Encorate Chrono 300 mg

Indications

Encorate Chrono is prescribed for the treatment of various types of epilepsy, including:

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

Additionally, Encorate Chrono is indicated for the management of bipolar disorder and the prevention of 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 syrup contains Sodium Valproate BP 200 mg.
• Sodium Valproate Controlled Release 200 Tablet: Each enteric-coated controlled release tablet contains Sodium Valproate 200 mg (Sodium Valproate BP 133.2 mg & Valproic Acid BP 58 mg).
• Sodium Valproate Controlled Release 300 Tablet: Each enteric-coated controlled release tablet contains Sodium Valproate 300 mg (Sodium Valproate BP 199.8 mg & Valproic Acid BP 87 mg).
• Sodium Valproate Controlled Release 500 Tablet: Each enteric-coated controlled release tablet contains Sodium Valproate 500 mg (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 component in Encorate Chrono, possesses broad-spectrum anti-epileptic properties effective against different seizure types. Although its exact mechanism of action is not fully understood, it is believed to enhance the levels of gamma-aminobutyric acid (GABA) in the brain, which helps in stabilizing neuronal activity and preventing seizures.

Dosage & Administration

Oral Administration:
Tablets can be taken once or twice daily, while syrup should be taken in divided doses.

• Epilepsy:
  • Adults: Start with 600 mg daily in two divided doses (preferably after food). Increase by 200 mg/day every three days up to a maximum of 2.5 g per day in divided doses until seizures are controlled. The usual maintenance dose ranges between 1-2 g daily (20-30 mg/kg/day).
  • Children (>20 kg): Begin with 400 mg daily in divided doses, adjusting as needed (usual range: 20-30 mg/kg/day, maximum 35 mg/kg/day).
  • Children (≤20 kg): Start with 20 mg/kg/day in divided doses.
• Febrile Convulsions: 20-30 mg/kg/day in three divided doses.
• Bipolar Disorder: Initial dose of 600 mg daily (20-30 mg/kg/day) in 2-3 divided doses, with maintenance dosage between 1000-2000 mg per day.
• Migraine Prevention: Typically, 400-600 mg daily, but some patients may require 1000-1500 mg daily.

Intravenous Administration:

• Adults: Slow IV injection over 3-5 minutes, typically 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. Can be administered via direct slow IV injection or infusion with compatible diluents such as 0.9% Sodium Chloride or 5% Dextrose Injection.

Use this medication only as prescribed by a registered physician.

Drug Interactions

Encorate Chrono acts as a broad-spectrum inhibitor of drug metabolism, leading to significant interactions with medications such as:

• Phenobarbital
• Phenytoin
• Warfarin
• Aspirin

Contraindications

Encorate Chrono should not be used in:

• Patients with a known hypersensitivity to Sodium Valproate.
• Individuals with liver dysfunction.
• Pregnant women and women of childbearing potential unless no other alternative is available.

Side Effects

Common side effects include:

• Gastrointestinal symptoms such as anorexia, nausea, and vomiting (reduced with enteric-coated tablets).
• Central nervous system effects such as drowsiness, ataxia, and tremors (typically dose-dependent and reversible).
• Skin reactions including rash and alopecia.
• Increased appetite leading to weight gain.

Serious but rare side effects:

• Liver enzyme elevation (asymptomatic in up to 40% of patients but requires monitoring).
• Rare cases of fatal fulminant hepatitis, especially in children under two years with underlying medical conditions or on multiple anti-epileptic drugs.
• Acute pancreatitis and hyperammonemia.

Pregnancy & Lactation

Sodium Valproate crosses the placenta, and first-trimester exposure is associated with neural tube defects such as spina bifida and anencephaly. Pregnant women taking this medication should undergo serum alpha-fetoprotein screening.

Sodium Valproate is excreted in breast milk, but available data suggest it poses minimal risk to breastfeeding infants.

Precautions & Warnings

• Liver function tests should be conducted before starting therapy and regularly during the first six months, particularly in high-risk patients.
• Assess coagulation parameters before initiating treatment and prior to major surgeries.
• Caution is advised in patients with renal impairment, systemic lupus erythematosus, or those who are pregnant or breastfeeding.
• Sodium Valproate is partially excreted as a ketone metabolite, which may cause false-positive results in urine ketone tests.
• Abrupt discontinuation should be avoided to prevent rebound seizures.
• Should not be used during pregnancy or in women of childbearing age unless absolutely necessary.

Therapeutic Class

Primary anti-epileptic drugs.

Storage Conditions

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