg/day to 1800mg/day. Therapy may be initiated by administering 300mg 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 2400mg/day have been well tolerated in long-term open-label clinical studies. Doses up to 3600mg/day have been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the three times a day schedule should not exceed 12 hours to prevent breakthrough convulsions.
_**Pediatric patients aged 3 to 12 years:**_
The starting dose should range from 10 to 15 mg/kg/day given in equally divided doses (three times a day), and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin in pediatric patients aged 5 years and older is 25 to 35 mg/kg/day given in equally divided doses (three times a day). The effective dose in pediatric patients aged 3 to less than 5 years is 40 mg/kg/day given in equally divided doses (three times a day). Doses up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.
**Neuropathic pain in adults**
The starting dose is 900 mg/day given in three equally divided doses, and increased if necessary, based on response, up to a maximum dose of 3600 mg/day. Therapy should be initiated by titrating the dose (Table 1).
**Dose adjustment in impaired renal function in patients with neuropathic pain or epilepsy**
Dose adjustment is recommended in patients with compromised renal function (Table 2) and/or in those undergoing hemodialysis.
**Dose adjustment in patients undergoing hemodialysis**
For patients undergoing hemodialysis who have never received gabapentin, a loading dose of 300 mg to 400 mg is recommended, and then 200 mg to 300 mg of gabapentin following each 4 hours of hemodialysis.
- Route Of Administration
- ORAL
- Indication Info
- **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 above. Safety and effectiveness for adjunctive therapy in pediatric patients below the age of 3 years have not been established.
**Neuropathic Pain:** Gabapentin is indicated for the treatment of neuropathic pain which includes diabetic neuropathy, post-herpetic neuralgia and trigeminal neuralgia in adults age 18 years and above. Safety and effectiveness in patients below the age of 18 years have not been established.
- Contraindications
- **CONTRAINDICATIONS**
Gabapentin is contraindicated in patients who are hypersensitive to gabapentin or the product’s components.
- Atc Code
- N03AX12
- Atc Item Name
- xn 03 ax 12
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
- Company Detail Path
- /organization/goldplus-universal-pte-ltd
