Valprol CR

Description

Valprol CR Tablet, containing Sodium Valproate (valproic acid), is an anticonvulsant medication used for various conditions.

Uses of Valprol CR Tablet

Valprol CR Tablet is prescribed for:

• Epilepsy: This includes a wide range of seizure types like partial seizures (complex and simple), absence seizures (petit mal), generalized tonic-clonic seizures (grand mal), myoclonic seizures, atonic seizures, and mixed seizures.
• Mental Health Conditions: It’s also used for anxiety disorder, post-traumatic stress disorder (PTSD), and manic episodes associated with bipolar disorder.
• Other Conditions: Valprol CR Tablet can be used for febrile convulsions, anorexia nervosa, panic attacks, and for preventing migraine headaches. Please note it’s not for treating acute migraine attacks.

Dosage Information

The dosage of Valprol CR Tablet varies depending on the condition and the patient’s age and weight. All doses below are taken orally.

Adult Dosing

• Complex Partial Seizures (Monotherapy and Adjunctive Therapy):
  • Start with 10-15 mg/kg/day.
  • Increase the dose by 5-10 mg/kg/day weekly.
  • The maximum dose is 60 mg/kg/day.
• Simple & Complex Absence Seizures (Monotherapy and Adjunctive Therapy):
  • Begin with 15 mg/kg/day, divided into doses every 6-12 hours.
  • Increase the dose by 5-10 mg/kg/day weekly.
  • The maximum dose is 60 mg/kg/day.
• Migraine Prophylaxis:
  • Take 250 mg every 12 hours.
  • Adjust the dose based on how well it works, but do not exceed 1000 mg/day.
• Bipolar Mania:
  • The usual starting dose is 750 mg/day in divided doses.
  • Adjust the dose as quickly as possible to achieve the desired effect, not exceeding 60 mg/kg/day.

Child Dosing

• Under 10 years: The safety and effectiveness of Valprol CR Tablet have not been established for this age group.
• Over 10 years:
  • Complex Partial Seizures (Monotherapy and Adjunctive Therapy): Same as adult dosing (start with 10-15 mg/kg/day, increase by 5-10 mg/kg/day weekly, max 60 mg/kg/day).
  • Simple & Complex Absence Seizures: 250 mg every 12 hours; adjust the dose based on clinical response up to 1000 mg/day.

Special Populations

• Hepatic Impairment: Lower doses are necessary. Valprol CR Tablet is contraindicated in severe liver impairment.
• Renal Impairment: No dose adjustment is needed for kidney problems.

Important Considerations and Warnings

Contraindications

Do not use Valprol CR Tablet if you have:

• A pre-existing history or family history of liver dysfunction.
• Active liver disease.
• Porphyria.
• Mitochondrial or urea cycle disorders.
• Are pregnant.

Precautions

• Liver Toxicity: Children under 2 years old, those with congenital metabolic disorders, organic brain disease, or severe seizure disorders are at a higher risk of hepatotoxicity.
• Other Conditions: Use with caution if you have HIV, cytomegalovirus (CMV) infection, or Systemic Lupus Erythematosus (SLE).
• Dose Adjustment: Consider reducing the dose or stopping the medication if you experience excessive sleepiness or decreased food or fluid intake.
• Withdrawal: If discontinuing Valprol CR Tablet or switching to another antiepileptic drug, do so gradually.
• Hyperammonemia: If you develop unexplained lethargy, vomiting, or changes in mental status, suspect hyperammonemic encephalopathy and get your ammonia levels checked.
• Bone Health: Patients who are immobilized or have insufficient sun exposure or calcium intake should consider vitamin supplementation.

Monitoring

Regular monitoring is essential during treatment:

• Liver Function Tests (LFTs): Monitor before and during the first six months of therapy.
• Blood Counts: Monitor blood cell count (including platelets), bleeding time, and coagulation tests before starting therapy, before surgery, and if you experience spontaneous bruising or bleeding.
• Mental Health: Monitor for unusual behavior, such as suicidal thoughts or behavior, during and after treatment.

Pregnancy and Lactation

Valprol CR Tablet is contraindicated during pregnancy. If you are breastfeeding, discuss this with your doctor.

Drug Interactions

Valprol CR Tablet can interact with many medications. Always inform your doctor about all drugs you are currently taking.

Increased Risk of Toxicity or Side Effects

• Bupropion: Increased risk of toxicity.
• Mefloquine: Increased risk of convulsions.
• Pivmecillinam and Pivampicillin: Increased risk of carnitine deficiency.
• Carbamazepine: Increased risk of hepatotoxicity and carbamazepine toxicity, along with a decrease in valproic acid levels.
• Ethosuximide: Can lead to decreased valproic acid and increased ethosuximide levels.
• Aspirin and Felbamate: May increase valproic acid levels.
• Olanzapine: Increased risk of hepatotoxicity.
• Phenobarbital, Nimodipine, Nifedipine, Lamotrigine, Zidovudine, Amitriptyline, Nortriptyline, and Benzodiazepines: Concurrent use can increase the levels of these drugs.
• Clonazepam: Increased risk of absence status.
• Topiramate: Increased risk of hyperammonemia.
• Highly Protein-Bound Drugs: Can increase free valproic acid concentrations.

Decreased Valproic Acid Levels

• Carbapenems (potentially fatal interaction): Concomitant use is not recommended as it can significantly decrease valproate levels.
• Rifampicin, Phenytoin, Phenobarbital (or primidone), and Antineoplastic Drug Regimens.

Other Important Interactions

• Salicylates: Avoid concurrent use in children under 3 years due to the risk of hepatotoxicity.
• Cosyntropin: Increased risk of hepatotoxicity.
• Ethanol (alcohol): Avoid concurrent use as it may increase central nervous system (CNS) depression.

Potential Side Effects

Common side effects (more than 10% of patients) include:

• Nausea
• Headache
• Increased bleeding time
• Thrombocytopenia (low platelet count)
• Tremor
• Alopecia (hair loss)
• Asthenia (weakness)
• Infection
• Somnolence (drowsiness)
• Amblyopia (lazy eye)
• Diarrhea
• Diplopia (double vision)
• Dizziness
• Dyspepsia (indigestion)
• Nystagmus (involuntary eye movements)
• Tinnitus (ringing in the ears)
• Vomiting

Less common side effects (1-10% of patients) include:

• Ataxia (lack of coordination)
• Increased appetite
• Rash
• Abdominal pain
• Back pain
• Mood changes
• Anxiety
• Confusion
• Abnormal gait
• Paresthesia (numbness/tingling)
• Hallucinations
• Catatonia
• Dysarthria (difficulty speaking)
• Tardive dyskinesia (involuntary movements)
• Vertigo
• Irregular menstrual periods
• Weight gain

Rare but serious side effects (frequency not defined) include:

• Anorexia
• Acute pancreatitis (may be life-threatening)
• Hepatic toxicity
• Hyperammonemia
• Weight loss
• Fractures, osteoporosis, osteopenia, decreased bone mineral density
• Cerebral pseudoatrophy

Mechanism of Action

Valproate is a general term for valproic acid, its salts, and derivatives. It’s a carboxylic acid anticonvulsant. Its antiepileptic activity is thought to be linked to an increase in brain levels of gamma-aminobutyric acid (GABA), which helps to regulate nerve impulses.

Note: Valprol CR 200mg Tablet is manufactured by Intas Pharmaceuticals Ltd. Its generic name is Sodium Valproate (valproic acid), and it is available in Nepal. This information is not intended for diagnosis, medical advice, or treatment and should not substitute for professional medical judgment. Always consult a healthcare professional for any health concerns.