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Why it's used

Levipil 500 Tablet is used to treat seizures affecting a part of the brain in adults and children (1 month or older with seizures), a sudden increase in muscle tone in adults and children from 12 years with myoclonic epilepsy started in childhood or teen years, seizures involving entire body in adults and children (from 12 years with epilepsy with unknown cause). Levipil 500 is given as combined therapy in these conditions. This medicine works by reducing abnormal brain excitement. Levipil 500 is also used to treat seizures affecting a part of the brain as single drug therapy in adults and children from 16 years with seizures.
Anti-epileptic Agent
Levipil 500 is a prescription medicine that belongs to a class of medicines called Anti-epileptic Agent. Antiepileptic drugs are a class of medicines which are used to treat epilepsy by controlling seizures.

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How to use

Follow directions on the product label, information guide, and provided by your doctor before using Levipil 500. Consume this medicine as per your doctor's instructions.
Levipil 500 is consumed with or without food. Levipil 500 tablets should be taken with a sufficient amount of liquid like a full glass of water. Levipil 500 is consumed Levipil 500 dose should be taken two times a day, half of the regular dose in the morning and half of the dose in the evening. This dosing schedule is followed in case of solution for infusion.

Typical Dosage

The typical adult dose of Levipil 500 is 250 mg twice daily. The typical dose for children is 250 mg twice daily for a child weighing 25 kg. The maximum dose for adults of Levipil 500 is 1500 mg twice daily per day. Levipil 500 is typically used at the same time every day.
Levipil 500 injection is for intravenous use only. To prepare an injection, Levipil 500 should be diluted in 100 ml of suitable diluent and given as per 15-minutes of infusion. This solution should be examined visually before use and solution with particles or discoloration should not be used. If a smaller dose is needed then the volume of diluent should not be larger than the maximum amount of Levipil 500 that is 15 mg/mL of diluted solution.

Talk to Your Doctor

Tell your doctor if your condition does not improve or worsens. Talk to your doctor if increased seizures. If you have any kidney disease, adjustment of the dose in kidney patients is required based on the creatinine clearance (mL/min) of the patient. Consult with your doctor before stopping the use of Levipil 500 Tablet.
You may need to gradually decrease the dose of this medicine before stopping.

Use in Children

The safety and effectiveness of using this medicine in children has not been established. Levipil 500, when used as single drug therapy, should not be used in children below 16 years.

Avoid Alcohol

Avoid drinking alcohol with Levipil 500.

Storage

Store Levipil 500 Tablet at 20°-25°C (68°-77°F), for injection. Keep this medicine away from children and pets.
Medicines may be given for uses other than those listed in the medicine guide. Do not use Levipil 500 Tablet for symptoms for which it was not prescribed. Do not give Levipil 500 Tablet to others who may have similar symptoms as you. Self-medication can cause harm.

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How to take Levipil 500

Your dose may depend on several personal factors. You should consult with your doctor to find out the dose that is best for you. The dose of Levipil 500 depends on the following factors:
  • patient's age
  • patient's weight
  • patient's health
  • the health of the patient's liver
  • response to treatment

Levipil 500 Dosage

Dosage for seizures with variety of epilepsy episodes

Adult (adults ≥18 years and children of 12 - 17 years with a weight of 50 kg or more than it)
  • Initial: 500 mg twice daily, if needed it may be increased or decreased after every two to four weeks. It is given as add-on therapy with Levipil 500
  • Maximum: 1500 mg twice daily

Dosage for seizures affecting a part of the brain

Adult (children and adults from 16 years with newly diagnosed seizures)
  • Recommended: 250 mg twice daily, it should be raised to a therapeutic dose of 500 mg initially twice every day after two weeks. It is used as a single drug therapy.
  • Maximum: 1500 mg twice daily

Dosage for seizures involving entire body

Adult (16 years and older patients with unknown epilepsy cause)
  • Recommended: 3000 mg and an additional dose of 1000 mg/day may be given every 2 weeks through veins
  • Initial: 1000 mg/day (500 mg twice daily)
Children (6 to <16 years)
  • Recommended: 60 mg/kg daily dose (27.2 mg/lb) or 30 mg/kg (13.6 mg/lb) twice daily and an additional dose of 20 mg/kg (9.09 mg/lb) may be given every 2 weeks through veins
  • Initial: 20 mg/kg (9.09 mg/lb) in 2 divided doses (10 mg/kg or 4.54 mg/lb twice daily) through veins

Dosage for seizures affecting a part of the brain

Adult (16 years or older patients with epilepsy)
  • Recommended: 3000 mg/day and an additional dose of 1000 mg/day may be given every 2 weeks through veins
  • Initial: 1000 mg/day (500 mg twice daily) through veins
  • Maximum: 3000 mg/day
Children (1 month to <6 months)
  • Recommended: 42 mg/kg daily dose (21 mg/kg twice daily) and an additional dose of 14 mg/kg may be given every 2 weeks through veins
  • Initial: 14 mg/kg (6.36 mg/lb) in 2 divided doses (7 mg/kg or 3.18 mg/lb twice daily) through veins
Children (6 months to <4 years)
  • Recommended: 50 mg/kg daily dose (22.7 mg/lb) or 25 mg/kg (11.3 mg/lb) twice daily and an additional dose of 20 mg/kg (9.09 mg/lb) may be given every 2 weeks through veins
  • Initial: 20 mg/kg (9.09 mg/lb) in 2 divided doses (10 mg/kg or 4.54 mg/lb twice daily) through veins
Children (4 years to <16 years)
  • Recommended: 60 mg/kg daily dose (27.2 mg/lb) or 30 mg/kg (13.6 mg/lb) twice daily and an additional dose of 20 mg/kg (9.09 mg/lb) may be given every 2 weeks through veins
  • Initial: 20 mg/kg (9.09 mg/lb ) in 2 divided doses (10 mg/kg or 4.54 mg/lb twice daily) through veins

Dosage for a sudden increase in muscle tone

Adult (adults and children of 12 years or older with epilepsy started in their childhood or in the teen years)
  • Recommended: 3000 mg/day and an additional dose of 1000 mg/day may be given every 2 weeks through veins
  • Initial: 1000 mg/day or 500 mg twice daily through veins

Dosage calculation for children

To calculate the dosage for children please use the weight based dose calculator to calculate the appropriate dosage as per the weight of your child.

Forms

Tablet
Strength: 250 mg, 500 mg, 750 mg, and 1000 mg
Injection
Strength: 5 mg/1 ml, 10 mg/1 ml, 15 mg/1 ml, and 100 mg/1 ml
Injection, solution, concentrate
Strength: 100 mg/1 ml and 500 mg/5 ml
Solution
Strength: 100 mg/1 ml, 500 mg/5 ml, 1000 mg/10 ml, and 1500 mg/15 ml
Tablet, extended release
Strength: 500 mg, 750 mg, 1000 mg and 1500 mg
Tablet, film coated
Strength: 250 mg, 500 mg, 750 mg, and 1000 mg
Tablet, film coated, extended release
Strength: 500 mg, 750 mg and 1000 mg

Special Instructions

Creatinine clearance >80 ml/min/1.73 m^2
The dose should be 500 to 1500 mg twice daily in patients having a weight greater than 50 kg with abnormal functioning of kidneys.
Creatinine clearance 50-79 ml/min/1.73 m^2
The dose should be 500 to 1,000 mg twice daily in patients having a weight greater than 50 kg with abnormal functioning of kidneys.
Creatinine clearance 30-49 ml/min/1.73m^2
The dose should be 250 to 750 mg twice daily in patients having weight greater than 50 kg with abnormal functioning of kidneys.
Creatinine clearance <30 ml/min/1.73m^2
The dose should be 250 to 500 mg twice daily in patients having a weight greater than 50 kg with abnormal functioning of kidneys.
Kidney disease
The dose should be 500 to 1000 mg once daily in patients having a weight greater than 50 kg with end-stage kidney disease undergoing a kidney purification process. It is recommended to have a loading dose of 750 mg on the first day of Levipil 500 treatment. During kidney purification therapy, it is advised to have a supplement dose of 250 to 500 mg.
Creatinine clearance >80 ml/min/1.73m^2
The dose should be 7 mg/kg (3.18 mg/lb) to 21 mg/kg (9.54 mg/lb) twice daily in infants (1 to <6 months) with abnormal functioning of kidneys.
Creatinine clearance 50-79 ml/min/1.73m^2
The dose should be 7 mg/kg (3.18 mg/lb) to 14 mg/kg (6.36 mg/lb) twice daily in infants (1 to <6 months) with abnormal functioning of kidneys.
Creatinine clearance 30-49 ml/min/1.73m^2
The dose should be 3.5 mg/kg (1.59 mg/lb) to 10.5 mg/kg (4.77 mg/lb) twice daily in infants (1 to <6 months) with abnormal functioning of kidneys.
Creatinine clearance <30 ml/min/1.73m^2
The dose should be 3.5 mg/kg (1.59 mg/lb) to 7 mg/kg (3.18 mg/lb) twice daily in infants (1 to <6 months) with abnormal functioning of kidneys.
Kidney disease
The dose should be 7 mg/kg (3.18 mg/lb) to 14 mg/kg (6.36 mg/lb) once daily in infants (1 to <6 months) with end-stage kidney disease undergoing kidney purification process. It is recommended to have a loading dose of 10.5 mg/kg (4.77 mg/lb) on the first day of Levipil 500 treatment. During kidney purification therapy, it is recommended to have a supplement dose of 3.5 - 7 mg/kg (1.59 - 3.18 mg/lb).

Missed Dose

It is advised to contact your doctor if you missed one or more doses. A double dose should not be taken to make up for a missed dose.

Overdose

What to do if you overdose on Levipil 500?
In case of overdose, vomiting should be induced by using the general supportive measure to eliminate the unabsorbed drug from the body. The symptoms of patients should be monitored properly. There is no particular antidote available for the overdose of Levipil 500.
Symptoms of an overdose of Levipil 500
If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:
  • aggression
  • anxiety
  • coma
  • reduced awareness
  • sleepiness
  • slow and ineffective breathing
If you think you have overdosed on Levipil 500 Tablet, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Levipil 500

Before you use Levipil 500, tell your doctor of your medical and health history including the following:
  • allergic reactions
  • depression
  • kidney disease
  • retarded growth
  • suicidal acts
  • unexpected maturation of reproductive organ
Before you use Levipil 500, tell your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information. Discuss with your doctor if you are allergic to pyrrolidone derivatives.
The use of Levipil 500 Tablet may change liver enzymes. There is an increase in the liver enzymes level.

Use when Pregnant

Consult with your doctor on the use of Levipil 500 during pregnancy or if you are planning to become pregnant. Levipil 500 can be used in pregnancy after complete monitoring of the patient by the doctor, and a low dose is recommended for pregnant women as an effective dose. There is no full estimation of the risk of birth defects to an unborn baby.

If Breastfeeding

Levipil 500 Tablet is not safe for use in women who are breastfeeding. If you are breastfeeding, discuss with your doctor if you should either discontinue breastfeeding, or stop using this medicine during this period. Levipil 500 has been shown to pass in breast milk. Therefore, it is not recommended during breastfeeding. However, if treatment is necessary during breastfeeding, the benefit/risk of Levipil 500 should be considered.

Alcohol

Dizziness

Levipil 500 can make you feel sleepy. Be careful, especially while driving, while using heavy machinery, or when doing any activity that needs you to be completely alert. The consumption of alcohol with Levipil 500 can worsen the sleepiness.

What precautions should be taken during Pregnancy and Nursing, and administering Levipil 500 to Children or the Older Adults?

Pregnant Women

Precaution
Warning: Levipil 500 can be used in pregnant women after complete monitoring by the doctor, and a low dose is used during pregnancy as an effective dose. There is no full estimation of the risk of birth defects to an unborn baby.

Breastfeeding

Contraindicated or Not Recommended
Warning: Levipil 500 should not be used in breastfeeding as it passes into breast milk. However, if treatment is necessary during breastfeeding, the benefit/risk of the Levipil 500 should be considered.

Younger Adults Population

Precaution
Warning: Levipil 500 tablets should not be used in children under the age of 6 years. Levipil 500 oral solution is preferred in this case. Oral solutions are also preferred in those cases in which available doses of tablets are not suitable for primary treatment of children having a weight less than 25 kg. Also in patients, who are not able to take tablets or for the use of dose below 250 mg.

Older Adults Population

Precaution
Warning: There is no difference in the safety profile of the elderly. In elderly patients, care should be taken in dose adjustment due to decreased functioning of kidneys.

Levipil 500 Side-effects

The following side-effects may commonly occur when using Levipil 500 Tablet. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
The following side-effects may commonly occur in older patients on the use of Levipil 500 Tablet. Discuss with your doctor if any of these side-effects last for a long time or are severe:
  • decreased functioning of kidneys
The following side-effects may commonly occur in children when using Levipil 500 Tablet. Discuss with your doctor if any of these side-effects last for a long time or are severe:
  • abnormal behavior
  • abnormal coordination
  • aggression
  • decreased appetite
  • irritability
  • lethargy
  • mood changes
  • restlessness
  • stuffy nose
  • vomiting
Rarely, the use of Levipil 500 Tablet may cause the following side-effects:
  • abnormal coordination
  • abnormal liver function test
  • abnormal sensation in the body
  • change in memory
  • decreased or increased weight
  • disturbance in attention
  • excessive sleep
  • hair loss
  • influenza
  • injury
  • memory loss
  • muscle pain
  • muscular weakness
  • severe itching
  • skin inflammation
  • walking abnormality
The following severe side-effects may also occur when using Levipil 500 Tablet:
  • stomach and intestinal disorders
    Symptoms: pancreas inflammation
  • Nervous system disorders
    Symptoms: involuntary twisting or writhing, involuntary movement of the body muscle spasm
  • Psychiatric disorders
    Symptoms: personality disorder, abnormal thinking, suicide attempt or ideation, psychotic disorder, abnormal behavior, hallucination, confusional state, panic attack, mood changes, restlessness, depression, aggression, anxiety irritability
  • Metabolism and nutrition disorders
    Symptoms: decreased sodium blood level
  • Blood and lymphatic system disorders
    Symptoms: decreased white blood cells, red blood cells, and platelets, low level of neutrophils, low level of thrombocytes decreased leukocytes
  • Liver disorders
  • Kidney and urinary disorders
  • Skin and subcutaneous tissue disorders
    Symptoms: severe skin disease severe allergic reactions
    If such symptoms occur, the use of Levipil 500 should not be continued and alternative treatment should be considered.
  • Musculoskeletal and connective tissue disorders
    Symptoms: muscle breakdown increased blood creatine phosphokinase
  • Eye disorders
    Symptoms: double vision blurred vision
Your doctor has prescribed this Levipil 500 because they have judged that the benefits outweigh the risks posed by side-effects. Many people using this medicine do not have serious side-effects. This is not a complete list of possible side-effects for Levipil 500.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Side-effects and Allergic Reactions of Levipil 500 by Severity and Frequency

Common Side-effects

Following are the common side-effects of this medicine:

Infrequent and Rare Side-effects

Following are the infrequent and rare side-effects of this medicine:

Severe Side-effects

Following are the severe side-effects of this medicine:

Side-effects in Older Adults

Following are the side-effects of this medicine in elderly patients:
  • decreased functioning of kidneys

Side-effects in Children

Following are the side-effects of this medicine in young patients:
  • abnormal behavior
  • abnormal coordination
  • aggression
  • agitation
  • decreased appetite
  • irritability
  • lethargy
  • mood swings
  • nasal congestion
  • vomiting

Mild Allergic Reactions

Following are the symptoms of mild allergic reactions to this medicine:
Levipil 500 should not be used at the first sign of a rash unless it is clear that the rash is not drug-related.

Serious Allergic Reactions

Following are the symptoms of serious allergic reactions to this medicine:
If such symptoms occur, the use of Levipil 500 should not be continued and alternative treatment should be considered.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Kidney Abnormality

The use of Levipil 500 in patients with kidney abnormality may require dose adjustment. Assessment of functioning of kidneys is advised before the dose selection in patients with critically abnormal liver function.

Acute Kidney Injury

Levipil 500 use has been rarely associated with acute kidney damage, with an onset of time ranging from some days to several months.

Blood Cell Counts

Cases of reduced blood cell counts (white blood cells, blood cells, and platelets) have been reported in association with Levipil 500 use. This is generally at the starting of the therapy. It is advised to perform blood tests in patients showing symptoms like weakness, fever, repeated infections or clotting disorders.

Suicide

Suicide attempt, suicide, suicidal behavior, and ideation have been seen in patients treated with Levipil 500. Patients should be monitored for symptoms of suicidal ideation and behaviors or depression. Proper treatment should be considered. Patients and their caregivers should be advised to seek medical advice when signs of depression or suicidal behavior appear.

Use in Children

The tablet form should not be used in infants and children below the age of 6 years.

Patients on a Controlled Sodium Diet

Patients who are on a controlled sodium diet are at an increased risk when using Levipil 500. Levipil 500 contains 19 mg of sodium in each vial. Therefore, patients who are on a controlled sodium diet should take caution.

Sleepiness and Fatigue

Levipil 500 may cause sleepiness and fatigue. Patients should be observed for sleepiness and fatigue. Patients are advised not to operate machinery or drive until they know whether Levipil 500 adversely affects their ability to operate machinery or drive.

Serious Skin Reactions

Severe skin conditions have been reported in children and adult treated with Levipil 500. Levipil 500 should not be used at the first sign of a rash unless it is clearly indicated that the rash is not drug-related. If symptoms suggest severe skin reaction, the use of this medicine should not be continued and alternative treatment should be considered.

Coordination Difficulties

Levipil 500 may cause difficulty in coordination. Patients should be monitored for the symptoms of coordination difficulties. They should be advised not to operate machinery or drive until they experience whether Levipil 500 could adversely alter their ability to operate machinery or drive.

Withdrawal Seizures

Levipil 500 should be withdrawn slowly in order to minimize the possibility of increased seizure frequency.

Seizure Control During Pregnancy

Physiological changes may slowly decrease blood levels of Levipil 500 during pregnancy. This reduction is more noticeable during the third trimester. It is advised that patients must be monitored during pregnancy. Patients should be monitored closely for the infections following childbirth particularly if the dose was changed in pregnancy.

Interactions with Levipil 500

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
This page does not contain all the possible interactions of Levipil 500 Tablet. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Laxatives

Levipil 500 Tablet may interact with laxatives (macrogol), which are used to loosen stools and increase bowel movements. Decreased Levipil 500 efficacy have been seen when the osmotic laxatives macrogol have been used in combination with oral Levipil 500. Therefore, laxatives should be avoided taking orally for at least one hour before and after taking Levipil 500.

Probenecid

There may be an interaction of Levipil 500 with kidney tubular secretion blocking agent (probenecid), which is used to treat gout and high amount of uric acid. Probenecid (a dose of 500 mg four times daily), has been shown to block the kidney clearance of the primary metabolite except for Levipil 500. But, the level of this metabolite remains low.

Methotrexate

Levipil 500 Tablet interacts with methotrexate, which is used to treat cancer, autoimmune diseases, and medical abortions. The combined use of Levipil 500 and methotrexate has been seen to reduce methotrexate clearance. Therefore, resulting in raised or prolonged blood methotrexate level to potentially lethal levels. Blood methotrexate and Levipil 500 levels should be monitored carefully in patients treated with this combination.

Food and Alcohol

Special instructions need to be followed while taking this medicine along with food and alcohol. The absorption of Levipil 500 was not changed by food, but the rate of absorption was slightly decreased.

Interactions of Levipil 500 by Severity

Serious

The following medicines may interact when taken together and can cause harmful effects in the body. Please consult with your doctor or pharmacist before taking these medicines together.

Moderate

The following medicines may interact when taken together and can increase your risk of harmful effects. Please consult with your doctor or pharmacist before taking these medicines together.

When should Levipil 500 be not used?

Known Allergic Reaction

Levipil 500 should not be used in patients having the previous history of allergic reactions to Levipil 500 or any of its excipients. These patients may have the following symptoms if they use this medicine:
  • severe skin reaction
  • severe allergic reaction
  • severe itching
  • rash
  • skin inflammation
  • hair loss

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Levipil 500 is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.
This page provides information for Levipil 500 Tablet .
Brain Diseases
Epilepsy
Seizures
Muscle Disorders

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