Proval Syrup (200mg/5ml)

Description

Proval Syrup contains sodium valproate, an anticonvulsant medication used to treat various types of seizures and bipolar disorder.

Pharmacology

Sodium valproate works through several mechanisms, including:

• Increasing levels of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter in the brain.

• Blocking voltage-dependent sodium channels, which reduces neuronal firing.

• Inhibiting histone deacetylase (HDAC) enzyme activity.

Dosage & Administration

The dosage of Proval Syrup varies depending on the condition being treated, the patient's age, and their response to the medication.

• Epilepsy:

  • Adults: The usual initial dose is 10-15 mg/kg/day, gradually increased at weekly intervals to achieve seizure control. The maximum recommended dose is 60 mg/kg/day.

  • Children: The initial dose is 15 mg/kg/day, increased in weekly intervals to 20-30 mg/kg/day. For children weighing over 20 kg, the adult dose may be used.

Proval Syrup can be taken with or without food.

Contraindications

Proval Syrup is contraindicated in patients with:

• Hypersensitivity to sodium valproate or any component of the formulation

• Significant hepatic dysfunction

Precautions & Warnings

• Hepatotoxicity: Valproate can cause liver damage, especially in children under two years old. Liver function tests should be performed before starting therapy and at frequent intervals thereafter, especially during the first six months.

• Pancreatitis: Valproate can cause pancreatitis. If symptoms such as abdominal pain, nausea, vomiting, or anorexia occur, the medication should be discontinued.

• Hyperammonemia: Valproate can cause hyperammonemia. If symptoms such as lethargy or vomiting occur, ammonia levels should be measured.

• Encephalopathy: There have been reports of encephalopathy with valproate use.

• Increased risk of bleeding: Valproate can inhibit platelet aggregation

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): DRESS, which can be fatal, has been reported with valproate.

• Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including valproate, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.

Side Effects

Common side effects of Proval Syrup include:

• Nausea

• Vomiting

• Indigestion

• Diarrhea

• Abdominal cramps

• Constipation

• Increased appetite

• Weight gain

• Transient hair loss

• Drowsiness

• Dizziness

• Headache

• Ataxia

• Tremor

• Dysarthria

• Blurred vision

• Diplopia

Less common side effects include:

• Skin rash

• Pruritus

• Photosensitivity

• Erythema multiforme