Keppra tabs 500mg #30

Keppra user manual

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Composition

The international non-proprietary name (INN) of the active substance is levetiracetam.
The concentrate for the further manufacture of the infusion solution includes 500 mg of levetiracetam, the active substance. Additional Ingredients: 45 mg - sodium chloride, 8.2 mg - sodium acetate trihydrate, up to 5 ml - water for injection, 10% acetic acid (to pH 5.5).
The solution for oral administration includes 100 mg of levetiracetam, the active substance. Additional ingredients: 0.06 mg - citric acid monohydrate, 1.05 mg sodium citrate, 2.7 mg methyl parahydroxybenzoate, 1.5 mg ammonium glycyrrhizate, 0.3 mg propyl parahydroxybenzoate, 300 mg maltitol, 235.5 mg - glycerol 85%, 4.5 mg - acesulfame potassium, 504 mg - purified water, 0.3 mg - flavoring grape 501040A.
The film-coated tablets in their composition contain 250 mg / 500 mg / 1000 mg of levetiracetam-an active substance. Additional ingredients are present in different mass parts, respectively, the content of the active ingredient: magnesium stearate, macrogol 6000, croscarmellose sodium, silicon dioxide.

Form of issue

The drug is available in three pharmacological forms:
    Concentrate for Keppra infusions;
    Keppra syrup;
    tablets in the shell of Keppra.

pharmachologic effect

Anticonvulsant, antiepileptic.

Pharmacodynamics and pharmacokinetics

The drug Keppra, whose active ingredient is levetiracetam, belongs to the derivatives of pyrrolidone and is distinguished in its chemical structure among the known drugs used to treat epilepsy, since it is obvious that its mechanism of action, although not fully understood, differs from mechanism of action of other antiepileptic drugs.
It is suggested that one of the mechanisms of action is the proven interaction of the synaptic SV2A vesicle protein, which are found in the gray matter of the spinal cord and brain with levetiracetam, which leads to an anticonvulsant effect, expressed in the antagonism of the hypersynchronization of neuronal activity.
Another mechanism of action is considered to be the effect of the active substance on glycine receptors and GABA receptors modulating these receptors with the help of various endogenous agents. Levetiracetam does not affect the activation of glutamate receptors and neurotransmission, however, inhibiting epileptiform neuronal outbreaks caused by the GABA agonist bicuculum.
The effectiveness of the drug is proven in relation to generalized and focal epileptic seizures.
The intravenous dose of levetiracetam 1500 mg corresponds to the same dose for oral administration.
After oral administration, it is absorbed well and quickly from the digestive tract.
Absorption is complete, of a linear nature, with full suction independent of the dose and food intake (suction rate is slightly reduced when eating).
Bioavailability is about 100%.
Cmax after a single oral intake of 1000 mg of the drug is observed after 80 minutes and is equal to 31 μg / ml. At repeated reception - 43 mcg / ml.
Cmax when administered intravenously 1500 mg of levetiracetam is reached after 15 minutes and is 51 ± 19 μg / ml.
With a double application of a single dose per day, the equilibrium state is observed after 48 hours.
Pharmacokinetics in children of children - a linear nature, in a daily dose of 20 mg to 60 mg per kilogram of weight.
Cmax - after 30-60 minutes.
Vd is about 0.5-0.7 l / kg.
The connection with plasma proteins is less than 10%.
Metabolism occurs by means of enzymatic hydrolysis.
T1 / 2 from plasma in children 5-6 hours, in adult patients approximately 7 hours, increasing by 40% in old age.
It is excreted by the kidneys.

Indications for use

Keppra's remedy is prescribed as a monotherapy for patients over 16 years of age with partial seizures with or without secondary generalization, with a re-diagnosed epilepsy.
In complex therapy the preparation is shown:
    with partial seizures without generalization or with secondary generalization, manifested in adult patients and children over 4 years of age with epilepsy (for tablets);
    with partial seizures without generalization or with secondary generalization, manifested in adult patients and children over 1 month old, suffering from epilepsy (for oral solution);
    with the development of myoclonic seizures in patients with juvenile myoclonic epilepsy, for the treatment of adults and adolescents over 12 years of age;
    with primary generalized convulsive attacks in patients with idiopathic generalized epilepsy, for the treatment of adults and adolescents over 12 years of age.
Keppra preparation in the form of a concentrate for infusions is prescribed as an alternative therapy, if it is impossible for the patient to take oral forms of the drug.

Contraindications

For tablets:
    children under 4 years old.
For all forms of the preparation:
    hypersensitivity to levetiracetam or other ingredients of the drug.
With extreme caution:
    patients over the age of 65;
    kidney failure;
    pathology of the liver in the stage of decompensation.

Side effects

Organs of vision:
    violation of accommodation;
    diplopia.
Respiratory system:
    increased cough.
Digestive system:
    abdominal pain;
    dyspepsia;
    diarrhea;
    a feeling of nausea;
    vomiting;
    weight change to a smaller side;
    anorexia;
    pancreatitis;
    hepatitis;
    liver failure;
    changes in hepatic samples.
Central nervous system:
    asthenic syndrome;
    a feeling of drowsiness;
    dizziness;
    ataxia;
    amnesia;
    convulsions;
    headache;
    tremor;
    hyperkinesia;
    disturbance of balance;
    memory impairment;
    decreased concentration of attention;
    excessive excitement;
    emotional lability;
    depression;
    frequent changes of mood;
    insomnia;
    aggression and hostility;
    irritability;
    nervousness;
    violation of thinking;
    personality disorders;
    paresthesia;
    anxiety;
    behavioral disorders;
    anxiety;
    hallucinations;
    confusion of consciousness;
    psychotic disorders;
    suicidal mood.
Skin:
    eczema;
    rash on the skin;
    itching;
    alopecia (it is possible to restore the hair after the abolition of therapy);
    erythema multiforme;
    Stevens-Johnson syndrome;
    toxic epidermal necrolysis.
The system of hematopoiesis:
    thrombocytopenia;
    neutropenia;
    leukopenia;
    pancytopenia (sometimes observed inhibition of bone marrow function).
Others:
    accession of infections;
    myalgia;
    nasopharyngitis.

Instructions for use (Method and dosage)

The instruction on Keppra in the form of a solution for infusions recommends a two-time intravenous infusion of a daily dose, in equal parts, for 15 minutes.
One ampoule of the drug contains 500 mg / 5ml levetiracetam. Before use, the solution is diluted in at least 100 ml of Ringer's solutions, 5% dextrose, or 0.9% sodium chloride.
Carry out the infusion immediately after the breeding process. In extreme cases, if it is not possible to conduct an immediate procedure, storing the solution in the refrigerator within 24 hours is allowed if the solution was prepared under aseptic conditions.
The dosage of intravenous infusion is determined by the attending physician.
The transition from intravenous administration to oral administration and vice versa can be carried out with preservation of dosage and multiplicity of application.
Oral administration of a daily dose of Keppra is carried out regardless of food intake in two equal parts, preferably with a 12-hour break.
Tablets are recommended to be washed down with a sufficient amount of water.
The instruction for the syrup presupposes its dosing with the aid of 10 ml of a measuring syringe included in the package, which corresponds to 1000 mg of levetiracetam.
To fill the syrup with a syringe, it is necessary to remove the lid from the vial and insert the syringe into the adapter, draw the necessary amount of solution by means of pulling the piston (dividing the syringe - 25 mg corresponds to 0.25 ml of the solution).
The metered solution is added to a pre-prepared beaker with 200 ml water and completely drunk.
After each new kit, it is necessary to thoroughly wash the syringe and tightly seal the bottle with a lid.

Monotherapy

Patients over the age of 16 years are recommended an initial daily dose of the drug - 500 mg, with taking in two stages of 250 mg every 12 hours. After 14 days, it is possible to increase the dose to the initial therapeutic dose, which is 1000 mg, with a dose of 500 mg twice a day. The maximum recommended daily dose of Keppra is 3000 mg.
In complex therapy
Patients older than 4 years of age are prescribed an initial daily dose of 20 mg / kg of body weight, with a two-time intake of 10 mg / kg of body weight per day. A change in dosage of 20 mg / kg of weight can occur every 14 days, until a recommended dose of 60 mg / kg body weight is received, with a twice-daily dose of 30 mg / kg. In case of patient intolerance of the recommended dose, it is reduced to a minimum effective.
The attending physician must prescribe Keppra's medication in the most suitable dosage form for each patient and dose the drug depending on the desired therapeutic dose and taking into account the body weight.
Patients of childhood with a body weight of up to 20 kg are advised to begin therapy with Keppra in the form of an oral solution.
Patients of child age with a body weight of more than 50 kg are recommended to carry out treatment with the use of therapy and dosage regimens for adult patients.
Patients over the age of 16 with a body weight of more than 50 kg are given an initial daily dose of 1000 mg, with a two-step regimen of 500 mg. Depending on the tolerability of the drug and the clinical response of the patient, the daily dose can be increased to the maximum recommended dose of 3000 mg, taken 2 times a day for 1500 mg. Dosage change of 500 mg 2 times a day can be performed every 14-28 days.
Due to the fact that levetiracetam is excreted in the urine, its dose, with the appointment of patients with kidney failure, must be adjusted.
Below are the maximum doses of Keppra in accordance with the creatinine clearance KK (ml / min):
    KK> 80 - 3000 mg;
    KK 50-79 - 2000 mg;
    KK 30-49 - 1500 mg.
Patients on dialysis are prescribed a saturating dose of 750 mg on the first day of therapy, after addition of 250 mg to 500 mg of the drug after dialysis.
The duration of the course of therapy with the use of Keppra is determined by the attending physician.

Overdose

When an overdose is possible manifestation: drowsiness, aggressiveness, anxiety of respiratory depression, depression of consciousness, and coma.
The recommended treatment in the acute period is the artificial invocation of vomiting and further washing of the stomach with the intake of adsorbents. If necessary, prescribe symptomatic therapy in a hospital, with hemodialysis.

Interaction

There was no interaction of Keppra with antiepileptic drugs (Phenytoin, Valproic acid, Carbamazepine, Phenobarbital, Gabapentin, Lamotrigine and Primidon).
Oral contraceptives Digoxin and Warfarin have no effect on the pharmacokinetics of levetiracetam.
Levetiracetam at a dose of 2000 mg per day is not affected by the pharmacokinetics of Warfarin and Digoxin and at a daily dose of 1000 mg per pharmacokinetics of oral contraceptives.
When combined with Topiramate, the risk of anorexia increases.

Storage conditions

Solution for infusion should be stored in a dark place at a temperature of no higher than 25 ° C.
Tablets should be stored at a temperature of no higher than 25 ° C, in a dry place.
Oral solution should be stored in a dark place at a temperature of no higher than 30 ° C.
Shelf life - 3 years.

special instructions

The withdrawal of Keppra is carried out gradually, with a decrease in the dose of 500 mg every 14-28 days (in children, a decrease in the dose of the drug should not exceed 10 mg / kg 2 times a day, every 14 days, in children up to 6 months - 7 mg / kg 2 times a day, every 14 days).
When transferring the patient to Keppra, it is desirable to cancel the antiepileptic medications taken slowly.
Patients with kidney pathologies and decompensated disease states of the liver are advised to conduct a study of the function of these organs before initiating therapy with levetiracetam to correct the dose.
The solution for infusion contains sodium, which must be taken into account when appointing patients who are on a low-sodium diet.
In connection with the fact that when using Keppra, there are data on cases of suicides, it is necessary to monitor the emotional and mental health of the patient. The patient is obliged to inform the attending physician of all symptoms of depression or suicidal moods.
Clinical experience in the use of Keppra's infusion solution for more than 4 days is not available.
Do not use syrup when changing its color or detecting foreign impurities in it.
The oral solution contains maltitol and is therefore contraindicated in patients with impaired tolerance to fructose.
The presence of propyl parahydroxybenzoate and methyl parahydroxybenzoate in the syrup can cause allergic reactions.

Children

It is prescribed for children in the recommended doses.

With alcohol

There is no reliable data on the effect of alcohol on therapy with levetiracetam.

In pregnancy and lactation

Due to the fact that special clinical studies on the effects and safety of the use of Keppra during pregnancy have not been conducted, do not recommend its administration to pregnant women, except in cases of acute necessity.
Levetiracetam is excreted in the mother's milk, so breastfeeding should be stopped when taking the drug.

Reviews on Keppra

Reviews of Keppra on the forums boil down to the fact that therapy with antiepileptic drugs should be selected exclusively individually. Given the large selection of drugs with a similar effect, the choice of an adequate treatment for an experienced doctor is not a problem.
Subject to compliance with all recommendations for use and an individual positive response to ongoing therapy, Keppra's drug shows good results.