Levetiracetam (Klevra) 500mg Film Coated Anticonvulsant Tablates 90's

Certainly! Here is the detailed information for Levetiracetam (Klevra) 500mg Film-Coated Anticonvulsant Tablets 90's:

Product Description:

Levetiracetam (Klevra) 500mg Film-Coated Anticonvulsant Tablets are prescribed for the treatment of epilepsy and seizures. Levetiracetam is an anticonvulsant or antiepileptic drug (AED) that works by stabilizing electrical activity in the brain to prevent abnormal brain waves that lead to seizures. It is commonly used as adjunctive therapy (alongside other medications) or as monotherapy in the management of certain types of epilepsy, including focal seizures and generalized seizures.

Each tablet contains 500 mg of Levetiracetam, and the product is typically sold in a pack containing 90 film-coated tablets.

Indications:

Levetiracetam (Klevra) is indicated for the following:

1. Epilepsy (Seizure Disorders):

   • As monotherapy in the treatment of focal seizures (partial seizures) with or without secondary generalization in adults and children 16 years of age and older.

   • As adjunctive therapy in the treatment of focal seizures, myoclonic seizures, and generalized tonic-clonic seizures in both adults and children (from 1 month of age and older).

2. Generalized Seizures:

   • For the treatment of generalized tonic-clonic seizures and myoclonic seizures in patients with epilepsy.

Dosages:

The typical dosage for Levetiracetam (Klevra) is determined by the patient’s age, the type of seizures, and other health factors. Below are general dosage guidelines:

• Adults and Adolescents (16 years and older):

  • Starting Dose: Initially, 500 mg once daily or 250 mg twice daily (morning and evening).

  • Maintenance Dose: After 2 weeks, the dose may be increased to 1000 mg once daily or 500 mg twice daily, depending on the clinical response. The maximum daily dose is usually 3000 mg (1500 mg twice daily).

• Children (6 to 15 years old):

  • Starting Dose: The typical starting dose is 10 mg/kg/day, divided into two doses (morning and evening).

  • Maintenance Dose: The dose can be increased depending on the clinical response, with a typical range of 20-60 mg/kg/day divided into two doses.

  • The maximum recommended dose is 3000 mg/day.

• Children (1 month to 5 years old):

  • Levetiracetam is typically given as adjunctive therapy, and the dosage is based on weight. The initial dose is typically 10 mg/kg/day, and it is adjusted based on the clinical response.

Note: Dosage adjustments are necessary for patients with impaired kidney function, and the dose may need to be reduced based on the degree of renal impairment.

Side Effects:

Like all medications, Levetiracetam (Klevra) can cause side effects. Some common and serious side effects include:

1. Common side effects:

   • Drowsiness

   • Fatigue

   • Headache

   • Dizziness

   • Irritability

   • Loss of appetite

   • Nausea

2. Serious side effects (less common):

   • Behavioral changes: These may include mood swings, depression, anxiety, aggression, or suicidal thoughts. Any unusual changes in behavior should be reported to a healthcare provider.

   • Allergic reactions: Symptoms may include swelling of the face, lips, tongue, or throat (angioedema), difficulty breathing, or skin rashes.

   • Severe dizziness or confusion: This could indicate serious side effects, such as a reaction to the drug affecting the brain.

   • Low blood cell count: Rarely, Levetiracetam can cause low white blood cells, which increases the risk of infection. Symptoms might include fever, chills, or persistent sore throat.

   • Liver problems: Symptoms like yellowing of the skin or eyes (jaundice) or dark urine should be monitored.

3. Very rare side effects:

   • Severe skin reactions such as blistering, peeling, or shedding.

   • Hematological issues: Such as low platelets or red blood cell counts, which may lead to bleeding or bruising.

Contraindications:

Levetiracetam (Klevra) should not be used in the following conditions:

1. Hypersensitivity: If you are allergic to Levetiracetam or any of its ingredients, this medication should be avoided.

2. Severe Renal Impairment: In patients with severe kidney disease, the dosage of Levetiracetam needs to be adjusted to prevent toxicity.

3. Pregnancy: Levetiracetam is classified as Category C for pregnancy, which means that it should only be used during pregnancy if the potential benefits justify the risks. It should be prescribed with caution, particularly during the first trimester.

4. Breastfeeding: Levetiracetam is excreted in breast milk, and although the effects on the infant are not fully known, it is generally not recommended during breastfeeding unless absolutely necessary and under the guidance of a healthcare provider.

Warnings and Precautions:

• Suicidal Thoughts and Behavior: Like other antiepileptic drugs, Levetiracetam has been associated with an increased risk of suicidal thoughts and behavior. Patients should be monitored for any signs of depression, mood changes, or suicidal thoughts, especially during the initial stages of treatment.

• Behavioral and Psychiatric Effects: Some patients may experience behavioral changes such as irritability, aggression, anxiety, or confusion. If these occur, the treating physician should be consulted, as dose adjustments or discontinuation may be required.

• Severe Allergic Reactions: If you develop swelling of the face, lips, tongue, or throat, or experience difficulty breathing, you should seek immediate medical attention.

• Caution in Kidney Dysfunction: Dosage adjustments may be necessary for patients with impaired renal function. Kidney function should be monitored regularly.

• Discontinuation of Therapy: Do not suddenly stop taking Levetiracetam without consulting your healthcare provider, as sudden discontinuation may increase the risk of seizures.

• Pregnancy and Birth Defects: Use in pregnancy should be carefully considered, as there may be potential risks to the fetus. Adequate contraception should be considered in women of childbearing age taking Levetiracetam.

Storage:

• Store Levetiracetam (Klevra) at room temperature, away from moisture, heat, and light.

• Keep out of reach of children.

Important Note: Always follow the prescribed dosage and consult with your healthcare provider if you experience any new or unusual symptoms. Regular monitoring may be required to adjust the dose for optimal treatment and to avoid potential side effects.