Bivara Tablet

Brivaracetam

25mg

ACI Limited

Pack size	10's pack
Dispensing mode
Source
Agent
Retail Price	40.00 AED

Available as:

50 mg/5 ml - Oral Solution 50 mg - Tablet

Indications

Bivara Tablet is used for: Partial-Onset Seizures,

Adult Dose

Partial-Onset Seizures Indicated for partial-onset seizures Adjunctive therapy in treating partial-onset seizures w/ or w/o secondary generalization in adults & adolescents >16 yr w/ epilepsy. 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). 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

Child Dose

Partial Onset Seizures Tablets or oral solution or Injection Child (16 years and older)- Initial dose: 50 mg twice daily (100 mg per day) Minimum and maximum maintenance dose: 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day). Child: (1 Month to less than 16 Years): The recommended dosage is based on body weight and is administered orally twice daily Child weighing 50 kg or more- Initial dose: 25 mg to 50 mg twice daily (50 mg to 100 mg per day) Minimum and maximum maintenance dose: 25 mg to 100 mg twice daily (50 mg to 200 mg per day) Child weighing 20 kg to less than 50 kg- Initial dose: 0.5 mg/kg to 1 mg/kg twice daily (1 mg/kg to 2 mg/kg per day) Minimum and maximum maintenance dose: 0.5 mg/kg to 2 mg/kg twice daily (1 mg/kg to 4 mg/kg per day) Child weighing 11 kg to less than 20 kg- Initial dose: 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 dose: 0.5 mg/kg to 2.5 mg/kg twice daily (1 mg/kg to 5 mg/kg per day) Child weighing less than 11 kg- Initial dose: 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 dose: 0.75 mg/kg to 3 mg/kg twice daily (1.5 mg/kg to 6 mg/kg per day) Injection: for intravenous use only when oral administration is temporarily not feasible; dosing is the same as oral regimen.

Renal Dose

Renal impairment Mild-to-moderate: No dose adjustment required ESRD undergoing dialysis: Not studied

Administration

Oral Administration May take with or without food IV Preparation Inspect visually for particulate matter and discoloration prior to administration; product with particulate matter or discoloration should not be used Vial is for single dose only IV Administration Can be administered IV without further dilution or may be mixed with diluents (see IV Compatibilities) Infuse IV over 2-15 minutes

Contra Indications

Hypersensitivity; bronchospasms and angioedema have occurred

Precautions

Suicidal Behavior Antiepileptic drugs increase the risk of suicidal behavior and ideation; monitor for the emergence or worsening of depression, unusual changes in mood or behavior, or suicidal thoughts, behavior, or self-harm; advise patients and caregivers/families to be alert for these behavioral changes and report them to their physician immediately Anyone considering prescribing an antiepileptic drug, such as this one, must balance risk of suicidal thoughts or behaviors with risk of untreated illness; epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior Should suicidal thoughts and behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated Neurological Adverse Reactions: Monitor for somnolence and fatigue, and advise patients not to drive or operate machinery until they have gained sufficient experience on Brivaracetam. 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 BRIVIACT if hypersensitivity occurs. Withdrawal of Antiepileptic Drugs: Brivaracetam should be gradually withdrawn. Monitoring Parameters Monitor patients for signs of suicidal ideation & behaviors. Monitor for the emergence or worsening of depression, unusual changes in mood or behavior, or suicidal thoughts, behavior, or self-harm. Monitor for somnolence and fatigue.

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). Rifampin: Because of decreased concentrations, increasing Brivaracetam 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 Brivaracetam. Phenytoin: Because phenytoin concentrations can increase, phenytoin levels should be monitored in patients on concomitant Brivaracetam. Levetiracetam: Brivaracetam had no added therapeutic benefit when coadministered with levetiracetam Contraindicated (1) thalidomide Serious (21) alfentanil buprenorphine buprenorphine buccal buprenorphine subdermal implant buprenorphine transdermal buprenorphine, long-acting injection fentanyl fentanyl intranasal fentanyl iontophoretic transdermal system fentanyl transdermal fentanyl transmucosal hydrocodone hydromorphone lonafarnib methadone metoclopramide intranasal morphine oxycodone oxymorphone remifentanil selinexor

Adverse 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%)

Mechanism 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 manufactured by ACI Limited. Its generic name is Brivaracetam. Bivara is availble in Bangladesh. Farmaco 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.

Some other brands of Brivaracetam :

Tablet

Briva ^{25 mg}

Acme Laboratories Ltd.

Oral Solution

Briva ^{10 mg/ml}

Acme Laboratories Ltd.

Tablet

Briva ^{50 mg}

Acme Laboratories Ltd.