PREGATAS-75 CAPSULE 75 MG

INTAS PHARMACEUTICALS LIMITED, CHACHARWADI / MATODA (INDIA)🇸🇬 Health Sciences Authority

Approval Date: Oct 30, 2018
Approval ID: 15103d88debf30a5
Company: INTAS PHARMACEUTICALS LIMITED, CHACHARWADI / MATODA (INDIA)
Type: Therapeutic

Approval Details

Approval Id: 15103d88debf30a5
Drug Name: PREGATAS-75 CAPSULE 75 MG
Product Name: PREGATAS-75 CAPSULE 75 MG
Approval Number: SIN15570P
Approval Date: 2018-10-30
Registrant: ACCORD HEALTHCARE PRIVATE LIMITED
Licence Holder: ACCORD HEALTHCARE PRIVATE LIMITED
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: CAPSULE, GELATIN COATED
Dosage: v. Recommended Dosage: 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. 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 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. 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 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/Pregatas-Formula1.png" alt="Pregatas 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/Pregatas-Table1.png" alt="Pregatas 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. 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. Method of administration Pregatas-75 / 150 may be taken with or without food.
Route Of Administration: ORAL
Indication Info: iv. Indication: Epilepsy Pregabalin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. Neuropathic pain Pregabalin is indicated for the treatment of neuropathic pain which includes diabetic peripheral neuropathy and post-herpetic neuralgia in adults. Fibromyalgia Pregabalin is indicated for the management of fibromyalgia.
Contraindications: vii. Contraindication: Hypersensitivity to the active substance or to any of the excipients (See section ii – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: N03AX16
Atc Item Name: xn 03 ax 16
Pharma Manufacturer Name: ACCORD HEALTHCARE PRIVATE LIMITED

Active Ingredients

Pregabalin

75 mg

PREGABALIN

75 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 30, 2018

Approval ID

15103d88debf30a5

Type

Therapeutic

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