Valex 200 mg

Description

Indications
Valex is used 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 seizures
• Prevention of febrile convulsions
• Prevention of post-traumatic epilepsy

In addition to its role in epilepsy management, Valex is also indicated for the treatment of bipolar disorder and the prevention of migraines.
Please use this medication as prescribed by a registered healthcare professional.

Composition

• Sodium Valproate tablet: Each enteric-coated tablet contains 200 mg of Sodium Valproate BP.
• Sodium Valproate syrup: Each 5 ml of syrup contains 200 mg of Sodium Valproate BP.
• Sodium Valproate controlled release 200 mg tablet: Each enteric-coated controlled-release tablet contains 200 mg of Sodium Valproate, which is composed of 133.2 mg of Sodium Valproate BP and 58 mg of Valproic acid BP.
• Sodium Valproate controlled release 300 mg tablet: Each enteric-coated controlled-release tablet contains 300 mg of Sodium Valproate, consisting of 199.8 mg of Sodium Valproate BP and 87 mg of Valproic acid BP.
• Sodium Valproate controlled release 500 mg tablet: Each enteric-coated controlled-release tablet contains 500 mg of Sodium Valproate, with 333 mg of Sodium Valproate BP and 145 mg of Valproic acid BP.
• Sodium Valproate injection: Each 5 ml of injectable solution contains Sodium Valproate BP, equivalent to 500 mg of Valproic Acid.

Pharmacology
The active ingredient, Sodium Valproate, is known for its anti-epileptic properties and is effective against a wide range of seizures. While the exact mechanism of action is not fully understood, it is believed to work by increasing the levels of gamma-aminobutyric acid (GABA) in the brain, which helps reduce seizure activity.

Dosage & Administration

• Oral administration:
  Sodium Valproate tablets may be taken once or twice a day. The syrup should be administered in divided doses.

  For Epilepsy:

  • Adults: Start with 600 mg daily in two divided doses, preferably after meals. The dose can be increased by 200 mg per day every 3 days until a maximum of 2.5 g daily in divided doses, as long as seizure control is achieved. The typical maintenance dose ranges from 1 to 2 g daily (20-30 mg/kg daily).
  • Children (over 20 kg): Start with 400 mg daily in divided doses, increasing until seizure control is achieved (usually in the range of 20-30 mg/kg daily). The maximum dose is 35 mg/kg daily.
  • Children (up to 20 kg): Start with 20 mg/kg daily in divided doses.
  • Febrile Convulsions: 20-30 mg/kg/day in 3 divided doses.

  For Bipolar Disorder:

  • Adults: Initially, 600 mg daily (20-30 mg/kg/day) in 2-3 divided doses, with the maintenance dose ranging from 1000 to 2000 mg per day.

  For Migraine Prophylaxis:

  • Typically 400-600 mg daily, although some individuals may require 1000-1500 mg daily.

• Injection:
  Adults: The intravenous injection should be administered slowly over 3-5 minutes, with the usual dosage being 400-800 mg depending on body weight (up to 10 mg/kg). This can be 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 administered as a direct intravenous injection or by infusion using compatible diluents like 0.9% Sodium Chloride or 5% Dextrose injections.

Always follow the advice of a registered healthcare professional.

Drug Interactions
Valex (Sodium Valproate) may inhibit the metabolism of certain drugs. Notable interactions include Phenobarbital, Phenytoin, Warfarin, and Aspirin, which may significantly alter the effectiveness of these medications.

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

Side Effects
Common side effects include anorexia, nausea, and vomiting. These symptoms are usually minimized when using enteric-coated tablets. Effects on the central nervous system may include sedation, ataxia, and tremor, though these are infrequent and typically resolve with a dosage adjustment. Other occasional side effects include rash, hair loss (alopecia), and increased appetite.

Valex may affect liver function, with elevated liver enzymes observed in up to 40% of patients. This is often asymptomatic during the first few months of treatment. In rare cases, severe liver damage, including fulminant hepatitis, may occur. Young children, particularly those under 2 years old and those taking multiple anti-epileptic drugs, are more vulnerable to liver injury, acute pancreatitis, and hyperammonemia, which are also associated with Valex use.

Pregnancy & Lactation
Sodium Valproate crosses the placenta and has been linked to 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 undergo serum alpha-fetoprotein testing. Sodium Valproate is excreted in breast milk, but breastfeeding is generally considered safe, with minimal risk to the infant.

Precautions & Warnings
Liver function tests should be performed before starting therapy and during the first 6 months, especially in patients at higher risk. Ensure there is no potential for excessive bleeding before starting treatment or before undergoing major surgery. Caution is required in patients with renal impairment, during pregnancy, while breastfeeding, and in those with systemic lupus erythematosus. Valex can affect the results of urine ketone tests due to its partial elimination in the urine as a ketone metabolite. Sudden discontinuation of therapy should be avoided.

Sodium Valproate is not recommended during pregnancy or in women of childbearing potential unless the benefits outweigh the risks.

Therapeutic Class
Primary Anti-Epileptic Drugs

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