Proval
Generic Name
Valproic Acid
Manufacturer
Various Manufacturers
Country
Global
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| proval 200 mg syrup | ৳ 75.50 | N/A |
Description
Overview of the medicine
Proval (Valproic Acid) is an anticonvulsant medication used to treat various types of seizures in epilepsy, bipolar disorder, and for the prevention of migraine headaches.
Uses & Indications
Dosage
Adults
Initial 10-15 mg/kg/day, increased at 1-week intervals by 5-10 mg/kg/day to achieve optimal clinical response, usually 20-30 mg/kg/day. Maximum 60 mg/kg/day.
Elderly
Lower initial doses and slower titration are recommended due to potential for decreased clearance and increased sensitivity to adverse effects.
Renal_impairment
No specific dose adjustment is generally required, but close monitoring of therapeutic response and adverse effects is advisable.
How to Take
Oral administration, often with food to minimize gastrointestinal upset. Tablets should be swallowed whole; do not crush or chew extended-release forms.
Mechanism of Action
Valproic acid's mechanism is complex, involving increased GABAergic activity (by inhibiting GABA transaminase and succinic semialdehyde dehydrogenase), blockade of voltage-gated sodium channels, and reduction of T-type calcium currents.
Pharmacokinetics
Onset
Variable; anticonvulsant effects may take several days to weeks to stabilize. Peak plasma levels in 1-4 hours (immediate release).
Excretion
Primarily excreted in urine as metabolites, with a small amount of unchanged drug.
Half life
9-16 hours (adults), 4-14 hours (children).
Absorption
Rapid and complete absorption from the gastrointestinal tract.
Metabolism
Extensively metabolized in the liver via glucuronidation and mitochondrial beta-oxidation.
Side Effects
Contraindications
- Hepatic disease or significant hepatic dysfunction
- Known urea cycle disorders
- Hypersensitivity to valproic acid or any component of the formulation
- Pregnancy (especially for migraine prophylaxis due to high teratogenic risk)
Drug Interactions
Aspirin
May increase free valproic acid levels and increase the risk of bleeding.
Warfarin
May displace warfarin from protein binding sites, increasing anticoagulant effect.
Lamotrigine
Valproate inhibits lamotrigine metabolism, potentially increasing lamotrigine toxicity.
Carbamazepine
May lead to decreased valproate levels and increased carbamazepine epoxide levels.
Phenobarbital/Phenytoin
Valproate may increase levels of phenobarbital and phenytoin.
Storage
Store below 30°C, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms include somnolence, heart block, coma, and respiratory depression. Management involves supportive care, activated charcoal for recent ingestions, and hemodialysis for severe cases.
Pregnancy & Lactation
Pregnancy Category D/X for migraine prophylaxis due to significant risk of neural tube defects and other developmental abnormalities. Not recommended during breastfeeding as valproic acid is excreted in breast milk.
Side Effects
Contraindications
- Hepatic disease or significant hepatic dysfunction
- Known urea cycle disorders
- Hypersensitivity to valproic acid or any component of the formulation
- Pregnancy (especially for migraine prophylaxis due to high teratogenic risk)
Drug Interactions
Aspirin
May increase free valproic acid levels and increase the risk of bleeding.
Warfarin
May displace warfarin from protein binding sites, increasing anticoagulant effect.
Lamotrigine
Valproate inhibits lamotrigine metabolism, potentially increasing lamotrigine toxicity.
Carbamazepine
May lead to decreased valproate levels and increased carbamazepine epoxide levels.
Phenobarbital/Phenytoin
Valproate may increase levels of phenobarbital and phenytoin.
Storage
Store below 30°C, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms include somnolence, heart block, coma, and respiratory depression. Management involves supportive care, activated charcoal for recent ingestions, and hemodialysis for severe cases.
Pregnancy & Lactation
Pregnancy Category D/X for migraine prophylaxis due to significant risk of neural tube defects and other developmental abnormalities. Not recommended during breastfeeding as valproic acid is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years, refer to the specific product packaging for exact expiry date.
Availability
Pharmacies, hospitals
Approval Status
Approved by FDA and DGDA
Patent Status
Generic available, patent expired
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established the efficacy and safety of valproic acid in its approved indications. Ongoing research continues to explore new applications and refine existing treatment protocols.
Lab Monitoring
- Liver function tests (baseline and periodically, especially in the first 6 months)
- Complete blood count (CBC) with platelets (baseline and periodically)
- Serum valproate levels (for therapeutic drug monitoring)
- Ammonia levels (if encephalopathy is suspected or patient is at risk of hyperammonemia)
Doctor Notes
- Emphasize baseline and regular monitoring of liver function tests (LFTs) and complete blood count (CBC).
- Educate female patients of childbearing potential about the high teratogenic risk and alternative contraceptive options or safer antiepileptic drugs if pregnancy is planned.
- Counsel patients on symptoms of pancreatitis and hyperammonemia, and instruct them to seek immediate medical attention if these occur.
Patient Guidelines
- Do not stop taking this medicine abruptly, as it can lead to increased seizure frequency.
- Report any unusual symptoms such as abdominal pain, nausea, vomiting, dark urine, or yellow skin/eyes immediately.
- Attend regular blood tests as advised by your doctor to monitor liver function and blood cell counts.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double doses.
Driving Precautions
Valproic acid may cause drowsiness, dizziness, or blurred vision. Avoid driving or operating heavy machinery until you know how this medication affects you.
Lifestyle Advice
- Avoid alcohol consumption while on this medication.
- Maintain good hydration and a balanced diet.
- Discuss any plans for pregnancy with your doctor before conception.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
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