Briva 10 mg/ml Oral Solution 50 ml bottle Composition
Briva 25 Tablet: Each film-coated tablet contains Brivaracetam INN 25 mg.
Briva 50 Tablet: Each film-coated tablet contains Brivaracetam INN 50 mg.
Briva Oral Solution: Each ml contains Brivaracetam INN 10 mg.
The precise mechanism by which Brivaracetam exerts its anticonvulsant 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 anticonvulsant effect.
Brivaracetam exhibits linear and time-independent pharmacokinetics at the approved doses. Brivaracetam is highly permeable and is rapidly and almost completely absorbed after oral administration. Brivaracetam is rapidly and evenly distributed in most tissues. More than 95% of the dose, including metabolites, is excreted in the urine.
Partial-Onset of Seizure including
Focal Impaired Awareness or Complex Partial Seizures
Focal Aware or Simple Partial Seizure
Secondarily Generalized Seizures or Bilateral Tonic Clonic Seizure
Dosage and Administration:
Route of Administration: Orally
Monotherapy or Adjunctive Therapy
The recommended dosage for adults and pediatric patients 4 years of age and older is included in below table. In pediatric patients (> 4 years to < 16 years of age), the recommended dosing regimen is dependent upon body weight. When initiating treatment, gradual dose escalation is not required. Dosage should be adjusted based on clinical response and tolerability.
Dose selection for an elderly patient should be judicious, usually starting at the low end of the dosing range.
Dose adjustment of Brivaracetam is not required for patients with impaired renal function. Use of Brivaracetam is not recommended in patients with end-stage renal disease undergoing dialysis.
For all stages of hepatic impairment, the recommended starting dosage of Brivaracetam is 25 mg twice daily (50 mg per day) and the recommended maximum dosage is 75 mg twice daily (150 mg per day).
OR AS DIRECTED BY THE PHYSICIAN
Contraindications Contraindicated in patient with hypersensitivity to Brivaracetam or any of the inactive ingredients in Brivaracetam.
Warnings and Precautions
Like other antiepileptic drugs, Brivaracetam may cause suicidal thoughts or actions in a very small number of people. Patients should be restricted from driving or operating machinery until they have gained sufficient experience on Brivaracetam. Brivaracetam should be gradually withdrawn. If Bronchospasm and Angioedema develops, should seek immediate medical care.
Common Side Effects: Sedation, Dizziness, Drowsiness, Fatigue and Nausea or Vomiting etc. Rare Side Effects: Cerebellar coordination and balance disturbances, Mood swings, Anxiety, Hallucination, Delusion, Irritability, Constipation, Bronchospasm, Decreased Neutrophils, Decreased White Blood Cells, Giant Hives etc. Pediatric Patients: Most common adverse reactions are similar to those seen in adult patients.
Pregnancy and Lactation
Pregnancy: Pregnancy Category of Brivaracetam is C. There is no adequate and well-controlled studies in pregnant women.
Brivaracetam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: No data are available regarding the presence of Brivaracetam in human milk, the effects on the breastfed infant or the effects of the drug on milk production.
Use in Children and Adolescent
Safety and effectiveness in pediatric patients below the age of 4 years have not been established.
With Medicine: Rifampin: Because of decreased concentrations, increasing Brivaracetam dosage in patients on concomitant Rifampin is recommended.
Carbamazepine: Consider reducing Carbamazepine dosage in patients on concomitant Brivaracetam. Phenytoin: Phenytoin levels should be monitored in patients on concomitant Brivaracetam.
With Food and Others: Food does not affect the extent of Brivaracetam absorption. Brivaracetam can be taken with or without food. Use of alcohol during Brivaracetam therapy is not recommended.
There is limited clinical experience with Brivaracetam overdose in humans. Vertigo, balance disorder, fatigue, nausea, diplopia, anxiety, and bradycardia were reported as adverse reaction of
Store below 300 C temperature and in a dry place, protected from light. Keep all medicines out of reach of children. Do not freeze the oral solution.
Briva 25 Tablet: Each Box contains 1X10 Tablets in Alu-Alu blister.
Briva 50 Tablet: Each Box contains 1X10 Tablets in Alu-Alu blister.
Briva Oral Solution: Each box contains a bottle containing 50 ml oral solution and a measuring cup.