PEGASET 25 CAPSULES 25MG

AUROBINDO PHARMA LIMITED - UNIT VII - INDIAAUROBINDO PHARMA LIMITED - UNIT XV (INDIA)🇸🇬 Health Sciences Authority

Approval Date: Dec 16, 2021
Approval ID: c254feda20ac104b
Company: AUROBINDO PHARMA LIMITED - UNIT VII - INDIAAUROBINDO PHARMA LIMITED - UNIT XV (INDIA)
Type: Therapeutic

Approval Details

Approval Id: c254feda20ac104b
Drug Name: PEGASET 25 CAPSULES 25MG
Product Name: PEGASET 25 CAPSULES 25MG
Approval Number: SIN16403P
Approval Date: 2021-12-16
Registrant: APOTHECA MARKETING PTE LTD
Licence Holder: APOTHECA MARKETING PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: CAPSULE
Dosage: Posology and method of administration Posology The dose range is 150 to 600 mg per day given in either two or three divided doses. Neuropathic pain Pregabalin treatment can be started at a dose of 150 mg per day given as two or three divided doses. Based on individual patient response and tolerability, the dose 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 given as two or three divided doses. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. The maximum dose 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 dose may be increased to 300 mg per day after 1 week. Following an additional week the dose may be increased to 450 mg per day. The maximum dose of 600 mg per day may be achieved after an additional week. Discontinuation of Pregabalin In accordance with current clinical practice, 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 Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. As Pregabalin clearance is directly proportional to creatinine clearance, dose 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/Pegaset-Formula1.png" alt="Pegaset Dosage Formula 1" /> Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). 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/Pegaset-Table1.png" alt="Pegaset Dosage Table 1" /> Patients with hepatic impairment No dose adjustment is required for patients with hepatic impairment. Paediatric population The safety and efficacy of Pregabalin in children below the age of 12 years and in adolescents (12–17 years of age) have not been established. No data is available. The use in children and adolescents is not recommended. Elderly (over 65 years of age) population Elderly patients may require a dose reduction of Pregabalin due to a decreased renal function (see patients with renal impairment). Method of administration Pregabalin may be taken with or without food. Pregabalin is for oral use only.
Route Of Administration: ORAL
Indication Info: Therapeutic indications Neuropathic pain Pregabalin Capsules are indicated for the treatment of neuropathic pain, which includes diabetic peripheral neuropathy and post-herpetic neuralgia, in adults. Epilepsy Pregabalin Capsules are indicated as adjunctive therapy in adults with partial seizures with or without secondary generalization. Generalised Anxiety Disorder Pregabalin Capsules are indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Contraindications: Contraindications Pregabalin Capsules are contraindicated in patients with hypersensitivity to Pregabalin or to any of the Excipients.
Atc Code: N03AX16
Atc Item Name: xn 03 ax 16
Pharma Manufacturer Name: APOTHECA MARKETING PTE LTD

Active Ingredients

Pregabalin

25 mg

PREGABALIN

25 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Dec 16, 2021

Approval ID

c254feda20ac104b

Type

Therapeutic

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