Burat CR
Generic Name
Burat CR
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| burat cr 50 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Burat CR (Sodium Valproate Extended-Release) is an anticonvulsant medication used to treat various types of seizures in epilepsy, acute manic or mixed episodes associated with bipolar disorder, and for the prophylaxis of migraine headaches.
Uses & Indications
Dosage
Adults
Epilepsy: Initially 10-15 mg/kg/day, increased by 5-10 mg/kg/week to achieve optimal clinical response, usually 25-60 mg/kg/day. Bipolar: Initially 25 mg/kg/day. Migraine: Initially 500 mg once daily for 1 week, then 1000 mg once daily.
Elderly
Start with lower doses and monitor closely due to potential for reduced hepatic/renal function and increased sensitivity to adverse effects.
Renal_impairment
No specific dose adjustment for mild to moderate renal impairment; monitor closely. Dosage reduction may be necessary in severe impairment.
How to Take
Take orally once daily. Tablets should be swallowed whole and not crushed or chewed, as this may interfere with the extended-release properties.
Mechanism of Action
Valproate is thought to exert its anticonvulsant effects by increasing brain concentrations of gamma-aminobutyric acid (GABA), blocking voltage-gated sodium channels, and modulating T-type calcium channels. These actions reduce neuronal excitability.
Pharmacokinetics
Onset
Onset of anticonvulsant effect can take several days to weeks. Mood stabilization may take longer.
Excretion
Mainly renal excretion of metabolites and a small amount of unchanged drug.
Half life
Approximately 9-16 hours (adults), varies with age and liver function.
Absorption
Well absorbed orally, with extended-release formulation providing prolonged absorption. Peak plasma concentrations reached 4-17 hours after administration.
Metabolism
Primarily hepatic metabolism via glucuronidation and mitochondrial beta-oxidation. Extensive first-pass metabolism.
Side Effects
Contraindications
- Hepatic dysfunction or severe liver disease
- Known urea cycle disorders
- Hypersensitivity to valproate or any component of the formulation
- Mitochondrial disorders
Drug Interactions
Aspirin
May increase valproate levels and risk of toxicity.
Warfarin
Valproate may displace warfarin from protein binding sites, increasing anticoagulant effect.
Lamotrigine
Valproate can significantly increase lamotrigine levels, increasing risk of serious rash. Lamotrigine dose reduction is usually required.
Phenobarbital, Phenytoin, Carbamazepine
Valproate can increase plasma levels of these anticonvulsants, leading to toxicity. Dose adjustment may be necessary.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, heart block, coma, and rarely, death. Management involves gastric lavage or activated charcoal, followed by supportive care, including naloxone if CNS depression is severe. Hemodialysis may be beneficial.
Pregnancy & Lactation
Pregnancy Category D (migraine prophylaxis contraindicated in pregnancy due to high teratogenic risk). Crosses placenta, known to cause neural tube defects and other congenital malformations. Passes into breast milk; use with caution, monitor infant for adverse effects.
Side Effects
Contraindications
- Hepatic dysfunction or severe liver disease
- Known urea cycle disorders
- Hypersensitivity to valproate or any component of the formulation
- Mitochondrial disorders
Drug Interactions
Aspirin
May increase valproate levels and risk of toxicity.
Warfarin
Valproate may displace warfarin from protein binding sites, increasing anticoagulant effect.
Lamotrigine
Valproate can significantly increase lamotrigine levels, increasing risk of serious rash. Lamotrigine dose reduction is usually required.
Phenobarbital, Phenytoin, Carbamazepine
Valproate can increase plasma levels of these anticonvulsants, leading to toxicity. Dose adjustment may be necessary.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, heart block, coma, and rarely, death. Management involves gastric lavage or activated charcoal, followed by supportive care, including naloxone if CNS depression is severe. Hemodialysis may be beneficial.
Pregnancy & Lactation
Pregnancy Category D (migraine prophylaxis contraindicated in pregnancy due to high teratogenic risk). Crosses placenta, known to cause neural tube defects and other congenital malformations. Passes into breast milk; use with caution, monitor infant for adverse effects.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months
Availability
Pharmacies in Bangladesh
Approval Status
Approved by DGDA
Patent Status
Off-patent (generic available)
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety of Sodium Valproate in the treatment of epilepsy, bipolar disorder, and migraine prophylaxis. Ongoing research continues to explore its full therapeutic potential and optimize its use.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin) prior to therapy and periodically thereafter, especially during the first 6 months.
- Platelet count and bleeding time periodically.
- Valproate plasma levels (if clinically indicated).
Doctor Notes
- Monitor LFTs regularly, especially in the first 6 months and in children.
- Educate patients about the black box warnings (hepatic failure, pancreatitis, teratogenicity).
- Consider therapeutic drug monitoring in cases of poor response or suspected toxicity.
- Counsel women of childbearing potential about contraception and alternative treatments.
Patient Guidelines
- Take medication regularly as prescribed; do not stop abruptly without consulting your doctor.
- Do not crush or chew the tablets.
- Report any unusual symptoms, especially yellowing of skin/eyes, severe abdominal pain, or unusual bleeding/bruising.
- Avoid sudden withdrawal, as it can precipitate seizures.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
May cause drowsiness, dizziness, or impaired coordination. Exercise caution when driving or operating machinery until you know how the medication affects you.
Lifestyle Advice
- Avoid alcohol consumption as it may increase side effects like drowsiness and dizziness.
- Maintain good oral hygiene to manage potential gum overgrowth.
- Discuss family planning if you are a woman of childbearing potential, due to high risks in pregnancy.
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