Valporin-CR
Generic Name
Sodium Valproate (Extended Release)
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| valporin cr 300 mg tablet | ৳ 8.00 | ৳ 48.00 |
Description
Overview of the medicine
Valporin-CR 300 mg Tablet contains Sodium Valproate, an antiepileptic used to treat various types of seizures, bipolar disorder, and migraine prophylaxis. Its controlled-release formulation allows for once or twice daily dosing, providing more stable blood levels of the drug.
Uses & Indications
Dosage
Adults
For Epilepsy: Initial dose typically 10-15 mg/kg/day, gradually increased by 5-10 mg/kg/week. Usual maintenance dose is 1000-2500 mg/day, given once or twice daily. For Bipolar disorder: Initial dose 750 mg daily in divided doses, adjusted to response, usually 1000-2500 mg/day. For Migraine prophylaxis: Initial dose 250 mg twice daily, adjusted to response, up to 1000 mg/day.
Elderly
Lower initial doses and slower titration are recommended due to potential for increased sensitivity to side effects. Careful monitoring is essential.
Renal_impairment
No specific dose adjustment is usually required for mild to moderate renal impairment. However, monitor for clinical signs of toxicity in severe impairment.
How to Take
Administer Valporin-CR tablets orally, whole, with or without food. Do not crush, chew, or divide the tablets, as this may compromise the extended-release properties.
Mechanism of Action
Valproate is thought to exert its antiepileptic effects by increasing brain levels of gamma-aminobutyric acid (GABA), blocking voltage-gated sodium channels, and modulating calcium channels. It also affects neurotransmitter levels and neuronal membrane excitability.
Pharmacokinetics
Onset
Varies; typically within hours for acute effects, but steady state concentrations are achieved over several days to weeks.
Excretion
Mainly renal, as metabolites. A small amount is excreted unchanged in urine.
Half life
9-16 hours (in adults), shorter in children. Hepatic impairment may prolong it.
Absorption
Well absorbed orally. Extended-release formulation provides sustained absorption, reducing peak-to-trough fluctuations. Bioavailability is approximately 90%.
Metabolism
Primarily hepatic, via glucuronidation and mitochondrial beta-oxidation. Significant first-pass metabolism.
Side Effects
Contraindications
- Known hypersensitivity to valproate or any component of the formulation.
- Hepatic dysfunction or severe liver disease.
- Urea cycle disorders.
- Mitochondrial disorders caused by POLG mutations (e.g., Alpers-Huttenlocher syndrome).
- Pregnancy (especially for migraine prophylaxis and bipolar disorder if non-valproate options exist due to high teratogenic risk).
Drug Interactions
Aspirin
May increase free valproate levels by displacing it from protein binding sites and inhibiting its metabolism.
Warfarin
May displace warfarin from protein binding sites, potentially enhancing its anticoagulant effect.
Lamotrigine
Valproate inhibits the metabolism of lamotrigine, significantly increasing lamotrigine levels and risk of serious rash (e.g., Stevens-Johnson syndrome).
Phenytoin, Phenobarbital, Primidone
May decrease valproate levels due to enzyme induction; valproate may also increase levels of these drugs.
Carbapenem antibiotics (e.g., Meropenem)
May significantly decrease valproate plasma levels, leading to loss of seizure control.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, heart block, deep coma, and hyperammonemia. Management involves gastric lavage, activated charcoal, supportive care, and monitoring of vital signs and valproate levels. Naloxone may reverse the CNS depression in severe cases.
Pregnancy & Lactation
Pregnancy Category D/X (depends on indication and timing). Valproate carries a high risk of major birth defects, particularly neural tube defects. It should not be used in pregnant women or women of childbearing potential unless other treatments are ineffective or not tolerated, and the benefits clearly outweigh the risks. Women should use effective contraception. Valproate is excreted into breast milk; use with caution in lactating mothers, monitoring the 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 caused by POLG mutations (e.g., Alpers-Huttenlocher syndrome).
- Pregnancy (especially for migraine prophylaxis and bipolar disorder if non-valproate options exist due to high teratogenic risk).
Drug Interactions
Aspirin
May increase free valproate levels by displacing it from protein binding sites and inhibiting its metabolism.
Warfarin
May displace warfarin from protein binding sites, potentially enhancing its anticoagulant effect.
Lamotrigine
Valproate inhibits the metabolism of lamotrigine, significantly increasing lamotrigine levels and risk of serious rash (e.g., Stevens-Johnson syndrome).
Phenytoin, Phenobarbital, Primidone
May decrease valproate levels due to enzyme induction; valproate may also increase levels of these drugs.
Carbapenem antibiotics (e.g., Meropenem)
May significantly decrease valproate plasma levels, leading to loss of seizure control.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, heart block, deep coma, and hyperammonemia. Management involves gastric lavage, activated charcoal, supportive care, and monitoring of vital signs and valproate levels. Naloxone may reverse the CNS depression in severe cases.
Pregnancy & Lactation
Pregnancy Category D/X (depends on indication and timing). Valproate carries a high risk of major birth defects, particularly neural tube defects. It should not be used in pregnant women or women of childbearing potential unless other treatments are ineffective or not tolerated, and the benefits clearly outweigh the risks. Women should use effective contraception. Valproate is excreted into breast milk; use with caution in lactating mothers, monitoring the infant for adverse effects.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, refer to package for exact date.
Availability
Pharmacies, hospitals
Approval Status
Approved by regulatory authorities
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Valproic acid, the active ingredient in Valporin-CR, has been extensively studied in numerous clinical trials establishing its efficacy and safety for various seizure types, bipolar disorder, and migraine prophylaxis. Controlled-release formulations have also undergone specific trials to confirm their pharmacokinetic profile and sustained therapeutic effect.
Lab Monitoring
- Liver function tests (LFTs) at baseline and periodically, especially during the first 6 months.
- Complete blood count (CBC) with platelets at baseline and periodically.
- Valproate serum levels to guide dosage adjustments and confirm therapeutic range.
- Ammonia levels if encephalopathy is suspected.
Doctor Notes
- Prioritize patient education regarding the importance of adherence, potential side effects (especially hepatotoxicity, pancreatitis, teratogenicity), and the need for regular monitoring.
- Initiate treatment with a low dose and titrate slowly to minimize adverse effects, especially gastrointestinal upset and sedation.
- For women of childbearing potential, thoroughly discuss reproductive risks and ensure effective contraception. Consider alternative treatments if appropriate.
Patient Guidelines
- Take Valporin-CR exactly as prescribed by your doctor; do not stop abruptly, as this may trigger seizures.
- Report any unusual bleeding, bruising, abdominal pain, jaundice, or changes in consciousness to your doctor immediately.
- Avoid alcohol consumption while taking this medicine.
- Women of childbearing potential should use effective contraception and discuss pregnancy risks with their doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Valporin-CR may cause drowsiness, dizziness, or blurred vision. Patients should avoid driving or operating heavy machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain a regular sleep schedule to help manage seizure control and mood stability.
- Engage in regular physical activity as appropriate, but avoid strenuous activities immediately after taking the medication if dizziness or drowsiness occurs.
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