- Approval Id
- 30f03f84fd155b44
- Drug Name
- EPIBALIN 50 CAPSULES 50MG
- Product Name
- EPIBALIN 50 CAPSULES 50MG
- Approval Number
- SIN15723P
- Approval Date
- 2019-06-21
- Registrant
- SYNERRV (S) PTE. LTD.
- Licence Holder
- SYNERRV (S) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- CAPSULE
- Dosage
- **Posology and method of administration**
The dose range is 150 to 600 mg per day given in either two or three divided doses. Pregabalin may be taken with or without food.
_Neuropathic pain_
Pregabalin treatment can be started at a dose of 150 mg per day. Based on individual patient response and tolerability, the dosage may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.
_Epilepsy_
Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dosage may be increased to 300 mg per day after 1 week. The maximum dosage of 600 mg per day may be achieved after an additional week.
_Generalized anxiety disorder_
The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment should be reassessed regularly. Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dosage may be increased to 300 mg per day after 1 week. Following an additional week the dosage may be increased to 450 mg per day. The maximum dosage of 600 mg per day may be achieved after an additional week.
_Fibromyalgia_
The recommended dose of pregabalin is 300 to 450 mg per day. Dosing should begin at 75 mg two times a day (150 mg per day) and may be increased to 150 mg two times a day (300 mg per day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg per day may be further increased to 225 mg two times a day (450 mg per day). Although pregabalin was also studied at 600 mg per day, there is no evidence that this dose confers additional benefit and that this dose was less tolerated.
In view of the dose-dependent adverse reactions, treatment with doses above 450 mg per day is not recommended.
_Discontinuation of pregabalin_
If pregabalin has to be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication.
Patients with renal impairment
Dosage reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in Table 1 determined using the following formula:
For patients receiving hemodialysis, the pregabalin daily dose should be adjusted based on renal function. In addition to the daily dose, a supplementary dose should be given immediately following every 4 hour hemodialysis treatment (see Table 1).
_Use in patients with hepatic impairment_
No dosage adjustment is required for patients with hepatic impairment.
_Use in children and adolescents (12 to 17 years of age)_
The safety and effectiveness of pregabalin in pediatric patients below the age of 12 years and adolescents have not been established. The use in children and adolescents is not recommended.
_Use in the elderly (over 65 years of age)_
Elderly patients may require a dose reduction of pregabalin due to decreased renal function.
- Route Of Administration
- ORAL
- Indication Info
- **Therapeutic indications**
_Neuropathic pain_
Pregabalin is indicated for the treatment of neuropathic pain which includes diabetic peripheral neuropathy and post-herpetic neuralgia in adults.
_Epilepsy_
Pregabalin is indicated as adjunctive therapy of partial seizures, with or without secondary generalisation, in adults.
_Generalized anxiety disorder_
Pregabalin is indicated for the treatment of Generalized Anxiety Disorder (GAD) in adults.
_Fibromyalgia_
Pregabalin is indicated for the management of fibromyalgia.
- Contraindications
- **Contraindications**
Hypersensitivity to the active substance or to any of the excipients.
- Atc Code
- N03AX16
- Atc Item Name
- xn 03 ax 16
- Pharma Manufacturer Name
- SYNERRV (S) PTE. LTD.
- Company Detail Path
- /organization/synerrv-s-pte-ltd
