Drug Information: Indications, Side Effects, Warnings
Category: Â Anticonvulsants
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Nosological classification (ICD-10):
G40.0 localized (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures with focal beginning
G40.1 localized (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
G40.2 localized (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
G40.3 Generalized idiopathic epilepsy and epileptic syndromes
G40.8 Other specified forms of epilepsy
Active ingredient: 250 mg, 500 mg, 1000 mg levetiracetam
excipients: Croscarmellose sodium – 10.75 mg; Macrogol 6000 – 2.5 mg; silicon dioxide – 5.188 mg; magnesium stearate – 0.313 mg
shell film: Opadry 85F20694 (dye indigo carmine (E132), macrogol 3350, polyvinyl alcohol, partially hydrolyzed, talc, titanium dioxide (E171) – 8.063 mg
Description pharmaceutical form
Tablets 250 mg: Blue, oval film-coated, with biconvex faces, one-sided risk on one side of which there is an engraving Â«ucbÂ», on the other – “250”; on a break – homogeneous, white.
Tablets 500 mg: light yellow, oval shaped, film-coated, with biconvex faces, one-sided risk on one side of which there is an engraving Â«ucbÂ», on the other – “500”; on a break – homogeneous, white.
Tablets, 1000 mg: white, oval-shaped, film-coated, with biconvex faces, one-sided risk on one side of which there is an engraving Â«ucbÂ», on the other – “1000”; on a break – homogeneous, white.
Indications for use
In monotherapy for treatment of the following conditions:
- Partial seizures with secondary generalization or without adults and adolescents from 16 years of age with newly diagnosed epilepsy.
- In the combined therapy in the treatment of the following conditions:
- Partial seizures with secondary generalization; or without in adults and children older than 4 years (concentrate for solution for infusion), 6 years (film-coated tablets), 1 month (oral solution), epilepsy;
- Myoclonic seizures in adults and adolescents over 12 years old suffering from juvenile myoclonic epilepsy;
- Primary generalized convulsive (tonic-clonic) seizures in adults and adolescents over 12 years old suffering from idiopathic generalized epilepsy.
Hypersensitivity to levetiracetam or other pyrrolidone derivatives, as well as any components of the drug;
breach of tolerance to fructose (oral solution);
Children under 4 years – for concentrate for solution for infusion and up to 1 month – for the oral solution (safety and efficacy have not been established).
Precautions: elderly patients (over 65 years); liver disease in the stage of decompensation; kidney failure.
Side effects and reactions
Infections and infestations: very often – nasopharyngitis; rarely – an infection.
From the blood and lymphatic system: Infrequent – thrombocytopenia, leukopenia; rarely – pancytopenia, agranulocytosis, neutropenia.
Immune system: rarely – drug reaction with eosinophilia and systemic symptoms (DRESS-syndrome).
From a metabolism: often – anorexia; infrequently – weight gain, weight loss.
Psychiatric disorders: often – depression, hostility / aggression, anxiety, insomnia, nervousness, irritability; infrequently – suicide attempt, suicidal ideation, psychotic disorders, behavioral disorders, hallucinations, anger, confusion, emotional lability, fickle mood, agitation, panic attacks; rarely – suicide, personality disorder, impaired thinking.
From the nervous system: very often – drowsiness, headache; often – convulsions, impaired balance, dizziness, lethargy, tremors; infrequently – amnesia, memory impairment, incoordination / ataxia, paraesthesia, decreased concentration; rarely – choreoathetosis, dyskinesia, hyperkinesia.
On the part of the organ of vision: rarely – diplopia, blurred vision.
On the part of the organ of hearing: often – vertigo.
The respiratory system: often – a cough.
From the digestive system: often – abdominal pain, diarrhea, dyspepsia, nausea, vomiting; rarely – pancreatitis.
On the part of the hepatobiliary system: Infrequent – change liver function tests; rarely – liver failure, hepatitis.
For the skin: often – a rash; rare – alopecia, eczema, pruritus; seldom – toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme.
From the musculoskeletal system: rarely – muscle weakness, myalgia.
General disorders: common – asthenia / fatigue.
Injuries, complications of treatments: Infrequent – accidental damage.
The risk of anorexia is higher when topiramate and levetiracetam taken together.
Sometimes there is a restoration of hair after the abolition of levetiracetam.
In some cases, pancytopenia: was recorded marrow depression.
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