Universal reference book for medicines

Active substance: levetiracetam

Type: Anticonvulsant drug

VE TIC. (Turkey)
Composition, form of production and packaging
Tablets, film-coated
1 tab.

levetiracetam hydrochloride 250 mg

10 pieces.
- blisters (5) - packs of cardboard.
Tablets, film-coated 1 tab.

levetiracetam hydrochloride 500 mg

10 pieces.
- blisters (5) - packs of cardboard.
Tablets, film-coated 1 tab.

levetiracetam hydrochloride 500 mg

10 pieces.
- blisters (5) - packs of cardboard.

Description of the drug approved by the manufacturer for the printed edition of 2012.


Levetiracetam is a pyrrolidone derivative (S-enantiomer of О±-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 is clear that it differs from the mechanism of action of known antiepileptic drugs. One of the proposed mechanisms of action is based on proven binding to the glycoprotein of the synaptic SV2A vesicles contained 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 the counteracting of the hypersynchronization of neuronal activity. Also, levetiracetam affects the GABA receptors and glycine receptors, modulating them through various endogenous agents. Levetiracetam does not change normal neurotransmission, but suppresses epileptiform neuronal flares induced by GABA-agonist bicuculine, and the excitation of glutamate receptors. The activity of the drug has been confirmed with respect to both focal and generalized epileptic seizures (epileptiform manifestations, photoparoxymal reaction).


After oral administration, levetiracetam is well absorbed from the gastrointestinal tract.
Absorption occurs completely and is linear in nature, due to which the concentration in the blood plasma can be predicted, based on the accepted dose of levetiracetam expressed in mg / kg of body weight. The degree of absorption does not depend on the dose and time of food intake. Bioavailability is approximately 100%. C max in blood plasma is achieved 1.3 hours after oral administration of levetiracetam at a dose of 1000 mg and at a single admission is 31 Ојg / ml, after repeated administration (2 times / day) 43 Ојg / ml. The equilibrium state is achieved after 2 days with a two-time intake of the drug. The pharmacokinetics of levetiracetam in children is linear in the dose range from 20 to 60 mg / kg / day, C max isachieved in 0.5-1 hour.

The binding of levetiracetam and its main metabolite to plasma proteins is less than 10%.
Vd is about 0.5-0.7 l / kg.

The formation of the primary pharmacologically inactive metabolite (ucb L057) occurs without the involvement of liver cytochrome P450.
Levetiracetam does not affect the enzymatic activity of hepatocytes. Excretion of T 1/2 from the blood plasma of an adult is 7 В± 1 h and does not depend on the mode of administration and dosing regimen. The average overall clearance is 0.96 ml / min / kg. 95% of the drug is excreted by the kidneys. The renal clearance of levetiracetam and its metabolite is 0.6 ml / min / kg and 4.2 ml / min / kg, respectively. In elderly patients, T 1/2 increases by 40% and is 10-11 hours, which is associated with impaired renal function in this category of people. In patients with impaired renal function, the clearance of levetiracetam and its primary metabolite correlates with creatinine clearance.Therefore, patients with renal failure are recommended to select a dose depending on the creatinine clearance. In the terminal stage of renal failure in adult patients, T1/2 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.
In patients with impaired liver function of mild and moderate severity, significant changes in the clearance of levetiracetam do not occur.
In most patients with severe impairment of liver function with concomitant renal failure, the clearance of levetiracetam declines by more than 50%. T 1/2 in children after a single oral administration of the drug at a 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 a monotherapy (first-choice drug) in the treatment of partial seizures with secondary generalization or without it in adults and adolescents over 16 years old with newly diagnosed epilepsy.

As part of complex therapy in the treatment of:

- partial seizures with secondary generalization or without it in adults and children older than 4 years suffering from epilepsy;

- Myoclonic seizures in adults and adolescents over 12 years with juvenile myoclonic epilepsy;

- Primary generalized convulsive (tonic-clonic) seizures in adults and adolescents over 12 years with idiopathic generalized epilepsy.


Inside, regardless of food intake.
The daily dose of the drug is divided into two doses in the same dose. Tablets are taken with a sufficient amount of liquid.

Adults and adolescents over 16 years of age should be treated with a daily dose of 500 mg divided into 2 divided doses (250 mg 2 times / day).
After 2 weeks, the dose may be increased to the initial therapeutic -1000 mg (500 mg 2 times / day). The maximum daily dose is 3000 mg (1500 mg 2 times / day).
As part of complex therapy

Children older than 4 years and adolescents 12-17 years old with a body weight of up to 50 kg should begin treatment with a daily dose of 20 mg / kg body weight divided into 2 doses (10 mg / kg body weight 2 times / day).
A dose change of 20 mg / kg body weight can be performed every 2 weeks until the recommended daily dose is 60 mg / kg body weight (30 mg / kg body weight 2 times / day). With intolerance of the recommended daily dose, it is possible to reduce it. The minimum effective dose should be used. The physician should prescribe the drug in the most suitable dosage form and dosage, depending on the patient's body weight and the required therapeutic dose.
Children with a body weight of more than 50 kg are dosed according to the scheme given for adults.

Adults and adolescents over 16 years of age with a body weight of more than 50 kg should be treated with a daily dose of 1000 mg divided into 2 divided doses (500 mg 2 times / day).
Depending on the clinical response and the tolerability of the drug, the daily dose can be increased to a maximum of 3000 mg (1500 mg 2 times / day). A dose change of 500 mg 2 times / day can be carried out every 2-4 weeks. Since levetiracetam is excreted from the body by the kidneys, when administered to patients with renal insufficiency and elderly patients, the dose should be adjusted depending on the amount of creatinine clearance (CC).
The creatinine clearance for men can be calculated from the serum creatinine concentration by the following formula:

[14-years (years)] С… body weight (kg)

KK (ml / min) = ------------------------------------------- -------------------------------

72 x KK serum (mg / dL)

The creatinine clearance for women can be calculated by multiplying the obtained value by a factor of 0.85.

Then the QC is adjusted taking into account the surface area of ​​the body (PPT) according to the following formula:

CK (ml / min)

KK (ml / min / 1.73 m 2 ) = ------------------------------------- -

PPT facility (m 2 )

Kidney failure KK (ml / min / 1.73 m 2 ) Dosing regimen

Norm> 80 from 500 mg to 1500 mg 2 times / day

Latent 50-79 from 500 mg to 1000 mg 2 times / day

Compensated 30-49 from 250 mg to 750 mg 2 times / day

Intermittent <30 from 250 mg to 500 mg per day

Terminal stage (patients on dialysis *) from 500 mg to 1000 mg 1 time / day **

On the first day of treatment, a saturating dose of 750 mg is recommended.

** After dialysis, an additional 250-500 mg dose is recommended.
Children with renal insufficiency correction of the dose of levetiracetam should be made taking into account the degree of renal failure, using recommendations given for adults.
Patients with a malfunction of the liver of mild and moderate severity of the correction of the dosing regimen is not required.
In patients with decompensated impairment of liver function and renal insufficiency, the level of decrease in creatinine clearance may not fully reflect the severity of renal failure. In such cases, when creatinine clearance <60 ml / min / 1.73 m 2 is recommended, a daily dose reduction of 50% is recommended.
The duration of the course of treatment is determined by the doctor.


From the nervous system and psyche: drowsiness, asthenic syndrome, amnesia, ataxia, convulsions, dizziness, headache, hyperkinesia, tremor, imbalance, decreased concentration, memory impairment, agitation, depression, emotional lability, mood swings, hostility / aggressiveness , insomnia, nervousness, irritability, personality disorders, impaired thinking, paresthesia, behavioral disorders, anxiety, anxiety, confusion, hallucinations, irritability
, psychotic disorders, suicide, suicide attempts and suicidal intentions.
On the part of the organs of vision: diplopia, a violation of accommodation.

From the respiratory system: increased cough.

On the part of the digestive system: abdominal pain, diarrhea, dyspepsia, nausea, vomiting, anorexia, weight gain, pancreatitis, hepatic insufficiency, hepatitis, changes in functional hepatic samples, weight loss.

From the skin: skin rash, eczema, itching, alopecia.

Changes in laboratory indicators: leukopenia, neutropenia, pancytopenia (in some cases with oppression of bone marrow function), thrombocytopenia.

Other: infections, nasopharyngitis, myalgia.


- hypersensitivity to levetiracetam or other pyrrolidone derivatives, as well as to any components of the drug;

- Children under 4 years of age (safety and efficacy not established);

- Children with body weight less than 20 kg (impossibility of accurate dosing).

Use with caution in elderly patients (over 65 years of age), with liver disease in the stage of decompensation, kidney failure.


Adequate and strictly controlled clinical studies on the safety of levetiracetam in pregnant women have not been conducted, so the drug should not be administered during pregnancy, except in cases of extreme necessity.
Physiological changes in the body of a woman during pregnancy can affect the concentration in blood plasma levetiracetam, as well as other antiepileptic drugs. During pregnancy, there was a decrease in the concentration of levetiracetam in the blood plasma. This decrease is more pronounced in the I trimester (up to 60% of the baseline concentration in the period preceding the pregnancy). Treatment with levetiracetam pregnant women should be carried out under special supervision. Interruptions in antiepileptic therapy may lead to a worsening of the course of the disease, which can harm the health of the mother and fetus. Levetiracetam is excreted in breast milk, so breastfeeding during treatment with the drug is not recommended.

Use with caution in renal failure.


Use with caution in diseases of the liver in the stage of decompensation.


Contraindicated in children under 4 years (safety and efficacy not established), as well as in children weighing less than 20 kg (the impossibility of accurate dosing).


Use with caution in elderly patients (over 65 years of age).


If it is required to stop taking the drug, it is recommended to cancel the treatment gradually (reducing the single dose by 500 mg every 2-4 weeks).
In children, the dose reduction should not exceed 10 mg / kg of body weight 2 times / day every 2 weeks.
Concomitant antiepileptic drugs (during the transfer of patients to receive levetiracetam) should be gradually phased out.

The available information on the use of the drug in children does not indicate any of its negative effects on development and puberty.
However, the long-term consequences on children's ability to learn, their intellectual development, growth, endocrine gland functions, sexual development and fertility remain unknown.
Patients with kidney disease and decompensated liver disease are recommended to study the function of the kidneys before treatment.
If the kidney function is impaired, a dose adjustment may be required.
Due to reports of cases of suicide, suicidal intentions and suicide attempts in the treatment with levetiracetam, patients should be warned to immediately notify the attending physician of any symptoms of depression or suicidal intentions.

Impact on the ability to drive vehicles and manage mechanisms

The effect of the drug on the ability to drive vehicles and control mechanisms is not specifically studied.
Nevertheless, due to the different individual sensitivity to the drug from the central nervous system, during the treatment period it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Symptoms: drowsiness, anxiety, aggressiveness, oppression of consciousness, respiratory depression, coma.

Treatment: in the acute period - artificial challenge of vomiting and gastric lavage followed by the appointment of activated charcoal.
There is no specific antidote for levetiracetam. If necessary, symptomatic treatment in a hospital using hemodialysis (dialysis efficiency for levetiracetam is 60%, for its primary metabolite - 74%).

Levetiracetam does not interact with antiepileptic drugs (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone).Levetiracetam in a daily dose of 1000 mg does not change the pharmacokinetics of oral contraceptives (ethinyl estradiol and levonorgestrel).
Levetiracetam in a daily dose of 2000 mg does not change the pharmacokinetics of digoxin and warfarin.
Digoxin, oral contraceptives and warfarin do not affect the pharmacokinetics of levetiracetam.

With joint admission with topiramate, the probability of anorexia is higher.

The effectiveness of the drug is not reduced by the action of probenecid (a drug that blocks renal tubular secretion).

Completeness of absorption of levetiracetam does not change under the influence of food, while the rate of absorption is somewhat reduced.
There are no data on the interaction of levetiracetam with alcohol.

It is released by prescription.


Store in the original packaging in a dry place inaccessible to children and protected from light at a temperature of no higher than 25 В° C.

Shelf life - 2 years.

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