Encorate Chrono 500 mg

Description

Indications

Encorate Chrono is prescribed for managing various forms of epilepsy, including:

• Partial seizures
• Absence seizures (petit mal)
• Generalized tonic-clonic seizures (grand mal)
• Myoclonic seizures
• Atonic seizures
• Mixed seizures involving absence episodes
• Prevention of febrile convulsions
• Prevention of post-traumatic epilepsy

Additionally, Encorate Chrono is used for treating bipolar disorder and preventing migraines.

Composition

• Sodium Valproate Tablet: Each enteric-coated tablet contains Sodium Valproate BP 200 mg.
• Sodium Valproate Syrup: Each 5 ml syrup contains Sodium Valproate BP 200 mg.
• Sodium Valproate Controlled Release Tablets:
  • 200 mg: Contains Sodium Valproate BP 133.2 mg & Valproic Acid BP 58 mg.
  • 300 mg: Contains Sodium Valproate BP 199.8 mg & Valproic Acid BP 87 mg.
  • 500 mg: Contains Sodium Valproate BP 333 mg & Valproic Acid BP 145 mg.
• Sodium Valproate Injection: Each 5 ml injectable solution contains Sodium Valproate BP equivalent to Valproic Acid 500 mg.

Pharmacology Sodium Valproate, the active ingredient, possesses broad-spectrum anti-epileptic properties. While its exact mechanism of action is not fully understood, it is believed to work by increasing gamma-aminobutyric acid (GABA) levels in the brain, thereby reducing seizure activity.

Dosage & Administration

• Oral Administration:
  • Epilepsy:
    • Adults: Initial dose of 600 mg per day in two divided doses, increased by 200 mg/day every three days until seizure control is achieved. Maximum dose: 2.5 g/day. Maintenance dose: 1-2 g/day (20-30 mg/kg daily).
    • Children over 20 kg: Starting dose of 400 mg per day in divided doses, gradually increased to a range of 20-30 mg/kg per day. Maximum: 35 mg/kg per day.
    • Children up to 20 kg: Initial dose of 20 mg/kg per day in divided doses.
  • Febrile Convulsions: 20-30 mg/kg/day in three divided doses.
  • Bipolar Disorder: Initial dose of 600 mg per day (20-30 mg/kg/day) in 2-3 divided doses. Maintenance dose: 1000-2000 mg per day.
  • Migraine Prevention: 400-600 mg per day, with some patients requiring up to 1000-1500 mg per day.
• Intravenous Administration:
  • Adults: Administered via slow IV injection over 3-5 minutes, typically 400-800 mg (up to 10 mg/kg), followed by continuous or repeated infusion with a maximum daily dose of 2500 mg.
  • Children: Initial dose of 20-30 mg/kg/day, with a maximum of 40 mg/kg/day. Administered through direct slow IV injection or infusion using compatible diluents such as 0.9% Sodium Chloride or 5% Dextrose injection.

Drug Interactions Sodium Valproate acts as a non-specific inhibitor of drug metabolism and may interact with medications such as Phenobarbital, Phenytoin, Warfarin, and Aspirin.

Contraindications Sodium Valproate should not be used in individuals with known hypersensitivity to the drug or those with liver dysfunction. Its use is also restricted in pregnancy and in women of childbearing potential unless absolutely necessary.

Side Effects Common side effects include anorexia, nausea, and vomiting, which are minimized with enteric-coated tablets. Other possible effects include sedation, ataxia, tremors, rash, alopecia, and increased appetite. Liver enzyme elevation occurs in approximately 40% of patients but is often asymptomatic. In rare cases, severe hepatic failure, pancreatitis, and hyperammonemia may develop, particularly in children under two years of age receiving multiple anti-epileptic drugs.

Pregnancy & Lactation Sodium Valproate crosses the placenta, and first-trimester exposure has been associated with neural tube defects such as spina bifida and anencephaly. Pregnant women should undergo serum alpha-fetoprotein testing. The drug is excreted in breast milk but is generally considered safe for breastfeeding.

Precautions & Warnings

• Liver function should be monitored before and during the first six months of treatment, especially in high-risk patients.
• Bleeding potential should be assessed before treatment initiation and major surgeries.
• Caution is advised in individuals with renal impairment, systemic lupus erythematosus, pregnancy, and breastfeeding.
• Sodium Valproate is partially excreted in the urine as a ketone metabolite, which may cause false-positive urine ketone test results.
• Abrupt discontinuation should be avoided to prevent seizure recurrence.
• The use of Sodium Valproate during pregnancy and in women of childbearing age should be limited to cases where no alternative treatment is available.

Therapeutic Class Primary anti-epileptic drugs

Storage Conditions Store below 30°C, away from light and moisture. Keep out of reach of children.