Dicorate Er 500 Mg Tablet (10 Tab)

DICORATE ER 500 MG TABLET

DICORATE ER 500 MG TABLET is an extended-release medication manufactured by Sun Pharma Laboratories Ltd., primarily used to manage various neurological and psychiatric conditions.

• Name:

  • Brand Name: DICORATE ER 500 MG TABLET
  • Common Name: Divalproex Sodium Extended-Release Tablets

• Composition:

  • Each tablet contains Divalproex Sodium 500 mg.

• Uses: DICORATE ER 500 MG TABLET is prescribed for a range of conditions by stabilizing brain activity and balancing neurotransmitters.

  • Epilepsy/Seizures: Used as monotherapy or adjunctive therapy for complex partial seizures, simple and complex absence seizures, and other types of seizures in adults and pediatric patients aged 10 years or older.
  • Bipolar Disorder: For the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.
  • Migraine Prophylaxis: Indicated for the prevention of migraine headaches in adults.

• Dosage and Administration:

  • DICORATE ER tablets are administered orally and can be taken with or without food.
  • The dosage is individualized by a healthcare professional based on the patient's condition and response.
  • For Mania: The recommended initial dose is 25 mg/kg/day given once daily, increasing rapidly to achieve the lowest therapeutic dose, with a maximum recommended dosage of 60 mg/kg/day.
  • For Migraine Prophylaxis: The recommended starting dose is 500 mg once daily for one week, then increasing to 1,000 mg once daily.
  • For Epilepsy/Seizures: Initial doses for absence seizures are typically 15 mg/kg/day, increasing by 5 to 10 mg/kg/day at one-week intervals.
  • Do not stop taking this medicine abruptly, as it may trigger seizures or worsen the condition.

• Side Effects:

  • Common Side Effects: Headache, nausea, vomiting, dizziness, sleepiness/drowsiness, weight gain, hair loss, abdominal pain, constipation, tremor, double vision, weakness, and rash.
  • Serious Side Effects:
    • Liver injury: Especially in children under two years of age, or those with congenital metabolic disorders.
    • Pancreatitis: Inflammation of the pancreas.
    • Suicidal thoughts or behavior: Patients should be monitored for changes in mood or behavior.
    • Bleeding problems: Due to thrombocytopenia (low blood platelet count).
    • Hyperammonemia: High ammonia levels in the blood, potentially leading to encephalopathy.
    • Hypothermia: Low body temperature.
    • Multi-organ hypersensitivity reaction.

• Precautions:

  • Pregnancy: Contraindicated in pregnant women and women of childbearing potential not using effective contraception, especially for migraine prophylaxis, due to risks of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations.
  • Liver Disease: Contraindicated in patients with liver disease, significant hepatic dysfunction, or a family history of liver problems. Liver function tests should be performed before and during therapy.
  • Mitochondrial Disease: Contraindicated in patients with mitochondrial disorders caused by POLG mutations and children under two years of age.
  • Urea Cycle Disorders: Contraindicated in patients with urea cycle disorders.
  • Alcohol: Avoid alcohol consumption as it may increase drowsiness and other side effects, and can increase the risk of seizures.
  • Driving/Operating Machinery: May cause drowsiness and dizziness, so caution is advised.
  • Interactions: Inform your doctor about all other medications, including anticonvulsants, oral contraceptives, anticoagulants (e.g., warfarin), NSAIDs, and other prescription/OTC drugs, to avoid potential interactions.
  • Monitoring: Regular blood tests may be necessary to monitor the medication's effect on the body, including liver function, platelet count, and ammonia levels.

• Storage:

  • Store in a cool and dry place, away from heat, direct light, and moisture.
  • Keep out of the reach of children and pets.

DICORATE ER 500 MG TABLET (10 TAB) contains Divalproex sodium, an anticonvulsant medication used to manage various neurological and psychiatric conditions.

Here are some frequently asked questions about DICORATE ER 500 MG TABLET:

What is DICORATE ER 500 MG TABLET used for?

DICORATE ER 500 MG TABLET is primarily used to treat epilepsy (seizures), manage manic episodes associated with bipolar disorder, and prevent migraine headaches.

How does DICORATE ER 500 MG TABLET work?

The active ingredient, Divalproex sodium, works by increasing the levels of a calming chemical substance called GABA (gamma-aminobutyric acid) in the brain. This helps to reduce excessive and abnormal nerve activity, thereby controlling seizures, stabilizing mood fluctuations in bipolar disorder, and preventing migraines.

What is the usual dosage for DICORATE ER 500 MG TABLET?

The dosage of DICORATE ER 500 MG TABLET varies depending on the condition being treated and individual patient response. For migraine prophylaxis, a common starting dose is 500 mg once daily for one week, which may then be increased to 1,000 mg once daily. For seizures and bipolar disorder, the dosage is often individualized based on body weight, typically starting between 10 to 25 mg/kg/day and gradually increased as needed, but generally not exceeding 60 mg/kg/day. It is crucial to follow your doctor's instructions and swallow the tablet whole without crushing or chewing it.

What are the possible side effects of DICORATE ER 500 MG TABLET?

Common side effects can include abdominal pain, nausea, vomiting, dizziness, headache, sleepiness, tremors, hair loss, weight gain, blurred vision, or problems with walking or coordination. More serious side effects, though rare, can include liver damage (especially within the first six months of treatment), pancreatitis (inflammation of the pancreas), suicidal thoughts or behavior, and severe skin reactions. You should report any concerning or persistent side effects to your doctor immediately.

Is DICORATE ER 500 MG TABLET safe during pregnancy or breastfeeding?

DICORATE ER 500 MG TABLET is generally not safe during pregnancy due to a significant risk of birth defects and developmental disorders, including neural tube defects, and it is contraindicated for migraine prevention in women who are pregnant or may become pregnant without effective contraception. Women of childbearing potential should use effective contraception while taking this medication. This medicine is also generally not recommended during breastfeeding, as Divalproex sodium can pass into breast milk and may cause side effects in the nursing infant, such as liver problems or unusual bleeding. Your doctor will discuss alternative feeding methods or treatment options.

Can DICORATE ER 500 MG TABLET be taken with other medications?

DICORATE ER 500 MG TABLET can interact with numerous other medications, including other anti-epileptic drugs (like lamotrigine, phenytoin, carbamazepine), blood thinners (like warfarin), certain antibiotics (e.g., carbapenem antibiotics), antidepressants, and drugs for mood disorders. These interactions can either increase the levels of DICORATE ER or other medications, leading to increased side effects, or decrease its effectiveness. It is important to inform your doctor about all prescription, over-the-counter medications, and herbal supplements you are taking. Alcohol consumption should be avoided while taking this medication as it can increase drowsiness and dizziness and intensify other side effects.

What precautions should be taken while on DICORATE ER 500 MG TABLET?

Do not stop taking DICORATE ER suddenly without consulting your doctor, as abrupt discontinuation can lead to worsening of seizures or other serious problems. Regular blood tests, including liver function tests, are necessary, especially during the first six months of treatment. Inform your doctor about any history of liver problems, kidney issues, urea cycle disorders, mitochondrial disease, or depression. Monitor for changes in mood or behavior, including suicidal thoughts. This medicine can cause drowsiness or dizziness, so exercise caution when driving or operating machinery until you know how it affects you.

What happens if a dose of DICORATE ER 500 MG TABLET is missed?

If you miss a dose of DICORATE ER 500 MG TABLET, 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 or extra dose to make up for the missed one. For extended-release formulations like DICORATE ER, a missed dose can typically be replaced up to 12 hours later without significant changes in blood valproic acid concentrations.

How should DICORATE ER 500 MG TABLET be stored?

DICORATE ER 500 MG TABLET should be stored at room temperature, typically between 68°F to 77°F (20°C to 25°C), away from light and moisture. Keep the medication out of reach of children.