Zefretol 400 Mg Tablet (10 Tab)

ZEFRETOL 400 MG TABLET

Zefretol 400 mg Tablet is an anti-epileptic medication manufactured by Sun Pharma Laboratories Ltd., used to manage seizures.

• Name:

  • Brand Name: ZEFRETOL 400 MG TABLET
  • Common Name: Eslicarbazepine (as Eslicarbazepine acetate)

• Composition:

  • Each tablet contains 400 mg of Eslicarbazepine acetate, which is a prodrug that is activated to eslicarbazepine. This active component stabilizes the inactive state of voltage-gated sodium channels in neurons, reducing excitability and repetitive firing that can lead to seizures. It may also modulate calcium and potassium channels.

• Uses: Zefretol 400 mg Tablet is primarily prescribed for the treatment of epilepsy. Specifically, it is used for:

  • Reducing the frequency and severity of partial-onset seizures in adults with epilepsy.
  • Managing seizures that originate from a specific area of the brain.
  • Adjunctive therapy (used alongside other anti-epileptic medicines) to improve their effectiveness in controlling partial-onset seizures.
  • As monotherapy in adults newly diagnosed with epilepsy.

• Dosage and Administration:

  • Zefretol 400 mg Tablet is taken orally, typically once daily, with or without food.
  • Tablets should be swallowed whole with a glass of water; they should not be crushed, broken, or chewed.
  • It is crucial to take the medicine regularly at the same time each day to maintain its effect and avoid stopping it suddenly without consulting a doctor, as this may increase seizure frequency.
  • The initial dosage for adults may be 400 mg once daily, with potential to start at 800 mg once daily if needed. Dosage can be increased in weekly increments of 400 mg to 600 mg, based on clinical response, to a recommended maintenance dosage of 800 mg to 1600 mg once daily.

• Side Effects:

  • Common Side Effects: Dizziness, drowsiness, headache, nausea, vomiting, rash, blurred or double vision, fatigue, balance disorder (ataxia), decreased appetite, and hyponatremia (low sodium levels in blood).
  • Serious Side Effects: Allergic reactions (rashes, hives, swelling, difficulty breathing/swallowing), severe skin reactions, liver problems, and suicidal thoughts or behavior.

• Precautions:

  • Pregnancy: Use with caution; may be unsafe. Consult a doctor.
  • Breastfeeding: Not recommended, as it may be excreted in human milk and affect the nursing infant.
  • Liver/Kidney Impairment: Use with caution in patients with liver or kidney problems; not recommended in severe cases.
  • Alcohol: Avoid or limit alcohol consumption as it may increase the risk of side effects.
  • Driving & Operating Machinery: May cause dizziness or drowsiness; avoid these activities until you know how the medicine affects you.
  • Drug Interactions: May interact with other anti-epileptic medicines (e.g., carbamazepine, phenytoin), mood stabilizers (e.g., valproate, lamotrigine), and statins, potentially reducing their effectiveness or increasing side effects.
  • Allergies: Contraindicated in individuals with known hypersensitivity to Eslicarbazepine acetate, oxcarbazepine, or other carboxamide derivatives.
  • Heart Conditions: Contraindicated in patients with second or third-degree atrioventricular (AV) block.

• Storage:

  • Store at room temperature below 30°C.
  • Keep the bottle tightly sealed to guard against moisture.
  • Keep away from direct sunlight and heat.
  • Keep out of reach of children.

What is ZEFRETOL 400 MG TABLET used for?

ZEFRETOL 400 MG TABLET, which contains Eslicarbazepine (400 mg), is primarily used to manage partial-onset seizures in adults with epilepsy. It can be prescribed as the sole treatment (monotherapy) for newly diagnosed adults or taken alongside other anti-epileptic medications to help reduce the frequency and severity of seizures.

How does ZEFRETOL 400 MG TABLET work?

The active ingredient, Eslicarbazepine, functions by stabilizing voltage-gated sodium channels in nerve cells in an inactive state. This reduces the excitability of these cells, thereby decreasing the likelihood of repetitive firing that can lead to seizures. It may also influence calcium and potassium channels, further contributing to seizure control.

What is the usual dosage for ZEFRETOL 400 MG TABLET?

The initial adult dosage is typically 400 mg once daily, though some patients may start with 800 mg daily if greater seizure reduction is needed and the increased risk of initial side effects is acceptable. The dose can be increased weekly by 400-600 mg based on response, with a recommended maintenance dose of 800-1600 mg once daily. For monotherapy, 800 mg/day may be considered if 1200 mg/day is not tolerated, and for adjunctive therapy, 1600 mg/day might be used if 1200 mg/day is insufficient. Always take the tablet whole with a glass of water, without crushing, breaking, or chewing it, preferably at the same time each day.

What are the possible side effects of ZEFRETOL 400 MG TABLET?

Common side effects include dizziness, drowsiness, headache, nausea, vomiting, skin rash, double vision, loss of muscle control (ataxia), and low sodium levels in the blood (hyponatremia). Most of these are temporary and often resolve on their own. More serious but rare side effects, including severe skin reactions and suicidal thoughts or behavior, have been observed with related medications and should be discussed with your doctor if they occur.

Is ZEFRETOL 400 MG TABLET safe during pregnancy or breastfeeding?

During Pregnancy: ZEFRETOL 400 MG TABLET should be used with caution during pregnancy. It has been linked to an increased risk of birth defects such as spina bifida and craniofacial malformations. If you are pregnant or planning to become pregnant, continue taking the medication but consult your doctor immediately. A high dose of folic acid (5mg daily) is often recommended before and during pregnancy. This medication can also decrease the effectiveness of hormonal contraceptives. During Breastfeeding: Use with caution. Eslicarbazepine passes into breast milk in small amounts, and while it is generally considered compatible with breastfeeding, it's important to monitor the baby for increased sleepiness, poor feeding, or jaundice.

Can ZEFRETOL 400 MG TABLET be taken with other medications?

Yes, but it can interact with various medications. Other anti-epileptic drugs like carbamazepine, phenytoin, and phenobarbital may reduce the levels of eslicarbazepine in your body, potentially making it less effective. Eslicarbazepine can also speed up the breakdown of mood stabilizers like valproate and lamotrigine, decreasing their effects, and may lower the levels of cholesterol-lowering medications (statins) such as simvastatin and rosuvastatin. Additionally, it can reduce the effectiveness of hormonal birth control. Always inform your doctor about all medications, supplements, and herbal remedies you are taking, as grapefruit juice and St. John's Wort can also interact with related drugs.

What precautions should be taken while taking ZEFRETOL 400 MG TABLET?

Do not stop taking this medicine suddenly, as abrupt discontinuation can worsen seizures. Your doctor will usually recommend a gradual reduction if the medication needs to be stopped. Because ZEFRETOL 400 MG TABLET can cause dizziness or drowsiness, avoid driving or operating heavy machinery until you understand how it affects you. Regular monitoring of sodium levels is advised due to the risk of hyponatremia. Inform your doctor immediately if you experience any unusual changes in mood or behavior, including suicidal thoughts. Caution is also advised for individuals with liver or kidney impairment.

What happens if a dose of ZEFRETOL 400 MG TABLET is missed?

If you miss a dose, 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 a forgotten one. Missing doses, especially if you have epilepsy, can potentially trigger a seizure.

How should ZEFRETOL 400 MG TABLET be stored?

ZEFRETOL 400 MG TABLET should be stored in a cool and dry place, away from direct sunlight and moisture. Keep it in a tightly closed container at room temperature and prevent it from freezing. Ensure it is kept out of the reach of children.