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 a tablet for oral use. It is used to treat seizure disorders and is prescribed for patients requiring long‑term seizure control.

GNH India supplies Orfiril as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.

Manufacturer / TM Owner

Desitin Arzneimittel Gmbh

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Indications & Clinical Uses

Orfiril is an antiepileptic drug that is employed across several seizure‑related conditions:

  • Epilepsy: helps control generalized tonic‑clonic and absence seizures.
  • Bipolar disorder: stabilises mood and reduces the frequency of manic episodes.
  • Migraine prophylaxis: decreases the number of migraine attacks when other therapies are insufficient.

How It Works

  • Sodium valproate increases the availability of gamma‑aminobutyric acid (GABA) in the brain by inhibiting its breakdown and enhancing its release, while also modulating voltage‑gated sodium channels and reducing neuronal excitability. These actions collectively suppress abnormal electrical activity that underlies seizures.

Side Effects

Adverse reactions to sodium valproate can vary in frequency and severity.

Common Side Effects

  • Nausea and vomiting: mild gastrointestinal upset.
  • Tremor: fine shaking of the hands.
  • Weight gain: gradual increase in body weight.
  • Hair loss: diffuse thinning of scalp hair.
  • Drowsiness: increased sleepiness during the day.
  • Elevated liver enzymes: mild, often transient changes in liver function tests.

Serious or Rare Side Effects

  • Hepatotoxicity: severe liver injury that may be life‑threatening.
  • Pancreatitis: inflammation of the pancreas, presenting with abdominal pain.
  • Thrombocytopenia: low platelet count increasing bleeding risk.
  • Severe skin reactions: such as Stevens‑Johnson syndrome.
  • Hyperammonemia: elevated blood ammonia levels causing confusion.
  • Fetal teratogenicity: risk of birth defects when used in pregnancy.

Precautions & Warnings

When prescribing sodium valproate, clinicians should consider several safety aspects:

  • Liver function monitoring: check baseline enzymes and repeat periodically.
  • Blood count surveillance: monitor platelets and white blood cells regularly.
  • Pregnancy risk: avoid use in women of childbearing potential unless no alternative exists.
  • Drug interactions: review concomitant medications for potential PK/PD effects.
  • Renal function: assess kidney health in patients with impairment.
  • Store at ambient temperature: keep tablets in original container, protect from moisture and direct sunlight.

Avoid Interactions

Sodium valproate interacts with a range of medicines that can alter its efficacy or safety profile.

Major Interactions (Avoid)

  • Carbamazepine: may reduce valproate levels and increase seizure risk.
  • Phenobarbital: can lower valproate concentrations, diminishing seizure control.
  • Topiramate: combined use raises risk of metabolic acidosis.

Moderate Interactions (Monitor Closely)

  • Warfarin: valproate may enhance anticoagulant effect, requiring INR monitoring.
  • Lamotrigine: increased risk of skin reactions, especially rash.
  • Oral contraceptives: valproate can decrease hormonal efficacy, risking unintended pregnancy.

Frequently Asked Questions

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Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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