Epilex

Description

Epilex Tablet: Uses, Dosage, and Important Information

Epilex Tablet, containing sodium valproate (valproic acid), is a medication primarily used to treat various types of epilepsy. It’s also prescribed for other conditions.

What is Epilex Tablet Used For?

Epilex Tablet is used to treat:

• Epilepsy:
  • Partial seizures: Simple and complex
  • Generalized seizures: Absence seizures (petit mal), tonic-clonic seizures (grand mal), myoclonic seizures, atonic seizures, and mixed seizure types.
• Migraine: To help prevent migraine headaches (not for acute treatment).
• Bipolar Disorder: For the treatment of manic episodes.
• Other conditions (less common indications, your doctor will advise if appropriate):
  • Anxiety disorder
  • Post-traumatic stress disorder (PTSD)
  • Febrile convulsions
  • Anorexia nervosa
  • Panic attacks

How to Take Epilex Tablet

Your doctor will determine the correct dose for you. Doses are typically adjusted based on your response to the medication.

Adult Dosage

• Complex Partial Seizures (alone or with other seizure types):
  • Starting Dose: 10-15 mg per kg of body weight per day.
  • Adjustment: Your doctor may increase the dose by 5-10 mg/kg/day weekly, up to a maximum of 60 mg/kg/day.
• Simple & Complex Absence Seizures (alone or with other seizure types):
  • Starting Dose: 15 mg per kg of body weight per day, divided into doses every 6-12 hours.
  • Adjustment: Your doctor may increase the dose by 5-10 mg/kg/day weekly, up to a maximum of 60 mg/kg/day.
• Migraine Prevention:
  • Typical Dose: 250 mg twice daily.
  • Adjustment: Your doctor will adjust the dose based on your response, but do not exceed 1000 mg per day.
• Bipolar Mania:
  • Typical Dose: 750 mg per day, divided into doses.
  • Adjustment: The dose will be adjusted rapidly to achieve the desired effect, not to exceed 60 mg/kg/day.

Use in Children

• Under 10 years: The safety and effectiveness of Epilex Tablet in children under 10 years old have not been established.
• Complex Partial Seizures (10 years and older):
  • Starting Dose: 10-15 mg per kg of body weight per day.
  • Adjustment: Your doctor may increase the dose by 5-10 mg/kg/day weekly, up to a maximum of 60 mg/kg/day.
• Simple & Complex Absence Seizures (10 years and older):
  • Typical Dose: 250 mg twice daily.
  • Adjustment: Your doctor will adjust the dose based on your response, up to a maximum of 1000 mg per day.

Important Dosing Considerations

• Liver Problems: If you have hepatic impairment (liver problems), your doctor will prescribe lower doses. Epilex Tablet is contraindicated if you have severe liver impairment.
• Kidney Problems: No dose adjustment is typically needed for kidney impairment.
• Administration: Taking Epilex Tablet with meals can help reduce stomach upset. Starting with a low dose and using enteric-coated formulations can also help with gastrointestinal side effects.

When Not to Take Epilex Tablet (Contraindications)

Do not take Epilex Tablet if you have:

• A pre-existing or family history of liver problems or active liver disease.
• Porphyria (a genetic blood disorder).
• Mitochondrial disorders or urea cycle disorders.
• Severe hepatic impairment.
• Pregnancy.

Important Precautions and Warnings

• Liver Toxicity: There is an increased risk of liver damage, especially in children under 2 years old, or those with congenital metabolic disorders, organic brain disease, or severe seizure disorders.
• Monitor for Side Effects:
  • Excessive sleepiness, decreased food/fluid intake: Your doctor may decrease your dose or stop the medication.
  • Hyperammonemic encephalopathy: If you experience unexplained lethargy, vomiting, or changes in mental status, your doctor will check your ammonia levels.
  • Pancreatitis: Seek medical attention immediately if you have signs of pancreatitis (severe abdominal pain, nausea, vomiting, loss of appetite).
  • Blood and Liver Toxicity: Your doctor will monitor your liver function before and during the first 6 months of treatment, and your blood cell count (including platelets) before starting therapy or surgery, and if you experience unusual bruising or bleeding.
  • Mental Health Changes: Monitor for any unusual behavior, including suicidal thoughts or actions, during and after treatment.
• Gradual Withdrawal: Do not stop taking Epilex Tablet suddenly. Your doctor will gradually reduce your dose or help you transition to another medication if needed.
• Bone Health: If you are immobilized or have insufficient sun exposure or calcium intake, your doctor may recommend vitamin supplements.
• Infections: Be cautious if you have HIV or cytomegalovirus (CMV) infection.
• Lactation: Discuss with your doctor if you are breastfeeding.

Potential Side Effects

Like all medications, Epilex Tablet can cause side effects.

Very Common (More than 10% of people)

• Nausea
• Headache
• Increased bleeding time, low platelet count (thrombocytopenia)
• Tremor
• Hair loss (alopecia)
• Weakness (asthenia)
• Infection
• Drowsiness (somnolence)
• Blurred vision (amblyopia), double vision (diplopia)
• Diarrhea, indigestion (dyspepsia), vomiting
• Dizziness, nystagmus (involuntary eye movements), tinnitus (ringing in ears)

Common (1% to 10% of people)

• Lack of coordination (ataxia)
• Increased appetite
• Rash
• Abdominal pain
• Back pain
• Mood changes, anxiety, confusion
• Abnormal gait (walking)
• Numbness or tingling (paresthesia)
• Hallucinations, catatonia
• Difficulty speaking (dysarthria), tardive dyskinesia (involuntary movements)
• Vertigo
• Irregular menstrual periods
• Weight gain

Other Potential Side Effects (Frequency Not Defined)

• Anorexia (loss of appetite)
• Acute pancreatitis (inflammation of the pancreas, can be life-threatening)
• Liver toxicity
• High ammonia levels in the blood (hyperammonemia)
• Weight loss
• Fractures, osteoporosis, osteopenia, decreased bone mineral density
• Cerebral pseudoatrophy (brain changes)

How Epilex Tablet Works (Mechanism of Action)

Valproate is thought to work by increasing levels of a natural calming chemical in the brain called gamma-aminobutyric acid (GABA), which helps reduce abnormal electrical activity that can lead to seizures.

Drug Interactions

Epilex Tablet can interact with other medications, which can affect how they work or increase the risk of side effects. Tell your doctor about all medications you are taking, including over-the-counter drugs and herbal supplements.

Increased Risk of Toxicity/Side Effects with:

• Bupropion (increased risk of toxicity)
• Mefloquine (increased risk of convulsions)
• Pivmecillinam, pivampicillin (increased risk of carnitine deficiency)
• Carbamazepine (increased risk of liver toxicity and carbamazepine toxicity, decreased valproic acid levels)
• Aspirin, felbamate (increased valproic acid levels)
• Olanzapine (increased risk of liver toxicity)
• Phenobarbital, nimodipine, nifedipine, lamotrigine, zidovudine, amitriptyline, nortriptyline, benzodiazepines (increased levels of these drugs)
• Clonazepam (increased risk of absence status epilepticus)
• Topiramate (increased risk of high ammonia levels)
• Highly protein-bound drugs (increased free valproic acid levels)

Decreased Valproic Acid Levels with:

• Carbapenems (antibiotics – concurrent use is not recommended and can be potentially fatal)
• Rifampicin
• Phenytoin
• Phenobarbital (or primidone)
• Certain anti-cancer drugs (antineoplastic drug regimens)
• Ethosuximide (decreased valproic acid levels, increased ethosuximide levels)

Avoid if Possible:

• Carbapenems: Avoid concurrent use due to potentially fatal decrease in valproate levels.
• Salicylates (e.g., aspirin): Avoid in children under 3 years due to increased risk of liver toxicity.
• Cosyntropin: Increased risk of liver toxicity.
• Ethanol (alcohol): May increase central nervous system depression.

Please Note: This information is for general knowledge and is not a substitute for professional medical advice. Always consult your doctor or pharmacist for personalized guidance regarding your medication. Epilex 500mg Tablet is manufactured by Abbott India Ltd. and is available in Nepal.