Valoate
Generic Name
Sodium Valproate
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| valoate 200 mg syrup | ৳ 100.30 | N/A |
Description
Overview of the medicine
Valoate 200 mg Syrup is used to treat various types of epilepsy, including partial, generalized, and absence seizures. It is also prescribed for the management of manic episodes associated with bipolar disorder and for the prophylaxis of migraine headaches.
Uses & Indications
Dosage
Adults
Initial dose 10-15 mg/kg/day, increased weekly by 5-10 mg/kg/day up to a maximum of 60 mg/kg/day. Administer in divided doses (usually 2-3 times daily).
Elderly
Lower initial doses and slower titration recommended due to potential for increased sensitivity and reduced hepatic/renal function. Monitor closely for side effects.
Renal_impairment
Generally no specific dose adjustment is required for mild to moderate renal impairment, but careful monitoring is advised. Valproate is poorly dialyzable.
How to Take
Valoate 200 mg Syrup is for oral administration. It can be taken with or without food. Taking it with food may help to reduce gastrointestinal upset such as nausea or indigestion. Use a calibrated measuring spoon or cup for accurate dosing.
Mechanism of Action
Valproate is thought to exert its anticonvulsant effects primarily by increasing gamma-aminobutyric acid (GABA) levels in the brain, which is an inhibitory neurotransmitter. It may also act by blocking voltage-gated sodium channels and modulating T-type calcium channels.
Pharmacokinetics
Onset
Anticonvulsant effect can be observed within hours to days. Full therapeutic effect for mood stabilization or migraine prophylaxis may take several days to weeks.
Excretion
Mainly excreted in the urine as metabolites and less than 3% as unchanged drug. Small amounts are excreted in feces and expired air.
Half life
Approximately 9 to 16 hours, highly variable among individuals.
Absorption
Rapid and complete oral absorption (bioavailability approaching 100%). Peak plasma concentrations occur within 1-4 hours.
Metabolism
Extensively metabolized in the liver, primarily via glucuronidation (50%) and mitochondrial beta-oxidation (40%). Other pathways include cytochrome P450-mediated oxidation.
Side Effects
Contraindications
- Known hypersensitivity to valproate or any component of the formulation
- Acute or chronic hepatitis or significant hepatic dysfunction
- Known urea cycle disorders
- Mitochondrial disorders (e.g., Alpers-Huttenlocher syndrome)
- Pregnancy (especially in epilepsy, due to high teratogenic risk)
Drug Interactions
Lamotrigine
Valproate inhibits lamotrigine metabolism, increasing lamotrigine levels and risk of severe rash. Reduce lamotrigine dose.
Carbamazepine
Valproate may decrease carbamazepine levels and increase levels of its active metabolite (carbamazepine epoxide), potentially leading to toxicity.
Phenobarbital
Valproate increases phenobarbital levels, leading to increased sedation and respiratory depression.
Aspirin/Anticoagulants
May increase the risk of bleeding due to valproate's effect on platelet aggregation.
Storage
Store below 30°C in a dry place, protected from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, heart block, deep coma, and respiratory depression. Management involves supportive care, gastric lavage, activated charcoal, and monitoring vital signs. Hemodialysis or hemoperfusion may be considered in severe cases or with very high serum levels.
Pregnancy & Lactation
Pregnancy Category D/X depending on indication and formulation. Valproate is highly teratogenic, especially during the first trimester, causing neural tube defects, craniofacial defects, and other major malformations. It is also associated with reduced IQ and developmental delay. Women of childbearing potential should use effective contraception and discuss risks with their doctor. If used during pregnancy, strict monitoring and folic acid supplementation are essential. Valproate passes into breast milk but is generally considered compatible with breastfeeding, with monitoring of the infant for drowsiness or feeding issues.
Side Effects
Contraindications
- Known hypersensitivity to valproate or any component of the formulation
- Acute or chronic hepatitis or significant hepatic dysfunction
- Known urea cycle disorders
- Mitochondrial disorders (e.g., Alpers-Huttenlocher syndrome)
- Pregnancy (especially in epilepsy, due to high teratogenic risk)
Drug Interactions
Lamotrigine
Valproate inhibits lamotrigine metabolism, increasing lamotrigine levels and risk of severe rash. Reduce lamotrigine dose.
Carbamazepine
Valproate may decrease carbamazepine levels and increase levels of its active metabolite (carbamazepine epoxide), potentially leading to toxicity.
Phenobarbital
Valproate increases phenobarbital levels, leading to increased sedation and respiratory depression.
Aspirin/Anticoagulants
May increase the risk of bleeding due to valproate's effect on platelet aggregation.
Storage
Store below 30°C in a dry place, protected from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, heart block, deep coma, and respiratory depression. Management involves supportive care, gastric lavage, activated charcoal, and monitoring vital signs. Hemodialysis or hemoperfusion may be considered in severe cases or with very high serum levels.
Pregnancy & Lactation
Pregnancy Category D/X depending on indication and formulation. Valproate is highly teratogenic, especially during the first trimester, causing neural tube defects, craniofacial defects, and other major malformations. It is also associated with reduced IQ and developmental delay. Women of childbearing potential should use effective contraception and discuss risks with their doctor. If used during pregnancy, strict monitoring and folic acid supplementation are essential. Valproate passes into breast milk but is generally considered compatible with breastfeeding, with monitoring of the infant for drowsiness or feeding issues.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the date of manufacture, when stored under recommended conditions. Refer to the packaging for the exact expiry date.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Off-patent (Generic available)
WHO Essential Medicine
YesClinical Trials
Valproate has undergone extensive clinical trials and research since its introduction, establishing its efficacy and safety profile for its approved indications. Ongoing research continues to explore new uses and optimize its therapeutic role.
Lab Monitoring
- Liver function tests (LFTs) before initiation and frequently during the first 6 months of therapy, then periodically.
- Complete Blood Count (CBC) with platelets before initiation and periodically.
- Ammonia levels, especially if encephalopathy is suspected or during concomitant topiramate use.
- Serum valproate levels to guide dosage adjustments and confirm therapeutic range.
Doctor Notes
- Thoroughly counsel all patients, especially women of childbearing potential, regarding the significant teratogenic risks of valproate.
- Emphasize the importance of regular adherence and not abruptly discontinuing therapy to prevent withdrawal seizures or mood destabilization.
- Monitor liver function tests, complete blood count (including platelets), and ammonia levels at baseline and regularly during treatment.
- Adjust dosage based on clinical response and serum valproate concentrations, maintaining levels generally between 50-100 mcg/mL for most indications.
Patient Guidelines
- Take exactly as prescribed by your doctor. Do not stop taking it abruptly as this may cause severe seizures.
- Report any unusual bleeding, bruising, signs of liver problems (e.g., yellowing skin/eyes, dark urine), or abdominal pain immediately to your doctor.
- Regular blood tests are crucial to monitor your response and potential side effects.
- Women of childbearing potential should use effective contraception and discuss pregnancy risks with their doctor.
Missed Dose Advice
If you miss a dose of Valoate 200 mg Syrup, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Valoate 200 mg Syrup may cause drowsiness, dizziness, or blurred vision, especially when first starting treatment or after a dose increase. Avoid driving or operating heavy machinery until you know how this medication affects you.
Lifestyle Advice
- Avoid consuming alcohol while on this medication as it can worsen side effects and central nervous system depression.
- Maintain a consistent dosing schedule to ensure optimal therapeutic levels and minimize the risk of breakthrough seizures or mood episodes.
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