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 oral tablets for oral use. It is employed to control 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.

Manufacturer / TM Owner

Desitin Arzneimittel Gmbh

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Indications & Clinical Uses

Orfiril (sodium valproate) is used across several neurological and psychiatric conditions where modulation of neuronal excitability is required.

  • Epilepsy: reduces the frequency of generalized tonic‑clonic, absence and myoclonic seizures.
  • Bipolar disorder: stabilises mood and prevents manic or depressive episodes.
  • Migraine prophylaxis: decreases the number of migraine attacks per month.

How It Works

  • Sodium valproate enhances gamma‑aminobutyric acid (GABA) concentrations by inhibiting GABA transaminase, blocks voltage‑gated sodium channels, and suppresses T‑type calcium currents, collectively reducing neuronal firing and stabilising neuronal membranes in the central nervous system.

Side Effects

Adverse reactions to sodium valproate can vary from mild to severe.

Common Side Effects

  • Nausea or gastrointestinal upset.
  • Tremor or unsteady movements.
  • Weight gain or increased appetite.
  • Hair thinning or loss.
  • Drowsiness or fatigue.
  • Mild rash.

Serious or Rare Side Effects

  • Hepatic failure or severe liver injury.
  • Acute pancreatitis.
  • Thrombocytopenia or significant drop in platelet count.
  • Hyperammonemic encephalopathy.
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Severe depression or suicidal thoughts.

Precautions & Warnings

Before initiating therapy, clinicians should assess specific risk factors and monitor patients regularly.

  • Pregnancy: sodium valproate carries a high risk of neural‑tube defects; avoid unless no alternative exists.
  • Liver function: perform baseline and periodic hepatic enzyme tests.
  • Blood counts: monitor platelet and white‑cell levels for hematologic toxicity.
  • Renal function: adjust dosing in severe impairment.
  • Drug interactions: review concomitant medications for potential metabolic effects.
  • Store at ambient temperature below 25°C: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

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

Major Interactions (Avoid)

  • Carbamazepine: induces valproate metabolism, reducing efficacy.
  • Lamotrigine: combined use increases risk of severe skin reactions.
  • Aspirin/NSAIDs: may heighten bleeding tendency.
  • Warfarin: potentiates anticoagulant effect, raising INR.
  • Oral contraceptives: valproate reduces hormonal efficacy, risking unintended pregnancy.

Moderate Interactions (Monitor Closely)

  • Phenytoin: may alter plasma levels of both agents.
  • Phenobarbital: can increase valproate clearance.
  • Topiramate: may enhance central nervous system depression.
  • Antidepressants (SSRIs): monitor for increased sedation.
  • Antiepileptic polytherapy: adjust doses based on therapeutic drug monitoring.

Frequently Asked Questions

Orfiril, containing sodium valproate, is prescribed for the management of epilepsy (including generalized tonic‑clonic, absence and myoclonic seizures), for mood stabilization in bipolar disorder, and as a preventive therapy for migraine headaches in adult patients.

Sodium valproate increases the level of the inhibitory neurotransmitter GABA, blocks voltage‑gated sodium channels, and inhibits T‑type calcium currents. These actions collectively dampen neuronal excitability, helping to control seizures, stabilize mood, and reduce migraine frequency.

The dosage of Orfiril is individualized. A qualified prescriber determines the appropriate dose based on the patient’s age, weight, clinical condition, and response to therapy. Patients should follow the prescribing physician’s instructions and not adjust the dose on their own.

Sodium valproate is associated with a high risk of congenital malformations, especially neural‑tube defects, when used during pregnancy. It is generally avoided unless no safer alternative exists. Valproate is excreted in breast milk; breastfeeding decisions should be made in consultation with a healthcare professional.

To place an order, submit an enquiry on the Orfiril product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

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

Orfiril tablets should be stored at ambient temperature below 25 °C, in their original packaging, protected from moisture and direct sunlight. Do not store in bathrooms or near heat sources to maintain product stability.

Orfiril is supplied as oral tablets that are taken by mouth with or without food, as directed by the prescribing clinician. The tablets should be swallowed whole with a glass of water; they are not intended for crushing, chewing, or sublingual use.

The most serious risks include severe liver injury, acute pancreatitis, life‑threatening blood disorders such as thrombocytopenia, hyperammonemic encephalopathy, and rare but severe skin reactions like Stevens‑Johnson syndrome. Patients should be monitored regularly for early signs of these conditions.

Orfiril is contraindicated in patients with known hypersensitivity to sodium valproate or any excipients, in individuals with severe hepatic disease, and in pregnant women unless no alternative therapy is available. Caution is also advised for patients with mitochondrial disorders such as POLG‑related disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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