Encorate Chrono 200 mg

Description

Indications

Encorate Chrono is prescribed for the treatment of 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 in managing bipolar disorder and as a prophylactic treatment for migraines.

Use this medication only as directed by a registered physician.

Composition

• Sodium Valproate Tablet: Each enteric-coated tablet contains Sodium Valproate BP 200 mg.
• Sodium Valproate Syrup: Each 5 ml of syrup contains Sodium Valproate BP 200 mg.
• Sodium Valproate Controlled Release Tablets:
  • 200 mg: Contains Sodium Valproate BP 133.2 mg and Valproic Acid BP 58 mg.
  • 300 mg: Contains Sodium Valproate BP 199.8 mg and Valproic Acid BP 87 mg.
  • 500 mg: Contains Sodium Valproate BP 333 mg and 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 in Encorate Chrono, exhibits anti-epileptic properties across multiple seizure types. While the exact mechanism of action remains unclear, it is believed to work by increasing the levels of gamma-aminobutyric acid (GABA) in the brain, which helps to prevent seizures.

Dosage & Administration

• Oral Administration:
  • Tablets may be taken once or twice daily, while the syrup should be administered in divided doses.
• For Epilepsy:
  • Adults: Start with 600 mg per day in two divided doses. Increase by 200 mg per day at three-day intervals, up to a maximum of 2.5 g daily. The usual maintenance dose is 1-2 g daily (20-30 mg/kg per day).
  • Children (above 20 kg): Initial dose of 400 mg per day in divided doses, with adjustments as needed (20-30 mg/kg per day, max 35 mg/kg per day).
  • Children (below 20 kg): Start with 20 mg/kg per day in divided doses.
  • For Febrile Convulsions: 20-30 mg/kg per day, divided into three doses.
• For Bipolar Disorder:
  • Start with 600 mg daily (20-30 mg/kg per day) in 2-3 divided doses. Maintenance dose ranges between 1000-2000 mg per day.
• For Migraine Prevention:
  • Typical dosage is 400-600 mg per day. Some individuals may require 1000-1500 mg per day.
• Injection:
  • Adults: Administer via slow intravenous injection over 3-5 minutes. The dose ranges from 400-800 mg (up to 10 mg/kg), followed by continuous or repeated infusion up to a maximum of 2500 mg/day.
  • Children: Initial dose of 20-30 mg/kg/day, with a maximum of 40 mg/kg/day. It can be administered via slow IV injection or infusion with compatible diluents (e.g., 0.9% Sodium Chloride or 5% Dextrose injection).

Use this medication only as directed by a registered physician.

Drug Interactions Encorate Chrono may inhibit the metabolism of various drugs. It has significant interactions with medications such as Phenobarbital, Phenytoin, Warfarin, and Aspirin, which may require dose adjustments.

Contraindications Sodium Valproate is contraindicated in individuals with known hypersensitivity to the drug and those with liver dysfunction. It is not recommended for use during pregnancy and in women of childbearing potential unless absolutely necessary.

Side Effects Common side effects include loss of appetite, nausea, and vomiting, which can be minimized by using enteric-coated tablets. Some patients may experience sedation, ataxia, or tremors, which often subside with dose reduction. Occasionally, rashes, hair loss, and increased appetite have been observed.

Liver enzyme levels may become elevated in up to 40% of patients, often without symptoms during the initial months of treatment. Rarely, severe hepatitis, which may be fatal, can occur. Infants under two years with additional medical conditions or those taking multiple anti-epileptic medications are at higher risk of liver damage, acute pancreatitis, and hyperammonemia.

Pregnancy & Lactation Sodium Valproate crosses the placenta, and first-trimester exposure has been linked to neural tube defects such as anencephaly and spina bifida in newborns. Pregnant women receiving this medication should undergo screening for serum alpha-fetoprotein. Sodium Valproate is also excreted in breast milk, though it generally poses no significant risk to the nursing infant.

Precautions & Warnings

• Liver function should be closely monitored before starting treatment and during the first six months, particularly in high-risk patients.
• Ensure no risk of bleeding disorders before initiating treatment or undergoing major surgery.
• Use cautiously in patients with renal impairment, systemic lupus erythematosus, or those who are pregnant or breastfeeding.
• A ketone metabolite of Sodium Valproate may lead to false-positive urine ketone test results.
• Abrupt discontinuation should be avoided to prevent withdrawal seizures.
• This medication should not be used during pregnancy or in women of childbearing potential unless necessary.

Therapeutic Class Primary anti-epileptic drugs

Storage Conditions

• Store below 30°C.
• Protect from light.
• Keep out of reach of children.