Epicure(Brivaracetam)
Therapeutic Group: Drugs of Nervous System, Antiepileptic
Presentation
Epicure 25 Tablet: Each tablet contains Brivaracetam INN 25 mg.
Epicure 50 Tablet: Each tablet contains Brivaracetam INN 50 mg.
Epicure Oral Solution: Each 5 ml solution contains Brivaracetam INN 50 mg.
Epicure 50 Injection: Each 5 ml injectable solution contains Brivaracetam INN 50 mg.
Description
The precise mechanism by which Brivaracetam exerts its anti-convulsant activity is not known. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anti-convulsant effect.
Indications
Brivaracetam is indicated for the treatment of partial onset seizures in patients 1 month of age and older.
Dosage & Administration
Recommended Dosage for Patients 1 Month of Age and Older
Age and Body Weight: Adults, Initial Dosage: 50 mg twice daily (100 mg per day), Minimum and Maximum Maintenance Dosage: 25 mg to 100 mg twice daily (50 to 200 mg per day);
Age and Body Weight: Pediatric patients weighing 50 kg or more, Initial Dosage: 25 mg to 50 mg twice daily (50 mg to 100 mg per day), Minimum and Maximum Maintenance Dosage: 25 mg to 100 mg twice daily (50 to 200 mg per day);
Age and Body Weight: Pediatric patients weighing 20 kg to less than 50 kg, Initial Dosage: 0.5 mg/kg to 1 mg/kg twice daily (1 mg/kg to 2 mg/kg per day), Minimum and Maximum Maintenance Dosage: 0.5 mg/kg to 2 mg/kg twice daily (1 mg/kg to 4 mg/kg per day);
Age and Body Weight: Pediatric patients weighing 11 kg to less than 20 kg , Initial Dosage: 0.5 mg/kg to 1.25 mg/kg twice daily (1 mg/kg to 2.5 mg/kg per day), Minimum and Maximum Maintenance Dosage: 0.5 mg/kg to 2.5 mg/kg twice daily (1 mg/kg to 5 mg/kg per day);
Age and Body Weight: Pediatric patients weighing less than 11 kg, Initial Dosage: 0.75 mg/kg to 1.5 mg/kg twice daily (1.5 mg/kg to 3 mg/kg per day), Minimum and Maximum Maintenance Dosage: 0.75 mg/kg to 3 mg/kg twice daily (1.5 mg/kg to 6 mg/kg per day);
Administration instruction of Brivaracetam injection: Brivaracetam injection may be used for adult patients when oral administration is temporarily not feasible. It can be administered intravenously without further dilution or may be mixed with diluents e.g. 0.9% Sodium Chloride injection/Lactated Ringer’s injection/5% Dextrose injection. It should be administered intravenously over 2 to 15 minutes.
Side Effects
The most common side-effects of Brivaracetam are nausea, vomiting, constipation, somnolence, sedation, dizziness, fatigue, irritability etc.
Precautions
Monitor patients for suicidal behavior and ideation, neurologic adverse reactions (somnolence & fatigue), psychiatric adverse reactions (irritability, depression, aggressive behavior, anxiety), hypersensitivity (bronchospasm & angioedema) when Brivaracetam is prescribed.
Use in Pregnancy & Lactation
Pregnancy: There are no adequate and well-controlled studies in pregnant women and Brivaracetam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Brivaracetam is excreted in human breast milk. The known benefits of breastfeeding should be weighed against the unknown risks of infant exposure to Brivaracetam.
Drug Interaction
Brivaracetam should be used with caution in combination with Rifampin, Carbamazepine, Phenytoin etc.
Over Dose
Overdose of Brivaracetam is limited and there is no specific antidote to Brivaracetam. If overdose occurs, standard medical practice for the management of overdose should be used.
Storage
Do not store above 30 degrees Celsius. Keep away from light and out of the reach of children.
Commercial Pack
Epicure 25 Tablet: Each box contains 1 blister strip of 10 tablets.
Epicure 50 Tablet: Each box contains 1 blister strip of 10 tablets.
Epicure Oral Solution: Each bottle contains 50 ml of Brivaracetam Oral Solution.
Epicure 50 Injection: Each box contains 1 vial of 5 ml injection.
