PDP-LEVETIRACETAM 100 MG — DIN 02490439

What is PDP-LEVETIRACETAM?

PDP-LEVETIRACETAM 100 MG contains LEVETIRACETAM : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02490439, held by PENDOPHARM DIVISION OF PHARMASCIENCE INC, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 30-Oct-2019. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is PDP-LEVETIRACETAM used for?

pdp-levetiracetam (levetiracetam oral solution and levetiracetam for injection) is indicated as adjunctive therapy in the management of patients with epilepsy who are not satisfactorily controlled by conventional therapy. pdp-levetiracetam (levetiracetam for injection) is indicated as an alternative for patients when oral administration is temporarily not feasible. In pediatric patients, pdp-levetiracetam (levetiracetam oral solution and levetiracetam for injection) is indicated as adjunctive therapy in the treatment of: partial onset seizures with or without secondary generalization in adolescents, children and infants from 1 month of age with epilepsy; myoclonic seizures in adolescents from 12 years of age with Juvenile Myoclonic Epilepsy; primary generalized tonic-clonic seizures in adolescents from 12 years of age with Idiopathic Generalized Epilepsy. pdp-levetiracetam (levetiracetam for injection) is indicated as an alternative for patients when oral administration is temporarily not feasible.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Adults (> 18 years) and adolescents (12 to 17 years) weighing 50 kg or more: Oral/IV Solution: Treatment should be initiated at a dose of 1000 mg/day, given as twice daily dosing (500 mg, b.i.d). Depending on the clinical response and tolerability, the daily dose may be increased every two weeks by increments of 1000 mg, to a maximum recommended daily dose of 3000 mg daily. pdp-levetiracetam IV Solution is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. There is no experience with administration of intravenous levetiracetam for a period longer than 4 days. Elderly Patients (65 years and older): Dose selection and titration should proceed cautiously, as renal function decreases with age. Adjustment of the dose is recommended in elderly patients with compromised renal function. Pediatric weight-based dosing for add-on therapy in children aged <12 years and adolescents (12-17 years) weighing <50 kg. Oral Solution is the preferred formulation over tablets for use in infants and children under the age of 6 years, or under 25 kg, and in any patients unable to swallow tablets. Oral Solution Weight-Based Dosing Calculation for Pediatric Patients: Total daily dose (mL/day) = (Daily dose (mg/kg/day) x patient weight (kg)) / 100 mg/mL. Add-on therapy in infants aged 1 month to <6 months: Oral Solution: Initial therapeutic dose is 7 mg/kg twice daily. Dose can be increased up to 21 mg/kg twice daily. Dose changes should not exceed increases or decreases of 7 mg/kg twice daily every 2 weeks. Administer oral solution using a 1 mL dosing syringe. IV Solution: IV dosing is the same as for the oral solution. Add-on therapy in infants aged 6 months to <4 years; children aged 4 to 11 years, and adolescents aged 12 to 17 years weighing less than 50 kg: Oral Solution: Initial therapeutic dose is 10 mg/kg twice daily. 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 2 weeks. For infants aged 6 months to less than 4 years, administer using a 3 mL dosing syringe. For children aged 4 years and older; adolescents and adults, administer using a 10 mL dosing syringe. IV Solution: IV dosing is the same as for the oral solution. Dose Adjustment for Children with Renal Impairment: Levetiracetam dose needs to be adjusted based on renal function. Switching between IV and oral administration: Conversion to or from IV and oral administration can be done directly without titration. The total daily dose and frequency of administration should be maintained. Reconstitution (IV Solution): For single use only. May be mixed with Sodium Chloride (0.9%) injection, USP; Lactated Ringer's injection; Dextrose 5% injection, USP. Also with Lorazepam, Diazepam, Valproate Sodium. Diluted solution should not be stored for more than 24 hours at room temperature (15 - 30°C). Administration (Oral Solution): For pediatric patients, dosing is weight-based (mg per kg) and should be dispensed using the appropriate dosing syringe. The daily dose is administered in two equally divided doses. May be diluted (e.g., in a glass of water or baby's bottle) and may be taken with or without food. Administration (IV Solution): For intravenous use only. Recommended dose must be diluted in 100 mL of a compatible diluent and administered intravenously as a 15-minute intravenous infusion. If a smaller volume is required (e.g. pediatric patients), the amount of diluent should be calculated to not exceed a maximum levetiracetam concentration of 15 mg per mL of diluted solution. Missed Dose: If a dose is missed by a few hours, take as soon as remembered. If almost time for next dose, take next dose at regular time. Do not take two doses at the same time.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

pdp-levetiracetam is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. It is also contraindicated in patients who are hypersensitive to other pyrrolidine derivatives.

Warnings and precautions

Cardiovascular: QT Prolongation has been observed. Use with caution in patients with QTc-interval prolongation, those treated with drugs affecting QTc-interval, or with pre-existing cardiac disease or electrolyte disturbances. Increased diastolic blood pressure in patients < 4 years of age. Monitor patients 1 month to < 4 years of age for increases in diastolic blood pressure. Dependence/Tolerance: Should be withdrawn gradually to minimize increased seizure frequency. Driving and Operating Machinery: May cause somnolence, fatigue, and other central nervous system related symptoms. Patients should not drive or operate machinery until effects are known. Hematologic: Cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders. Hepatic/Biliary/Pancreatic: Reports of hepatitis and hepatic failure in patients taking levetiracetam. Immune: Serious hypersensitivity reactions with dermatological involvement (Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, Drug Reaction with Eosinophilia and Systemic Symptoms) have been reported. Discontinue if suspected and alternative cause cannot be established. Anaphylaxis and Angioedema: Can cause anaphylaxis or angioedema. Discontinue if signs/symptoms occur and seek immediate medical attention. Neurologic: Coordination Difficulties (ataxia, abnormal gait, incoordination) may occur. Seizure Worsening: Paradoxical worsening of seizure may be observed. Psychiatric: Behavioural Abnormalities and Psychotic Symptoms (aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, hyperkinesia, irritability, nervousness, neurosis, personality disorder, hallucinations, psychosis, psychotic depression) may occur. More common in children. Suicidal Behaviour and Ideation: Increased risk with antiepileptic agents. Monitor for signs of suicidal ideation and behaviour. Renal: Dosage should be reduced in patients with impaired renal function. Acute kidney injury has been rarely associated with use.