PREGAREDI CAPSULE 150 MG

DR REDDY&#x27S LABORATORIES LIMITED - FORMULATIONS TECH OPERATIONSS II (INDIA)🇸🇬 Health Sciences Authority

Approval Date: Apr 18, 2023
Approval ID: 2bbd27847de6a735
Company: DR REDDY&#x27S LABORATORIES LIMITED - FORMULATIONS TECH OPERATIONSS II (INDIA)
Type: Therapeutic

Approval Details

Approval Id: 2bbd27847de6a735
Drug Name: PREGAREDI CAPSULE 150 MG
Product Name: PREGAREDI CAPSULE 150 MG
Approval Number: SIN16761P
Approval Date: 2023-04-18
Registrant: ZYFAS PHARMA PTE LTD
Licence Holder: ZYFAS PHARMA PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
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. 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) as indicated in Table 1 determined using the following formula: <img src="/TGIF/Pregaredi-Formula1_090525.png" alt="Pregaredi 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/Pregaredi-Table1_090525.png" alt="Pregaredi Dosage 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 paediatric 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: 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: ZYFAS PHARMA PTE. LTD.
Company Detail Path: /organization/zyfas-pharma-pte-ltd

Active Ingredients

Pregabalin

150mg

PREGABALIN

150 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Apr 18, 2023

Approval ID

2bbd27847de6a735

Type

Therapeutic

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