Brivaracetam 75mg Tablets

Adult dose

This medication is taken twice daily. The recommended initial dose is 25mg or 50mg per dose, based on the healthcare professional's assessment of the potential adverse effects in relation to seizure reduction. Based on clinical response and tolerability, the dose may be increased or decreased from 50mg/day [25mg per dose, twice daily] to 200mg/day [100mg per dose, twice daily]. This medication is a film-coated tablet. Swallow it whole with water. It may be taken with or without food. If you miss a dose If you miss one or more doses, take a single dose as soon as you remember, and then take the next dose at the usual morning or evening time. Discontinuation If you wish to discontinue this medication, gradually reduce the dose by 50mg/day at 1-week intervals. After taking 50mg/day for 1 week, a dose of 20mg/day is recommended for the final week (see section 2. Warnings). Elderly patients (65 years and older) No dose adjustment is necessary in elderly patients. Clinical experience in elderly patients aged 65 years and older is limited. Renal impairment No dose adjustment is necessary in patients with renal impairment. This medication is not recommended for patients with end-stage renal disease receiving hemodialysis. Hepatic impairment Exposure to this medication is increased in patients with hepatic impairment. The recommended initial dose for patients with hepatic impairment is 50mg/day [25mg per dose, twice daily], and the recommended maximum dose is 150mg/day [75mg per dose, twice daily].

This medication is an antiepileptic drug and is associated with the risk of suicidal thoughts and suicidal behaviors; thus, patients and caregivers should closely monitor for such symptoms. Additionally, this drug can cause central nervous system side effects such as drowsiness, fatigue, dizziness, and coordination disturbances, requiring particular caution during the initial use or upon dosage increase. When discontinuing treatment, it should be done gradually to prevent an increase in seizure frequency. Patients who are allergic to the active ingredient or other components of this medication should not take it, and those with genetic issues such as lactose intolerance should also not be administered this drug. Patients with impaired liver function may require dosage adjustments and should be administered with caution. While taking this medication, possible adverse reactions include drowsiness, dizziness, depression, anxiety, suicidal thoughts, and psychotic symptoms, hence any unusual symptoms should be communicated to healthcare providers immediately. Severe skin reactions such as Stevens-Johnson syndrome have been reported; if symptoms such as rash or redness occur, the medication should be discontinued immediately, and healthcare providers should be notified. This drug may exacerbate impairments in mental and motor functions and attention when combined with alcohol, so alcohol should be avoided. Moreover, there may be changes in drug concentrations when taken with other antiepileptic drugs, so it’s important to discuss potential interactions with healthcare providers regarding other medications being taken. The safety of this drug during pregnancy has not been sufficiently established; hence use during pregnancy should be decided cautiously and only when needed, and because this drug is excreted in breast milk, caution should also be exercised regarding breastfeeding. The safety and efficacy in pediatric patients under 16 years have not yet been established. Drowsiness or dizziness may occur when driving or operating machinery while taking this medication; therefore, caution should be exercised until the patient is accustomed to such symptoms. In cases of overdose, symptoms such as drowsiness, dizziness, anxiety, and suicidal thoughts may arise, and since there is no specific antidote, immediate medical attention is required. Finally, this medication should be stored out of reach of children and it is important not to transfer it to another container to maintain its quality.

• suicidal ideation
• suicidal behavior
• drowsiness
• fatigue
• dizziness
• akathisia
• influenza
• type 1 hypersensitivity reaction
• neutropenia
• decreased appetite

This medication must be stored in a tightly closed container to prevent exposure to air and moisture. It is crucial to maintain the storage temperature between 1 degree to 30 degrees Celsius at room temperature to safely preserve the effect of the medication.

Appearance

Purple oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle