Valex CR 300 mg

Description

Indications
Valex CR is indicated 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
• Prophylaxis of febrile convulsions
• Prevention of post-traumatic epilepsy

Additionally, Valex CR is used in the management of bipolar disorder and the prevention of migraine attacks.
Always follow the advice of a registered healthcare provider when using this medication.

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 200 mg tablet: Each enteric-coated controlled release tablet contains Sodium Valproate 200 mg, consisting of Sodium Valproate BP 133.2 mg and Valproic Acid BP 58 mg.
• Sodium Valproate controlled release 300 mg tablet: Each enteric-coated controlled release tablet contains Sodium Valproate 300 mg, consisting of Sodium Valproate BP 199.8 mg and Valproic Acid BP 87 mg.
• Sodium Valproate controlled release 500 mg tablet: Each enteric-coated controlled release tablet contains Sodium Valproate 500 mg, consisting of 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 500 mg of Valproic Acid.

Pharmacology
Sodium Valproate, the active ingredient in this product, exhibits anti-epileptic properties across various types of seizures. Although the exact mechanism of action is not fully understood, it is believed that its effects are due to an increase in the levels of gamma-aminobutyric acid (GABA) in the brain.

Dosage & Administration

• Oral administration:
  Sodium Valproate tablets can be taken once or twice daily, while the syrup should be administered in divided doses.

  For Epilepsy:

  • Adults: Initially, 600 mg per day in two divided doses, preferably after food. The dose may be increased by 200 mg/day at 3-day intervals, up to a maximum of 2.5 g per day in divided doses until seizure control is achieved. The usual maintenance dose is 1-2 g per day (20-30 mg/kg per day).
  • Children (over 20 kg): Initially, 400 mg per day in divided doses, increased until seizure control is achieved (typically within the range of 20-30 mg/kg per day); maximum dose of 35 mg/kg per day.
  • Children (up to 20 kg): Initially, 20 mg/kg per day in divided doses.
  • Febrile convulsion: 20-30 mg/kg/day in 3 divided doses.

  For Bipolar Disorder:

  • Adults: Start with 600 mg daily (20-30 mg/kg/day) in 2-3 divided doses. The maintenance dose is typically 1000-2000 mg per day.

  For Migraine Prophylaxis:

  • 400-600 mg daily, though some patients may require 1000-1500 mg daily.

• Injection:
  Adults: A slow intravenous injection may be given over 3-5 minutes, with a usual dose of 400-800 mg depending on body weight (up to 10 mg/kg), followed by continuous or repeated infusion up to a maximum of 2500 mg per day.
  Children: Initial dose is 20-30 mg/kg/day, with a maximum of 40 mg/kg/day. This can be given by direct slow intravenous injection or infusion using compatible diluents, such as 0.9% Sodium Chloride or 5% Dextrose.

Always follow the advice of a registered healthcare provider when using this medication.

Drug Interactions
Valex CR (Sodium Valproate) may act as a non-specific inhibitor of drug metabolism. The most significant interactions occur with medications such as Phenobarbital, Phenytoin, Warfarin, and Aspirin.

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

Side Effects
The most common side effects include anorexia, nausea, and vomiting. However, these are typically minimized when using enteric-coated tablets. CNS-related effects may include sedation, ataxia, and tremor, though these symptoms are infrequent and usually respond to a reduction in dosage. Other occasional side effects include rash, hair loss (alopecia), and increased appetite.

Valex CR may affect liver function, with elevated liver enzymes observed in up to 40% of patients, often asymptomatically during the first few months of treatment. In rare cases, severe liver damage such as fulminant hepatitis may develop. Children under 2 years old, especially those with other medical conditions or taking multiple anti-epileptic drugs, are at higher risk of hepatic injury, acute pancreatitis, and hyperammonemia.

Pregnancy & Lactation
Sodium Valproate crosses the placenta and has been associated with neural tube defects, such as anencephaly and spina bifida, in newborns when used during the first trimester of pregnancy. Pregnant women using Sodium Valproate should be offered testing for serum alpha-fetoprotein levels. Although Sodium Valproate is excreted in breast milk, breastfeeding is generally considered safe for mothers taking this medication, with no known significant risk to the child.

Precautions & Warnings
Liver function should be monitored before therapy and during the first 6 months of treatment, particularly in patients at higher risk. Ensure there is no potential for excessive bleeding before starting treatment or prior to major surgery. Caution is advised in patients with renal impairment, during pregnancy and breastfeeding, and in individuals with systemic lupus erythematosus. Valex CR may interfere with urine ketone tests as it is partially eliminated in the urine as a ketone metabolite. Sudden discontinuation of therapy should be avoided.

Valex CR is not recommended for use during pregnancy or in women of childbearing potential.

Therapeutic Class
Primary Anti-Epileptic Drugs

Storage Conditions
Store at temperatures not exceeding 30°C. Keep away from light and out of reach of children.