Side effects of levetiracetam – NHS

Like all medicines, levetiracetam can cause side effects, although not everyone gets them.

Common side effects

These common side effects of levetiracetam may happen in more than 1 in 10 people. There are things you can do to help cope with them:

A blocked nose or itchy throat

If it’s bothering you, ask your pharmacist for something to help your symptoms. If they do not wear off, tell your doctor.

Feeling drowsy, sleepy or dizzy

Do not drive, ride a bike, or operate machinery until you feel more alert.

As your body gets used to levetiracetam, these side effects should wear off. If they do not wear off within 1 or 2 weeks, your doctor may reduce your dose or increase it more slowly. If that does not work, you may need to switch to a different medicine.

Headaches

Make sure you rest and drink plenty of fluids. Do not drink too much alcohol. If headaches are a problem, ask your pharmacist to recommend a painkiller.

Talk to your doctor if your headaches last longer than a week or are severe.

Aggression, or feeling irritable or agitated

Talk to your doctor if you have any of these side effects.

Feeling sick or being sick (nausea or vomiting)

Stick to simple meals and do not eat rich or spicy food. It might help to take your levetiracetam after a meal or snack.

If you’re being sick, take small, frequent sips of water to avoid dehydration. Signs of dehydration include peeing less than usual or having dark, strong-smelling pee.

Do not take any medicines to treat vomiting without speaking to a pharmacist or doctor. Speak to a doctor if your symptoms get worse or last longer than a week.

If you take contraceptive pills and you’re being sick, your contraception may not protect you from pregnancy. Check the pill packet to find out what to do.

Serious side effects

Tell a doctor or call 111 straight away if you have a serious side effect, including:

• fits or seizures getting worse
• passing very little pee, feeling tired or confused, or having swollen legs, ankles or feet – these could be signs of kidney problems
• signs of serious mental changes, or someone around you notices signs of confusion, sleepiness, loss of memory, forgetfulness, abnormal behaviour or uncontrolled movements

Very few people taking levetiracetam have serious side effects.

Immediate action required: Go to A&E or call 999 now if:

• you have thoughts of harming or killing yourself

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction (anaphylaxis) to levetiracetam.

Immediate action required: Call 999 now if:

• your lips, mouth, throat or tongue suddenly become swollen
• you’re breathing very fast or struggling to breathe (you may become very wheezy or feel like you’re choking or gasping for air)
• your throat feels tight or you’re struggling to swallow
• your skin, tongue or lips turn blue, grey or pale (if you have black or brown skin, this may be easier to see on the palms of your hands or soles of your feet)
• you suddenly become very confused, drowsy or dizzy
• someone faints and cannot be woken up
• a child is limp, floppy or not responding like they normally do (their head may fall to the side, backwards or forwards, or they may find it difficult to lift their head or focus on your face)

You or the person who’s unwell may also have a rash that’s swollen, raised, itchy, blistered or peeling.

These can be signs of a serious allergic reaction and may need immediate treatment in hospital.

Other side effects

These are not all the side effects of levetiracetam. For a full list, see the leaflet inside your medicine packet.

Information:

You can report any suspected side effect using the Yellow Card safety scheme.

Visit Yellow Card for further information.

Page last reviewed: 10 May 2022

Next review due: 10 May 2025

Levetiracetam Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Uses

Levetiracetam is used with other medications to treat seizures (epilepsy). It belongs to a class of drugs known as anticonvulsants. Levetiracetam may decrease the number of seizures you have.

How to use Levetiracetam Tablet For Suspension

Read the Medication Guide provided by your pharmacist before you start taking levetiracetam and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually twice a day.

Carefully remove the tablet(s) from the foil packet as directed by the product package. Do not push the tablet(s) through the foil. Dry your hands before handling the medication. Place each dose on the tongue and take a sip of liquid. Allow the medication to completely dissolve before swallowing it. Do not swallow the tablet(s) whole.

The tablet(s) may also be placed in a cup with a small amount of liquid (1 tablespoon/15 milliliters). Swirl the mixture gently, then drink all of the mixture right away. To make sure you have taken all of the medication, add another small amount of liquid to the cup to rinse it, and drink it right away.

The dosage is based on your medical condition and response to treatment. The dosage in children is also based on weight. To reduce your risk of side effects (such as dizziness and drowsiness), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Do not stop taking this medication without consulting your doctor. Your seizures may become worse when the drug is suddenly stopped. Your dose should be gradually decreased.

Tell your doctor if your seizures lasts, change, or gets worse.

Side Effects

Drowsiness, dizziness, unusual tiredness, or weakness may occur. These side effects are more common during the first 4 weeks and usually lessen as your body adjusts to the medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, such as: loss of coordination (such as difficulty walking and controlling muscles), mental/mood changes (such as irritability, aggression, agitation, anger, anxiety), signs of infection (such as sore throat that doesn’t go away, fever, chills), signs of anemia (such as unusual tiredness that doesn’t go away, pale skin, fast breathing, fast heartbeat), easy bruising/bleeding.

A small number of people who take anticonvulsants for any condition (such as seizures, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Levetiracetam can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www. fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking levetiracetam, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (such as dialysis treatment), mental/mood disorders (such as depression).

This drug may make you dizzy or drowsy, especially during the first month of treatment. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, ride a bicycle, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (such as prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of the drug, especially mental/mood changes (such as irritability, aggression, agitation, anger, anxiety, depression, thoughts of suicide). Children younger than 4 years may be at greater risk for increased blood pressure while using this drug (see also Notes section).

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness or loss of coordination. These side effects can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

A product that may interact with this drug is: orlistat.

Does Levetiracetam Tablet For Suspension interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, loss of consciousness.

Do not share this medication with others.

Lab and/or medical tests (such as kidney function, complete blood count) may be done while you are taking this medication. In children younger than 4 years, blood pressure may also be monitored. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

The use of levetiracetam in the treatment of children with cancer

Anticonvulsant

Trademarks:

Keppra®, Spiratam®

Often used for:

Seizures

Levetiracetam is a drug that helps relieve seizures.

During therapy, tests may be performed to monitor the level of levetiracetam in the blood. Depending on the content in the blood, the dosage of the drug may vary.

This drug is available in regular and extended release forms. Follow dosage instructions carefully.

Administered intravenously (through a drip) in liquid form

Oral tablets

Oral liquid form

• Drowsiness
• Increased fatigue or general weakness
  
• Nausea and vomiting
• Loss of appetite
• Dizziness
• Loss of balance or coordination
• Diarrhea
• Constipation
• Abdominal pain
• Headache
• Stuffy nose
• Sleep disorders
• Irritability, mood swings or personality changes

The listed side effects are not observed in all patients who are prescribed levetiracetam. The most common side effects are highlighted in bold, but others are not excluded. Report all possible side effects to your doctor or pharmacist.

Be sure to discuss these and other recommendations with your doctor or pharmacist.

• This drug may cause dizziness and drowsiness and increase the risk of falls.
• You can stop taking levetiracetam only in consultation with your doctor.
• Patients of reproductive age who have been prescribed levetiracetam should consult their doctor before planning pregnancy.
• Pregnant or breastfeeding patients should notify their physician.

Levetiracetam home use:

• The drug should be taken at the same time every day.
• The tablets should be swallowed whole. Do not crush or chew before taking.
• Absorbable tablets (Spritam®) should be held on the tongue until completely dissolved (about 10 seconds) and then taken with a sip of liquid. You can also dissolve the tablet in 1 teaspoon of liquid and swallow immediately. Pour some more liquid into the glass and drink to get the full dose of the drug. It is not allowed to swallow the drug whole, as well as crush or chew it.
• When taking levetiracetam in liquid form, measure the dosage using the measuring device included in the kit.
• Store at room temperature.
• Take your dose as soon as possible if you miss it. Do not do this only if there are no more than 4 hours left until the next appointment. In no case do not double the dose at the next dose!
• Do not use an expired drug.
• Follow instructions for safe storage and disposal of this product.

Learn more about levetiracetam

Active substance LEVETIRACETAM (LEVETIRACETAMUM) | Compendium – drug reference book

• Pharmacological properties
• Indications for LEVETIRACETAM
• Application of LEVETIRACETAM
• Contraindications
• Side effects
• Special instructions
• Interactions
• Overdose
• Diagnosis
• Recommended alternatives

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an antiepileptic drug, a pyrrolidone derivative ( S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine-acetamide), differs in chemical structure from known antiepileptic drugs.

The mechanism of action of levetiracetam is not fully understood, but it has been established that it differs from the mechanism of action of known antiepileptic drugs. One of the proposed mechanisms is based on proven binding to the SV2A synaptic vesicle glycoprotein found in the gray matter of the brain and spinal cord. It is believed that in this way the anticonvulsant effect is realized, which is expressed in counteracting the hypersynchronization of neuronal activity. Levetiracetam also acts on GABA receptors and glycine receptors, modulating them through various endogenous agents. Does not change normal neurotransmission, but suppresses epileptiform neuronal bursts induced by the GABA agonist bicuculin and excitation of glutamate receptors. The activity of the drug has been confirmed in relation to both focal and generalized epileptic seizures (epileptiform manifestations / photoparoxysmal reaction).

After oral administration, levetiracetam is well absorbed from the gastrointestinal tract. Absorption is complete and linear, so the plasma concentration depends on the dose of the drug in mg/kg of body weight. The degree of absorption does not depend on the dose and time of ingestion. Bioavailability is about 100%.

After taking the drug at a dose of 1 g, C _{max in blood plasma is reached after 1.3 hours and is 31 mcg / ml, after repeated administration (2 times a day) – 43 mcg / ml.}

AUC is achieved after 2 days with a double dose of the drug. Plasma protein binding of levetiracetam and its main metabolite is less than 10%. The volume of distribution of levetiracetam is about 0.5–0.7 l/kg.

The formation of the primary pharmacologically inactive metabolite (ucb L057) occurs without the participation of cytochrome P450 isoenzymes in the liver. Levetiracetam does not affect the enzymatic activity of hepatocytes.

In adults T _½ from blood plasma is 7 ± 1 hour and does not change depending on the dose, route of administration or repeated administration. The average clearance is 0.96 ml / min / kg. 95% of the dose is excreted by the kidneys. The renal clearance of levetiracetam and its inactive metabolite is 0.6 and 4.2 ml/min/kg, respectively.

In elderly patients T _½ increases by 40% and is 10-11 hours, which is associated with a decrease in kidney function in this category of people.

In patients with impaired renal function, the clearance of levetiracetam and its primary metabolite correlates with creatinine clearance (CC). Therefore, patients with renal insufficiency are advised to select a dose depending on the CC. In end-stage renal disease in adult patients T _½ is 25 hours between dialysis sessions and 3.1 hours during dialysis. During a 4-hour dialysis session, up to 51% of levetiracetam is removed.

There are no significant changes in levetiracetam clearance in patients with mild to moderate hepatic impairment. In severe hepatic impairment with concomitant renal insufficiency, the clearance of levetiracetam is reduced by more than 50%.

The pharmacokinetics of levetiracetam in children is linear in the dose range of 20–60 mg/kg/day. C _{max is achieved in 0.5-1 hour. T ½ in children after a single oral dose of 20 mg / kg of body weight is 5-6 hours. The total clearance of levetiracetam in children is approximately 40% higher than in adults, and is directly related to body weight.}

as monotherapy (first choice drug) in the treatment of:

• partial seizures with or without secondary generalization in adults and adolescents over 16 years of age with newly diagnosed epilepsy.

As part of complex therapy in the treatment of:

• partial seizures with or without secondary generalization in adults and children over 4 years of age with epilepsy;
• myoclonic seizures in adults and adolescents over 12 years of age with juvenile myoclonic epilepsy;
• primary generalized convulsive (tonic-clonic) seizures in adults and adolescents over 12 years of age with idiopathic generalized epilepsy.

as monotherapy for adults and adolescents over the age of 16 is prescribed at an initial dose of 500 mg divided into 2 doses (250 mg 2 times a day). After 2 weeks, the dose can be increased to the initial therapeutic dose – 1 g (500 mg 2 times a day). The maximum daily dose is 3 g (1.5 g 2 times a day).

As part of complex therapy in children over 4 years of age, treatment should begin with a daily dose of 20 mg/kg of body weight divided into 2 doses (10 mg/kg of body weight 2 times a day). A dose change of 20 mg/kg of body weight can be carried out every 2 weeks until the recommended daily dose of 60 mg/kg of body weight (30 mg/kg of body weight 2 times a day) is reached. If the recommended daily dose is not tolerated, it may be reduced. The lowest effective dose should be used.

The drug should be prescribed in the most appropriate dosage form and dose, depending on the patient’s body weight and the required therapeutic dose.

For children weighing ≤20 kg, it is recommended to start treatment with the drug in the form of an oral solution.

Children weighing >50 kg are dosed according to the adult schedule.

Adults and adolescents over 16 years of age weighing >50 kg should begin treatment with a daily dose of 1 g divided into 2 doses (500 mg 2 times a day). Depending on the clinical response and tolerability of the drug, the daily dose may be increased to a maximum of 3 g (1.5 g 2 times a day). A dose change of 500 mg 2 times a day can be done every 2-4 weeks.

Since levetiracetam is excreted by the kidneys when the drug is administered to elderly patients and patients with renal insufficiency, the dose should be adjusted depending on the size of the CC.

Dosing regimen for renal failure:

• normal renal function (CC> 80 ml / min) – from 500 to 1500 mg 2 times a day;
• mild degree (CC 50-79 ml / min) – from 500 to 1000 mg 2 times a day;
• medium degree (CC 30-49 ml / min) – from 250 to 750 mg 2 times a day;
• severe (CC <30 ml / min) - from 250 to 500 mg 2 times a day;
• terminal stage (patients on hemodialysis *) – from 500 to 1000 mg 1 time per day **.

* On the first day of treatment with levetiracetam, a loading dose of 750 mg is recommended.

** An additional dose of 250–500 mg is recommended after dialysis.

Patients with mild to moderate hepatic impairment do not require dosage adjustment. In patients with decompensated liver dysfunction and renal failure, a decrease in CC may not fully reflect the severity of renal failure. In such cases, with QC <60 ml / min per 1.73 m ² a 50% reduction in the daily dose is recommended.

hypersensitivity to levetiracetam or other pyrrolidone derivatives, as well as to the components of the drug, age up to 4 years (safety and efficacy of the drug have not been established), elderly patients (over 65 years), severe liver dysfunction, renal failure.

from the side of the central nervous system: very often – drowsiness, asthenic syndrome; often – amnesia, ataxia, convulsions, dizziness, headache, hyperkinesia, tremor, imbalance, decreased concentration of attention, memory impairment, agitation, depression, emotional lability, hostility / aggressiveness, insomnia, nervousness, irritability, personality disorders, impaired thinking; sometimes – paresthesia, behavioral disorders, anxiety, anxiety, confusion, hallucinations, irritability, psychotic disorders, suicide, suicide attempts and suicidal intentions.

On the part of the organ of vision: often – diplopia, disturbance of accommodation.

From the respiratory system: often – increased cough.

From the digestive system: often – abdominal pain, diarrhea, dyspepsia, nausea, vomiting, anorexia, weight gain; sometimes – pancreatitis, liver failure, hepatitis, changes in liver function tests, weight loss.

Skin: often – skin rash, eczema, itching; sometimes – alopecia (in some cases, restoration of the hairline was observed after discontinuation of the drug).

Changes in laboratory parameters: sometimes – leukopenia, neutropenia, pancytopenia (in some cases with suppression of bone marrow function), thrombocytopenia.

Other: sometimes – infections, nasopharyngitis, myalgia.

if it is necessary to stop taking the drug, withdrawal is recommended to be carried out gradually (for example, in adults, reducing a single dose by 500 mg every 2-4 weeks, in children, a single dose reduction should be carried out by no more than 10 mg / kg every 2 weeks).

Adults and children with partial epilepsy taking levetiracetam may experience an increase in seizures (approximately 25% in adults and 14% in children). But to date, the relationship with the drug has not been proven, because in adults and children who received placebo, this was observed in 26 and 21% of cases, respectively. When using the drug for the treatment of primary tonic-clonic seizures in adults and adolescents with idiopathic generalized epilepsy, there was no increase in the frequency of seizures. Since levetiracetam is excreted from the body by the kidneys, when prescribing the drug to patients with renal insufficiency and elderly patients, the dose should be adjusted depending on the level of CK.

The drug is not used during pregnancy, except when the drug is prescribed for health reasons, since it must be borne in mind that interruptions in antiepileptic therapy can lead to a deterioration in the condition, and this can harm the health of both the mother and the fetus. The drug passes into breast milk, so if necessary, breastfeeding should be stopped for the mother.

The drug is contraindicated for use in children under 4 years of age due to the lack of data on the safety and efficacy of the drug.

No studies have been conducted to study the effect of the drug on the ability to drive vehicles and work with mechanisms. Due to possible individual sensitivity, some patients may experience drowsiness and other symptoms associated with effects on the central nervous system, especially at the beginning of treatment or in the process of increasing the dose. Therefore, such patients should be careful when engaging in activities that require concentration, such as driving a car or operating machinery.

Levetiracetam does not interact with other antiepileptic drugs (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin, primidone).

Levetiracetam at a daily dose of 1000 mg does not change the pharmacokinetics of oral contraceptives (ethinyl estradiol, levonorgestrel) and at a daily dose of 2000 mg – digoxin and warfarin.

Digoxin, oral contraceptives and warfarin do not affect the pharmacokinetics of levetiracetam.

When used simultaneously with topiramate, there is a high risk of developing anorexia.

There are no data on the interaction of levetiracetam with alcohol.

The complete absorption of levetiracetam when taken orally does not change under the influence of food, while the absorption rate is slightly reduced.

symptoms: drowsiness, anxiety, aggressiveness, depression of consciousness, respiratory depression, coma.