Indications
Bivara Tablet is used for:
Partial-Onset Seizures, Adjunctive therapy in treating partial-onset seizures w/ or w/o secondary generalisation in adults & adolescents ≥16 yr w/ epilepsy.
Adult Dose
Partial-Onset Seizures
Indicated for partial-onset seizures
50 mg PO/IV q12hr initially; based on individual patient tolerability and therapeutic response, adjust dose between to 25-100 mg PO/IV BID (50-200 mg/day)
Injection may be used for patients when oral administration is temporarily not feasible; clinical study experience with injection is limited to 4 consecutive days of treatment
Hepatic impairment
All stages: Decrease starting dose to 25 mg BID and do not exceed 75 mg BID (150 mg/day)
Child Dose
Partial Onset Seizures
Tablets or oral solution
Indicated for partial-onset seizures in children and adolescents ?4 years
<4 years: Safety and efficacy not established
4 to <16 years
11 to <20 kg: 0.5-1.25 mg/kg PO BID (1-2.5 mg/kg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between to 0.5-2.5 mg/kg PO BID (1-5 mg/kg/day)
20 to <50 kg: 0.5-1 mg/kg PO BID (1-2 mg/kg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between to 0.5-2 mg/kg PO BID (1-4 mg/kg/day)
?50 kg: 25-50 mg PO BID (50-100 mg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between to 25-100 mg PO BID (50-200 mg/day)
>16 years
50 mg PO BID (100 mg/day) initially; based on individual patient tolerability and therapeutic response, adjust dose between to 25-100 mg PO BID (50-200 mg/day)
Injection
Indicated for partial-onset seizures in adolescents ?16 years with epilepsy
Injection may be used for patients when oral administration is temporarily not feasible
<16 years: Safety and efficacy not established
>16 years: 50 mg IV q12hr initially; based on individual patient tolerability and therapeutic response, adjust dose between to 25-100 mg IV BID (50-200 mg/day)
Clinical study experience with injection is limited to 4 consecutive days of treatment
Renal Dose
Renal impairment
Mild-to-moderate: No dose adjustment required
ESRD undergoing dialysis: Not studied
Administration
Contra Indications
Hypersensitivity; bronchospasms and angioedema have occurred
Precautions
Monitor patients for signs of suicidal ideation & behaviours. Minor or moderate influence on the ability to drive & use machines. Hepatic impairment. Not recommended in end-stage renal disease patients undergoing dialysis. Women of childbearing potential. Pregnancy & lactation. Elderly ≥65 yr. Childn <16 yr. FC tab: Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Oral soln: Rare hereditary problems of fructose intolerance. Contains methyl parahydroxybenzoate (E218). Oral soln & vial: Patients on controlled Na diet.
Pregnancy-Lactation
Pregnancy
No adequate and well-controlled studies in pregnant women
In animal studies, brivaracetam produced evidence of developmental toxicity at plasma exposures greater than clinical exposure
Lactation
Unknown if distributed in human breast milk
Studies in rats have shown excretion in milk
Because many drugs are excreted into human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
Interactions
Doubled effect of alcohol on psychomotor function, attention & memory. Possible increase in plasma conc w/ strong CYP2C19 inhibitors (eg, fluconazole, fluvoxamine). Decreased plasma conc w/ strong enzyme inducers (eg, rifampicin; carbamazepine, phenobarb, phenytoin; St. John's wort). May increase plasma conc of CYP2C19-metabolised products (eg, lansoprazole, omeprazole, diazepam); OAT3-transported medicinal products. May decrease plasma conc of CYP2B6-metabolised products (eg, efavirenz). Increased conc of carbamazepine epoxide.
Side Effects
Side effects of Brivaracetam :
>10%
Somnolence and sedation (16%)
Dizziness (12%)
1-10%
Fatigue (9%)
Nausea and vomiting (5%)
Cerebellar coordination and balance disturbances (3%)
Irritability (3%)
Constipation (2%)
Mode of Action
Exact mechanism unknown
Displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect
Note
Bivara 25mg Tablet generic name is Brivaracetam. Bivara 25mg Tablet is manufactured by ACI LimitedBivara is availble in all over Bangladesh.
Mes BD drug index information on Bivara Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.