REGADEX CAPSULE 25MG

DEXCEL LTD. (ISRAEL)🇸🇬 Health Sciences Authority

Approval Date: Aug 14, 2019
Approval ID: 58d64e65518742f1
Company: DEXCEL LTD. (ISRAEL)
Type: Therapeutic

Approval Details

Approval Id: 58d64e65518742f1
Drug Name: REGADEX CAPSULE 25MG
Product Name: REGADEX CAPSULE 25MG
Approval Number: SIN15775P
Approval Date: 2019-08-14
Registrant: APEX PHARMA MARKETING PTE. LTD.
Licence Holder: APEX PHARMA MARKETING PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: CAPSULE
Dosage: 4.2 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. Generalised 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) (see Section 5.2 Pharmacokinetic properties, Pharmacokinetics in special patient groups, Renal impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), as indicated in Table 1 determined using the following formula: <img src="/TGIF/Regadex-Formula1.png" alt="Regadex Dosage Formula 1" /> For patients receiving haemodialysis, 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 haemodialysis treatment (see Table 1). <img src="/TGIF/Regadex-Table1_250722.png" alt="Regadex Dosage Table 1" /> Use in patients with hepatic impairment No dosage adjustment is required for patients with hepatic impairment (see Section 5.2 Pharmacokinetic properties, Pharmacokinetics in special patient groups, Hepatic impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Use in children and adolescents (12 to 17 years of age) The safety and effectiveness of pregabalin in paediatric patients below the age of 12 years and adolescents have not been established. The use in children and adolescents is not recommended (see Section 5.3 Preclinical safety data – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Use in the elderly (over 65 years of age) Elderly patients may require a dose reduction of pregabalin due to decreased renal function (see Section 5.2 Pharmacokinetic properties, Pharmacokinetics in special patient groups, Elderly (over 65 years of age) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: ORAL
Indication Info: 4.1 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. Generalised anxiety disorder Pregabalin is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. Fibromyalgia Pregabalin is indicated for the management of fibromyalgia.
Contraindications: 4.3 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: APEX PHARMA MARKETING PTE. LTD.

Active Ingredients

PREGABALIN

25 mg

PREGABALIN

25 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Aug 14, 2019

Approval ID

58d64e65518742f1

Type

Therapeutic

Back to HSA Approvals