Valporin-CR
Generic Name
Valproic Acid 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 500 mg tablet | ৳ 12.00 | ৳ 72.00 |
Description
Overview of the medicine
Valporin-CR 500 mg Tablet is an extended-release formulation of valproic acid, an anticonvulsant medication used to treat various types of seizures, manic episodes associated with bipolar disorder, and for the prophylaxis of migraine headaches. Its controlled-release nature helps maintain stable drug levels and reduce the frequency of dosing.
Uses & Indications
Dosage
Adults
Varies widely based on indication and patient response. Typically initiated at 10-15 mg/kg/day, increased gradually to target therapeutic levels. Common maintenance doses are 1000-2500 mg/day in divided doses for CR formulation.
Elderly
Initiate with lower doses and titrate slowly, monitoring for adverse effects and valproate levels.
Renal_impairment
Dose adjustment is generally not necessary for renal impairment alone, but close monitoring is advised due to altered protein binding.
How to Take
Oral, swallow whole, do not crush or chew. Can be taken with or without food. For CR formulation, usually once or twice daily.
Mechanism of Action
Valproic acid is believed to exert its anticonvulsant effects through several mechanisms, including increasing brain levels of gamma-aminobutyric acid (GABA) by inhibiting GABA transaminase and succinic semialdehyde dehydrogenase, blocking voltage-gated sodium channels, and modulating T-type calcium channels. These actions lead to stabilization of neuronal membranes and inhibition of rapid neuronal firing.
Pharmacokinetics
Onset
Antiepileptic effects may be observed within days, but full therapeutic effect and mood stabilization can take weeks.
Excretion
Primarily renal (urine) as metabolites and a small amount unchanged drug.
Half life
Approximately 9-16 hours in adults; can be shorter in children and longer in hepatic impairment.
Absorption
Well absorbed from the GI tract. Peak plasma concentrations of CR formulation are reached later and are lower than with immediate-release forms, but provide smoother plasma levels. Bioavailability is nearly complete.
Metabolism
Primarily hepatic, through glucuronidation and mitochondrial beta-oxidation. Extensive metabolism in the liver.
Side Effects
Contraindications
- Hepatic disease or significant hepatic dysfunction.
- Known urea cycle disorders.
- Hypersensitivity to valproate.
- Mitochondrial disorders caused by mutations in the nuclear gene encoding the mitochondrial enzyme polymerase gamma (POLG).
- Pregnancy, especially in the first trimester, for migraine prophylaxis or if not absolutely necessary for epilepsy.
Drug Interactions
Lamotrigine
Valproate inhibits lamotrigine metabolism, increasing lamotrigine levels and risk of severe rash.
Aspirin, Warfarin
Can increase valproate levels and risk of bleeding.
Phenytoin, Phenobarbital, Carbamazepine
Valproate can alter levels of these drugs and be affected by them.
Carbapenem antibiotics (e.g., meropenem)
Can significantly decrease valproate levels, leading to loss of seizure control.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms include somnolence, heart block, deep coma, and death. Naloxone may reverse CNS depressant effects. General supportive measures, gastric lavage, and activated charcoal are recommended. Hemodialysis may be beneficial.
Pregnancy & Lactation
Pregnancy: Category D/X depending on indication. High risk of major congenital malformations (e.g., neural tube defects) and developmental issues. Use only if benefits outweigh risks, and consider folic acid supplementation. Discuss with a specialist. Lactation: Valproate is excreted in breast milk. Weigh the benefits of breastfeeding against potential risks to the infant. Monitoring the infant for adverse effects is recommended.
Side Effects
Contraindications
- Hepatic disease or significant hepatic dysfunction.
- Known urea cycle disorders.
- Hypersensitivity to valproate.
- Mitochondrial disorders caused by mutations in the nuclear gene encoding the mitochondrial enzyme polymerase gamma (POLG).
- Pregnancy, especially in the first trimester, for migraine prophylaxis or if not absolutely necessary for epilepsy.
Drug Interactions
Lamotrigine
Valproate inhibits lamotrigine metabolism, increasing lamotrigine levels and risk of severe rash.
Aspirin, Warfarin
Can increase valproate levels and risk of bleeding.
Phenytoin, Phenobarbital, Carbamazepine
Valproate can alter levels of these drugs and be affected by them.
Carbapenem antibiotics (e.g., meropenem)
Can significantly decrease valproate levels, leading to loss of seizure control.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms include somnolence, heart block, deep coma, and death. Naloxone may reverse CNS depressant effects. General supportive measures, gastric lavage, and activated charcoal are recommended. Hemodialysis may be beneficial.
Pregnancy & Lactation
Pregnancy: Category D/X depending on indication. High risk of major congenital malformations (e.g., neural tube defects) and developmental issues. Use only if benefits outweigh risks, and consider folic acid supplementation. Discuss with a specialist. Lactation: Valproate is excreted in breast milk. Weigh the benefits of breastfeeding against potential risks to the infant. Monitoring the infant for adverse effects is recommended.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years, as indicated on the package
Availability
Pharmacies, Hospitals
Approval Status
Approved in many countries globally including Bangladesh
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials support its efficacy and safety for epilepsy, bipolar disorder, and migraine prophylaxis. Ongoing research continues to explore new uses and formulations.
Lab Monitoring
- Liver function tests (baseline and frequently during initial therapy, then periodically).
- Complete Blood Count (CBC) with platelets (baseline and periodically).
- Serum valproate levels (to ensure therapeutic range).
- Ammonia levels (if hyperammonemia suspected).
Doctor Notes
- Monitor LFTs, CBC, and valproate levels regularly.
- Counsel female patients of childbearing potential about the high teratogenic risk and discuss contraception.
- Be vigilant for signs of hepatotoxicity or pancreatitis.
- Do not discontinue abruptly due to risk of seizure exacerbation.
Patient Guidelines
- Take exactly as prescribed, do not stop abruptly.
- Report any unusual bruising, bleeding, abdominal pain, jaundice, or changes in mood/behavior to your doctor immediately.
- Avoid alcohol while on this medication.
- Regular laboratory monitoring is crucial.
Missed Dose Advice
If a dose is missed, take it as soon as you remember unless it is almost time for the next dose. Do not double the dose to catch up. Contact your doctor if you frequently miss doses.
Driving Precautions
May cause drowsiness, dizziness, or impaired judgment. Avoid driving or operating heavy machinery until you know how this medicine affects you.
Lifestyle Advice
- Maintain a consistent sleep schedule.
- Avoid activities requiring mental alertness until you know how the drug affects you.
- Carry identification stating you are taking this medication.
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