Bricet 25

Brivaracetam is an anti-epileptic medicine used to treat seizures (fits) in epilepsy. It can be used alone or along with other medicines. It helps to prevent seizures for as long as you continue to take it. Brivaracetam suppresses the abnormal electrical activity in the brain. You can take it regularly with or without food but try to take it at the same time each day to get the most benefit. The dose and how often you need it will be decided by your doctor so that you get the right amount to control your seizures. It may be increased gradually. It is generally advised as a long-term treatment. You should continue taking it for as long as your doctor has told you to, even if you feel well. If you stop or miss doses your seizures could get worse. Do not stop taking this medicine unless your doctor tells you to. This is because stopping the medicine suddenly could make your seizures worse. Some common side effects of this medicine include dizziness, headache, irritation, nausea, and vomiting. You may also experience behavioral changes, aggressive behavior, irritation, agitation, etc. Side effects are more common during the first few weeks and usually lessen as your body gets used to the medicine. Most of these side effects do not need medical attention, but some of them can be serious. A small number of people being treated with this medicine have had thoughts of harming or killing themselves. Contact your doctor if your mood changes for the worse. Before taking it, you should tell your doctor if you have liver or kidney-related problems, depression or suicidal thoughts and if you are pregnant or planning to become pregnant. Breastfeeding mothers should also consult their doctor before taking this medicine. Brivaracetam is an antiepileptic medication. It works by attaching itself to specific sites (SV2A) on the surfaces of nerve cells. This suppresses the abnormal activity of the nerve cells in the brain and prevents the spread of electrical signals that cause seizures.

• Epilepsy/Seizures

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

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 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: 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

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Brivaracetam may be taken with or without food, but it is better to take it at a fixed time.

Common: • Dizziness • Fatigue • Nausea • Sleepiness • Vomiting • Constipation • Irritation

[UNSAFE] Brivaracetam may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur. Brivaracetam should be taken regularly as directed by your doctor as missing doses can trigger seizures. Do not change the brand of your medicine and make sure that you have sufficient amount of medicine present with you. Some healthy tips to prevent seizures: It may cause sleepiness or drowsiness. If this happens to you, do not drive or use machinery. Inform your doctor if you have a history of liver disease, kidney disease or drug abuse. Do not stop using Brivaracetam without talking to your doctor, even if you feel better.

Hypersensitivity; bronchospasms and angioedema have occurred

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.

[UNSAFE] It is unsafe to consume alcohol with Brivaracetam.

[CONSULT YOUR DOCTOR] Brivaracetam may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

[CONSULT YOUR DOCTOR] Information regarding the use of Brivaracetam during breastfeeding is not available. Please consult your doctor.

[SAFE IF PRESCRIBED] Brivaracetam is safe to use in patients with kidney disease. No dose adjustment of Brivaracetam is recommended. It is not recommended in end-stage renal disease due to a lack of clinical trial data. [CAUTION] Brivaracetam should be used with caution in patients with liver disease. Dose adjustment of Brivaracetam may be needed. Please consult your doctor.

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