LEVIPIL - LEVETIRACETAM INJECTION USP 100MG/ML

SUN PHARMACEUTICAL MEDICARE LTD. (INDIA)🇸🇬 Health Sciences Authority

Approval Date: Jun 25, 2021
Approval ID: a6ccac4748bb4ebb
Company: SUN PHARMACEUTICAL MEDICARE LTD. (INDIA)
Type: Therapeutic

Approval Details

Approval Id: a6ccac4748bb4ebb
Drug Name: LEVIPIL - LEVETIRACETAM INJECTION USP 100MG/ML
Product Name: LEVIPIL - LEVETIRACETAM INJECTION USP 100MG/ML
Approval Number: SIN16250P
Approval Date: 2021-06-25
Registrant: RANBAXY (MALAYSIA) SDN. BHD.
Licence Holder: RANBAXY (MALAYSIA) SDN. BHD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION
Dosage: DOSE AND METHOD OF 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. Levetiracetam Injection 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. There is no experience with administration of intravenous levetiracetam for longer period than 4 days. Levetiracetam Injection is an alternative for patients (adults and children from 4 years of age) when oral administration is temporarily not feasible. Levetiracetam Injection USP 100mg/ml Table presents the recommended preparation and administration of levetiracetam Injection to achieve a total daily dose of 500 mg, 1000 mg, 2000 mg or 3000 mg in two divided doses. <img src="/TGIF/Levipil-Table1_060122.png" alt="Levipil Dosage Table 1" /> This medicinal product is for single use only, any unused solution should be discarded. This medicinal product must not be mixed with other medicinal products except those mentioned below. Levetiracetam Injection was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 15–30°C. Diluents: <ul> <li>Sodium chloride (0.9%) injection</li> <li>Lactated Ringer's injection</li> <li>Dextrose 5% injection</li> </ul> Medicinal product with particulate matter or discolouration should not be used. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 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 safety and efficacy of Levetiracetam Injection 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 Children (4 to 11 years) and Adolescents (12 to 17 years) weighing less than 50 kg Other formulation of levetiracetam should be used in children under the age of 6 years. For children 6 years and above, levetiracetam 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. <img src="/TGIF/Levipil-Table2_060122.png" alt="Levipil Dosage Table 2" /> Infants and children less than 4 years There are insufficient data to recommend the use of levetiracetam 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 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/Levipil-Formula1_060122.png" alt="Levipil Dosage Formula 1" /> Then CLcr is adjusted for body surface area (BSA) as follows: <img src="/TGIF/Levipil-Formula2_060122.png" alt="Levipil Dosage Formula 2" /> <img src="/TGIF/Levipil-Table3_060122.png" alt="Levipil Dosage Table 3" /> 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 WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: INTRAVENOUS
Indication Info: INDICATIONS Levetiracetam 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 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 Injection is an alternative for patients (adults and children from 4 years of age) when oral administration is temporarily not feasible.
Contraindications: CONTRAINDICATIONS <ul> <li>Hypersensitivity to levetiracetam or other pyrrolidone derivatives or to any of the excipients.</li> </ul>
Atc Code: N03AX14
Atc Item Name: levetiracetam
Pharma Manufacturer Name: RANBAXY (MALAYSIA) SDN. BHD.
Company Detail Path: /organization/ranbaxy-malaysia-sdn-bhd

Active Ingredients

Levetiracetam

100.00mg/ml

Levetiracetam

100.00mg/ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jun 25, 2021

Approval ID

a6ccac4748bb4ebb

Type

Therapeutic

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