Valex

Indications

Valex Vaiproate Oral is prescribed for the management 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
• Prophylaxis of Post-Traumatic Epilepsy

Additionally, Valex Vaiproate is effective in treating Bipolar Disorder and for the Prophylaxis of Migraines.

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

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 (133.2 mg Sodium Valproate BP + 58 mg Valproic Acid BP).
• Sodium Valproate Controlled Release 300 mg Tablet: Each controlled-release tablet contains 300 mg of Sodium Valproate (199.8 mg Sodium Valproate BP + 87 mg Valproic Acid BP).
• Sodium Valproate Controlled Release 500 mg Tablet: Each controlled-release tablet contains 500 mg of Sodium Valproate (333 mg Sodium Valproate BP + 145 mg Valproic Acid BP).
• Sodium Valproate Injection: Each 5 ml contains 500 mg of Sodium Valproate, equivalent to Valproic Acid BP.

Pharmacology

Sodium Valproate is known for its anti-epileptic properties across a wide range of seizures. While the exact mechanism remains unclear, it is believed to work by increasing gamma-aminobutyric acid (GABA) levels in the brain, contributing to seizure control.

Dosage & Administration

Oral Dosage:

• Adults: Begin with 600 mg daily in 2 divided doses, preferably after meals. The dose may be increased by 200 mg every 3 days, up to a maximum of 2.5 g daily until seizure control is achieved. The typical maintenance dose ranges from 1-2 g daily (20-30 mg/kg).
• Children (over 20 kg): Start with 400 mg daily, gradually increasing to 20-30 mg/kg daily (maximum 35 mg/kg).
• Children (up to 20 kg): Begin with 20 mg/kg daily, divided into multiple doses.

Febrile Convulsion: 20-30 mg/kg/day in 3 divided doses.

Bipolar Disorder: Start with 600 mg daily (20-30 mg/kg/day) in 2-3 divided doses, with a maintenance dose of 1000-2000 mg daily.

Migraine Prophylaxis: 400-600 mg daily, though some individuals may require 1000-1500 mg daily.

Injection Dosage:

• Adults: Administer slowly via intravenous injection (3-5 minutes) at 400-800 mg (up to 10 mg/kg), followed by continuous infusion up to a maximum of 2500 mg/day.
• Children: Begin with 20-30 mg/kg/day, up to 40 mg/kg/day. Can be administered via slow intravenous injection or infusion using compatible diluents such as 0.9% Sodium Chloride or 5% Dextrose.

Always follow a registered healthcare provider’s guidance for proper dosage.

Interactions

Valex Vaiproate may inhibit the metabolism of several drugs, including Phenobarbital, Phenytoin, Warfarin, and Aspirin. Close monitoring is advised when combining with these medications.

Contraindications

Sodium Valproate is contraindicated for individuals with hypersensitivity to the drug or liver dysfunction. It should be avoided during pregnancy and by women of childbearing age unless specifically advised by a healthcare provider.

Side Effects

Common side effects include:

• Gastrointestinal: Anorexia, nausea, and vomiting (which can be minimized with enteric-coated tablets).
• CNS Effects: Sedation, ataxia, and tremors (generally rare and responsive to dose adjustment).
• Other: Rash, hair loss, increased appetite, and elevated liver enzymes (in some patients). Rarely, fulminant hepatitis may occur, potentially leading to fatality. Young children and those taking multiple anti-epileptic drugs are at higher risk for liver toxicity and other severe effects like acute pancreatitis and hyperammonemia.

Pregnancy & Lactation

Sodium Valproate can cross the placenta, and exposure during the first trimester has been associated with neural tube defects such as spina bifida and anencephaly. Women who are pregnant or planning pregnancy should consult their doctor before using this medication. Sodium Valproate is also excreted in breast milk, but breastfeeding is generally considered safe under medical supervision.

Precautions & Warnings

• Monitor liver function before starting therapy and within the first six months, especially for at-risk individuals.
• Ensure no abnormal bleeding risk before starting treatment or undergoing surgery.
• Exercise caution in cases of renal impairment, pregnancy, breastfeeding, and systemic lupus erythematosus.
• Sudden withdrawal of treatment should be avoided.
• Valex may cause false results in urine ketone tests.

Therapeutic Class

• Primary Anti-Epileptic Drug

Storage Conditions

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