Brivazen 100 Mg Tablet (10 Tab)

BRIVAZEN 100 MG TABLET (10 TAB) by INTAS PHARMACEUTICALS LTD.

Brivazen 100 mg Tablet is an anti-epileptic medication manufactured by Intas Pharmaceuticals Ltd., primarily used in the management of epilepsy.

• Composition Each tablet contains Brivaracetam 100 mg as the active ingredient.

• Uses Brivazen 100 mg Tablet is prescribed for the treatment of seizures (fits) in individuals with epilepsy. It is specifically effective for partial-onset seizures, which involve abnormal electrical activity in only one part of the brain, in patients aged one month and older. It can be used alone (monotherapy) or in combination with other anti-epileptic drugs (adjunctive therapy). The medication works by stabilizing abnormal electrical signals in the brain, binding to synaptic vesicle protein 2A (SV2A) to reduce the spread of electrical activity that causes seizures.

• Dosage and Administration Take Brivazen 100 mg Tablet orally, as directed by your doctor. The tablet should be swallowed whole with a glass of water; it must not be crushed, chewed, or broken. It can be taken with or without food, but it is recommended to take it at the same time each day to maximize its benefits. The dosage, which typically ranges from 50 mg to 200 mg per day for adults, and is weight-dependent for children, will be determined and gradually adjusted by your physician. Do not stop taking this medicine abruptly, as sudden withdrawal can worsen seizures.

• Side Effects

  • Common Side Effects: Drowsiness, dizziness, fatigue, nausea, vomiting, headache, constipation, irritability, mood changes, flu-like symptoms, anxiety, insomnia (difficulty sleeping), infections of the nose and throat (common cold), cough, decreased appetite, restlessness, and agitation.
  • Serious Side Effects: Thoughts of self-harm or suicide and behavioral changes.

• Precautions

  • Do not stop treatment abruptly without consulting your doctor, as this may lead to an increase in seizure frequency.
  • Avoid driving or operating heavy machinery if you experience dizziness, drowsiness, or lack of coordination.
  • Inform your doctor immediately if you experience any unusual behavior, mood changes, or thoughts of harming yourself.
  • Avoid alcohol consumption while on this medication, as it may enhance side effects like dizziness and drowsiness.
  • Pregnancy and Breastfeeding: Brivazen 100 mg Tablet is generally not recommended during pregnancy or breastfeeding due to limited safety data and the potential for the medicine to pass into breast milk. Consult your doctor for advice.
  • Liver/Kidney Impairment: Use with caution in patients with liver disease, as dose adjustments may be necessary. It is not recommended for patients with severe liver problems or end-stage renal disease. Inform your doctor if you have kidney problems.
  • Drug Interactions: Inform your doctor about all prescription, over-the-counter, herbal, and vitamin supplements you are currently taking to avoid potential interactions. It may interact with medications such as rifampicin, St. John's wort, certain antiepileptic drugs (e.g., carbamazepine, phenytoin), and central nervous system depressants (e.g., opioids, antidepressants, antianxiety medicines).
  • Pediatric Use: While used in patients one month of age and older for partial-onset seizures, it is generally not recommended for children under 4 years of age.

• Storage Store Brivazen 100 mg Tablet in its original packaging at room temperature, below 30°C (or between 10ºC to 25ºC). Protect it from light and moisture, and keep it out of the reach of children and pets.

BRIVAZEN 100 MG TABLET, containing the active ingredient Brivaracetam, is an anti-epileptic medication manufactured by Intas Pharmaceuticals Ltd. It is primarily used for the management of seizures in individuals with epilepsy.

Here are some frequently asked questions about BRIVAZEN 100 MG TABLET:

What is BRIVAZEN 100 MG TABLET used for?

BRIVAZEN 100 MG TABLET is used to treat partial-onset seizures (also known as fits) in people with epilepsy. It can be prescribed for adults and children aged 1 month and older, either alone or in combination with other anti-epileptic medications.

How does BRIVAZEN 100 MG TABLET work?

Brivaracetam, the active ingredient, works by binding with high affinity to a specific protein in the brain called synaptic vesicle protein 2A (SV2A). This action helps to regulate abnormal electrical activity in nerve cells and prevents the excessive spread of electrical signals that cause seizures. It may also have additional effects on voltage-gated sodium channels and the GABAergic system, further contributing to its anti-seizure properties.

What is the usual dosage for BRIVAZEN 100 MG TABLET?

For adults and adolescents 16 years of age and older, the typical starting dose is 50 mg twice daily, with doses adjusted by your doctor based on your response and tolerability, usually ranging between 25 mg and 100 mg twice daily. For children aged 1 month to less than 16 years, the dosage is determined by a doctor and is based on body weight. The tablet should be swallowed whole with liquid, with or without food, preferably at the same time each day.

What are the possible side effects of BRIVAZEN 100 MG TABLET?

Common side effects can include drowsiness, dizziness, fatigue, nausea, and vomiting. More serious but less common side effects may involve mood and behavioral changes such as anxiety, aggression, depression, irritability, and even suicidal thoughts or actions. Rarely, serious allergic reactions like bronchospasm (difficulty breathing) and angioedema (swelling of the face, lips, tongue, or throat) have been reported. Report any concerning side effects to your doctor immediately.

Is BRIVAZEN 100 MG TABLET safe during pregnancy or breastfeeding?

During Pregnancy: BRIVAZEN 100 MG TABLET is generally not recommended during pregnancy, as animal studies have shown potential harmful effects on the developing baby. Limited human studies are available. Your doctor will carefully weigh the benefits against the potential risks before prescribing it during pregnancy.

During Breastfeeding: It is not recommended to use BRIVAZEN 100 MG TABLET while breastfeeding, as the medication may pass into breast milk, and its effects on the breastfed infant are not well-established. Consult your doctor for advice on the best way to feed your baby during treatment.

Can BRIVAZEN 100 MG TABLET be taken with other medications?

BRIVAZEN 100 MG TABLET can be used alongside other anti-epileptic drugs. However, it can interact with certain medications. For instance, its effectiveness might be reduced when taken with other antiepileptic medicines like carbamazepine and phenytoin, or certain antibiotics such as rifampicin. Additionally, combining it with central nervous system (CNS) depressants like opioids, antidepressants, or anti-anxiety medications can increase side effects such as drowsiness and sedation. Always inform your doctor about all prescription and over-the-counter medicines, supplements, and herbal products you are currently taking.

What precautions should be taken while taking BRIVAZEN 100 MG TABLET?

It is crucial not to stop taking BRIVAZEN 100 MG TABLET suddenly, as this can lead to an increase in seizure frequency or the occurrence of severe seizures (status epilepticus). Avoid consuming alcohol, as it can intensify side effects like dizziness and drowsiness. Due to potential dizziness and drowsiness, you should avoid driving or operating heavy machinery until you know how the medicine affects you. Inform your doctor if you have a history of liver or kidney problems, depression, or suicidal thoughts, as these conditions may require dose adjustments or close monitoring. Closely monitor for any new or worsening mood or behavioral changes and report them to your doctor immediately.

What happens if a dose of BRIVAZEN 100 MG TABLET is missed?

If you miss a dose of BRIVAZEN 100 MG TABLET, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one, as this may increase the risk of side effects.

How should BRIVAZEN 100 MG TABLET be stored?

BRIVAZEN 100 MG TABLET should be stored below 30°C. Keep it in its original packaging to protect it from light and moisture, and ensure it is kept out of the reach of children and pets.