Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Desitrend 100 mg/ml Oral Solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Levetiracetam may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for 2. What you need to know before you take Desitrend 3. How to take Desitrend 4. Possible side effects 5. How to store Desitrend
How to take it
Desitrend Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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Laetus-Code: ohne
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- Fill the syringe with a small amount of solution by pulling the piston down (figure 4), then push the piston upward in order to remove any possible bubble (figure 5). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 6).
- Turn the bottle the right way up.
- Remove the syringe from the adaptor. 7
- Empty the contents of the syringe in a glass of water or baby's bottle by pushing the piston to the bottom (figure 7).
- Drink the whole contents of the glass / baby's bottle. 8
- Close the bottle with the plastic screw cap.
- Wash the syringe with water only (figure 8). Duration of treatment: Desitrend is used as a chronic treatment. You should continue Desitrend treatment for as long as your doctor has told you. Do not stop your treatment without your doctor's advice as this could increase your seizures. If you take more Desitrend than you should: The possible side effects of an overdose of Desitrend are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma. Contact your doctor if you took more Desitrend than you should. Your doctor will establish the best possible treatment of overdose. If you forget to take Desitrend: Contact your doctor if you have missed one or more doses. Do not take a double dose to make up for a forgotten dose. If you stop taking Desitrend: If stopping treatment, Desitrend should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Desitrend treatment, he/she will instruct you about the gradual withdrawal of Desitrend. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all me dicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately, or go to your nearest emergency department, if you experience:
- weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction
- swelling of the face, lips, tongue and throat (Quincke's oedema)
- flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])
- symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function
- a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
- a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
- a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
- signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy. The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time. Very common: may affect more than 1 user in 10 people
- nasopharyngitis;
- somnolence (sleepiness), headache. Common: may affect 1 to 10 users in 100 people
- anorexia (loss of appetite);
- depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
- convulsion, balance disorder (equilibrium dis order), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);
- vertigo (sensation of rotation);
- cough;
- abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
- rash;
- asthenia/fatigue (tiredness).
MOCKUP
Uncommon: may affect 1 to 10 users in 1,000 people
- decreased number of blood platelets, decreased number of white blood cells;
- weight decrease, weight increase;
- suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/ mood swings, agitation;
- amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
- diplopia (double vision), vision blurred;
- elevated/abnormal values in a liver function test;
- hair loss, eczema, pruritus;
- muscle weakness, myalgia (muscle pain);
- injury. Rare: may affect 1 to 10 users in 10,000 people
- infection;
- decreased number of all blood cell types;
- severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]);
- decreased blood sodium concentration;
- suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
- uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
- pancreatitis;
- liver failure, hepatitis;
- sudden decrease in kidney function;
- skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (StevensJohnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis);
- rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients. Reporting of side effects If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard. By reporting
Possible side effects
you can help provide more information on the safety of this medicine.
How to store it
Desitrend Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the cardboard box and bottle after EXP:. The expiry date refers to the last day of the month. Do not use after 7 months of first opening the bottle. Store in the original bottle, in order to protect from light. Store in an upright position. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Desitrend contains The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam. The other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), grapefruit flavour, purified water. What Desitrend looks like and contents of the pack Desitrend 100 mg/ml oral solution is a clear liquid. 300 ml solution in an amber glass bottle with a white child resistant closure is packed in a cardboard box containing a 1 ml oral syringe (graduated every 0.05 ml) with adaptor and a 10 ml oral syringe (graduated every 0.25 ml) with adaptor. Marketing Authorisation Holder Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany [email protected] Manufacturer Bluepharma Indústria Farmacêutica, S.A. S. Martinho de Bispo 3045-016 Coimbra Portugal This medicinal product is authorised in the Member States of the EEA under the following names: United Kingdom: Desitrend 100 mg/ml oral solution This leaflet was last revised in 01/2017.
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Contents of the pack and other information
Desitrend must be taken twice a day, once in the morning and once in the evening, at about the same time each day. Take the oral solution following your doctor's instructions.
Monotherapy Dose in adults and adolescents (from 16 years of age): 1. What Desitrend is and what it is used for Levetiracetam is an antiepileptic medicine (a medi- Measure the appropriate dosage using the 10 ml syringe. cine used to treat seizures in epilepsy). General dose: Desitrend is taken twice daily, in Desitrend is used: two equally divided doses, each individual dose
- on its own in adults and adolescents from being measured between 5 ml (500 mg) and 15 ml 16 years of age with newly diagnosed epilepsy, (1,500 mg). to treat a certain form of epilepsy. Epilepsy is a When you will first start taking Desitrend, your doccondition where the patients have repeated fits tor will prescribe you a lower dose (500 mg each (seizures). Levetiracetam is used for the epilepsy day) during 2 weeks before giving you the lowest form in which the fits initially affect only one side general dose of 1,000 mg. of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset Add-on therapy seizure with or without secondary generalisation). Levetiracetam has been given to you by Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more: your doctor to reduce the number of fits.
- as an add-on to other antiepileptic medicines to Measure the appropriate dosage using the 10 ml syringe. treat:
- partial onset seizures with or without generali General dose: Desitrend is taken twice daily, in sation in adults, adolescents, children and two equally divided doses, each individual dose being measured between 5 ml (500 mg) and infants from one month of age
- myoclonic seizures (short, shock-like jerks of 15 ml (1,500 mg). a muscle or group of muscles) in adults and Dose in children 6 months and older: adolescents from 12 years of age with juvenile For dosages of up to 2.5 ml (250 mg), use the myoclonic epilepsy 1 ml syringe.
- primary generalised tonic-clonic seizures For dosages of more than 2.5 ml (250 mg), use (major fits, including loss of consciousness) in the 10 ml syringe. adults and adolescents from 12 years of age Both syringes, 1 ml and 10 ml, are included in the with idiopathic generalised epilepsy (the type package. of epilepsy that is thought to have a genetic General dose: Desitrend is taken twice daily, in two cause). equally divided doses, each individual dose being measured between 0.1 ml (10 mg) and 0.3 ml (30 2. What you need to know before you take mg), per kg bodyweight of the child (see table Desitrend below for dose examples). Do not take Desitrend
- if you are allergic to levetiracetam, pyrrolidone Dose in children 6 months and older: derivatives or any of the other ingredients of this Weight Starting dose: Suitable Maximum dose: Suitable medicine (listed in section 6).
0.1 ml/kg syringe size 0.3 ml/kg syringe size
twice daily 1ml 10 ml twice daily 1ml 10 ml Warnings and precautions 6 kg 0.6 ml 1.8 ml Talk to your doctor before taking Desitrend twice daily yes no twice daily yes no
- If you suffer from kidney problems, follow your 8 kg 0.8 ml 2.4 ml doctor's instructions. He/she may decide if your
twice daily yes no twice daily yes no dose should be adjusted. 10 kg 1 ml 3 ml
- If you notice any slow down in the growth or twice daily yes no twice daily no yes unexpected puberty development of your child, 15 kg 1.5 ml 4.5 ml please contact your doctor. twice daily yes no twice daily no yes
- A small number of people being treated with anti- 20 kg 2 ml 6 ml epileptics such as Desitrend have had thoughts twice daily yes no twice daily no yes of harming or killing themselves. If you have any 25 kg 2.5 ml 7.5 ml symptoms of depression and/or suicidal idea twice daily no yes twice daily no yes tion, please contact your doctor. From Children and adolescents 50 kg 5 ml 15 ml Desitrend is not indicated in children and adoles- twice daily no yes twice daily no yes cents below 16 years on its own (monotherapy). Dose in infants (1 month to less than 6 months): Other medicines and Desitrend Tell your doctor or pharmacist if you are taking, For infants 1 month to less than 6 months, have recently taken or might take any other medi- measure the appropriate dosage using the 1 ml syringe. cines. General dose: Desitrend is taken twice daily, in two Do not take macrogol (a drug used as laxative) equally divided doses, each individual dose being for one hour before and one hour after taking measured between 0.07 ml (7 mg) and 0.21 ml levetiracetam as this may result in a reduction of (21 mg), per kg bodyweight of the infant (see table its effect. below for dose examples). Dose in infants (1 month to less than 6 Pregnancy and breast-feeding If you are pregnant or breastfeeding, think you may months): be pregnant or are planning to have a baby, ask Weight Starting dose: Maximum dose: your doctor for advice before taking this medicine. 0.07 ml/kg twice daily 0.21 ml/kg twice daily Desitrend should not be used during pregnancy 4 kg 0.3 ml twice daily 0.85 ml twice daily unless clearly necessary. A risk of birth defects for 5 kg 0.35 ml twice daily 1.05 ml twice daily your unborn child cannot be completely exclud6 kg 0.45 ml twice daily 1.25 ml twice daily ed. Desitrend has shown unwanted reproductive 7 kg 0.5 ml twice daily 1.5 ml twice daily effects in animal studies at dose levels higher than you would need to control your seizures. Method of administration: Breast-feeding is not recommended during treat- After measuring the correct dose with an appropriment. ate syringe, Desitrend oral solution may be diluted in a glass of water or baby's bottle. You may take Driving and using machines Desitrend may impair your ability to drive or operate Desitrend oral solution with or without food. any tools or machinery, as it may make you feel Instructions for use: sleepy. This is more likely at the beginning of treat• Open the bottle: press the cap ment or after an increase in the dose. You should 1 and turn it anticlockwise not drive or use machines until it is established (figure 1). that your ability to perform such activities is not
- Choose the syringe and adaptor affected. suitable for your dosage (see Desitrend contains methyl parahydroxyben dosage information). zoate, propyl parahydroxybenzoate and 2
- Insert the syringe adaptor into maltitol the bottle neck (figure 2). Ensure Desitrend oral solution includes methyl parahyit is well fixed. droxybenzoate (E218) and propyl parahydroxyben• Take the syringe and put it in the zoate (E216) which may cause allergic reactions adaptor opening (figure 2). (possibly delayed). Desitrend oral solution also contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 3
- Turn the bottle upside down before taking this medicinal product. (figure 3).
Frequently asked questions about Desitrend 100 mg/ml Oral Solution
How do I take Desitrend 100 mg/ml Oral Solution?
Desitrend 100 mg/ml Oral Solution comes as oral solution containing 100mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Desitrend 100 mg/ml Oral Solution?
The active substance in Desitrend 100 mg/ml Oral Solution is levetiracetam.
Are there equivalent medicines to Desitrend 100 mg/ml Oral Solution?
Medicines with the same active substance, strength and form include: Keppra 100 mg/ml oral solution, Levetiracetam Amarox 100 mg/ml oral solution, Levetiracetam Milpharm 100 mg/ml oral solution. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Desitrend 100 mg/ml Oral Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Desitrend 100 mg/ml Oral Solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: levetiracetam
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Desitrend is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
Desitrend is indicated as adjunctive therapy
• in the treatment of partial onset seizures with or without secondary generalization in adults, adolescents, children and infants from 1 month of age with epilepsy.
• in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
• in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from12 years of age with Idiopathic Generalised Epilepsy.
4.2. Posology and method of administration
Posology
Monotherapy for adults and adolescents from 16 years of age
The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1,500 mg twice daily.
Add-on therapy for adults (≥ 18 years) and adolescents (12 to 17 years) weighing 50 kg or more
The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily. Dose changes can be made in 500 mg twice daily increases or decreases every two to four weeks.
Discontinuation
If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in infants older than 6 months, children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks; in infants (less than 6 months): dose decrease should not exceed 7 mg/ kg twice daily every two weeks).
Special populations
Elderly (65 years and older)
Adjustment of the dose is recommended in elderly patients with compromised renal function (see “Renal impairment” below).
Renal impairment
The daily dose must be individualised according to renal function.
For adult patients, refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighting 50 kg or more, the following formula:
Then CLcr is adjusted for body surface area (BSA) as follows:
Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal function
Group
Creatinine clearance (ml/min/1.73 m2)
Dose and frequency
Normal
> 80
500 to 1,500 mg twice daily
Mild
50-79
500 to 1,000 mg twice daily
Moderate
30-49
250 to 750 mg twice daily
Severe
< 30
250 to 500 mg twice daily
End-stage renal disease patients undergoing dialysis (1)
-
500 to 1,000 mg once daily (2)
(1)A 750 mg loading dose is recommended on the first day of treatment with levetiracetam.
(2)Following dialysis, a 250 mg to 500 mg supplemental dose is recommended.
For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function. This recommendation is based on a study in adult renally impaired patients.
The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination, for young adolescents, children and infants, using the following formula (Schwartz formula):
ks= 0.45 in Term infants to 1 year old; ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
Dosing adjustment for infants, children and adolescents patients weighing less than 50 kg with impaired renal function:
Group
Creatinine clearance (ml/min/1.73m2)
Dose and frequency (1)
Infants 1 to less than 6 months
Infants 6 to 23 months, children and adolescents weighing less than 50 kg
Normal
> 80
7 to 21 mg/kg (0.07 to 0.21 ml/kg) twice daily
10 to 30 mg/kg (0.10 to 0.30 ml/kg) twice daily
Mild
50-79
7 to 14 mg/kg (0.07 to 0.14 ml/kg) twice daily
10 to 20 mg/kg (0.10 to 0.20 ml/kg) twice daily
Moderate
30-49
3.5 to 10.5 mg/kg (0.035 to 0.105 ml/kg) twice daily
5 to 15 mg/kg (0.05 to 0.15 ml/kg) twice daily
Severe
< 30
3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) twice daily
5 to 10 mg/kg (0.05 to 0.10 ml/kg) twice daily
End-stage renal disease patients undergoing dialysis
--
7 to 14 mg/kg (0.07 to 0.14 ml/kg) once daily (2) (4)
10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily (3) (5)
(1) Desitrend oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets or sachets of coated-granules and for patients unable to swallow tablets.
(2) A 10.5 mg/kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
(3) A 15 mg/kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam
(4) Following dialysis, a 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) supplemental dose is recommended.
(5) Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
Hepatic impairment
No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency. Therefore, a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m2.
Paediatric population
The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to age, weight and dose.
Desitrend oral solution is the preferred formulation for use in infants and children under the age of 6 years. In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 250 mg. In all of the above cases Desitrend oral solution should be used.
Monotherapy
The safety and efficacy of Desitrend in children and adolescents below 16 years as monotherapy treatment have not been established. No data are available.
Add-on therapy for infants aged 6 to 23 months, children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg
The initial therapeutic dose is 10 mg/kg twice daily.
Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/kg twice daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks. The lowest effective dose should be used. Dose in children 50 kg or greater is the same as in adults.
Dose recommendations for infants from 6 months of age, children and adolescents:
Weight
Starting dose: 10 mg/kg twice daily
Maximum dose: 30 mg/kg twice daily
6 kg (1)
60 mg (0.6 ml) twice daily
180 mg (1.8 ml) twice daily
10 kg (1)
100 mg (1 ml) twice daily
300 mg (3 ml) twice daily
15 kg (1)
150 mg (1.5 ml) twice daily
450 mg (4.5 ml) twice daily
20 kg (1)
200 mg (2 ml) twice daily
600 mg (6 ml) twice daily
25 kg
250 mg twice daily
750 mg twice daily
From 50 kg (2)
500 mg twice daily
1,500 mg twice daily
(1) Children 25 kg or less should preferably start the treatment with Desitrend 100 mg/ml oral solution.
(2) Dose in children and adolescents 50 kg or more is the same as in adults.
Add-on therapy for infants aged from 1 month to less than 6 months
The initial therapeutic dose is 7 mg/kg twice daily.
Depending upon the clinical response and tolerability, the dose can be increased up to 21 mg/kg twice daily. Dose changes should not exceed increases or decreases of 7 mg/kg twice daily every two weeks. The lowest effective dose should be used.
Infants should start the treatment with Desitrend 100 mg/ml oral solution.
Dose recommendations for infants aged from 1 month to less than 6 months:
Weight
Starting dose:
7 mg/kg twice daily
Maximum dose:
21 mg/kg twice daily
4 kg
28 mg (0.3 ml) twice daily
84 mg (0.85 ml) twice daily
5 kg
35 mg (0.35 ml) twice daily
105 mg (1.05 ml) twice daily
7 kg
49 mg (0.5 ml)twice daily
147 mg (1.5 ml) twice daily
Four presentations are available:
- A 300 ml bottle with a 1 ml oral syringe (delivering up to 100 mg levetiracetam) graduated every 0.05 ml (corresponding to 5 mg) and a 10 ml oral syringe (delivering up to 1,000 mg levetiracetam) graduated every 0.25 ml (corresponding to 25 mg).
- A 300 ml bottle with a 10 ml oral syringe (delivering up to 1,000 mg levetiracetam) graduated every 0.25 ml (corresponding to 25 mg).
This presentation should be prescribed for children aged 4 years and older, adolescents and adults.
- A 150 ml bottle with a 3 ml oral syringe (delivering up to 300 mg levetiracetam) graduated every 0.1 ml (corresponding to10 mg)
In order to ensure the accuracy of the dosing, this presentation should be prescribed for infants and young children aged from 6 months to less than 4 years.
- A 150 ml bottle with a 1 ml oral syringe (delivering up to 100 mg levetiracetam) graduated every 0.05 ml (corresponding to 5 mg)
In order to ensure the accuracy of the dosing, this presentation should be prescribed for infants aged 1 month to less than 6 months.
Method of administration
The oral solution may be diluted in a glass of water or baby´s bottle and may be taken with or without food. Either one or two graduated oral syringes, an adaptor for each syringe and instructions for use in the package leaflet are provided with Desitrend.
4.3. Contraindications
Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Renal impairment
The administration of levetiracetam to patients with renal impairment may require dose adjustment. In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection (see section 4.2).
Acute Kidney injury
The use of levetiracetam has been very rarely associated with acute kidney injury, with a time to onset ranging from a few days to several months.
Blood cell counts
Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with levetiracetam administration, generally at the beginning of the treatment. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders (see section 4.8).
Suicide
Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam). A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour. The mechanism of this risk is not known.
Therefore, patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.
Paediatric population
Available data in children did not suggest impact on growth and puberty. However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.
Excipients
Desitrend 100 mg/ml oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
It also contains maltitol liquid; patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
4.5. Interaction with other medicinal products and other forms of interaction
Antiepileptic medicinal products
Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60 mg/kg/day levetiracetam.
A retrospective assessment of pharmacokinetic interactions in children and adolescents with epilepsy (4 to 17 years) confirmed that adjunctive therapy with orally administered levetiracetam did not influence the steady-state serum concentrations of concomitantly administered carbamazepine and valproate. However, data suggested a 20 % higher levetiracetam clearance in children taking enzyme- inducing antiepileptic medicinal products. Dose adjustment is not required.
Probenecid
Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite, but not of levetiracetam. Nevertheless, the concentration of this metabolite remains low.
Methotrexate
Concomitant administration of levetiracetam and methotrexate has been reported to decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels. Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two drugs.
Oral contraceptives and other pharmacokinetics interactions
Levetiracetam 1,000 mg daily did not influence the pharmacokinetics of oral contraceptives (ethinylestradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not modified. Levetiracetam 2,000 mg daily did not influence the pharmacokinetics of digoxin and warfarin; prothrombin times were not modified. Co-administration with digoxin, oral contraceptives and warfarin did not influence the pharmacokinetics of levetiracetam.
Laxatives
There have been isolated reports of decreased levetiracetam efficacy when the osmotic laxative macrogol has been concomitantly administered with oral levetiracetam. Therefore, macrogol should not be taken orally for one hour before and for one hour after taking levetiracetam.
Food and alcohol
The extent of absorption of levetiracetam was not altered by food, but the rate of absorption was slightly reduced. No data on the interaction of levetiracetam with alcohol are available.
4.6. Fertility, pregnancy and lactation
Pregnancy
Postmarketing data from several prospective pregnancy registries have documented outcomes in over 1,000 women exposed to levetiracetam monotherapy during the first trimester of pregnancy. Overall, these data do not suggest a substantial increase in the risk for major congenital malformations, although a teratogenic risk cannot be completely excluded. Therapy with multiple antiepileptic medicinal products is associated with a higher risk of congenital malformations than monotherapy and, therefore, monotherapy should be considered. Studies in animals have shown reproductive toxicity (see section 5.3). Desitrend is not recommended during pregnancy and in women of childbearing potential not using contraception unless clinically necessary.
Physiological changes during pregnancy may affect levetiracetam concentration. Decrease in levetiracetam plasma concentrations has been observed during pregnancy. This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy). Appropriate clinical management of pregnant women treated with levetiracetam should be ensured. Discontinuation of antiepileptic treatments may result in exacerbation of the disease which could be harmful to the mother and the foetus.
Breastfeeding
Levetiracetam is excreted in human breast milk. Therefore, breast-feeding is not recommended. However, if levetiracetam treatment is needed during breastfeeding, the benefit/risk of the treatment should be weighed considering the importance of breastfeeding.
Fertility
No impact on fertility was detected in animal studies (see section 5.3). No clinical data are available, potential risk for human is unknown.
4.7. Effects on ability to drive and use machines
Levetiracetam has minor or moderate influence on the ability to drive and use machines.
Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase. Therefore, caution is recommended in those patients when performing skilled tasks, e.g. driving vehicles or operating machinery. Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.
4.8. Undesirable effects
Summary of the safety profile
The most frequently reported adverse reactions were nasopharyngitis, somnolence, headache, fatigue and dizziness. The adverse reaction profile presented below is based on the analysis of pooled placebo-controlled clinical trials with all indications studied, with a total of 3,416 patients treated with levetiracetam. These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience. The safety profile of levetiracetam is generally similar across age groups (adult and paediatric patients) and across the approved epilepsy indications.
Tabulated list of adverse reactions
Adverse reactions reported in clinical studies (adults, adolescents, children and infants > 1 month) and from post-marketing experience are listed in the following table per System Organ Class and per frequency. Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
MedDRA SOC
Frequency category
Very common
Common
Uncommon
Rare
Infections and infestations
Nasopharyngitis
Infection
Blood and lymphatic system disorders
Thrombocytopenia, leukopenia
Pancytopenia, neutropenia, agranulocytosis
Immune system disorders
Drug reaction with eosinophilia and systemic symptoms (DRESS), hypersensitivity (including angioedema and anaphylaxis)
Metabolism and nutrition disorders
Anorexia
Weight decreased , weight increase
Hyponatraemia
Psychiatric disorders
Depression, hostility/ aggression, anxiety, insomnia, nervousness/irritability
Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state , panic attack, affect lability/mood swings, agitation
Completed suicide, personality disorder, thinking abnormal
Nervous system disorders
Somnolence, headache
Convulsion, balance disorder, dizziness, lethargy, tremor
Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention
Choreoathetosis, dyskinesia, hyperkinesia
Eye disorders
Diplopia, vision blurred
Ear and labyrinth disorders
Vertigo
Respiratory, thoracic and mediastinal disorders
Cough
Gastrointestinal disorders
Abdominal pain, diarrhoea, dyspepsia, vomiting, nausea
Pancreatitis
Hepatobiliary disorders
Liver function test abnormal
Hepatic failure, hepatitis
Skin and subcutaneous tissue disorders
Rash
Alopecia, eczema, pruritus,
Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Musculoskeletal and connective tissue disorders
Muscular weakness, myalgia
Rhabdomyolysis and blood creatine phospokinase increased*
Renal and Urinary Disorders
Acute Kidney injury
General disorders and administration site conditions
Asthenia/fatigue
Injury, poisoning and procedural complications
Injury
* Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
Cases of encephalopathy have been rarely observed after levetiracetam administration. These undesirable effects generally occurred at the beginning of the treatment (few days to a few months) and were reversible after treatment discontinuation.
Description of selected adverse reactions
The risk of anorexia is higher when levetiracetam is coadministered with topiramate.
In several cases of alopecia, recovery was observed when levetiracetam was discontinued.
Bone marrow suppression was identified in some of the cases of pancytopenia.
Paediatric population
In patients aged 1 month to less than 4 years, a total of 190 patients have been treated with levetiracetam in placebo-controlled and open label extension studies. Sixty of these patients were treated with levetiracetam in placebo-controlled studies. In patients aged 4-16 years, a total of 645 patients have been treated with levetiracetam in placebo-controlled and open label extension studies. 233 of these patients were treated with levetiracetam in placebo-controlled studies. In both these paediatric age ranges, these data are supplemented with the post-marketing experience of the use of levetiracetam.
In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study. No new safety concerns for levetiracetam were identified for infants less than 12 months of age with epilepsy.
The adverse reaction profile of levetiracetam is generally similar across age groups and across the approved epilepsy indications. Safety results in paediatric patients in placebo-controlled clinical studies were consistent with the safety profile of levetiracetam in adults except for behavioural and psychiatric adverse reactions which were more common in children than in adults. In children and adolescents aged 4 to 16 years, vomiting (very common, 11.2%), agitation (common, 3.4%), mood swings (common, 2.1%), affect lability (common, 1.7%), aggression (common, 8.2%), abnormal behaviour (common, 5.6%), and lethargy (common, 3.9%) were reported more frequently than in other age ranges or in the overall safety profile. In infants and children aged 1 month to less than 4 years, irritability (very common, 11.7%) and coordination abnormal (common, 3.3%) were reported more frequently than in other age groups or in the overall safety profile.
A double-blind, placebo-controlled paediatric safety study with a non-inferiority design has assessed the cognitive and neuropsychological effects of levetiracetam in children 4 to 16 years of age with partial onset seizures. It was concluded that levetiracetam was not different (non inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population. Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL – Achenbach Child Behavior Checklist).
However subjects, who took levetiracetam in the long-term open label follow-up study, did not experience a worsening, on average, in their behavioural and emotional functioning; in particular measures of aggressive behaviour were not worse than baseline.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Symptoms
Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam overdoses.
Management of overdose
After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis. There is no specific antidote for levetiracetam. Treatment of an overdose will be symptomatic and may include haemodialysis. The dialyser extraction efficiency is 60 % for levetiracetam and 74 % for the primary metabolite.
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Medicines containing Levetiracetam
- Desitrend 100 mg/ml concentrate for solution for infusion
- Desitrend 1000 mg coated granules in sachet
- Desitrend 250 mg coated granules in sachet
- Desitrend 500 mg coated granules in sachet
- Keppra 100 mg/ml concentrate for solution for infusion
- Keppra 100 mg/ml oral solution
- Keppra 1000 mg film-coated tablets
- Keppra 250 mg film-coated tablets
- Keppra 500 mg film-coated tablets
- Keppra 750 mg film-coated tablets
- Levetiracetam 100 mg/ml concentrate for solution for infusion
- Levetiracetam 1000 mg film-coated tablets
- Levetiracetam 250 mg film-coated tablets
- Levetiracetam 500 mg film-coated tablets