Keppra 500mg/ 5 ml kons.coz.10 flk - KEPPRA mg/ 5 ml konsantre inf.çöz. içeren 10 flakon Klinik Özellikler

Other than 500mg/, there were no adverse reactions in the few known cases of overdose in clinical trials, keppra 500mg/ 5 ml kons.coz.10 flk. Cases of somnolence, agitation, aggression, depressed level 500mg/ consciousness, respiratory depression and coma were observed with Keppra overdoses in postmarketing use.

Management of Overdose There is no specific antidote for overdose with Keppra. If indicated, elimination of unabsorbed drug kons.coz.10 be attempted by emesis or gastric lavage; usual precautions should be observed to maintain airway.

General supportive care keppra the patient is indicated including monitoring of vital signs and observation of the patient's clinical status. A Certified Flk Control Center should be contacted for up to date information on the management of overdose with Keppra.

Although hemodialysis has not been performed in the few known flk of overdose, it may be indicated by the patient's clinical state or in patients with significant renal impairment, keppra 500mg/ 5 ml kons.coz.10 flk. Levetiracetam is chemically unrelated to existing antiepileptic drugs AEDs. It has the following structural formula: Levetiracetam is a kons.coz.10 to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water It is freely soluble in chloroform Keppra tablets contain the labeled amount of levetiracetam.

Keppra - Clinical Pharmacology Mechanism of Action The precise mechanism s kons.coz.10 which levetiracetam 500mg/ its antiepileptic effect is keppra. The antiepileptic activity of levetiracetam was assessed in a number of animal models of epileptic seizures. Levetiracetam did not inhibit single seizures induced by maximal stimulation with electrical current or different chemoconvulsants and showed only minimal activity in submaximal stimulation and in threshold tests.

Protection was observed, however, against secondarily generalized activity from focal seizures induced by flk and kainic acid, two chemoconvulsants that induce seizures that mimic some features of human complex partial seizures with secondary generalization.

Levetiracetam also displayed inhibitory properties in the kindling model in rats, another model of human complex partial seizures, both during kindling development and in the fully keppra state. The predictive value of these animal models for specific flk of human epilepsy is uncertain.

In vitro and in vivo recordings of epileptiform activity from the hippocampus flk shown that levetiracetam inhibits burst firing without affecting normal flk excitability, suggesting that levetiracetam may selectively prevent hypersynchronization of epileptiform burst firing and propagation of seizure activity. Furthermore, in vitro studies 500mg/ failed to find an effect of levetiracetam on neuronal voltage-gated sodium or Keppra calcium currents and levetiracetam does not appear to directly facilitate GABAergic neurotransmission.

However, in vitro studies have demonstrated that levetiracetam opposes the activity of negative modulators of GABA- and glycine-gated keppra and partially inhibits N-type calcium currents in neuronal cells.

A keppra and stereoselective neuronal binding site in rat brain tissue has been medicamento cymbalta 60mg preço for levetiracetam. Experimental data indicate that this binding site is the synaptic vesicle protein SV2A, thought to be involved in the regulation of vesicle exocytosis.

Although the molecular significance of levetiracetam binding to SV2A is not understood, levetiracetam and related analogs showed a rank order of affinity for SV2A which correlated with the potency of their antiseizure activity in audiogenic seizure-prone mice. These findings suggest that the interaction of levetiracetam with the SV2A protein may contribute to the antiepileptic mechanism of action of the drug.

Pharmacodynamics Effects on QTc Interval The effect of Keppra on QTc prolongation was evaluated in a randomized, double-blind, positive-controlled moxifloxacin mg and placebo-controlled crossover study of Keppra mg or mg in 52 healthy subjects.

Therefore, there was no evidence of significant QTc prolongation in this study, keppra 500mg/ 5 ml kons.coz.10 flk. Pharmacokinetics Absorption and Distribution Absorption of levetiracetam is rapid, with flk plasma concentrations occurring in about an hour following oral administration in fasted subjects, keppra 500mg/ 5 ml kons.coz.10 flk. The pharmacokinetics of levetiracetam are linear over the dose range of mg. Steady state is achieved after 2 500mg/ of multiple twice-daily dosing.

Metabolism Levetiracetam is not extensively metabolized in humans. The major metabolite is inactive in animal seizure models. There is no enantiomeric interconversion of levetiracetam or its major metabolite.

The total body clearance is 0. Kons.coz.10 mechanism of excretion is glomerular filtration with subsequent partial tubular reabsorption. Levetiracetam elimination is correlated to creatinine clearance. Levetiracetam clearance is reduced in patients with renal impairment [see Use in Specific Populations 8. This is most likely due to the decrease in renal function in these subjects.

The potential interaction of levetiracetam with other AEDs was also evaluated in these patients. Levetiracetam had no significant effect on the keppra concentrations of carbamazepine, valproic acid, topiramate or lamotrigine.

500mg/ pharmacokinetic results indicated that half-life was shorter 5. Population pharmacokinetic analysis showed that body weight was significantly correlated to the clearance of levetiracetam in pediatric patients; clearance increased with an increase in body weight. Pregnancy Levetiracetam levels may decrease during pregnancy.

Keppra, clearances adjusted for body weight were comparable. Race Formal pharmacokinetic studies of the effects of race have not been conducted. Because levetiracetam is primarily renally excreted and there are no important racial differences in creatinine clearance, pharmacokinetic differences due to race are not expected. Renal Impairment The disposition of levetiracetam was studied in adult subjects 500mg/ varying degrees of renal function.

Clearance of levetiracetam is correlated with creatinine clearance. Hepatic Impairment In subjects with mild Child-Pugh A to moderate Child-Pugh B hepatic impairment, the pharmacokinetics of levetiracetam were unchanged. No dose adjustment is needed for patients with hepatic impairment. Drug Interactions In vitro data on metabolic interactions indicate that levetiracetam is unlikely to produce, or be subject to, pharmacokinetic interactions.

Levetiracetam and its major metabolite, at concentrations well above Cmax levels kons.coz.10 within the therapeutic dose range, are neither inhibitors of, nor high affinity substrates for, human liver cytochrome P isoforms, keppra 500mg/ 5 ml kons.coz.10 flk, epoxide hydrolase or UDP-glucuronidation enzymes.

In addition, levetiracetam does not affect the 500mg/ vitro glucuronidation of valproic acid. Potential pharmacokinetic interactions of or with levetiracetam were assessed in clinical pharmacokinetic studies phenytoin, valproate, warfarin, digoxin, oral contraceptive, probenecid and through pharmacokinetic screening in the placebo-controlled clinical studies in epilepsy patients. Phenytoin Keppra mg daily had no effect on the pharmacokinetic disposition of phenytoin flk patients with refractory epilepsy.

Pharmacokinetics of levetiracetam were also not affected by phenytoin. Valproate Keppra mg twice daily did not alter the pharmacokinetics of valproate in healthy volunteers, keppra 500mg/ 5 ml kons.coz.10 flk. Valproate mg twice daily did not modify the rate or extent of levetiracetam absorption or its plasma clearance or urinary excretion. There also was no effect on exposure to and the excretion of the primary metabolite, ucb L These events occurred most frequently within the first 4 weeks of treatment.

Patients should be monitored for these signs and symptoms and advised not to dapoxetine 120mg or operate machinery until they have gained sufficient experience on KEPPRA to gauge whether it could adversely affect their ability to drive or operate machinery. Hematologic kons.coz.10 occurred in clinical trials and included decreases in white blood cell WBCneutrophiland red blood cell RBC counts; decreases in hemoglobin and hematocrit ; and increases in eosinophil counts.

Cases of agranulocytosispancytopeniaand thrombocytopenia have been reported best price for brand cialis the postmarketing setting, keppra 500mg/ 5 ml kons.coz.10 flk.

A complete blood count is recommended in patients experiencing significant weakness, pyrexia, recurrent infections, or coagulation disorders. A total of 3. Of the KEPPRA-treated patients with a low neutrophil count, all but one rose towards or to baseline with continued treatment.

No patient kons.coz.10 discontinued secondary to low neutrophil counts. Mean relative lymphocyte counts increased by 1. No patient was discontinued secondary to low WBC or neutrophil counts. In the controlled cognitive and kons.coz.10 safety study, 5 patients 8.

KISA ÜRÜN BİLGİSİ 1. BEŞERİ TIBBİ ÜRÜNÜN ADI

There was no overall difference in mean diastolic blood pressure between the treatment groups. This disparity between the KEPPRA and placebo treatment groups was not observed in the studies of older children or in adults. Seizure Control During Pregnancy Physiological changes may gradually decrease plasma levels of levetiracetam throughout pregnancy. This decrease is more pronounced during the third trimester.

It is recommended that patients be monitored carefully during pregnancy. Close monitoring should continue through the postpartum period especially if the dose was changed during pregnancy.

Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during KEPPRA therapy. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, keppra 500mg/ 5 ml kons.coz.10 flk, patients can call the toll free number [see Use In Specific Populations].

Firma Bilgileri

There was no evidence of flk. It was not clastogenic in an in vitro analysis of metaphase chromosomes obtained from Chinese hamster ovary cells or in kons.coz.10 in vivo mouse micronucleus assay. The hydrolysis product and major human metabolite of levetiracetam ucb L was not mutagenic in the Ames test or the in 500mg/ mouse lymphoma assay. Pregnancy Category C There are no adequate and controlled studies in pregnant women.

In animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses.

KEPPRA should be used during pregnancy only if the potential benefit justifies the potential keppra to the fetus, keppra 500mg/ 5 ml kons.coz.10 flk. There was no overt maternal toxicity at the doses used in this study. There was no evidence of maternal toxicity in this study.

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