Levetiracetam STADA
Antiepileptic oral solution for the treatment of epilepsy and seizure disorders
Quick facts about Levetiracetam STADA
Key takeaways about Levetiracetam STADA
- Versatile epilepsy treatment: Used as monotherapy for focal seizures from age 16 and as add-on therapy for multiple seizure types from 1 month of age
- Never stop suddenly: Abrupt discontinuation may cause increased seizure frequency – always taper under medical supervision
- Monitor mood and behaviour: Levetiracetam may cause behavioural changes including irritability, aggression, depression, and in rare cases suicidal thoughts
- Dose adjustment for kidney problems: If you have reduced kidney function, your doctor will adjust the dose accordingly
- Avoid macrogol interaction: Do not take macrogol (polyethylene glycol laxatives) within one hour before or after taking levetiracetam
What Is Levetiracetam STADA and What Is It Used For?
Levetiracetam STADA is an antiepileptic medicine containing the active substance levetiracetam at a concentration of 100 mg/ml oral solution. It is used to treat epilepsy by reducing the frequency of seizures. It can be used alone (monotherapy) in adults and adolescents from 16 years, or as an add-on to other antiepileptic drugs across all age groups from 1 month.
Levetiracetam belongs to a class of medicines known as antiepileptic drugs (AEDs), also sometimes referred to as anticonvulsants. Epilepsy is a neurological condition characterised by recurrent seizures caused by abnormal electrical activity in the brain. Levetiracetam works through a unique mechanism of action – it binds to a protein called synaptic vesicle protein 2A (SV2A), which helps regulate the release of neurotransmitters and thereby reduces the excessive electrical discharges that cause seizures.
Unlike many other antiepileptic medications, levetiracetam does not significantly interact with the liver’s cytochrome P450 enzyme system, which means it has fewer drug interactions than many alternative treatments. The oral solution form makes it particularly suitable for patients who have difficulty swallowing tablets, including young children and infants. It has high oral bioavailability (approximately 100%), meaning nearly all of the dose taken by mouth reaches the bloodstream.
Monotherapy use (from 16 years of age)
As a standalone treatment, Levetiracetam STADA is approved for adults and adolescents aged 16 years and older with newly diagnosed epilepsy. In this setting, it is specifically used for focal (partial) seizures with or without secondary generalisation. Focal seizures begin in one specific area of the brain and may or may not spread to involve both hemispheres. Your doctor prescribes levetiracetam to reduce the number and severity of these seizures.
Add-on therapy
As an adjunctive (add-on) treatment used alongside other antiepileptic medicines, Levetiracetam STADA is approved for a broader range of seizure types and age groups:
- Focal (partial) seizures with or without secondary generalisation in adults, adolescents, children, and infants from 1 month of age
- Myoclonic seizures (sudden, brief involuntary muscle jerks) in adults and adolescents from 12 years with juvenile myoclonic epilepsy
- Primary generalised tonic-clonic seizures (major seizures involving loss of consciousness and violent muscle contractions) in adults and adolescents from 12 years with idiopathic generalised epilepsy
The International League Against Epilepsy (ILAE) recognises levetiracetam as a first-line or important second-line treatment option for several epilepsy syndromes. Clinical trials have demonstrated that levetiracetam significantly reduces seizure frequency compared with placebo, with response rates (50% or greater seizure reduction) ranging from 20% to 40% higher than placebo in pivotal trials.
What Should You Know Before Taking Levetiracetam STADA?
Do not take Levetiracetam STADA if you are allergic to levetiracetam, pyrrolidone derivatives, or any other ingredients. Tell your doctor about kidney problems, irregular heartbeat, pregnancy, or if you are breastfeeding. Be aware that this medicine may cause mood or behavioural changes. Do not take macrogol within one hour of your dose.
Before starting Levetiracetam STADA, it is essential to have a thorough discussion with your prescribing physician about your medical history, current medications, and any existing conditions. This allows your doctor to determine whether levetiracetam is appropriate for you and, if so, what dose is needed. Certain conditions and circumstances may require dose adjustments or additional monitoring.
Contraindications
You must not take Levetiracetam STADA if you are allergic (hypersensitive) to:
- Levetiracetam (the active substance)
- Other pyrrolidone derivatives
- Any of the other ingredients listed in the composition section, including methylparahydroxybenzoate (E218), liquid maltitol (E965), or benzyl alcohol
If you have previously experienced an allergic reaction to any medication in this class, inform your doctor immediately. Allergic reactions can range from mild skin rashes to severe anaphylaxis, and re-exposure could trigger a more serious response.
Warnings and Precautions
Speak with your doctor or pharmacist before taking Levetiracetam STADA in the following situations:
- Kidney problems: Levetiracetam is primarily eliminated through the kidneys. If you have impaired kidney function, your doctor will need to adjust your dose to prevent drug accumulation and potential toxicity.
- Growth concerns in children: If you notice slowed growth or unexpected pubertal development in your child, contact your doctor promptly.
- Psychiatric history: A small number of patients treated with antiepileptic drugs, including levetiracetam, have experienced thoughts of self-harm or suicide. If you develop any symptoms of depression, unusual thoughts, or suicidal ideation, seek medical attention immediately.
- Heart rhythm disorders: If you or a family member has a history of irregular heart rhythm (visible on an ECG), or if you have a condition or are receiving treatment that increases susceptibility to arrhythmias or electrolyte imbalances, inform your doctor before starting treatment.
Tell your doctor immediately if you experience any of the following during treatment: abnormal thoughts, irritability, unusually aggressive reactions, or if you, your family, or friends notice significant changes in mood or behaviour. Also seek urgent medical advice if your seizures worsen or become more frequent, particularly during the first month of treatment or after a dose increase.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking Levetiracetam STADA. Levetiracetam may be used during pregnancy, but only if your doctor considers it medically necessary after carefully weighing the benefits against the potential risks.
You should not stop your treatment without first discussing it with your doctor, as uncontrolled seizures during pregnancy can be harmful to both mother and baby. While a risk of birth defects cannot be completely excluded, two studies have shown no increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, the available data on levetiracetam’s effects on neurodevelopment remain limited.
Breastfeeding is not recommended during treatment with Levetiracetam STADA, as the medicine passes into breast milk. If breastfeeding is important to you, discuss the potential options with your healthcare provider.
Driving and Operating Machinery
Levetiracetam STADA may impair your ability to drive or operate machinery because it can cause drowsiness, dizziness, or reduced alertness. These effects are more likely at the start of treatment or after a dose increase. You should not drive or use machines until it has been established that your ability to perform such activities is not affected. You are personally responsible for assessing whether you are fit to drive or perform tasks requiring concentration.
Important Information About Excipients
Levetiracetam STADA oral solution contains several excipients that certain patients should be aware of:
- Methylparahydroxybenzoate (E218): May cause allergic reactions, possibly delayed
- Liquid maltitol (E965): If you have an intolerance to certain sugars, speak with your doctor before taking this medicine
- Sodium: Contains less than 1 mmol sodium (23 mg) per ml, making it essentially sodium-free
- Benzyl alcohol: Contains 0.0016 mg per ml. Do not use for longer than 1 week in children under 3 years unless advised by a healthcare professional. If you have impaired liver or kidney function, consult your doctor before use, as large amounts of benzyl alcohol may accumulate and cause metabolic acidosis.
How Does Levetiracetam STADA Interact with Other Drugs?
Levetiracetam has relatively few drug interactions compared with many other antiepileptic drugs. The most important known interaction is with macrogol (polyethylene glycol), which must not be taken within one hour before or after levetiracetam. Always inform your doctor about all medications you are taking, including over-the-counter medicines and supplements.
One of the advantages of levetiracetam compared with many older antiepileptic drugs is its favourable drug interaction profile. Because levetiracetam does not undergo significant hepatic metabolism through the cytochrome P450 enzyme system, it has minimal impact on the metabolism of other drugs. However, some interactions have been identified and should be considered.
Known Drug Interactions
| Interacting Drug | Type | Effect | Recommendation |
|---|---|---|---|
| Macrogol (PEG) | Absorption reduction | May significantly reduce levetiracetam absorption and effectiveness | Do not take within 1 hour before or after levetiracetam |
| Methotrexate | Reduced clearance | Levetiracetam may decrease methotrexate clearance, increasing its plasma levels | Monitor methotrexate levels if co-administered |
| Other antiepileptic drugs | Minimal interaction | No clinically significant pharmacokinetic interactions with common AEDs | Can be safely co-administered; individual dose adjustments may apply |
| Oral contraceptives | No significant interaction | No impact on contraceptive efficacy (unlike many other AEDs) | No dose adjustment needed for oral contraceptives |
| Warfarin | Minimal interaction | No clinically significant effect on prothrombin time | Routine monitoring as per standard warfarin therapy |
| Digoxin | No significant interaction | No clinically meaningful impact on digoxin pharmacokinetics | No dose adjustment necessary |
Always tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or might take. This includes prescription medicines, over-the-counter products, herbal remedies, and dietary supplements. While levetiracetam has a favourable interaction profile, individual circumstances may vary, and your healthcare team can best assess any potential risks.
The relatively clean drug interaction profile of levetiracetam makes it particularly valuable for patients taking multiple medications. Unlike older antiepileptic drugs such as carbamazepine, phenytoin, or phenobarbital, which are potent enzyme inducers that can reduce the effectiveness of numerous other drugs, levetiracetam allows for more predictable co-prescribing. This is especially important for patients with comorbidities who require ongoing treatment with other medications.
What Is the Correct Dosage of Levetiracetam STADA?
Levetiracetam STADA is taken twice daily (morning and evening) at approximately the same times each day. Adult monotherapy dose ranges from 500 mg to 1,500 mg twice daily. For children, the dose is calculated based on body weight (10–30 mg/kg twice daily for children from 6 months; 7–21 mg/kg twice daily for infants 1–6 months). Always follow your doctor’s instructions exactly.
Always take this medicine exactly as your doctor or pharmacist has told you. The dose depends on your age, body weight, kidney function, and whether levetiracetam is being used alone or with other antiepileptic medications. The oral solution should be measured using the appropriate syringe provided in the package and can be diluted in a glass of water or infant bottle. Levetiracetam may be taken with or without food, though it may leave a bitter taste.
Adults and Adolescents (from 16 years) – Monotherapy
Monotherapy Dosing for Adults and Adolescents (16+ years)
Use the 10 ml oral syringe provided in the package.
- Starting dose: Your doctor will prescribe a lower dose for the first 2 weeks
- Usual dose: 500 mg to 1,500 mg (5 ml to 15 ml) twice daily
- Total daily dose: 1,000 mg to 3,000 mg
Adults and Adolescents (12–17 years) – Add-on Therapy
Add-on Therapy Dosing for Adults and Adolescents
Use the 10 ml oral syringe provided in the package.
- Usual dose: 500 mg to 1,500 mg (5 ml to 15 ml) twice daily
- Total daily dose: 1,000 mg to 3,000 mg
Children (6 months to 17 years) – Add-on Therapy
Your doctor will prescribe the most suitable formulation based on the child’s age, weight, and required dose. Each individual dose ranges from 10 mg/kg to 30 mg/kg body weight (0.1 ml/kg to 0.3 ml/kg) given twice daily.
| Body Weight | Starting Dose (twice daily) | Maximum Dose (twice daily) |
|---|---|---|
| 6 kg | 0.6 ml (60 mg) | 1.8 ml (180 mg) |
| 8 kg | 0.8 ml (80 mg) | 2.4 ml (240 mg) |
| 10 kg | 1 ml (100 mg) | 3 ml (300 mg) |
| 15 kg | 1.5 ml (150 mg) | 4.5 ml (450 mg) |
| 20 kg | 2 ml (200 mg) | 6 ml (600 mg) |
| 25 kg | 2.5 ml (250 mg) | 7.5 ml (750 mg) |
| 50 kg or more | 5 ml (500 mg) | 15 ml (1,500 mg) |
Infants (1 month to under 6 months) – Add-on Therapy
For the youngest patients, doses are calculated at 7 mg/kg to 21 mg/kg (0.07 ml/kg to 0.21 ml/kg) twice daily. The 1 ml oral syringe is used for precise dosing.
| Body Weight | Starting Dose (twice daily) | Maximum Dose (twice daily) |
|---|---|---|
| 4 kg | 0.3 ml (30 mg) | 0.85 ml (85 mg) |
| 5 kg | 0.35 ml (35 mg) | 1.05 ml (105 mg) |
| 6 kg | 0.45 ml (45 mg) | 1.25 ml (125 mg) |
| 7 kg | 0.5 ml (50 mg) | 1.5 ml (150 mg) |
Elderly Patients
In elderly patients, dose adjustment may be necessary based on kidney function, as renal clearance tends to decrease with age. Your doctor will assess your kidney function through blood tests and prescribe an appropriate dose accordingly. There is no specific maximum age limit for levetiracetam use, but close monitoring is advised in older adults due to a generally higher susceptibility to side effects such as drowsiness and dizziness.
Missed Dose
If you miss a dose, contact your doctor for advice. Do not take a double dose to make up for a missed one. Maintaining a regular dosing schedule is important for optimal seizure control, so try to take your medicine at approximately the same times each day.
Overdose
If you or someone else has taken too much Levetiracetam STADA, contact your doctor, hospital, or poison control centre immediately. Possible symptoms of overdose include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma. Your doctor will determine the best course of treatment.
Stopping Treatment
If your doctor decides to discontinue your Levetiracetam STADA treatment, the dose will be gradually reduced over time to avoid an increase in seizure frequency. Never stop taking levetiracetam abruptly or on your own without medical guidance. Sudden withdrawal of antiepileptic medication is a well-known risk factor for status epilepticus, a life-threatening condition involving prolonged or repeated seizures.
Open the child-resistant cap by pressing down and twisting counter-clockwise. Insert the adapter into the bottle neck. Place the syringe into the adapter opening and invert the bottle. Draw a small amount of solution, then push the plunger to remove air bubbles. Draw the correct dose as prescribed. Return the bottle upright, remove the syringe, and empty it into a glass of water or infant bottle. Drink the entire contents. Rinse the syringe with water only after each use.
What Are the Side Effects of Levetiracetam STADA?
The most common side effects are nasopharyngitis (nose/throat inflammation), drowsiness, and headache. Common side effects include decreased appetite, depression, anxiety, dizziness, and fatigue. Drowsiness and dizziness are more frequent at the start of treatment and usually diminish over time. Seek immediate medical attention for severe allergic reactions, skin reactions, or significant mood changes.
Like all medicines, Levetiracetam STADA can cause side effects, although not everybody gets them. The likelihood and severity of side effects can vary between individuals and may be influenced by factors such as dose, duration of treatment, age, and concurrent medications. Side effects are generally more common at the beginning of treatment or following dose increases and tend to decrease as your body adjusts to the medication.
- Weakness, dizziness, or difficulty breathing (signs of severe allergic/anaphylactic reaction)
- Swelling of the face, lips, tongue, or throat (angioedema)
- Flu-like symptoms with facial rash, widespread rash with fever, elevated liver enzymes, and swollen lymph nodes (DRESS syndrome)
- Reduced urine output, tiredness, nausea, confusion, and limb swelling (sudden kidney function deterioration)
- Severe skin reactions with blisters – erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis
- Signs of serious mental changes including confusion, drowsiness, memory loss, or involuntary movements (encephalopathy)
Very Common
- Nasopharyngitis (inflammation of the nose and/or throat)
- Somnolence (drowsiness)
- Headache
Common
- Anorexia (loss of appetite)
- Depression, hostility or aggression, anxiety, insomnia, nervousness or irritability
- Convulsions, balance disorders, dizziness, lethargy, tremor (involuntary shaking)
- Vertigo (sensation of spinning)
- Cough
- Abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea
- Rash
- Asthenia/fatigue (weakness/tiredness)
Uncommon
- Decreased platelet count, decreased white blood cell count
- Weight loss, weight gain
- Suicide attempt, suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, mood swings, agitation
- Amnesia (memory loss), impaired coordination/ataxia, paraesthesia (tingling), attention disturbance
- Double vision, blurred vision
- Abnormal liver function tests
- Hair loss, eczema, pruritus (itching)
- Muscle weakness, muscle pain (myalgia)
- Injury
Rare
- Infection, pancytopenia (decrease in all blood cell types)
- Severe allergic reactions (DRESS, anaphylaxis, angioedema)
- Hyponatraemia (low blood sodium levels)
- Suicide, personality disorders, abnormal thinking
- Delirium, encephalopathy
- Worsening of seizures
- Uncontrollable muscle spasms, difficulty controlling movements, hyperkinesia
- Altered heart rhythm (electrocardiogram changes)
- Pancreatitis, liver failure, hepatitis
- Acute kidney injury
- Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
- Rhabdomyolysis (muscle tissue breakdown) – incidence significantly higher in Japanese patients
- Gait disturbance, difficulty walking
It is important to report suspected side effects after authorisation of the medicine. This helps monitor the ongoing benefit-risk balance. Healthcare professionals and patients can report side effects to their national medicines regulatory authority.
The psychiatric side effects of levetiracetam deserve particular attention. While most patients tolerate the medication well, behavioural changes such as irritability, aggression, and mood disturbances have been reported. These effects are generally more common in patients with a pre-existing psychiatric history. If you or those around you notice significant changes in mood or behaviour, it is important to contact your healthcare provider promptly. In many cases, a dose adjustment or gradual switch to an alternative antiepileptic drug can resolve these issues.
How Should You Store Levetiracetam STADA?
Store Levetiracetam STADA out of sight and reach of children. After opening, store at or below 25°C and use within 7 months. Do not use after the expiry date on the carton and bottle. Dispose of unused medicine through a pharmacy – never via household waste or drains.
Proper storage of Levetiracetam STADA is essential to ensure the medicine remains effective and safe throughout its use. Incorrect storage conditions can lead to degradation of the active substance, potentially reducing its therapeutic efficacy or creating harmful breakdown products.
- Before opening: No special storage conditions are required. Store in the original packaging.
- After first opening: Store at temperatures not exceeding 25°C (77°F). The opened bottle should be used within 7 months of first opening.
- Expiry date: Do not use this medicine after the expiry date stated on the carton and bottle after “EXP”. The expiry date refers to the last day of that month.
- Keep out of reach: Always store this medicine out of the sight and reach of children. Use the child-resistant cap provided.
- Disposal: Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.
It is good practice to write the date you first opened the bottle on the label, so you can easily track when the 7-month use period expires. If the solution appears cloudy, discoloured, or contains particles, do not use it and consult your pharmacist for a replacement.
What Does Levetiracetam STADA Contain?
The active substance is levetiracetam, with each ml containing 100 mg. Other ingredients include sodium citrate, citric acid, methylparahydroxybenzoate (E218), glycerol (E422), acesulfame potassium (E950), liquid maltitol (E965), raspberry flavouring (contains benzyl alcohol), and purified water. The oral solution is a clear liquid.
Active Substance
Each millilitre of Levetiracetam STADA oral solution contains 100 mg of levetiracetam. Levetiracetam is the S-enantiomer of alpha-ethyl-2-oxo-1-pyrrolidine acetamide, a pyrrolidone derivative. It has a molecular weight of 170.21 g/mol and is highly water-soluble, which facilitates its formulation as an oral solution and contributes to its rapid and complete absorption from the gastrointestinal tract.
Other Ingredients (Excipients)
- Sodium citrate – pH adjustment
- Citric acid – pH adjustment
- Methylparahydroxybenzoate (E218) – preservative
- Glycerol (E422) – humectant and sweetener
- Acesulfame potassium (E950) – artificial sweetener
- Liquid maltitol (E965) – sweetener and bulking agent
- Raspberry flavouring – contains benzyl alcohol for taste
- Purified water – solvent
Appearance and Pack Sizes
Levetiracetam STADA 100 mg/ml oral solution is a clear liquid supplied in glass bottles. Three pack configurations are available depending on the patient’s age group:
- 300 ml bottle (for children from 4 years, adolescents, and adults) – includes a 10 ml oral syringe graduated in 0.25 ml increments and an adapter
- 150 ml bottle (for infants from 6 months to 4 years) – includes a 3 ml oral syringe graduated in 0.1 ml increments and an adapter
- 150 ml bottle (for infants from 1 month to under 6 months) – includes a 1 ml oral syringe graduated in 0.05 ml increments and an adapter
Not all pack sizes may be available in every market.
Marketing Authorisation Holder
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany. The medicine is manufactured at several sites including Remedica Ltd (Cyprus), STADA Arzneimittel GmbH (Austria), and Galenica Pharmaceutical Industry S.A. (Greece).
Frequently Asked Questions About Levetiracetam STADA
Medical References and Sources
This article is based on current medical research, regulatory authority approvals, and international clinical guidelines. All claims are supported by scientific evidence from peer-reviewed sources.
- European Medicines Agency (EMA). “Levetiracetam – Summary of Product Characteristics.” EMA product database. Available at: www.ema.europa.eu
- Brodie MJ, Perucca E, Ryvlin P, Ben-Menachem E, Meencke HJ (2007). “Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy.” Neurology, 68(6): 402-408. DOI: 10.1212/01.wnl.0000252941.50833.4a
- International League Against Epilepsy (ILAE). “Updated ILAE evidence review of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes.” Epilepsia, 2023.
- National Institute for Health and Care Excellence (NICE). “Epilepsies in children, young people and adults: diagnosis and management.” NICE guideline [NG217], 2022, updated 2024.
- World Health Organization (WHO). “WHO Model List of Essential Medicines – 23rd List, 2023.” Levetiracetam listed as an essential antiepileptic medicine.
- Cochrane Database of Systematic Reviews. “Levetiracetam add-on for drug-resistant focal epilepsy: an updated Cochrane Review.” Cochrane Library, 2022.
- Tomson T, Battino D, Bonizzoni E et al. (2018). “Comparative risk of major congenital malformations with eight different antiepileptic drugs: a prospective cohort study of the EURAP registry.” The Lancet Neurology, 17(6): 530-538.
- Lynch BA, Lambeng N, Bhatt D et al. (2004). “The synaptic vesicle protein SV2A is the binding site for the antiepileptic drug levetiracetam.” Proceedings of the National Academy of Sciences, 101(26): 9861-9866.
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