KEPPRA SOLUTION 100MG/ML 300ML BOTTLE

Packaging

Indications and usage

Epilepsy (focal epileptic seizures with or without a transition to secondary large seizures) - as part of complex therapy.

• Hypersensitivity to levetiracetam or other derivatives
• pyrrolidone, as well as to any component of the drug;
• violation of fructose tolerance; 
• Children up to 4 years old (safety and efficacy not established).

Pregnancy and Breastfeeding

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 a woman’s body during pregnancy can affect plasma concentrationslevetiracetam, 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. 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.

Keppra is taken orally, regardless of the meal.
The daily dose of the drug is divided into two doses in the same dose. Dosing of the solution is carried out using a measuring syringe with a nominal capacity of 10 ml (corresponds to 1000 mg of levetiracetam) and with a division value of 25 mg (corresponding to 0.25 ml), which is supplied with the preparation. A measured dose of the drug is diluted in a glass of water (200 ml).

Monotherapy

Adults and teenagers over 16 years oldTreatment 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

Children over 4 years oldTreatment 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). In case of intolerance to the recommended daily dose, its reduction is possible. A minimum effective dose should be applied. The physician must prescribe the drug in the most appropriate dosage form and dosage, depending on the patient's body weight and the required therapeutic dose. For children weighing 20 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.

Adults and adolescents over 16 years old weighing over 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.

Adverse reactions

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

Nervous system: very often - drowsiness, fatigue, asthenia; often - amnesia, ataxia, convulsions, dizziness, headache, hyperkinesia, tremor, imbalance, loss of concentration, memory impairment, arousal, depression, emotional lability, mood variability, hostility / aggressiveness, insomnia, nervousness, irritability, personality disorders, impaired thinking; individual messages are paresthesia, behavioral disorders, anxiety, anger, confusion, hallucinations, psychotic disorders, suicide, suicide attempts, and suicidal intent.

Special senses: often - diplopia, blurred vision.

Respiratory: often - increased cough, nasopharyngitis.

Gastrointestinal: often - abdominal pain, diarrhea, dyspepsia, nausea, vomiting, anorexia, weight gain; individual reports - pancreatitis, liver failure, hepatitis, weight loss.

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

Changes in laboratory parameters: often - thrombocytopenia; individual reports - leukopenia, neutropenia, pancytopenia (in some cases with bone marrow depression), changes in liver function tests.

Other: individual messages - infections, myalgia, vertigo, accidental damage.

Special notes

If you want to stop taking the drug, it is recommended to cancel treatment 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 a day every 2 weeks.
Concomitant antiepileptic drugs (during the transfer of patients to receive levetiracetam), it is desirable to cancel gradually. 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.

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 do not take Keppra® in the appropriate dosage form.In children, dose reduction should not exceed 10 mg / kg of body weight 2 times a day every 2 weeks.

Concomitant antiepileptic drugs (during the transfer of patients to receive levetiracetam), it is desirable to cancel gradually. 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.

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 in contraindicated.

Drug Interactions

The drug does not interact with other antiepileptic drugs (phenytoin, Carbamazepine, valproic acid, phenobarbital, lamotrigine, Gabapentin, primidone).

Levetiracetam in a daily dose of 1000 mg does not change the pharmacokinetics of oral contraceptives (ethinyl estradiol, levonorgestrel) and in a daily dose of 2000 mg - Digoxin and Warfarin .

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

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

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

The amount of absorption of levetiracetam when administered orally does not change under the influence of food, and the rate of absorption sucks somewhat.

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

Treatment: in the acute period - induction of vomiting and gastric lavage followed by the appointment of Activated carbon (with an overdose of oral forms). 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).

At a temperature not higher than 30 ° С, in a dark place.

Keppra