Epival (500mg/5ml) 1 Injection for IV Infusion

The mechanism of action of Sodium Valproate involves multiple pathways in the brain. Primarily, it enhances gamma-aminobutyric acid (GABA) activity, an inhibitory neurotransmitter, by increasing the brain's GABA levels and binding to specific GABA receptors, thereby promoting neuronal hyperpolarization and reducing neuronal excitability. Sodium Valproate also blocks voltage-gated sodium channels, inhibiting the repetitive firing of action potentials and decreasing the propagation of seizure activity. Additionally, it may modulate the activity of glutamate, an excitatory neurotransmitter, by reducing its release and inhibiting certain glutamate receptors, which further contributes to its anticonvulsant effects. These combined actions help to stabilize neuronal membranes and prevent the excessive firing of neurons, ultimately reducing the occurrence of seizures.

Anticonvulsant/Antiepileptic

injection

The following are the uses of Sodium Valproate 500mg injection:

• Used for treating seizures and epilepsy, helping to control and prevent frequent seizures.
• Used for managing manic episodes in bipolar disorder, stabilizing mood and reducing symptoms.
• Used for preventing migraine headaches by regulating brain activity.
• Used for treating specific movement disorders like chorea to control involuntary movements.
• Used for certain types of pain management, particularly neuralgia, by calming overactive nerves.
• Used for specific psychiatric disorders as prescribed by a specialist.
• Used for certain behavioral disorders in children, aiding in impulse control and mood stabilization.

In the case of an overdose of Sodium Valproate 500mg injection, the individual may experience symptoms such as extreme drowsiness, loss of coordination, and a significant decrease in breathing rate. It is important to seek medical assistance promptly and provide the healthcare professional with information regarding the estimated amount ingested. They may administer activated charcoal to prevent further absorption and closely monitor vital signs to ensure the patient's safety. Prompt medical intervention is vital in managing the potential risks associated with such an overdose.

In the case of a missed dose of Sodium Valproate 500mg injection, it is important to administer the medication as soon as you remember. If it is almost time for the next scheduled dose, skip the missed dose and continue with the regular dosing schedule. Do not double the dose to make up for a missed one. If you miss multiple doses, contact your healthcare provider for guidance, as they may recommend adjusting the dosage or provide specific instructions to ensure the medication's effectiveness. It is crucial to maintain a consistent medication routine to achieve optimal seizure control.

To administer Sodium Valproate 500mg injection, draw the prescribed dose into a syringe and inject it intramuscularly or intravenously, ensuring the injection site is clean, and follow the dosage instructions provided by your healthcare professional for the prescribed frequency and duration of treatment.

Following are the conditions or situations when Sodium Valproate 500mg injection should not be administered:

• Should not be used in individuals with a known hypersensitivity or allergy to Sodium Valproate or any other valproic acid derivatives.
• Contraindicated in patients with a history of liver disease, especially those with severe liver impairment.
• Not recommended for individuals with a personal or family history of urea cycle disorders or severe mitochondrial disorders.
• Should not be used in patients with known or suspected genetic disorders affecting the urea cycle or mitochondrial function.
• Contraindicated in individuals with a history of pancreatitis, especially if it is related to previous valproate use.
• Not suitable for patients with a history of blood disorders or low blood cell counts.
• Should not be administered to individuals with a history of brain or spinal cord disorders.
• Contraindicated during pregnancy unless the potential benefits outweigh the risks, as it may cause harm to the developing fetus.

The side effects of Sodium Valproate 500mg Injection may include:

• Nausea and vomiting
• Drowsiness or fatigue
• Tremors or shaking
• Weight gain
• Hair loss or thinning
• Liver problems (elevated liver enzymes)
• Skin rashes or itching
• Changes in mood or behavior, including depression and suicidal thoughts

Following are the precautions and warnings for Sodium Valproate 500mg injection:

• Not recommended for individuals with known hypersensitivity or allergy to Sodium Valproate or related compounds.
• Patients with liver or pancreatic disorders should be closely monitored as Sodium Valproate can affect these organs.
• Regular monitoring of liver function and blood parameters is essential during long-term treatment.
• May cause drowsiness or dizziness; patients should avoid driving or operating heavy machinery until fully alert.
• Elderly patients may be more susceptible to side effects, and dosage adjustments might be necessary.
• Should be used with caution in patients with a history of neurological or psychiatric disorders.
• Sodium Valproate may interact with other medications; patients should inform their healthcare provider of all medications they are taking.
• Women of childbearing age should use effective contraception while on this medication due to potential risks during pregnancy.

Following are the drug interactions for Sodium Valproate 500mg injection:

• Increases effects of drugs metabolized by CYP2C9 (e.g., warfarin, phenytoin, tolbutamide).
• May increase levels of lamotrigine, leading to toxicity.
• Concomitant use with other CNS depressants (e.g., benzodiazepines, barbiturates) can enhance sedation and respiratory depression.
• May reduce effectiveness of doxycycline, potentially leading to treatment failure.
• Carbapenem antibiotics may decrease valproate levels, requiring monitoring and dose adjustments.
• Rifampicin can decrease valproate levels, necessitating increased valproate doses.
• Probenecid may decrease renal clearance of valproate, resulting in higher drug levels.

Following are the food interactions for Sodium Valproate 500mg injection:

• Avoid excessive alcohol consumption while on this medication as it can increase the risk of liver damage and enhance the sedative effects.
• Grapefruit and grapefruit juice should be consumed with caution as they may alter the blood levels of Sodium Valproate, potentially leading to increased side effects.
• High-fat meals can slow down the absorption of Sodium Valproate, affecting its effectiveness.
• Carbohydrate-rich foods may reduce the absorption of Sodium Valproate, so it is advisable to take the medication on an empty stomach or with a light meal.
• Foods rich in protein can enhance the metabolism of Sodium Valproate, potentially reducing its effectiveness.
• Avoid herbal supplements like St. John's Wort, as they may decrease blood levels of Sodium Valproate.
• Vitamin K-rich foods like leafy green vegetables may interact with Sodium Valproate, affecting blood clotting.
• Sodium Valproate may cause increased appetite and weight gain, so monitor calorie intake and maintain a balanced diet.

Sodium Valproate 500mg injection should be stored in a controlled environment, specifically at room temperature, ensuring it remains between 15°C and 30°C (59°F and 86°F). Protect the injection from direct sunlight and moisture, and keep it in its original packaging, tightly sealed, to maintain its integrity and prevent contamination. Avoid exposing the medication to extreme temperatures, including freezing or excessive heat, as this can compromise its effectiveness. Always verify the expiration date on the packaging, and never use the injection beyond its expiry. When disposing of unused or expired injections, do not flush or pour them down the drain; instead, follow local regulations or consult a pharmacist for safe disposal methods. Keep the medication securely stored, out of the reach of children, to prevent accidental exposure or ingestion.

Following are the quick tips for Sodium Valproate 500mg Injection:

• Administer the injection under medical supervision for safety and proper dosage.
• Ensure the injection is prepared and stored as per the manufacturer's instructions.
• Before administration, visually inspect the solution for any discoloration or particulate matter.
• Use a sterile syringe and needle for the injection, and ensure proper disposal after use.
• Inject the medication slowly as directed, and rotate injection sites to minimize discomfort.
• Do not reuse or share needles to prevent infections.
• Store the injection at room temperature, away from direct sunlight and moisture.