Product image of Orfiril (Sodium Valproate) supplied by GNH India

Orfiril

Active Ingredient:
Sodium Valproate
Origin:
EU

Orfiril (Sodium Valproate)

Sodium valproate, the active ingredient in Orfiril, is an anticonvulsant presented as an oral formulation for systemic use. It is employed to control generalized and focal seizures, stabilize mood in bipolar disorder, and prevent migraine attacks in adult patients.

GNH India supplies Orfiril as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory documentation for global distribution. Customers benefit from reliable supply chains, competitive pricing, and responsive technical support.

Manufacturer / TM Owner

Desitin Arzneimittel Gmbh

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Indications & Clinical Uses

  • Orfiril (sodium valproate) acts on neuronal excitability and is indicated for several neurological and psychiatric conditions.
  • Epilepsy (generalized and focal seizures): reduces seizure frequency and severity, improving daily functioning.
  • Bipolar disorder (manic episodes): stabilizes mood and prevents manic relapses.
  • Migraine prophylaxis: decreases the number of migraine attacks per month, helping to reduce disability.

How It Works

  • Sodium valproate increases brain gamma‑aminobutyric acid (GABA) concentrations by inhibiting GABA transaminase and enhancing its synthesis. It also stabilizes neuronal membranes through blockade of voltage‑gated sodium channels and modulation of calcium currents, thereby reducing neuronal hyperexcitability and seizure propagation.

Side Effects

Sodium valproate may cause a range of adverse reactions, which are classified by frequency and severity.

Common Side Effects

  • Nausea or gastrointestinal upset
  • Weight gain or increased appetite
  • Tremor or mild shakiness
  • Drowsiness or fatigue
  • Hair thinning or loss
  • Mild rash or skin irritation

Serious or Rare Side Effects

  • Hepatotoxicity, including severe liver injury
  • Acute pancreatitis, presenting with abdominal pain
  • Severe skin reactions such as Stevens‑Johnson syndrome
  • Thrombocytopenia or significant drop in platelet count
  • Hyperammonemia leading to encephalopathy
  • Suicidal thoughts or mood changes

Precautions & Warnings

  • When prescribing Orfiril, clinicians should observe several safety considerations to minimize risk.
  • Pregnancy: Category D – use only if benefits outweigh potential fetal risks.
  • Liver function: Monitor hepatic enzymes regularly, especially during the first six months.
  • Blood counts: Periodic complete blood count to detect thrombocytopenia or leukopenia.
  • Hypersensitivity: Discontinue if signs of allergic reaction such as rash or swelling occur.
  • Metabolic disorders: Avoid in patients with known urea cycle defects or mitochondrial disorders.
  • Store at ambient temperature: Keep below 25 °C in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Sodium valproate interacts with various medicines; some require avoidance while others need careful monitoring.

Major Interactions (Avoid)

  • Carbamazepine, phenytoin, phenobarbital: strong enzyme inducers that lower valproate levels.
  • Lamotrigine: concurrent use increases risk of severe skin reactions.
  • Other hepatotoxic drugs (e.g., isoniazid): may amplify liver injury risk.

Moderate Interactions (Monitor Closely)

  • Oral contraceptives: valproate can reduce contraceptive efficacy; additional methods advised.
  • Warfarin: valproate may enhance anticoagulant effect, requiring INR monitoring.
  • Acetaminophen (high doses): combined use can increase hepatic toxicity risk.

Frequently Asked Questions

Orfiril, containing sodium valproate, is prescribed for the management of generalized and focal seizures in epilepsy, for the stabilization of mood during manic episodes of bipolar disorder, and as a preventive therapy to reduce the frequency of migraine attacks in adult patients.

Sodium valproate enhances the inhibitory neurotransmitter GABA by inhibiting its breakdown and increasing its synthesis. It also blocks voltage‑gated sodium channels and modulates calcium currents, which together reduce neuronal hyperexcitability and help control seizures, mood swings, and migraine pathways.

The dosage of Orfiril is individualized and determined by a qualified prescriber based on the patient’s age, weight, clinical condition, and response to therapy. Physicians adjust the dose to achieve optimal seizure control or mood stabilization while monitoring for safety.

Orfiril is classified as pregnancy category D, indicating evidence of risk to the fetus. It should be used only when the potential benefits justify the risks. Sodium valproate is excreted in breast milk, so breastfeeding decisions should be made in consultation with a healthcare professional.

To request Orfiril, visit the product page on gnhindia.com, enter the desired quantity, and submit the enquiry form. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details, and any required import documentation.

Compared with alternatives such as carbamazepine or lamotrigine, sodium valproate offers broad-spectrum seizure control and mood‑stabilizing properties but carries a higher risk of hepatic and metabolic side effects. Choice of therapy depends on the specific seizure type, patient comorbidities, and tolerance to potential adverse effects.

Orfiril should be stored at ambient temperature, preferably below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and do not store it in areas with high humidity or extreme heat.

Orfiril is taken orally, usually as a tablet or capsule, and should be swallowed whole with a glass of water. Doses are typically divided throughout the day as prescribed, and it may be taken with or without food depending on the prescriber’s instructions.

The most serious risks include severe liver injury, acute pancreatitis, life‑threatening skin reactions such as Stevens‑Johnson syndrome, and hematologic abnormalities like thrombocytopenia. Patients should be monitored regularly for signs of hepatic dysfunction, abdominal pain, rash, or unexplained bruising.

Orfiril is contraindicated in individuals with known hypersensitivity to sodium valproate, those with urea cycle disorders, mitochondrial diseases, or severe hepatic impairment. It should also be avoided in pregnant women unless no safer alternative exists and the therapeutic benefit outweighs fetal risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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