LEVETIRACETAM PILLS 1G

Levetiracetam tablets

INN:levetiracetam

Pharmacotherapeutic group:antiepileptic drug

Indications for use 
As a monotherapy in the treatment of:
- partial seizures with or without secondary generalization in adults and adolescents over 16 years of age with the first diagnosed epilepsy.
As part of complex therapy in the treatment of:
- partial seizures with or without secondary generalization in adults and children over 6 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.

Contraindications 
- Hypersensitivity to levetiracetam or other pyrrolidone derivatives, as well as other components of the drug;
- children's age up to 6 years (safety and efficacy not established);
- children weighing less than 25 kg (impossibility of accurate dosing).

Carefully 
Elderly patients (over 65 years). Liver disease in the stage of decompensation. Renal failure.

Use during pregnancy and during breastfeeding 
Adequate and strictly controlled studies on the safety of levetiracetam in pregnant women have not been conducted.Animal studies have revealed reproductive toxicity. Women with preserved reproductive function must be given contraceptive measures during treatment with levetiracetam. The drug should be prescribed during pregnancy only if absolutely necessary.
Physiological changes in the body of a woman during pregnancy can affect the plasma concentration of levetiracetam, as well as other antiepileptic drugs. During pregnancy, a decrease in plasma concentration of levetiracetam was observed. This decrease is more pronounced in the third trimester (up to 60% of the baseline concentration observed before pregnancy). Treatment with levetiracetam pregnant should be carried out under special control. Interruptions in antiepileptic therapy can worsen the course of the disease, which can harm the health of both the mother and the fetus.
Levetiracetam is excreted in breast milk, so breastfeeding is not recommended for drug treatment. However, if treatment with levetiracetam is necessary during breastfeeding, the risk / benefit ratio of treatment should be carefully weighed against the importance of breastfeeding.

Dosage and administration 
Inside, regardless of the meal.
The daily dose of the drug is divided into two doses in the same dose.
pills are taken with a large amount of liquid.

Monotherapy 
Adults and teenagers over 16 years old Treatment should begin with a daily 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 one - 1000 mg (500 mg 2 times a day). The maximum daily dose is 3000 mg (1500 mg 2 times a day).

As part of complex therapy 
Adults and adolescents 12-17 years old with a body weight of more than 50 kgtreatment should begin with a daily dose of 1000 mg, 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 3000 mg (1500 mg 2 times a day). Changing the dose of 500 mg 2 times a day can be done every 2-4 weeks.
Children over 6 years old and adolescents 12-17 years old with body weight less than 50 kg Treatment should begin with a daily dose of 20 mg / kg body weight, divided into 2 doses (10 mg / kg 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 is reached - 60 mg / kg of body weight (30 mg / kg of body weight 2 times a day). INN:levetiracetam

Pharmacotherapeutic group:antiepileptic drug

Indications for use 
As a monotherapy in the treatment of:
- partial seizures with or without secondary generalization in adults and adolescents over 16 years of age with the first diagnosed epilepsy.
As part of complex therapy in the treatment of:
- partial seizures with or without secondary generalization in adults and children over 6 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.

Contraindications 
- Hypersensitivity to levetiracetam or other pyrrolidone derivatives, as well as other components of the drug;
- children's age up to 6 years (safety and efficacy not established);
- children weighing less than 25 kg (impossibility of accurate dosing).

Carefully 
Elderly patients (over 65 years). Liver disease in the stage of decompensation. Renal failure.

Use during pregnancy and during breastfeeding 
Adequate and strictly controlled studies on the safety of levetiracetam in pregnant women have not been conducted. Animal studies have revealed reproductive toxicity. Women with preserved reproductive function must be given contraceptive measures during treatment with levetiracetam. The drug should be prescribed during pregnancy only if absolutely necessary.
Physiological changes in the body of a woman during pregnancy can affect the plasma concentration of levetiracetam, as well as other antiepileptic drugs. During pregnancy, a decrease in plasma concentration of levetiracetam was observed. This decrease is more pronounced in the third trimester (up to 60% of the baseline concentration observed before pregnancy). Treatment with levetiracetam pregnant should be carried out under special control.Interruptions in antiepileptic therapy can worsen the course of the disease, which can harm the health of both the mother and the fetus.
Levetiracetam is excreted in breast milk, so breastfeeding is not recommended for drug treatment. However, if treatment with levetiracetam is necessary during breastfeeding, the risk / benefit ratio of treatment should be carefully weighed against the importance of breastfeeding.

Dosage and administration 
Inside, regardless of the meal.
The daily dose of the drug is divided into two doses in the same dose.
pills are taken with a large amount of liquid.

Monotherapy 
Adults and teenagers over 16 years old Treatment should begin with a daily 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 one - 1000 mg (500 mg 2 times a day). The maximum daily dose is 3000 mg (1500 mg 2 times a day).

As part of complex therapy 
Adults and adolescents 12-17 years old with a body weight of more than 50 kgtreatment should begin with a daily dose of 1000 mg, 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 3000 mg (1500 mg 2 times a day). Changing the dose of 500 mg 2 times a day can be done every 2-4 weeks.
Children over 6 years old and adolescents 12-17 years old with body weight less than 50 kg Treatment should begin with a daily dose of 20 mg / kg body weight, divided into 2 doses (10 mg / kg 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 is reached - 60 mg / kg of body weight (30 mg / kg of body weight 2 times a day).

For children weighing 25 kg or less, it is recommended to start treatment with the drug in the form of oral solution.
Children with a body weight of more than 50 kg dosing is carried out according to the scheme given for adults.
In case of intolerance to the recommended daily dose, its reduction is possible. A minimum effective dose should be applied. The physician should prescribe the drug in the most appropriate dosage form and dosage, depending on the patient's body weight and the required therapeutic dose.
Since levetiracetam is excreted by the kidneys, when prescribing the drugpatients with renal failure and elderly patients dose should be adjusted depending on the amount of creatinine clearance (CC).
Children with renal insufficiency dose adjustment levetiracetam should be made taking into account the degree of renal failure.
Patients with hepatic impairment mild to moderate severity correction dosage is not required. In patients with decompensated liver dysfunction and renal failure, the level of reduction in creatinine clearance may not fully reflect the severity of renal failure.In such cases, with creatinine clearance <60 ml / min / 1.73 m2, a daily dose reduction of 50% is recommended.
The duration of the course of treatment is determined by the doctor.

Side effect 
The most frequently reported adverse reactions are nasopharyngitis, drowsiness, headache, weakness, dizziness. The safety profile of levetiracetam is generally similar for different age groups of adults and children.
The incidence of side effects is classified according to the recommendations of the World Health Organization: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely ( > 1/10 000, <1/1000), very rarely (<1/10 000, including individual messages), frequency is unknown - not enough data to estimate the frequency of development.
Infectious and parasitic diseases: very often - nasopharyngitis; rarely infections.
Violations of the blood and lymphatic system:infrequently - thrombocytopenia, leukopenia; rarely, neutropenia, pancytopenia (in some cases bone marrow suppression was recorded).
Immune system disorders: rarely, drug allergy with eosinophilia and systemic manifestations (DRESS syndrome).
Metabolic and nutritional disorders: often - anorexia; infrequently - weight loss, weight gain; rarely - hyponatremia.
Mental Disorders: often - depression, hostility, aggression, anxiety, insomnia, nervousness, irritability; infrequently - attempts at suicide, suicidal thoughts,psychotic disorders, behavioral disorders, hallucinations, anger, confusion, panic attacks, emotional lability, mood variability, agitation; rarely - suicide, personality disorder, impaired thinking.
Nervous system disorders: very often - drowsiness, headache; often - convulsions, imbalance, dizziness, lethargy, tremor; infrequently - amnesia, memory impairment, impaired coordination / ataxia, paresthesia, decreased concentration of attention; rarely - choreoathetosis, dyskinesia, hyperkinesia.
Violations by the organ of vision: infrequently - diplopia, blurred vision.
Disturbances from an organ of hearing and labyrinth disturbances:often - vertigo.
Disorders of the respiratory system, organs of the chest and mediastinum: often - cough.
Violations of the gastrointestinal tract: often - abdominal pain, diarrhea, dyspepsia , vomiting, nausea; rarely - pancreatitis.
Disorders of the liver and biliary tract: infrequently - deviation of laboratory parameters of liver function from the norm; rarely - liver failure, hepatitis.
Violation of the skin and subcutaneous tissues: often - skin rash; infrequently - alopecia, eczema, itching; rarely, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme.
Disorders of the musculoskeletal and connective tissue: infrequently - myalgia, muscular weakness.
General disorders and disorders at the site of administration: often - general weakness / fatigue. Injuries, intoxication and complications of manipulation: infrequently - accidental damage.
With simultaneous use of levetiracetam and topiramate increases the likelihood of anorexia.
In some cases, hair restoration was observed after the abolition of levetiracetam.
The safety profile of levetiracetam as a whole does not differ depending on age (in adults and children), and does not depend on the approved indications for use (various epilepsy variants). With the exception of behavioral and psychiatric adverse reactions, which occur more often in children than in adults, the safety profile in children is comparable to that of levetiracetam in adults. In children and adolescents aged 4 to 16, the following adverse reactions were more frequently recorded: vomiting (very often, 11.2%), agitation (often, 3.4%), mood variability (often, 2.1%), emotional lability (often, 1.7%), aggressiveness (often, 8.2%), behavioral disorders (often, 5.6%) and lethargy (often, 3.9%). In children aged 1 month to 4 years, the following adverse reactions were more often recorded: irritability (very often, 11.7%) and impaired coordination (often, 3.3%).

Storage conditions 
At a temperature not higher than 25 ° С.
Keep out of the reach of children.

Vacation conditions 
On prescription.