Ampanel 6mg Tab

AMPANEL 6MG Tablet

AMPANEL 6MG Tablet is an antiepileptic medication manufactured by Sun Pharmaceutical Industries Ltd.

• Name:

  • Common Name: Perampanel
  • Brand Name: Ampanel 6mg Tablet

• Composition:

  • Each tablet contains Perampanel 6 mg as the active ingredient.

• Uses: AMPANEL 6MG Tablet is used to treat epilepsy and seizures. It is prescribed for:

  • Partial-onset seizures, with or without secondarily generalized seizures, in patients aged 4 years and older.
  • Primary generalized tonic-clonic seizures in adults and adolescents aged 12 years and older. It works by blocking specific glutamate receptors (AMPA receptors) in the brain, which helps to regulate and suppress excessive nerve cell activity, thereby reducing the frequency and intensity of seizures.

• Dosage and Administration:

  • AMPANEL 6MG Tablet should be taken orally, with or without food, at the same time each day, preferably before going to bed.
  • The tablet should be swallowed whole with a glass of water; do not chew, crush, or break it.
  • Dosage and duration are determined by a doctor based on individual response and tolerance.
  • It is crucial not to stop taking this medicine suddenly without consulting a doctor, as abrupt discontinuation can lead to an increase in seizure frequency and withdrawal symptoms like anxiety, irritability, and sleeplessness.

• Side Effects:

  • Common Side Effects: Dizziness, sleepiness (somnolence), fatigue, anger, nausea, weight gain, vertigo, impaired coordination, altered walking, and balance disorders (loss of balance).
  • Serious Side Effects: Psychiatric and behavioral reactions such as aggression, hostility, irritability, anger, and suicidal or violent thoughts. Rare but serious skin reactions like Stevens-Johnson syndrome and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported.

• Precautions:

  • Alcohol: Avoid consuming alcohol as it can worsen side effects like drowsiness and dizziness and may increase the risk of seizures.
  • Pregnancy and Breastfeeding: Not recommended during pregnancy or for women planning pregnancy. It is probably unsafe during breastfeeding as the drug may pass into breast milk and harm the baby. Consult a doctor.
  • Liver and Kidney Impairment: Use with caution in patients with liver or kidney problems; dose adjustments or additional monitoring may be required.
  • Psychiatric Conditions: Use with caution in patients with a history of depression, aggression, suicidal thoughts, or substance abuse, as perampanel may worsen these conditions.
  • Driving and Operating Machinery: May cause dizziness and sleepiness, affecting the ability to drive or operate heavy machinery. Avoid these activities until you know how the medicine affects you.
  • Drug Interactions: Inform your doctor about all other medications being taken, including other antiepileptics (e.g., carbamazepine, phenytoin), rifampicin, St. John's Wort, ketoconazole, and hormonal contraceptives, as interactions may occur.

• Storage:

  • Store in a cool and dry place below 30°C.
  • Protect from light and moisture.
  • Keep out of the sight and reach of children.

AMPANEL 6MG TAB contains the active ingredient Perampanel, an anti-epileptic medication used to manage seizures.

What is AMPANEL 6MG TAB used for?

AMPANEL 6MG TAB (Perampanel) is used to treat certain types of epilepsy. It is approved as an adjunctive therapy for partial-onset seizures, with or without secondary generalization, in patients aged 4 years and older, and for primary generalized tonic-clonic seizures in patients aged 12 years and older.

How does AMPANEL 6MG TAB work?

Perampanel, the active ingredient in AMPANEL 6MG TAB, works by selectively blocking AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptors in the brain. Glutamate is a major excitatory neurotransmitter. By antagonizing these receptors, Perampanel reduces the excessive electrical activity in nerve cells that can lead to seizures.

What is the usual dosage of AMPANEL 6MG TAB?

The usual starting dosage for adults and children aged 4 years and older (for partial-onset seizures) or 12 years and older (for generalized tonic-clonic seizures) is 2 mg once daily, taken at bedtime. The dose is typically increased by 2 mg daily at weekly intervals, based on clinical response and tolerability. The recommended maintenance dose often ranges from 8 mg to 12 mg once daily, though some patients may respond to 4 mg daily. Dosage adjustments may be necessary if taken with certain other medications or in patients with liver impairment.

What are the possible side effects of AMPANEL 6MG TAB?

Common side effects include dizziness, sleepiness (somnolence), fatigue, irritability, nausea, weight gain, vertigo (a sensation of spinning), problems with balance or coordination, headache, anxiety, vomiting, and abdominal pain.

More serious side effects can include severe psychiatric and behavioral reactions such as aggression, hostility, anger, and even homicidal ideation or threats. Suicidal thoughts or behaviors have also been reported. Rare but serious skin reactions (like DRESS syndrome) and issues with blood or liver have also occurred.

Is AMPANEL 6MG TAB safe during pregnancy or breastfeeding?

Pregnancy: AMPANEL (Perampanel) is in Pregnancy Category C, meaning caution is advised, and its use during pregnancy should only occur if the potential benefits outweigh the potential risks. Animal studies have shown potential for fetal harm. Women of child-bearing age should discuss contraception with their doctor. A pregnancy registry (North American Antiepileptic Drug Pregnancy Registry) is available to collect information on the safety of anti-seizure medicines during pregnancy.

Breastfeeding: Perampanel has been found in the breast milk of animals, but it is not known if it passes into human breast milk. It is important to discuss the risks and benefits with your healthcare provider, and if breastfeeding, the infant should be monitored for drowsiness and weight gain.

Can AMPANEL 6MG TAB be taken with other medications?

Yes, but with caution, as Perampanel can interact with other medications. It may reduce the effectiveness of hormonal birth control, especially those containing levonorgestrel, and additional non-hormonal contraception is recommended. Taking Perampanel with alcohol or other CNS depressants (e.g., antihistamines, sedatives, prescription pain medications) can increase sedative effects like dizziness and sleepiness. Certain other anti-epileptic drugs (like carbamazepine, phenytoin, oxcarbazepine) and other medications (like rifampin, St. John's Wort) can decrease the levels of Perampanel in the body, potentially reducing its effectiveness.

What precautions should be taken while taking AMPANEL 6MG TAB?

Patients and caregivers should closely monitor for any new or worsening psychiatric or behavioral changes, such as aggression, hostility, anger, anxiety, irritability, or suicidal thoughts, particularly during the initial treatment period and with dose increases. Due to the potential for dizziness and sleepiness, avoid driving or operating heavy machinery until you understand how the medication affects you. Do not stop taking AMPANEL suddenly without consulting your doctor, as this can increase the frequency of seizures. Use with caution if you have liver or kidney problems, or a history of alcohol or drug abuse. There is an increased risk of falls, especially in elderly patients.

What happens if a dose is missed?

If you miss a single dose of AMPANEL, you can take it as soon as you remember, or you can skip the missed dose and resume your regular dosing schedule the following day. Do not take two doses at the same time or extra doses. If you miss more than one day of dosing, it is important to contact your healthcare provider for advice.

How should AMPANEL 6MG TAB be stored?

AMPANEL tablets should be stored at room temperature, typically between 68°F to 77°F (20°C to 25°C), away from heat, moisture, and direct light. If you have the oral suspension, store it below 86°F (30°C) and do not freeze it. The oral suspension should be used within 90 days after the bottle is first opened. Always keep this medicine out of the reach of children.