An initial experience with therapeutic drug monitoring of levetiracetam as reported from a pediatric clinical setting in India

Mathew, Binu; Fleming, DH; Thomas, Maria; Prabha, Ratna; Saravanakumar, K

doi:10.4103/0028-3886.96382

Cited by 13 publications

(11 citation statements)

References 10 publications

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“…In this study, the serum LEV levels (nontrough) showed a negligible negative correlation with the dose of LEV given per kilogram (kg) bodyweight. [7][8][9] Although there exists a linear relationship between the dose and the trough serum levels of LEV over a dose range of 500-5000 mg, some studies have however suggested that serum levels of LEV can get affected by a number of parameters such as age, bodyweight, comedication, hepatic, or renal insufficiency. [6] Furthermore, the LEV concentrations depend on the time interval from the last dose taken, and because of short half-life (6-8 h), large fluctuations are expected during the day; as a result, nontrough levels of LEV could not be well correlated with the dose.…”

Section: Discussionmentioning

confidence: 99%

“…[9] Serum levels of LEV showed negligible positive correlation with the age of the patients as also seen by Mathew et al (r = 0.19) in their study. [7,8] Elderly patients showed higher serum LEV levels as compared to younger patients. This is in conjunction with a study conducted by May et al according to which older patients need a lower LEV dose per bodyweight than young adults to achieve comparable LEV levels.…”

Section: Discussionmentioning

confidence: 99%

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An Analytical Study to Correlate Serum Levels of Levetiracetam with Clinical Course in Patients with Epilepsy

Gupta

Singh

et al. 2016

Journal of Neurosciences in Rural Practice

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Introduction:With the advancement of therapeutics, newer antiepileptic drugs (AEDs) like Levetiracetam (LEV), with good therapeutic efficacy and tolerability are available. But unfortunately, therapeutic drug monitoring is not routinely done in India for these drugs.Objectives:The objective of this study is to determine the range of serum levels of LEV in patients at stabilized doses and correlate them with their clinical course.Materials and Methods:Patients with epilepsy and started on LEV were enrolled from the Neurology Department after the Ethics Committee approval. Serum levels of LEV were estimated using high-performance liquid chromatography and correlated with patient demographics, dosage, dosage forms, concomitant AEDs, compliance of the patient, therapeutic effect, adverse drug reactions (ADRs), and suspected toxicity.Results:Serum levels of LEV ranged from 0.4 to 102.2 μg/ml at different time points and demonstrated a negligible positive correlation with age of the patients (r = 0.12) but negligible negative correlation with bodyweight (r = −0.19). No conclusive relationship could be established for dose, gender, dosage forms, clinical efficacy (seizure frequency), ADRs, and toxicity. Compliance was verified in all the patients. Levels were found to reduce with the use of concomitant enzyme inducer drugs (56.78%) whereas increase with valproic acid (7.8%).Conclusion:These findings emphasize the need for monitoring the serum levels of newer AEDs like LEV considering the various parameters studied here, so as to maintain the therapeutic efficacy by preventing under or over dosage and to generate a broader database of serum levels of LEV in the Indian population to help appropriate prescribing with more confidence.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

An Analytical Study to Correlate Serum Levels of Levetiracetam with Clinical Course in Patients with Epilepsy

Gupta

Singh

et al. 2016

Journal of Neurosciences in Rural Practice

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“…Consistent with other AEDs, there have not been any randomized controlled trials performed with LEV to determine whether TDM improves efficacy and tolerability compared to usual care. Furthermore, a robust correlation between efficacy and plasma concentrations of LEV has not been shown in either adults or children (4)(5)(6)(7)(8). Nevertheless, variable reference ranges have been suggested with the most commonly cited one being 12-46 mg/L (9).…”

Section: Therapeutic Drug Monitoringmentioning

confidence: 99%

“…Four prospective observational studies have included LEV concentrations as part of routine monitoring but a correlation has not been noted between concentrations and efficacy or toxicity (7,(11)(12)(13). In the study by Mink et al, seizure prophylaxis with valproic acid therapy has been compared to LEV in 35 patients with aneurysmal subarachnoid hemorrhage and drug levels were taken daily (12).…”

Section: Therapeutic Drug Monitoringmentioning

confidence: 99%

Therapeutic Drug Monitoring of Levetiracetam in Select Populations

Jarvie

Mahmoud

2018

J Pharm Pharm Sci

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“…The median serum concentration with inducers (7.30 µg/ mL) was 50% lower than for patients with inhibitors (14.40 µm/mL) and 56% lower than for patients without interfering AED co-medication (16.60 µg/ mL). The difference was statistically significant between inducers and inhibitors (P = 0.008) and between inducers and those without interfering AED co-medication (P = 0.004) [13]. These findings might be suggestive of dose adjustments of LEV, depending upon the enzyme induction/inhibition property of the co-medications.…”

Section: Drug Interactionsmentioning

confidence: 82%

Levetiracetam: Pharmacological properties, safety and efficacy in the pediatric population with epilepsy

Ansari

2015

J Pediatr Neurol

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Age-specific distribution of epilepsy is bimodal, with the highest incidence being in childhood. Seizures can affect life as early as day one. There is a paramount variation of epilepsy in childhood and adolesence with regards to its etiology and prognosis. Antiepileptic drugs, being the mainstay of treatment, necessitates that their use in this vulnerable age group must be made after a thorough look into the available evidence. The data on levetiracetam (LEV), a second-generation antiepileptic, spans from randomized controlled trials to case reports in various pediatric epilepsy and epileptic syndromes. This review is a compilation and critical analysis of the data on the differences in the pharmacokinetic properties of LEV in children versus adults, drug-interactions, efficacy of LEV in various contexts, namely, as add-on, as monotherapy, in partial and generalized seizures, in specific epilepsy syndromes such as benign epilepsy with centrotemporal spikes, epileptic syndromes with continuous spike and wave during sleep, Lennox-Gastaut syndrome, Jeavons syndrome and epilepsy associated with tuberous sclerosis. LEV is an effective option for the treatment of partial-onset seizures as both an add-on in refractory epilepsy and monotherapy in newly diagnosed focal epilepsies. There are preliminary but promising data available on various epileptic syndromes and epileptic encephalopathies that can nudge researchers towards further work in these areas in order to generate evidences that is more substantial. The safety and tolerability profile of LEV is favorable, though, behavioral and neuropsychiatric adverse events are reportedly higher in children versus adults. The neuropsychiatric adverse events are often observed against the background of previously existing behavioral issues and neurocognitive impairments.

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An initial experience with therapeutic drug monitoring of levetiracetam as reported from a pediatric clinical setting in India

Abstract: Levetiracetam monitoring has a role in patients on antiepileptic polypharmacy and for confirmation of compliance.

Cited by 13 publications

References 10 publications

An Analytical Study to Correlate Serum Levels of Levetiracetam with Clinical Course in Patients with Epilepsy

An Analytical Study to Correlate Serum Levels of Levetiracetam with Clinical Course in Patients with Epilepsy

Therapeutic Drug Monitoring of Levetiracetam in Select Populations

Levetiracetam: Pharmacological properties, safety and efficacy in the pediatric population with epilepsy

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