Medicine Information

Encorate Chrono

Name: Encorate Chrono
Brand: Encorate Chrono
Rating: 4.5 (117 reviews)

Extended-release Tablet300 mgAnticonvulsant; Mood StabilizerATC: N03AG01

Generic Name

Valproic Acid Extended-release Tablet

Manufacturer

Sun Pharmaceutical Industries Ltd.

Country

India

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
encorate chrono 300 mg tablet	৳ 9.00	৳ 90.00

Description

Overview of the medicine

Valproic acid is an anticonvulsant and mood-stabilizing medication primarily used to treat epilepsy, bipolar disorder, and to prevent migraine headaches. Encorate Chrono is an extended-release formulation, which allows for less frequent dosing and a more stable blood concentration of the drug.

Uses & Indications

Epilepsy (complex partial seizures, simple partial seizures, absence seizures, generalized tonic-clonic seizures)

Manic or mixed episodes associated with bipolar disorder

Prophylaxis of migraine headaches

Dosage

Adults

Initial dose is often 25 mg/kg/day, taken once daily. The dose is gradually increased based on clinical response and tolerability, usually reaching a maintenance dose between 1000 mg to 2500 mg per day. Maximum recommended dose is 60 mg/kg/day.

Elderly

Start with lower initial doses and titrate slowly, with careful monitoring due to potential for increased sensitivity and altered pharmacokinetics.

Renal_impairment

No significant dosage adjustment is generally required for mild to moderate renal impairment, but close monitoring of clinical response and adverse effects is recommended.

How to Take

Take orally, swallow the tablet whole with a glass of water. Do not crush, chew, or break the tablet as it is an extended-release formulation. It can be taken with or without food, but taking it with food may help reduce gastrointestinal upset.

Mechanism of Action

Valproic acid exerts its anticonvulsant effects through several mechanisms, including increasing the levels of gamma-aminobutyric acid (GABA) in the brain, blocking voltage-gated sodium channels, and inhibiting T-type calcium channels. These actions contribute to stabilizing neuronal membranes and reducing abnormal electrical activity in the brain.

Pharmacokinetics

Onset

Varies based on indication, within days to weeks for therapeutic effect.

Excretion

Renal (as metabolites and unchanged drug).

Half life

Approximately 9-16 hours.

Absorption

Well absorbed orally; peak plasma levels reached within 4-17 hours for extended-release formulation.

Metabolism

Primarily hepatic (glucuronidation, beta-oxidation).

Side Effects

Contraindications

Severe hepatic dysfunction or active hepatic disease
Known urea cycle disorders
Hypersensitivity to valproic acid or any component of the formulation
Pregnancy, especially when used for migraine prophylaxis due to significant teratogenic risks.

Drug Interactions

Aspirin

Can displace valproic acid from protein binding sites, increasing free valproic acid levels and potential toxicity.

Warfarin

May enhance the anticoagulant effect of warfarin.

Lamotrigine

Valproic acid can increase lamotrigine levels, increasing risk of serious rash (e.g., Stevens-Johnson syndrome).

Carbapenem antibiotics (e.g., Meropenem, Ertapenem)

Can significantly decrease valproic acid serum concentrations, leading to loss of seizure control.

Storage

Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.

Overdose

Symptoms of overdose may include somnolence, heart block, profound coma, and death. Management is primarily supportive. Activated charcoal can be considered shortly after ingestion. Hemodialysis or hemoperfusion may be effective in severe cases to remove the drug.

Pregnancy & Lactation

Pregnancy: Valproic acid is classified as Pregnancy Category D. It is associated with a high risk of birth defects (e.g., neural tube defects, facial abnormalities, cardiovascular defects) and developmental problems. Women of childbearing potential should use effective contraception. If pregnancy occurs, the risks and benefits should be carefully evaluated, and folic acid supplementation is strongly recommended. Lactation: Valproic acid is excreted into breast milk. Although the amounts are typically small, potential effects on the infant should be considered. Breastfeeding should be approached with caution, and infant monitoring for adverse effects (e.g., sedation, feeding difficulties) is advised.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

10 tablets (1 blister strip)30 tablets (3 blister strips)

Shelf Life

Typically 2-3 years from the date of manufacture

Availability

Pharmacies, Hospitals

Approval Status

Approved by regulatory bodies (e.g., FDA, DGDA)

Patent Status

Generic/Off-patent

WHO Essential Medicine

Yes

Clinical Trials

Valproic acid has undergone extensive clinical trials supporting its efficacy and safety in various indications, including epilepsy, bipolar disorder, and migraine prophylaxis. Specific trials for Encorate Chrono focus on its extended-release profile and bioavailability.

Lab Monitoring

Liver function tests (ALT, AST, bilirubin) at baseline and periodically during treatment
Complete blood count (CBC) with platelet count at baseline and periodically
Serum valproic acid levels (therapeutic drug monitoring)
Amylase and lipase levels if pancreatitis is suspected

Doctor Notes

Counsel patients, especially women of childbearing potential, regarding the significant teratogenic risks and the need for effective contraception and folic acid supplementation.
Regularly monitor liver function tests, complete blood count with platelets, and serum valproic acid levels.
Educate patients on symptoms of hepatotoxicity and pancreatitis, and advise immediate medical attention if they occur.

Patient Guidelines

Take this medication exactly as prescribed by your doctor. Do not stop taking it suddenly without consulting your doctor, as this can trigger seizures.
Swallow the tablet whole; do not chew, crush, or break it.
Report any unusual side effects, especially abdominal pain, dark urine, yellowing of skin/eyes, or unusual bleeding/bruising, to your doctor immediately.

Missed Dose Advice

If you miss a dose, 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 to catch up.

Driving Precautions

This medication may cause drowsiness, dizziness, or impaired coordination. Avoid driving or operating heavy machinery until you know how it affects you.

Lifestyle Advice

Avoid alcohol consumption while taking this medication as it can increase side effects like drowsiness and dizziness.
Maintain a balanced diet and stay adequately hydrated.