LEVETIRACETAM-AFT ORAL SOLUTION 100MG/ML

ONE PHARMA INDUSTRIAL PHARMACEUTICAL COMPANY SOCIETE ANONYME (GREECE)🇸🇬 Health Sciences Authority

Approval Date: Nov 7, 2018
Approval ID: d66605a1a5218565
Company: ONE PHARMA INDUSTRIAL PHARMACEUTICAL COMPANY SOCIETE ANONYME (GREECE)
Type: Therapeutic

Approval Details

Approval Id: d66605a1a5218565
Drug Name: LEVETIRACETAM-AFT ORAL SOLUTION 100MG/ML
Product Name: LEVETIRACETAM-AFT ORAL SOLUTION 100MG/ML
Approval Number: SIN15575P
Approval Date: 2018-11-07
Registrant: APEX PHARMA MARKETING PTE. LTD.
Licence Holder: APEX PHARMA MARKETING PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: SOLUTION
Dosage: DOSAGE AND ADMINISTRATION Levetiracetam therapy can be initiated with either intravenous or oral administration. Conversion to or from oral to intravenous administration can be done directly without titration. The total daily dose and frequency of administration should be maintained. Oral solution The oral solution may be diluted in a glass of water and may be taken with or without food. The daily dose is administered in two equally divided doses. Concentrate for solution for infusion Levetiracetam-AFT concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as 15-minute intravenous infusion (see Section Incompatibilities and Use and Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). There is no experience with administration of intravenous Levetiracetam-AFT for longer period than 4 days. Levetiracetam-AFT concentrate is an alternative for patients (adults and children from 4 years of age) when oral administration is temporarily not feasible. For patients requiring the tablet formulation, there are other brands available. Route of Administration For oral use: Levetiracetam-AFT Oral Solution 100 mg/ml For intravenous use: Levetiracetam-AFT Concentrate for Solution for Infusion 100 mg/ml Please refer to Section INCOMPATIBILITIES AND USE AND HANDLING for recommendation on the preparation and administration of Levetiracetam-AFT Concentrate for Solution for Infusion 100 mg/ml – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Adults <ul> <li>Monotherapy Adults and adolescents from 16 years of age The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1500 mg twice daily.</li> <li>Add-on therapy Adults (≥18 years) and adolescents (12 to 17 years) of 50 kg or more The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. Depending upon the clinical response and tolerance, the daily dose can be increased up to 1,500 mg twice daily. Dose changes can be made in 500 mg twice daily increases or decreases every two to four weeks.</li> </ul> Children The physician should prescribe the most appropriate pharmaceutical form and strength according to age, weight and dose. The tablet formulation is not adapted for use in children under the age of 6 years. Levetiracetam-AFT oral solution is the preferred formulation for use in this population. In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 250 mg. In all of the above cases Levetiracetam-AFT oral solution should be used. The safety and efficacy of Levetiracetam-AFT concentrate for solution for infusion in children less than 4 years have not been established. Monotherapy The safety and efficacy of levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established. There are no data available. Add-on Therapy for Children (4 to 11 years) and Adolescents (12 to 17 years) weighing less than 50 kg Levetiracetam-AFT Oral Solution is the preferred formulation for use in children under the age of 6 years. For children 6 years and above, Levetiracetam-AFT oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets. The initial therapeutic dose is 10 mg/kg twice daily. Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/kg twice daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks. The lowest effective dose should be used. Dose in children 50 kg or greater is the same as in adults. Dose recommendations for children and adolescents: <img src="/TGIF/Levetiracetam-AFT-Table1.png" alt="Levetiracetam-AFT Dosage Table 1" /> Infants and children less than 4 years There are insufficient data to recommend the use of Levetiracetam-AFT in children under 4 years of age. Elderly Adjustment of the dose is recommended in elderly patients with compromised renal function. Renal impairment The daily dose must be individualised according to renal function (see section Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). For adult patients, refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighing 50 kg or more, using the following formula: <img src="/TGIF/Levetiracetam-AFT-Formula1.png" alt="Levetiracetam-AFT Dosage Formula 1" /> Then CLcr is adjusted for body surface area (BSA) as follows: <img src="/TGIF/Levetiracetam-AFT-Formula2.png" alt="Levetiracetam-AFT Dosage Formula 2" /> Dosing adjustment for adult and adolescent patients weighing more than 50 kg with impaired renal function <img src="/TGIF/Levetiracetam-AFT-Table2.png" alt="Levetiracetam-AFT Dosage Table 2" /> For children with renal impairment, Levetiracetam dose needs to be adjusted based on the renal function as Levetiracetam clearance is related to renal function. This recommendation is based on a study in adult renally impaired patients. Hepatic impairment No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency. Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is <60 ml/min/1.73m2 (see section Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: ORAL
Indication Info: INDICATIONS Levetiracetam-AFT is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam-AFT is indicated as adjunctive therapy in the treatment of: <ul> <li>partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.</li> <li>myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.</li> <li>primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.</li> </ul> Levetiracetam-AFT concentrate is an alternative for patients (adults and children from 4 years of age) when oral administration is temporarily not feasible.
Contraindications: CONTRAINDICATIONS Hypersensitivity to levetiracetam or other pyrrolidone derivatives or any of the excipients (refer to DESCRIPTION – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: N03AX14
Atc Item Name: levetiracetam
Pharma Manufacturer Name: APEX PHARMA MARKETING PTE. LTD.

Active Ingredients

LEVETIRACETAM

100MG/ML

LEVETIRACETAM

100 MG/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Nov 7, 2018

Approval ID

d66605a1a5218565

Type

Therapeutic

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