Levera Solution 100 Ml

LEVERA SOLUTION 100 ML

Name

Brand Name: Levera Solution Common Name: Levetiracetam Oral Solution

Composition

Levera Solution contains Levetiracetam at a concentration of 100 mg/ml as its active ingredient. It also includes Methylparaben (1.8 mg/ml) and Propyl Paraben (0.2 mg/ml) as preservatives.

Uses

Levera Solution is an anti-epileptic medicine prescribed for the treatment of seizures (fits) due to epilepsy in both adults and children over 1 month old. It is effective in controlling various types of seizures, including partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic (grand mal) seizures. It works by slowing down abnormal electrical signals in the brain that cause seizures, thereby helping to prevent their occurrence.

Dosage and Administration

Levera Solution should be taken orally, with or without food, usually twice a day, or as directed by a doctor. It is recommended to take the medicine at the same time each day to maintain consistent levels in the body. The bottle should be shaken well before each use, and the dose should be measured using a provided measuring device. Do not stop taking this medicine abruptly without consulting a doctor, as it may worsen seizures.

Side Effects

Common side effects include sleepiness, dizziness, fatigue, headache, decreased appetite, irritation, agitation, and behavioral changes such as aggressive behavior. Serious side effects can include suicidal thoughts, severe allergic reactions (anaphylaxis), and a decrease in kidney function.

Precautions

Caution is advised for patients with a history of kidney disease, liver disease, or mental conditions like depression or suicidal thoughts. Alcohol consumption should be avoided as it may increase drowsiness and calmness. Levera Solution may cause dizziness or drowsiness, affecting the ability to drive or operate machinery. Pregnant or breastfeeding women should consult their doctor before use. Interactions can occur with other anti-epileptic medications, potentially leading to severe drowsiness or breathing problems.

Storage

Store Levera Solution in a cool and dry place, away from direct sunlight, at a temperature between 10ºC to 25ºC or below 30ºC. Keep it out of the sight and reach of children.

LEVERA SOLUTION 100 ML by INTAS PHARMACEUTICALS LTD. is an anti-epileptic medication containing Levetiracetam as its active ingredient. It is used to manage and prevent various types of seizures associated with epilepsy.

What is Levera Solution used for?

Levera Solution is primarily used to treat seizures (fits) caused by epilepsy in both adults and children. It is effective for managing partial-onset seizures (with or without secondary generalization), myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in individuals with idiopathic generalized epilepsy. It can be prescribed alone or in combination with other anti-epileptic medicines.

How does Levera Solution work?

Levera Solution contains Levetiracetam, which works by binding to a specific protein called SV2A (synaptic vesicle protein 2A) in the brain's nerve cells. This action helps to regulate the release of chemical messengers (neurotransmitters) between nerve cells, thereby stabilizing abnormal electrical activity in the brain that causes seizures and preventing their spread. It helps reduce the frequency of seizures but does not cure epilepsy.

What is the usual dosage for Levera Solution?

The dosage of Levera Solution depends on the patient's age, weight, the type of seizure, and renal function. It is usually taken twice daily, approximately 12 hours apart, with or without food. Your doctor will prescribe a low initial dose and gradually increase it over a few weeks to prevent side effects and find the most effective dose. It is crucial to use a calibrated measuring device provided with the solution, not a household spoon, to ensure accurate dosing, especially for pediatric patients where dosing is weight-based.

What are the possible side effects of Levera Solution?

Common side effects of Levera Solution may include drowsiness, dizziness, weakness, headache, irritability, aggression, loss of appetite, and fatigue. Some individuals may experience mood and behavioral changes such as anxiety, agitation, and depression. Serious but rare side effects can include severe skin reactions (like Stevens-Johnson syndrome) and suicidal thoughts or behavior. If any side effects persist, worsen, or cause concern, contact your doctor.

Is Levera Solution safe during pregnancy or breastfeeding?

Pregnancy: Levetiracetam can be used during pregnancy if considered clinically necessary by your doctor after careful assessment. It is important to continue treatment for epilepsy during pregnancy, as uncontrolled seizures can harm both the mother and the baby. Physiological changes during pregnancy can affect levetiracetam concentrations, and your doctor may need to adjust your dose. Folic acid supplementation is recommended if you are trying to conceive or are pregnant. Do not stop taking the medicine suddenly without consulting your doctor.

Breastfeeding: Levetiracetam is excreted in human breast milk. While breastfeeding is generally not recommended, if treatment is essential during lactation, the benefit/risk should be weighed. Levels in milk can be high in some women and may occasionally cause sedation or other adverse effects in breastfed infants, particularly in younger, exclusively breastfed infants or when other anticonvulsants are also used. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones.

Can Levera Solution be taken with other medications?

Levetiracetam does not significantly influence the plasma concentrations of many other antiepileptic drugs (AEDs) like carbamazepine, gabapentin, lamotrigine, phenobarbital, phenytoin, primidone, and valproate. However, it can interact with sedatives (e.g., diazepam, lorazepam) and certain antidepressants (e.g., SSRIs like fluoxetine), potentially enhancing CNS depression or causing dizziness/confusion. It's crucial to inform your doctor about all prescription and non-prescription medications, vitamins, nutritional supplements, and herbal products you are taking to avoid potential interactions. There are 240 known drug interactions for levetiracetam, with 6 major and 231 moderate interactions.

What precautions should be taken when using Levera Solution?

• Do not stop abruptly: Suddenly discontinuing Levera Solution can lead to increased seizures or status epilepticus (seizures that won't stop). Any changes to your dosage should be made under medical supervision.
• Mental and behavioral changes: Levetiracetam can cause behavioral abnormalities, mood changes, and psychotic symptoms, including agitation, anxiety, depression, aggression, and suicidal thoughts. Monitor for any unusual changes and report them to your doctor immediately.
• Kidney impairment: Caution is advised for patients with kidney problems, as dose adjustments may be necessary due to renal excretion of levetiracetam.
• Dizziness and drowsiness: The medicine may cause drowsiness, dizziness, or affect coordination, especially at the beginning of treatment or after a dose increase. Avoid driving or operating machinery until you know how the medicine affects you.
• Allergic reactions and skin rashes: Rarely, serious allergic reactions or skin rashes (e.g., Stevens-Johnson syndrome, DRESS) can occur. Seek immediate medical attention if you experience rash, fever, swelling, or difficulty breathing.
• Measuring: Always use the provided measuring device to ensure the correct dose.

What happens if a dose is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double doses to make up for a forgotten one, as this can cause serious problems or increase side effects. Consistent dosing is important to control seizures.

How should Levera Solution be stored?

Levera Solution should be stored at room temperature, typically between 15°C to 30°C (59°F to 86°F), away from heat and direct light. Keep the bottle well-capped and out of the sight and reach of children. If repackaged into oral plastic syringes, levetiracetam 100 mg/mL oral solution has been found stable for up to six months when stored at refrigeration (2-8°C) or room temperature (20-25°C) in amber polypropylene oral syringes.