Keppra is a drug with anticonvulsant and antiepileptic effects.
Release form and composition
Keppru produced in the form of:
- Concentrate for solution for infusion - a clear, colorless solution. On 5 ml in glass bottles, on 5 bottles in planimetric cellular packings, on 2 packings in cardboard packs;
- Tablets, film coated - oval, biconvex, with the inscription "ucb", on a fracture - white, homogeneous. Depending on the dosage: 250 mg - blue, with the inscription "250"; 500 mg each - white, with the inscription "500"; 1000 mg each - light yellow color, with the inscription "1000". 10 pcs. in blisters, 3 or 6 blisters in carton packs;
- Solution for oral administration - almost colorless, transparent, with a characteristic odor. On 300 ml in dark glass bottles, on 1 bottle in cardboard packs with the measured syringe in a set.
The composition of 1 ml of concentrate for preparing a solution for infusion includes:
- Active ingredient: levetiracetam - 100 mg;
- Auxiliary components: sodium acetate trihydrate, sodium chloride, 10% acetic acid (to pH 5.5), water for injection (up to 5 ml).
The composition of 1 tablet includes:
- Active ingredient: levetiracetam dihydrochloride - 250 mg, 500 mg or 1000 mg;
- Auxiliary components: macrogol 6000, croscarmellose sodium, silica, magnesium stearate.
The composition of the film coating of tablets:
- 250 mg: opadry 85F20694 (macrogol 3350, talc, E132 (indigo carmine dye), partially hydrolyzed polyvinyl alcohol, E171 (titanium dioxide));
- 500 mg: opadry 85F32004 (macrogol 3350, talc, E172 (iron dye yellow oxide), partially hydrolyzed polyvinyl alcohol, E171 (titanium dioxide));
- 1000 mg: opadry 85F18422 (talc, macrogol 3350, partially hydrolyzed polyvinyl alcohol, E171 (titanium dioxide)).
The composition of 1 ml of oral solution includes:
- Active ingredient: levetiracetam - 100 mg;
- Auxiliary components: sodium citrate, ammonium glycyrrhizinate, citric acid monohydrate, propyl parahydroxybenzoate, grape flavoring 501040A, methyl parahydroxybenzoate, maltitol, 85% glycerol, acesulfame potassium, purified water.
Indications for use
As monotherapy, Keppru is prescribed for the treatment of partial seizures with secondary generalization or without it in adolescents from 16 years of age and adults with newly diagnosed epilepsy.
Simultaneously with other drugs, Keppru is used to treat the following conditions:
- Primary generalized tonic-clonic (convulsive) seizures in adolescents from 12 years and adults with idiopathic generalized epilepsy;
- Myoclonic seizures in adolescents from 12 years of age and adults with juvenile myoclonic epilepsy;
- Partial seizures with or without secondary generalization in patients with epilepsy (adults and children from 4 years old - concentrate for preparing a solution for infusions, children from 6 years old - film-coated tablets, children from 1 month - oral solution).
Keppra in the form of a concentrate for preparing an infusion solution can be used as a temporary alternative if it is impossible to take the drug in oral forms.
Hypersensitivity to the components of the drug and other pyrrolidone derivatives.
Depending on the dosage form, contraindications to the use of Keppra are also:
- Tablets, a concentrate for preparation of solution for infusions - children's age up to 4 years;
- Solution for ingestion - violation of tolerance to fructose, children up to 1 month.
The drug should be used with caution in patients over 65 years of age, as well as in patients with liver disease in the stage of decompensation and renal failure.
Dosing and Administration
Keppra in the form of tablets are taken orally, regardless of the meal, and washed down with a liquid in sufficient quantity.
Dosing of the solution for oral administration is carried out using a measuring syringe with a capacity of 10 ml (1 g of levetiracetam) with a division value of 25 mg (corresponding to 0.25 ml), which is supplied with the preparation. A measured dose of Keppra should be diluted in 200 ml of water (1 cup).
Before use, the concentrate for preparing the solution for infusion should be diluted with a solvent of at least 100 ml. The time of intravenous drip is 15 minutes. The following solvents are used: Ringer's lactate solution for injections, 0.9% sodium chloride solution for injections, 5% dextrose solution for injections. The drug is recommended to be used immediately after dilution. The chemical stability of the solution is maintained for 24 hours at a temperature of 15-25 ° C in bags of polyvinyl chloride. Storage is allowed at a temperature of 2-8 ° C, provided that the dilution was performed under aseptic conditions.
The transition from oral to intravenous administration and back can be carried out with preservation of the frequency of administration and dose. The prescribed daily dose of Keppra is divided into two administrations or doses in the same dose.
The drug is prescribed in the most appropriate dosage form and dose, determined by the patient's body weight and indications.
With monotherapy for adolescents from 16 years of age and adults, therapy should begin with a daily dose of 500 mg divided into 2 administrations or doses. After 14 days, the dose can be increased by 2 times - up to 1000 mg. The maximum dose is 3000 mg per day.
Simultaneously with other drugs for children 1-6 months, Keppru is prescribed in the form of oral solution in an initial dose of 7 mg / kg 2 times a day. Depending on tolerance and clinical efficacy, it can be increased to 21 mg / kg 2 times a day. The dose can be changed 1 time in 14 days at a rate not exceeding 7 mg / kg 2 times a day. Therapy should be started with the minimum effective dose.
In children from 6 months to 17 years old with a body weight of up to 50 kg, treatment should be started with 10 mg / kg body weight divided into 2 doses. The daily dose can be increased by 3 times. Changing the dosage regimen at 10 mg / kg body weight can be done every 14 days. It is recommended to apply the minimum effective dose.
For children weighing up to 20 kg, it is recommended to begin therapy with the drug intake in the form of oral solution.
For children weighing 50 kg or more, the same doses are applied as for adults.
In case of intolerance to the prescribed daily dose, it may be reduced.
Adults and adolescents weighing from 50 kg of therapy begin with a daily dose of 1000 mg, divided into 2 administration or admission. Depending on the tolerability of the drug and the clinical response, the daily dose can be gradually increased (1 time in 14 days, 500 mg 2 times a day) up to a maximum of 3000 mg.
Since Keppra is excreted by the kidneys, when it is administered to patients with renal insufficiency and patients in old age, the dose is adjusted depending on the amount of creatinine clearance (CK).
Children with renal insufficiency dose adjustment is carried out taking into account the degree of renal failure, using recommendations for adults.
Patients with impaired liver function of moderate and mild severity do not require correction of the dosage regimen. With decompensated abnormal liver function and renal failure, a decrease in creatinine clearance may not fully reflect the severity of renal failure. In these cases, when creatinine clearance is less than 60 ml / min / 1.73 m2, a daily dose reduction of 50% is recommended.
The duration of the treatment course is determined by the doctor.
Most often during therapy occur: drowsiness, nasopharyngitis, headache, dizziness and fatigue.
Also, when using Keppra, the development of disorders on the part of certain body systems is possible:
- Blood and lymphatic system: infrequently - leukopenia, thrombocytopenia; rarely - agranulocytosis, pancytopenia, neutropenia;
- Invasions and infections: very often - nasopharyngitis; rarely, infections;
- Metabolism: often - anorexia; infrequently - a decrease or increase in body weight;
- Immune system: rarely - drug reaction with systemic manifestations and eosinophilia;
- Nervous system: very often - headache, drowsiness; often - an imbalance, convulsions, lethargy, tremor, dizziness; infrequently - decrease in concentration of attention, memory impairment, amnesia, ataxia / incoordination, paresthesia; rarely - dyskinesia, choreoathetosis, hyperkinesia;
- Mental disorders: often - anxiety, depression, aggressiveness / hostility, nervousness, irritability, insomnia; infrequently - emotional lability, suicidal intentions, suicide attempts, behavioral and psychotic disorders, panic attacks, confusion, hallucinations, anger, agitation, mood swings; rarely, thought disorder, personality disorder, suicide;
- Hepatobiliary system: infrequently - changes in liver function tests; rarely - hepatitis, liver failure.
- Organ of vision: infrequently - blurred vision, diplopia;
- Respiratory system: often - cough;
- Musculoskeletal system: infrequently - myalgia, muscle weakness;
- Organ of hearing: often - vertigo;
- Skin: often - a rash; infrequently - itching, eczema, alopecia; rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme;
- The digestive system: often - vomiting, abdominal pain, nausea, dyspepsia, diarrhea; rarely - pancreatitis;
- Complications of procedures, injuries: infrequently - accidental damage;
- General disorders: often - fatigue / asthenia.
In some cases of pancytopenia, bone marrow suppression has been reported.
After the abolition of levetiracetam, hair restoration was observed in a number of cases.
In children 4-16 years of age, development was most often noted: very often - vomiting; often - excitement, emotional lability, mood variability, behavioral disorders, lethargy and aggressiveness. In children from 1 month to 4 years, during therapy, irritability and impaired coordination most often occurred.
As a result of a double-blind, placebo-controlled study that assessed the neuropsychological and cognitive effects of the drug in children 4-16 years old with partial attacks, it was found that Keppra did not differ from placebo with respect to changes in the amount of points in the “Combined Memory Screening” and “ Attention and Memory "in comparison with the original data.
In the course of long-term observations in the open phase of studies, it was noted that in patients during therapy, the indicators of aggressive behavior did not deteriorate compared to baseline.
Strictly controlled and adequate clinical studies on the safety of Keppra use were not conducted by pregnant women, so they are not recommended to use the drug, unless absolutely necessary. Therapy of patients during pregnancy should be carried out under special control, taking into account the fact that interruptions in the conduct of antiepileptic treatment can lead to a worsening of the course of the disease, which is harmful for the mother and fetus.
Keppra is excreted in breast milk, so if you need to use it, you need to carefully weigh the benefit / risk ratio regarding the importance of breastfeeding.
If it is necessary to stop taking Keppra, it is recommended to cancel, gradually, reducing a single dose every 2-4 weeks by 500 mg. In children, the dose reduction should not exceed 10 mg / kg of body weight 2 times a day every 14 days.
During the transfer of patients to Keppra, it is desirable to cancel concomitant anti-epileptic drugs gradually.
Because of reports of suicidal intent and cases of suicide, during therapy, patients should be warned about the need to immediately inform the prescribing doctor about the occurrence of any symptoms of suicidal intentions or depression.
Available information on the use of Keppra in children does not indicate any negative effect of the drug on puberty and development. However, the long-term effects of therapy on the intellectual development of children, their ability to learn, growth, endocrine gland functions, fertility and sexual development remain unknown.
Before treatment, patients with decompensated liver and kidney diseases are advised to do a study of renal function. In cases of functional disorders of the kidneys, dose adjustment is possible.
During the period of therapy, one should refrain from driving vehicles and performing potentially hazardous types of work requiring high concentration of attention and speed of psychomotor reactions.
Keppra does not interact with anticonvulsant drugs (valproic acid, carbamazepine, phenytoin, lamotrigine, phenobarbital, primidone, and gabapentin).
The drug does not change the pharmacokinetics in the daily dose:
- 1 g - oral contraceptives (levonorgestrel and ethinyl estradiol);
- 2 g - digoxin and warfarin.
Oral contraceptives, warfarin and digoxin do not affect Keppra's pharmacokinetics.
The likelihood of developing anorexia increases with simultaneous use with topiramate.
Data on the interaction of Keppra with alcohol are not available.
Terms and conditions of storage
Store in a dark, dry, out of reach of children.
- Tablets - 3 years at temperatures up to 25 ° C;
- Oral solution - 3 years at temperatures up to 30 ° C;
- Concentrate for the preparation of infusions - 2 years at temperatures up to 25 ° C.