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Ropakin inj®

Patient Details

Ropakin®

Generic Name: Sodium Valproate
Dosage Form: Lyophilized powder containing 400 mg sodium valproate for preparation of injectable solution
Pharmacologic Class: Anticonvulsant
Indications: This medicine is used for the control of seizures and treatment-resistant migraine.

Ropakin®

Ropakin® (Sodium Valproate) is a medication acting on the nervous system that works by enhancing the activity of GABA (an inhibitory neurotransmitter), blocking voltage-dependent sodium channels, and inhibiting rapid neuronal firing, thereby reducing the excitability of nerve cells.

Indications of Ropakin®

  • Various types of seizures (partial and generalized)
  • Status epilepticus
  • Treatment-resistant migraine

Dosage Form of Ropakin®

Vial containing 400 mg lyophilized powder for preparation of injectable solution.

Preparation of Ropakin® Solution

Add 4 mL of sterile water for injection to the contents of the vial until the powder is completely dissolved.
The solution should be prepared immediately before administration.
Each vial of Ropakin® is for single use only; any remaining solution should be discarded after use.

Compatible diluents:

  • Sodium Chloride 0.9%
  • Dextrose 5%
  • Ringer’s Lactate

Dosage and Administration of Ropakin®

This drug should be administered only by slow intravenous injection or intravenous infusion.
In most cases, Ropakin® may be given as an intravenous infusion over 60 minutes at a rate not exceeding 20 mg per minute, after dilution with an appropriate solvent.

Monitoring Parameters During Ropakin® Use

Before and during treatment, your physician may order periodic evaluations including:

  • Complete blood count (CBC)
  • Bone density
  • Coagulation tests
  • Plasma valproate levels
  • Liver function tests
  • Kidney function tests
  • Blood glucose levels
  • Plasma electrolytes (sodium and potassium)
  • Urinalysis (for glucose and electrolytes)
  • Symptoms of pancreatitis
  • Signs of DRESS syndrome (rash, redness, blisters, etc.)
  • Signs of polycystic ovary syndrome (PCOS)
  • Level of alertness and mental or motor performance

Contraindications of Ropakin®

  • Hypersensitivity to valproic acid or its derivatives, or to any excipient in the formulation
  • Severe hepatic impairment
  • Urea cycle disorders
  • Suspected POLG-related disorder in children under two years of age
  • Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG)
  • Pregnancy, unless no suitable alternative
  • Women of childbearing potential, unless the requirements of the Pregnancy Prevention Program are fulfilled
  • Porphyria

Warnings and Precautions

  • Sodium valproate may cause drowsiness; if this occurs, avoid activities requiring mental alertness such as driving or operating machinery.
  • Injectable sodium valproate is not recommended for children under 2 years of age.
  • Report immediately to your physician if symptoms of liver dysfunction occur (dark urine, fatigue, loss of appetite, stomach discomfort, pale stools, facial swelling, vomiting, or yellowing of skin/eyes).
  • Report signs of pancreatic problems (abdominal pain, vomiting, loss of appetite).
  • Report signs of increased ammonia (confusion, drowsiness, lethargy, cognitive disturbances).
  • Report signs of low platelets (bruising, bleeding, difficulty in blood clotting).
  • Report symptoms of urea cycle disorder (irritability, fatigue, vomiting, imbalance).
  • Seek immediate medical attention for allergic or hypersensitivity reactions (rash, swelling, blistering, skin peeling, eye redness, or ulcers in the mouth, throat, nose, or eyes).
  • Inform your doctor if you have a history of bariatric (weight-loss) surgery.
  • Always inform your doctor of all other medications or supplements you are taking to prevent drug interactions.
  • Elderly patients are more sensitive to dehydration and drowsiness; use with caution in this group.

Use of Ropakin® During Pregnancy and Lactation

  • Consult your doctor before using sodium valproate during pregnancy or breastfeeding.
  • Use of sodium valproate during pregnancy may cause neural tube defects and other congenital malformations in the fetus.
  • Women of childbearing potential must use reliable contraception during therapy.
  • Estrogen-containing contraceptives (such as LD, Yaz, Rokin, etc.) may lower valproate blood levels and increase seizure risk.

Possible Side Effects of Ropakin®

Like all medicines, this drug may cause unwanted side effects, although not everyone experiences them. Possible adverse reactions include:

  • Headache, weakness, fever
  • Nausea, vomiting, abdominal pain, diarrhea, loss of appetite, indigestion, constipation
  • Tremor, dizziness, blurred or double vision, nystagmus
  • Loss of balance, emotional instability, confusion, memory issues
  • Flu-like symptoms, respiratory infections, runny nose
  • Weight gain or loss
  • Hair loss
  • Fatigue, drowsiness, weakness, dizziness
  • Sleep disturbances

Drug Interactions

Consult your doctor or pharmacist before taking sodium valproate with other medications or supplements.

Packaging

Each pack contains 1 vial.

Storage Conditions

  • Keep out of sight and reach of children.
  • Store below 25°C, away from light and moisture.
  • Do not use after the expiry date indicated on the packaging.
  • Keep in the original package.

References

  1. Valproate (valproic acid): Drug information, UpToDate 2025

  2. Medicines.org.uk - Product No.1445

  3. Valproate (valproic acid) FDA Label 2025

Ropakin® inj
Prescribing Information