Tablets "Levicitam 500" are used for the following indications:
The active ingredient is levetiracetam (one tablet contains levetiracetam 500 mg).
Excipients: microcrystalline cellulose, copolyvidone, crospovidone, pregelatinized corn starch, magnesium stearate, coating for coating Opadry II White (polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide (E 171)).
Hypersensitivity to levetiracetam or other pyrrolidone derivatives, as well as to any components of the drug.
The tablets are taken orally with a sufficient amount of liquid, regardless of the meal. Divide the daily dose into 2 equal doses.
Monotherapy (adults and adolescents over the age of 16)
Monotherapy for adults and children over 16 years old should be started with a recommended dose of 500 mg / day (250 mg 2 times a day), followed by an increase in the dose to 1000 mg / day (up to 500 mg 2 times a day) after two weeks. It is possible to increase the dose by 500 mg / day (250 mg 2 times a day) every two weeks, depending on the clinical effect. The maximum daily dose is 3000 mg / day (1500 mg 2 times a day).
The safety and efficacy of using the drug "Levicitam 500" in children and adolescents under 16 years of age as monotherapy have not been established.
Adjunctive therapy for adults (≥ 18 years old) and adolescents (aged 12 to 17 years) weighing 50 kg or more
For adults and children over 12 years old with a body weight of more than 50 kg, treatment should be started with a dose of 1000 mg / day (500 mg 2 times a day). This starting dose is given on the first day of treatment. Depending on the clinical picture and tolerability of the drug, the daily dose can be increased to a maximum of 3000 mg / day (1500 mg 2 times a day). You can change the dose by 1000 mg / day (500 mg 2 times a day) every 2-4 weeks.
Additional therapy for children from 6 years old and adolescents (aged 12 to 17 years) weighing less than 50 kg
The doctor must prescribe the most appropriate dosage form, method of administration and the number of doses of the drug, depending on body weight and dose.
As an additional therapy, children over 6 years old should start with a dose of 10 mg / kg body weight 2 times a day. Depending on the clinical response and tolerability, the dose can be increased to 30 mg / kg 2 times a day. The dose can be increased or decreased by more than 10 mg / kg 2 times a day every two weeks. The minimum effective dose should be used.
For children weighing more than 50 kg, the dose is prescribed according to the scheme given for adults.
If it is necessary to cancel the drug, it is recommended to cancel the drug gradually (for example, for adults and adolescents weighing 50 kg or more - reduce the dose of 500 mg 2 times a day every 2-4 weeks, for children and adolescents weighing less than 50 kg - a single dose should be reduced by no more than 10 mg / kg 2 times a day every two weeks).
Pregnant
Levetiracetam should not be used during pregnancy, except in cases of extreme necessity, as well as in women of reproductive age who do not use contraception.
Levetiracetam passes into breast milk, so breastfeeding is not recommended. If levetiracetam is to be used during breastfeeding, the benefits and risks of treatment, as well as the importance of breastfeeding, must be weighed.
No effect on reproductive function was found in animal studies. The potential risk to humans is unknown because there are no clinical data available.
Drivers
Levetiracetam slightly or moderately affects the ability to drive vehicles or operate machinery. Due to possible individual sensitivity, some patients may notice drowsiness, dizziness and other symptoms associated with exposure to the central nervous system, especially at the beginning of treatment or during the course of increasing the dose. Therefore, such patients should be careful when performing work that requires an increased concentration of attention, for example, when driving a car or working with mechanisms. Patients are advised to refrain from driving and operating machinery until it is established that their ability to engage in such activities is not impaired.
Symptoms
In case of an overdose of the drug, drowsiness, agitation, aggression, respiratory depression, confusion, coma were observed.
Treatment
In case of acute overdose, it is necessary to flush the stomach or induce vomiting. There is no specific antidote. If necessary, symptomatic treatment is carried out, including using hemodialysis (up to 60% of levetiracetam and 74% of the primary metabolite are excreted).
The most commonly reported adverse reactions were nasopharyngitis, drowsiness, headache, fatigue, and dizziness.
Store in its original packaging at a temperature not exceeding 25 ° C, out of the reach of children.
Shelf life is 3 years.
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