Epicure50 ml

Epicure 50 ml is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of Epicure 50 ml injection in pediatric patients has not been established, Epicure 50 ml injection is indicated for the treatment of partial-onset seizures only in adult patients (16 years of age and older).

Adjunct anti-epileptic drugs

The precise mechanism by which Epicure 50 ml exerts its anticonvulsant activity is not known. Epicure 50 ml displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.Epicure 50 ml binds SV2A with high affinity. SV2A is known to play a role in epileptogenesis through modulation of synaptic GABA release. It is thought that Epicure 50 ml exerts its anti-epileptogenic effects through its binding to SV2A. Epicure 50 ml is also known to inhibit Na+ channels which may also contribute to its anti-epileptogenic action

Adults (16 Years and older): The recommended starting dosage for monotherapy or adjunctive therapy is 50 mg twice daily (100 mg per day).Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day).Pediatric Patients (4 Years to less than 16 Years): The recommended dosage is based on body weight and is administered orally twice dailyInjection: for intravenous and adult use only when oral administration is temporarily not feasible; dosing is the same as oral regimen.

Epicure 50 ml injection should be administered intravenously over 2 to 15 minutes. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Product with particulate matter or discoloration should not be used. Epicure 50 ml injection is for single dose only.

Rifampin: Because of decreased concentrations, increasing Epicure 50 ml dosage in patients on concomitant rifampin is recommended.Carbamazepine: Because of increased exposure to carbamazepine metabolite, if tolerability issues arise, consider reducing carbamazepine dosage in patients on concomitant Epicure 50 ml.Phenytoin: Because phenytoin concentrations can increase, phenytoin levels should be monitored in patients on concomitant Epicure 50 ml.Levetiracetam: Epicure 50 ml had no added therapeutic benefit when co-administered with levetiracetam.

Hypersensitivity to Epicure 50 ml or any of the inactive ingredients in Epicure 50 ml

Most common adverse reactions (at least 5% for Epicure 50 ml and at least 2% more frequently than placebo) are somnolence/sedation, dizziness, fatigue, and nausea or vomiting.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Epicure 50 ml, during pregnancy. No data are available regarding the presence of Epicure 50 ml in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Studies in lactating rats have shown excretion of Epicure 50 ml or metabolites in milk

Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and ideation.Neurological Adverse Reactions: Monitor for somnolence and fatigue, and advise patients not to drive or operate machinery until they have gained sufficient experience on Epicure 50 ml.Psychiatric Adverse Reactions: Behavioral reactions including psychotic symptoms, irritability, depression, aggressive behavior, and anxiety; monitor patients for symptoms.Hypersensitivity: Bronchospasm and Angioedema: Advise patients to seek immediate medical care. Discontinue and do not restart Epicure 50 ml if hypersensitivity occurs. Withdrawal of Antiepileptic Drugs: Epicure 50 ml should be gradually withdrawn.

Store at 25°C; excursions permitted between 15°C to 30°C

Hepatic Impairment: Dose adjustment is recommended for all stages of hepatic impairment.Renal Impairment: Dose adjustments are not required for patients with impaired renal function.

Adjunct anti-epileptic drugs

The precise mechanism by which Epicure 50 ml exerts its anticonvulsant activity is not known. Epicure 50 ml displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.Epicure 50 ml binds SV2A with high affinity. SV2A is known to play a role in epileptogenesis through modulation of synaptic GABA release. It is thought that Epicure 50 ml exerts its anti-epileptogenic effects through its binding to SV2A. Epicure 50 ml is also known to inhibit Na+ channels which may also contribute to its anti-epileptogenic action

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Epicure 50 ml, during pregnancy. No data are available regarding the presence of Epicure 50 ml in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Studies in lactating rats have shown excretion of Epicure 50 ml or metabolites in milk

Hepatic Impairment: Dose adjustment is recommended for all stages of hepatic impairment.Renal Impairment: Dose adjustments are not required for patients with impaired renal function.