Keppra pills 500mg №60

Indications

As monotherapy (drug of first choice) in the treatment of:

- partial seizures with or without secondary generalization in adults and adolescents over 16 years of age with newly diagnosed epilepsy.

As part of complex therapy in the treatment of:

- partial seizures with or without secondary generalization in adults and children over 4 years old, suffering from epilepsy (for tablets);

- partial seizures with or without secondary generalization in adults and children older than 1 month suffering from epilepsy (for solution);

- 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.

Dosage and administration

The daily dose is divided into 2 identical doses.

years old the drug is prescribed in the form of pills or oral solution at the initial dose of 500 mg divided into 2 doses (250 mg 2 times / day). After 2 weeks, the dose can be increased to the initial therapeutic dose - 1 g (500 mg 2 times / day). The maximum daily dose - 3 g (1.5 g 2 times / day).

the drug is prescribed in the form of oral solution. The initial therapeutic dose is 7 mg / kg 2 times / day. Depending on the clinical efficacy and tolerability, the dose may be increased to 21 mg / kg 2 times / day. The dose change should not exceed plus or minus 7 mg / kg 2 times / day every 2 weeks. It is necessary to prescribe the minimum effective dose.

Recommendations for dosing Keppra^® in the form of oral solution for children under 6 months presented in the table.

Treatment should begin with a dose of 10 mg / kg body weight, divided into 2 doses (10 mg / kg body weight 2 times / day). Depending on the clinical response and tolerability of the drug, the daily dose may be increased to 30 mg / kg 2 times / day. A dose change of 10 mg / kg body weight can be administered every 2 weeks. A minimum effective dose should be applied.

Doses for children weighing 50 kg and more is the same as for adults.

Recommended doses for children aged 6 months and teenagers presented in the table.

Havechildren over 4 years old Treatment should begin 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 carried out every 2 weeks until the recommended daily dose is reached - 60 mg / kg body weight (30 mg / kg body weight 2 times / day). In case of intolerance to the recommended daily dose, its reduction is possible. A minimum effective dose should be applied.

The drug should be prescribed in the most appropriate dosage form and dose, depending on the patient's body weight and the required therapeutic dose.

It is recommended to start treatment with the drug in the form of oral solution.

Dosing is carried out according to the scheme given for adults.

Treatment should begin with a daily dose of 1 g, divided into 2 doses (500 mg 2 times / day). Depending on the clinical response and tolerability of the drug, the daily dose may be increased to a maximum of 3 g (1.5 g, 2 times a day). Changing the dose of 500 mg 2 times / day can be done every 2-4 weeks.

Since levetiracetam is eliminated by the kidneys when prescribing elderly patients and patients with renal insufficiency dose should be adjusted depending on the value of QC.

QC can be calculated based on the concentration of serum creatinine, according to the following formula.

QC (ml / min) = [140-age (years)] × body weight (kg) / 72 × serum creatinine (mg / dL)

received value x 0.85

* - on the first day of treatment with Keppra^® 750 mg saturating dose is recommended.

** - after dialysis, an additional dose of 250-500 mg is recommended.

dose adjustment of levetiracetam should be made taking into account the degree of renal failure, using the recommendations given for adults.

impaired liver function mild to moderate severity correction of the dosing regimen is not required. Have patients with decompensated liver dysfunction and renal failure the value of QC may not reflect the true degree of renal dysfunction, therefore, when QC <70 ml / min It is recommended to reduce the daily dose by 50%.

Pills should be taken orally, drinking plenty of liquid, regardless of the meal.

Dosing solution carried out using a measuring syringe with a nominal capacity of 10 ml (corresponds to 1 g of levetiracetam) and with a dividing price of 25 mg (corresponding to 0.25 ml) supplied with the product. A measured dose of the drug is diluted in a glass of water (200 ml).

To dispense the solution using a measuring syringe, open the bottle: to do this, press the cap and turn it counterclockwise. Insert the syringe adapter into the neck of the bottle, then take the syringe and place it into the adapter. Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the plunger down, then push the plunger up to remove air bubbles. Pulling the plunger, fill the syringe with a solution before dividing, corresponding to the amount of ml of solution prescribed by the doctor. Pull the syringe out of the adapter. Enter the contents of the syringe into a glass of water, pushing the piston until it stops. You should drink all the contents of the glass. Then rinse the syringe with water and close the bottle with a plastic cap.

Side effect

Possible side effects are listed below for body systems and frequency of occurrence: very often (> 1/10), often (> 1/100, <1/10).

From the side of the central nervous system: very often - drowsiness, asthenic syndrome; often - amnesia, ataxia, convulsions, dizziness, headache, hyperkinesia, tremor, imbalance, loss of concentration, memory loss, agitation, depression, emotional lability, mood swings, hostility / aggressiveness,insomnia, nervousness, irritability, personality disorders, impaired thinking; in some cases, paresthesia, behavioral disorders, anxiety, anxiety, confusion, hallucinations, irritability, psychotic disorders, suicide, suicide attempts, and suicidal intent.

On the part of the organ of vision: often - diplopia, disturbance of accommodation.

On the part of the respiratory system: often - increased cough.

From the digestive system: often - abdominal pain, diarrhea, dyspepsia , nausea, vomiting, anorexia, weight gain; in some cases - pancreatitis, liver failure, hepatitis, changes in liver function tests, weight loss.

Dermatological reactions: often - skin rash, eczema, itching; in some cases, alopecia (in some cases, hair restoration was observed after discontinuation of the drug), Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis.

From the hemopoietic system: in some cases - leukopenia, neutropenia, pancytopenia (in some cases with inhibition of bone marrow function), thrombocytopenia.

Other: in some cases, infections, nasopharyngitis, myalgia.

Contraindications

- children's age up to 4 years (for tablets) (safety and efficacy of the drug have not been established);

- children's age up to 1 month (for solution) (safety and efficacy of the drug have not been established);

- violation of tolerance to fructose (for solution);

- hypersensitivity to the drug;

- hypersensitivity to other pyrrolidone derivatives.

WITH caution It should be prescribed the drug to elderly patients (over 65 years), with liver diseases in the stage of decompensation, renal failure.

Use during pregnancy and lactation

Adequate and strictly controlled clinical studies on the safety of levetiracetam in pregnant women have not been conducted, so the drug should not be prescribed during pregnancy, except in cases of emergency.

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 first trimester (up to 60% of the baseline concentration in the period before pregnancy).

Treatment with levetiracetam pregnant should be carried out under special control. It should be borne in mind that interruptions in antiepileptic therapy may worsen the course of the disease, which is harmful for 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 lactation, then the risk / benefit ratio of treatment should be carefully weighed against the importance of breastfeeding.

Application for violations of the liver

With mild and moderate violations of the liver, dose adjustment is not required.

WITH caution It should appoint a drug for liver diseases in the stage of decompensation.

Application for violations of kidney function

dose is selected individually in accordance with the recommendations given in the table.

* On the first day of treatment with Keppra, it is recommended to take a 750 mg saturating dose.

** after dialysis, an additional dose of 250-500 mg is recommended.

Use in children

Contraindicated: children under 4 years old (for tablets) (safety and efficacy of the drug have not been established); children up to 1 month (for solution) (safety and efficacy of the drug have not been established);

Use in elderly patients

WITH caution The drug should be prescribed to elderly patients (over 65 years).

special instructions

If you want to stop taking the drug, it is recommended to cancel, gradually, reducing a single dose of 500 mg every 2-4 weeks. In children, 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), it is desirable to cancel gradually.

Patients with kidney disease and decompensated liver disease are recommended to study kidney function before starting treatment. If kidney function is abnormal, a dose adjustment may be necessary.

In connection with the reported cases of suicide, suicidal intent and attempted suicide in the treatment with levetiracetam, patients should be warned about the need to immediately inform their doctor about any symptoms of depression or suicidal intentions.

The oral solution contains maltitol, therefore, patients with impaired fructose tolerance should receive Keppra^® in the appropriate dosage form is contraindicated.

Use in pediatrics

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 effects of treatment on children's ability to learn, their intellectual development, growth, endocrine gland functions, sexual development and fertility remain unknown.

Influence on ability to drive motor transport and control mechanisms

Effect of Keppra^® on the ability to drive vehicles and control mechanisms has not been specifically studied. However, due to the varying individual sensitivity to the drug on the part of the central nervous system during the period of treatment, it is necessary to refrain from driving vehicles and practicing potentially hazardous activities that require high concentration of attention and quickness of psychomotor reactions.

Overdose

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

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

Drug interaction

Levetiracetam does not interact with anticonvulsants (phenytoin, Carbamazepine , valproic acid, phenobarbital, lamotrigine, Gabapentin , and primidone).

Levetiracetam in a daily dose of 1 g does not change the pharmacokinetics of oral contraceptives (ethinyl estradiol and levonorgestrel).

Levetiracetam in a daily dose of 2 g does not change the pharmacokinetics of Warfarin and Digoxin .

Digoxin, oral contraceptives and warfarin do not affect the pharmacokinetics of levetiracetam.

When combined with topiramate , the likelihood of anorexia is higher.

The completeness of the absorption of levetiracetam does not change under the influence of food, while the rate of absorption somewhat decreases.

Data on the interaction of levetiracetam with alcohol are not available.

Terms and conditions of storage

Tablets should be stored in a dry place at a temperature not higher than 25 ° C. Shelf life - 3 years.

The solution for ingestion should be stored in a dark place at a temperature not exceeding 30 ° C.