VALPROL CR 750 MG TABLET

Name: VALPROL CR 750 MG TABLET. Manufactured by Intas Pharmaceuticals Ltd.

Composition: Each film-coated controlled-release tablet contains Sodium Valproate (499.5 mg) and Valproic Acid (217.5 mg), which together correspond to Sodium Valproate 750 mg.

Uses: Valprol CR 750 MG Tablet is an anticonvulsant primarily used to manage various neurological and psychiatric conditions. It is prescribed for:

• Epilepsy/Seizures/Fits: Helps control seizures by stabilizing abnormal electrical activity in the brain.
• Mood Disorders: Used in conditions like bipolar disorder to regulate mood swings and reduce episodes of mania or depression.
• Migraine Prophylaxis: Effective in preventing and reducing the frequency and intensity of migraine attacks.

Dosage and Administration: Take Valprol CR 750 MG Tablet exactly as prescribed by your doctor. It should be swallowed whole with food to minimize stomach upset and should not be crushed or chewed. The dosage is typically adjusted gradually until the condition stabilizes. For epilepsy, a starting dose of 10-15 mg/kg per day is common, while for bipolar disorder, it might be around 750 mg/day.

Side Effects: Common side effects include nausea, vomiting, weight gain, loss of appetite, headaches, drowsiness, tremors, dizziness, and hair loss. More serious, though less common, side effects can include liver injury or increased liver enzymes, bleeding gums, stomach pain, and in rare cases, mood changes or suicidal thoughts.

Precautions:

• Pregnancy and Breastfeeding: Avoid during pregnancy due to potential birth defects; use effective contraception if of childbearing age. Consult a doctor if breastfeeding.
• Liver/Kidney Issues: Use with caution in patients with liver or kidney disease; not recommended for severe liver disease. Regular blood tests to monitor liver function may be necessary.
• Alcohol: Avoid alcohol consumption as it may increase the risk of side effects and seizures.
• Driving/Machinery: May cause drowsiness or dizziness; avoid driving or operating heavy machinery until you know how the medicine affects you.
• Children: Caution is advised for children under 3 years due to a higher risk of liver issues.

Storage: Store in a cool, dry place, away from direct sunlight and moisture, and out of reach of children and pets. Keep in its original packaging.

VALPROL CR 750 MG TABLET (10 TAB) by INTAS PHARMACEUTICALS LTD. - Frequently Asked Questions

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What is Valprol CR 750 mg Tablet used for?

Valprol CR 750 mg Tablet, a combination of Sodium Valproate and Valproic Acid, is primarily used to treat various types of epilepsy/seizures/fits. It is also prescribed for managing mood disorders, such as bipolar disorder, and for the prevention of migraine headaches.

How does Valprol CR 750 mg Tablet work?

This medicine works by decreasing excessive and abnormal nerve activity in the brain. It increases the levels of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter in the brain, which helps to block nerve transmissions and produce a calming effect. It may also inhibit voltage-gated sodium and calcium channels.

What is the usual dosage for Valprol CR 750 mg Tablet?

The exact dosage is determined by your doctor based on your condition, age, body weight, and response to treatment. For adults with epilepsy, initial doses typically range from 10 to 15 mg/kg per day, which may be gradually increased weekly by 5 to 10 mg/kg up to a maximum of 60 mg/kg/day. For bipolar disorder, a common starting dose might be around 750 mg/day, adjusted rapidly to achieve the desired therapeutic effect, not exceeding 60 mg/kg/day. For migraine prevention, adult starting doses are usually 200 mg to 400 mg per day in divided doses. Valprol CR tablets are extended-release and usually taken once daily, often with food to minimize stomach upset. The tablet should be swallowed whole and not crushed or chewed.

What are the possible side effects of Valprol CR 750 mg Tablet?

Common side effects can include nausea, vomiting, headache, drowsiness, dizziness, tremors, weight gain, appetite changes, diarrhea, and transient hair loss. More serious but less common side effects can include liver injury, pancreatitis, hyperammonemia (high ammonia levels in the blood), and an increased risk of suicidal thoughts. If you experience persistent or severe side effects, or any unusual changes in mood or behavior, consult your doctor.

Is Valprol CR 750 mg Tablet safe during pregnancy or breastfeeding?

Pregnancy: Valprol CR 750 mg Tablet (Valproic acid) is generally not recommended during pregnancy as it can cause serious birth defects, especially affecting the brain and spinal cord, and may lead to developmental problems in the child. If you are pregnant or planning to become pregnant, your doctor will discuss the risks and potential alternative treatments. Do not stop taking the medicine without consulting your doctor, as this could worsen your condition.

Breastfeeding: Valproic acid passes into breast milk in small amounts. While some sources suggest it may be safe to use during breastfeeding if prescribed by a doctor, especially if it's the only effective medicine, it's generally not recommended. If you are breastfeeding, discuss this with your doctor, who will weigh the benefits against potential risks and monitor your baby for any side effects like unusual sleepiness or poor feeding.

Can Valprol CR 750 mg Tablet be taken with other medications?

Valprol CR 750 mg Tablet can interact with various medications. It can increase the effects of neuroleptics, monoamine oxidase inhibitors (MAOIs), and other antidepressants. It can also affect the levels of other antiepileptic drugs like phenytoin and lamotrigine. Other interactions include cimetidine (prolongs valproate's half-life), cholestyramine (decreases absorption), carbapenems (may decrease valproate levels), aspirin (increases valproic acid levels and risk of hepatotoxicity in young children), and bupropion (increased toxicity risk). Always inform your doctor about all other medications, supplements, or herbal preparations you are taking to avoid potential interactions.

What precautions should be taken with Valprol CR 750 mg Tablet?

• Liver Function: Caution is advised for patients with hepatic disease or a history of liver problems. Liver function tests should be performed before and regularly during treatment, especially in the first six months.
• Children: Increased risk of hepatotoxicity in children under 2 years old, especially those on multiple anticonvulsants or with certain metabolic disorders.
• Alcohol: Avoid alcohol consumption as it can increase side effects like dizziness and drowsiness and may worsen certain side effects or increase seizure risk.
• Driving & Operating Machinery: This medicine may cause drowsiness, dizziness, or blurred vision, so avoid driving or operating heavy machinery until you know how it affects you.
• Pancreatitis & Bleeding Disorders: Use with caution in patients with a history of pancreatitis or bleeding disorders.
• Suicidal Thoughts: Monitor for unusual changes in mood or behavior, new or worsening depression, or suicidal thoughts.
• Weight Gain: Valprol CR can cause weight gain; a healthy diet and regular exercise are recommended.
• Do not stop suddenly: Do not stop taking Valprol CR 750 mg Tablet suddenly without consulting your doctor, as this can lead to an increase in seizure frequency or worsening of your condition.

What happens if a dose of Valprol CR 750 mg Tablet is missed?

If you miss a dose, 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.

How should Valprol CR 750 mg Tablet be stored?

Store Valprol CR 750 mg Tablet below 25°C or 30°C, protected from light and moisture, and out of the reach of children.