Valporin CR
Generic Name
Valproic Acid (Controlled Release)
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| valporin cr 200 mg tablet | ৳ 5.00 | ৳ 50.00 |
Description
Overview of the medicine
Valporin CR 200 mg Tablet is an anticonvulsant medication containing Valproic Acid in a controlled-release formulation. It is used to treat various types of epilepsy, manic episodes of bipolar disorder, and for the prophylaxis of migraine headaches.
Uses & Indications
Dosage
Adults
Initial: 10-15 mg/kg/day, usually given once daily or in divided doses. Gradually increase by 5-10 mg/kg/week. Maintenance: 750-2500 mg/day depending on indication and patient response. Maximum 60 mg/kg/day.
Elderly
Lower initial doses and slower titration may be appropriate due to potential for increased sensitivity and reduced hepatic/renal function. Closely monitor for adverse effects.
Renal_impairment
No dosage adjustment needed for patients with renal impairment. Protein binding of valproic acid is reduced, leading to higher free drug levels, which should be considered.
How to Take
Valporin CR tablets should be swallowed whole, without crushing or chewing. Can be taken with or without food. Taking with food may reduce gastrointestinal upset.
Mechanism of Action
Valproic Acid is thought to exert its anticonvulsant effects through several mechanisms, including increasing brain concentrations of gamma-aminobutyric acid (GABA), blocking voltage-gated sodium channels, and modulating calcium channels, thereby stabilizing neuronal membranes and reducing neuronal excitability.
Pharmacokinetics
Onset
Therapeutic effects may take several days to weeks to become apparent. Anticonvulsant effects can be seen within hours for acute situations, but chronic therapy requires steady state.
Excretion
Mainly excreted in urine as metabolites and less than 3% as unchanged drug.
Half life
Approximately 9 to 16 hours in adults, but can be shorter in children and longer in patients with hepatic impairment.
Absorption
Well absorbed orally. Controlled-release formulation provides sustained plasma concentrations, reducing peak-trough fluctuations.
Metabolism
Extensively metabolized in the liver, primarily via glucuronidation (50%) and mitochondrial beta-oxidation (40%).
Side Effects
Contraindications
- Known hypersensitivity to valproate or any component of the formulation.
- Hepatic dysfunction or severe liver disease.
- Urea cycle disorders.
- Mitochondrial disorders (e.g., Alpers-Huttenlocher Syndrome) in children <2 years old.
Drug Interactions
Aspirin
May increase valproate levels by displacing it from protein binding sites.
Warfarin
May enhance anticoagulant effects, increasing bleeding risk.
Topiramate
Concomitant use may increase risk of hyperammonemia.
Lamotrigine
Valproate significantly increases lamotrigine levels, increasing risk of rash (e.g., Stevens-Johnson syndrome).
Carbamazepine, Phenytoin, Phenobarbital
May alter valproate levels and vice versa, requiring close monitoring.
CNS Depressants (e.g., alcohol, benzodiazepines)
Increased CNS depression.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, heart block, and coma. Management involves supportive care, gastric lavage or activated charcoal if recent ingestion, and potentially naloxone for CNS depression. Hemodialysis can be effective in removing the drug.
Pregnancy & Lactation
Pregnancy Category D: Valproic Acid is associated with a high risk of birth defects (e.g., neural tube defects, facial dysmorphism, cardiac defects). Use in pregnancy should only be considered if benefits outweigh risks, and effective contraception is advised for women of childbearing potential. It is excreted into breast milk; caution is advised, and monitor infant for adverse effects.
Side Effects
Contraindications
- Known hypersensitivity to valproate or any component of the formulation.
- Hepatic dysfunction or severe liver disease.
- Urea cycle disorders.
- Mitochondrial disorders (e.g., Alpers-Huttenlocher Syndrome) in children <2 years old.
Drug Interactions
Aspirin
May increase valproate levels by displacing it from protein binding sites.
Warfarin
May enhance anticoagulant effects, increasing bleeding risk.
Topiramate
Concomitant use may increase risk of hyperammonemia.
Lamotrigine
Valproate significantly increases lamotrigine levels, increasing risk of rash (e.g., Stevens-Johnson syndrome).
Carbamazepine, Phenytoin, Phenobarbital
May alter valproate levels and vice versa, requiring close monitoring.
CNS Depressants (e.g., alcohol, benzodiazepines)
Increased CNS depression.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, heart block, and coma. Management involves supportive care, gastric lavage or activated charcoal if recent ingestion, and potentially naloxone for CNS depression. Hemodialysis can be effective in removing the drug.
Pregnancy & Lactation
Pregnancy Category D: Valproic Acid is associated with a high risk of birth defects (e.g., neural tube defects, facial dysmorphism, cardiac defects). Use in pregnancy should only be considered if benefits outweigh risks, and effective contraception is advised for women of childbearing potential. It is excreted into breast milk; caution is advised, and monitor infant for adverse effects.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved (DGDA)
Patent Status
Generic available, patent expired
WHO Essential Medicine
YesClinical Trials
Valproic acid has been extensively studied in numerous clinical trials establishing its efficacy and safety for epilepsy, bipolar disorder, and migraine prophylaxis. Its controlled-release formulation aims to improve tolerability and reduce dosing frequency.
Lab Monitoring
- Liver function tests (LFTs) at baseline and periodically.
- Complete Blood Count (CBC) with platelet count at baseline and periodically.
- Valproate serum levels (therapeutic range 50-100 mcg/mL).
- Ammonia levels, especially if encephalopathy or lethargy occurs.
- Pancreatic enzyme levels if pancreatitis is suspected.
Doctor Notes
- Carefully monitor liver function tests (LFTs) and complete blood count (CBC) regularly.
- Educate female patients of childbearing potential about the significant teratogenic risks and the need for effective contraception.
- Warn patients about the risk of pancreatitis and the symptoms to watch for (e.g., severe abdominal pain, nausea/vomiting).
Patient Guidelines
- Take Valporin CR exactly as prescribed by your doctor.
- Do not stop taking this medicine abruptly without consulting your doctor, as it may worsen your condition or cause seizures.
- Swallow the tablet whole; do not crush, chew, or break it.
- Report any unusual bleeding, bruising, abdominal pain, persistent nausea/vomiting, or changes in alertness to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Valporin CR may cause drowsiness, dizziness, or blurred vision. Avoid driving, operating machinery, or performing tasks requiring mental alertness until you know how this medicine affects you.
Lifestyle Advice
- Avoid alcohol consumption while taking Valporin CR.
- Maintain a regular sleep schedule.
- Inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
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