Epilex Chrono 300 Tablet

EPILEX CHRONO 300 TABLET by ABBOTT

Name

Common Name: Valproic Acid / Sodium Valproate (Divalproex Sodium) Brand Name: Epilex Chrono 300 Tablet

Composition

Each controlled-release tablet contains a combination of Sodium Valproate (200mg) and Valproic Acid (87mg), collectively referred to as Divalproex.

Uses

EPILEX CHRONO 300 TABLET is primarily prescribed for the treatment of various neurological and psychiatric conditions:

• Epilepsy: It is effective in managing different forms of epilepsy, including partial seizures, generalized seizures, simple and complex absence seizures, myoclonic seizures, and tonic-clonic (grand mal) seizures. It works by stabilizing electrical activity in the brain and reducing abnormal nerve activity.
• Bipolar Disorder: It is used in the management of manic episodes associated with bipolar disorder, helping to stabilize mood swings.
• Migraine Prophylaxis: It can also be used for the prevention of migraine headaches.

Dosage and Administration

EPILEX CHRONO 300 TABLET should be taken orally as directed by a healthcare professional.

• The tablet should be swallowed whole with a glass of water and not crushed, broken, or chewed, as it is an extended-release formulation designed for gradual and consistent release of active ingredients.
• It can be taken with or without food; however, taking it with food is often advised to minimize stomach upset.
• Dosage is individualized based on the patient's condition, age, weight, and response to the medication, typically taken once or twice daily.
• Abrupt discontinuation should be avoided as it can lead to worsening seizures or mood changes. The dose should be gradually reduced under medical supervision.

Side Effects

Common side effects may include:

• Dizziness, drowsiness, and sleepiness
• Nausea, vomiting, abdominal pain, diarrhea, and constipation
• Increased appetite and weight gain
• Hair loss, headache, and tremor
• Impaired coordination, confusion, and irregular periods

Serious side effects, though less common, can include:

• Liver dysfunction (hepatotoxicity), especially in young children
• Pancreatitis (inflammation of the pancreas)
• Suicidal thoughts or behavior
• Severe allergic reactions
• Thrombocytopenia (low blood platelet count), hyperammonemia (high ammonia levels in the blood), and hypothermia (low body temperature)

Precautions

• Contraindications: Do not use if you have active liver disease, significant hepatic dysfunction, known urea cycle disorders, mitochondrial disorders caused by POLG gene mutations, or hypersensitivity to sodium valproate, valproic acid, or any other ingredients.
• Pregnancy: EPILEX CHRONO 300 TABLET is categorized as Pregnancy Category D. It should generally be avoided during pregnancy due to a significant risk of serious birth defects (e.g., spina bifida) and potential developmental issues in the child (e.g., lower cognitive abilities, autism, ADHD). Women of childbearing age should use effective contraception.
• Breastfeeding: It is generally not recommended during breastfeeding as it can pass into breast milk.
• Alcohol: Avoid or limit alcohol consumption as it can increase side effects such as dizziness and drowsiness.
• Driving and Operating Machinery: This medicine may cause dizziness, drowsiness, and affect thinking and motor skills. Patients should avoid driving or operating machinery until they know how the medication affects them.
• Children: Use with caution, especially in children under 18 years due to a higher risk of hepatotoxicity, and under 3 years due to an increased risk of liver damage. Dosage should be adjusted based on body weight.
• Liver/Kidney Conditions: Exercise caution in patients with kidney problems. Regular monitoring of liver function and blood counts is recommended during treatment.
• Drug Interactions: Inform your doctor about all other medications, including herbal supplements, as EPILEX CHRONO 300 TABLET can interact with various drugs (e.g., other anticonvulsants, benzodiazepines, carbapenem antibiotics, warfarin, certain antidepressants, and anti-malarials).

Storage

Store in a cool, dry place, typically below 30°C (or 25°C), away from direct sunlight. Keep this medicine out of the sight and reach of children.

What is Epilex Chrono 300 Tablet used for?

Epilex Chrono 300 Tablet is primarily used to treat various forms of epilepsy, including partial and generalized seizures. It is also utilized in the management of manic episodes associated with bipolar disorder and for the prevention of migraine headaches.

How does Epilex Chrono 300 Tablet work?

Epilex Chrono 300 Tablet contains Sodium Valproate and Valproic Acid. It works by increasing the levels of an inhibitory neurotransmitter called gamma-aminobutyric acid (GABA) in the brain, which helps reduce abnormal electrical activity and calm overexcited neurons. It also blocks voltage-gated sodium channels and T-type calcium channels involved in epileptic seizure propagation, and inhibits the enzyme GABA transaminase, which breaks down GABA, further ensuring increased GABA levels. These combined actions stabilize abnormal electrical activity in the brain.

What is the usual dosage for Epilex Chrono 300 Tablet?

The dosage of Epilex Chrono 300 Tablet is determined by your doctor and is individualized based on your condition and response to treatment. For epilepsy, a typical starting dose is 10-15 mg/kg per day, gradually increased. For bipolar disorder, the starting dose might be around 750 mg/day. For migraines, the usual starting dose for adults is 200 mg to 400 mg per day in divided doses. It is usually taken with food to minimize stomach upset. Tablets should be swallowed whole and not crushed or chewed.

What are the possible side effects of Epilex Chrono 300 Tablet?

Common side effects may include dizziness, nausea, vomiting, increased appetite, weight gain, hair loss, tremor, headache, drowsiness, and abdominal pain. If these effects persist or worsen, consult your doctor. More serious side effects can include liver damage and suicidal thoughts.

Is Epilex Chrono 300 Tablet safe during pregnancy or breastfeeding?

Epilex Chrono 300 Tablet is generally not recommended during pregnancy (Pregnancy Category D) as it may cause major congenital malformations and neurodevelopmental disorders in the unborn child. It is important to discuss this with your doctor if you are pregnant or planning to conceive, and effective contraception should be used by women of child-bearing age.

During breastfeeding, Epilex Chrono 300 Tablet is found in breast milk and is generally not recommended. It is best to consult your doctor to weigh potential risks against benefits.

Can Epilex Chrono 300 Tablet be taken with other medications?

Yes, Epilex Chrono 300 Tablet can interact with various other medicines. Inform your doctor about all medicines you are taking, including over-the-counter and herbal medicines. Some interactions include:

• Other anticonvulsants like phenytoin, carbamazepine, and lamotrigine, which may affect the levels of these medicines or Epilex Chrono.
• Benzodiazepines (e.g., diazepam, lorazepam) which can cause excessive sleepiness or sedation.
• Carbapenem antibiotics (e.g., meropenem, imipenem) can reduce the levels of Epilex Chrono 300 Tablet.
• Aspirin and other salicylates can increase valproic acid levels.
• Antidepressants (e.g., SSRIs, Tricyclics) may increase the risk of serotonin syndrome.
• Warfarin (blood thinners) may have increased effects.

What precautions should be taken?

Avoid or limit alcohol consumption while taking Epilex Chrono 300 Tablet, as it may increase drowsiness or affect the medicine's functioning. Do not drive or operate machinery until you know how the medicine affects you, as it can cause dizziness, sedation, or confusion.

This medicine is contraindicated if you have active liver disease or significant hepatic dysfunction. Use with caution if you have kidney problems, a history of liver disease, bleeding disorders, urea cycle disorders, or mitochondrial disorders. Regular blood tests may be required to monitor liver function and blood counts. Children under 18 and older patients require caution and medical supervision. Do not stop taking the medicine abruptly, as this may lead to an increase in seizure frequency.

What happens if a dose is missed?

If you miss a dose of Epilex Chrono 300 Tablet, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed one and continue with your regular dosage schedule. Do not double the dose to compensate for a missed one.

How should it be stored?

Epilex Chrono 300 Tablet should be stored in a cool and dry place, away from sunlight and moisture. Keep it out of the sight and reach of children. Store below 30°C.