Keppra solution for oral administration 100mg ml300ml
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Active ingredients
Levetiracetam
Release form
Solution
Composition
1 ml of Levetiracetam 100 mg.
Pharmacological effect
The antiepileptic drug, a derivative of pyrrolidone (S-enantiomer &. 945. -Ethyl-2-oxo-1-pyrrolidine-acetamide), differs in its chemical structure from the known anti-epileptic drugs. The mechanism of action of levetiracetam is not fully understood, but it is obvious that it differs from the mechanism of action of known antiepileptic drugs. In vitro studies have shown that levetiracetam affects the intraneuronal concentration of Ca2 + ions, partially inhibiting Ca2 + current through N-type channels and reducing the release of calcium from the intraneuronal depots. In addition, levetiracetam partially restores currents through GABA- and glycine-dependent channels, reduced by zinc and и .46-carbolines. One of the putative mechanisms is based on proven binding to the glycoprotein of the SV2A synaptic vesicle contained in the gray matter of the brain and spinal cord. It is believed that in this way the anticonvulsant effect is realized, which is expressed in counteracting the hypersynchronization of neural activity. Does not alter normal neurotransmission, however, suppresses epileptiform neuronal outbursts induced by a GABA agonist biculin and stimulation of glutamate receptors. The activity of the drug is confirmed in relation to both focal and generalized epileptic seizures (epileptiform manifestations / photoparoxysmal reaction).
Indications
As a monotherapy (drug of first choice) in the treatment of: - partial seizures with secondary generalization or without it 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 secondary generalization or without it in adults and children over 4 years old, suffering from epilepsy (for pills). - 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.
Contraindications
- children's age up to 4 years (for pills) (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) - impaired fructose tolerance (for solution) - hypersensitivity to the components drug - hypersensitivity to other pyrrolidone derivatives. Precautions 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.
Side effects
Possible side effects are listed below for body systems and frequency of occurrence: very often (> 1/10), often (> 1/100, less than 1/10). From the side of the central nervous system: very often - drowsiness, asthenic syndrome. often - amnesia, ataxia, convulsions, dizziness, headache, hyperkinesia, tremor, balance disorder, loss of concentration, memory loss, agitation, depression, emotional lability, mood swings, hostility / aggressiveness, insomnia, nervousness, irritability, personality disorders,disturbed 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. On the part of 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. On the part of 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.
special instructions
Possible side effects are listed below for body systems and frequency of occurrence: very often (> 1/10), often (> 1/100, less than 1/10). From the side of the central nervous system: very often - drowsiness, asthenic syndrome. often - amnesia, ataxia, convulsions, dizziness, headache, hyperkinesia, tremor, balance disorder, loss of concentration, memory loss, agitation, depression, emotional lability, mood swings, hostility / aggressiveness, insomnia, nervousness, irritability, personality disorders, disturbed 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. On the part of 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. On the part of 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.