Briva Oral Solution
Brivaracetam
10 mg/ml
Acme Laboratories Ltd.
| Pack size | 50 ml |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 800.00 AED |
Available as:
Indications
Briva Oral Solution 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
Briva 10 mg/ml Oral Solution manufactured by Acme Laboratories Ltd.. Its generic name is Brivaracetam. Briva is availble in Bangladesh.
Farmaco BD drug index information on Briva Oral Solution is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.