In this study 67 children of 59 females with epilepsy and on anticonvulsants were investigated. Children of epileptic women on medication with Primidon are of lower weight and have smaller heads than children from epileptic mothers without medication and children from parents without epilepsy.
Generic antiepileptic drug use was associated with significantly greater medical utilization and risk of epilepsy-related medical events, compared to brand use. This relationship was observed even in patients characterized as stable. AED = antiepileptic drug; CI = confidence interval; ER = emergency room; HR = hazard ratio; ICD = International Classification of Diseases; IRR = incidence rate ratio.
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To date, immunoassays are commercially available for quantification of valproic acid, salicylic acid, paracetamol, phenobarbital, phenytoin, and primidone. As they are no longer available, a fast, simple, and cost-effective quantitative gas chromatography-mass spectrometry (GC-MS) method was developed and fully validated for these drugs.
Essential vocal tremor is difficult to treat. An effective pharmacologic treatment could allow patients to avoid or decrease the frequency or dosage of botulinum neurotoxin injections.
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The purpose of this pilot single-site study was to assess efficacy and safety of levetiracetam for essential tremor, using a placebo-controlled, double-blind, randomized crossover design with an interim analysis planned after completion of the first 10 to 15 subjects. The study was designed to detect a mean 30% reduction in composite tremor score, comparable to that of primidone or propranolol, which can be demonstrated with 30 or fewer subjects. Each treatment arm included baseline tremor assessments, a 4-week medication titration, 2 weeks of stable dose, and treatment tremor assessments. Levetiracetam was titrated to 3,000 mg/day or to a lower maximal tolerated dose. The median age was 72 years, with 28 years median tremor duration. There was no statistically significant difference in response between placebo and levetiracetam on any tremor rating scale or accelerometry measure. The 95% confidence interval for the true mean difference between placebo and levetiracetam treatments was +18.5 to -22.5%, which excludes the minimum 30% drop required to consider levetiracetam clinically effective to a degree comparable to primidone or propranolol. Whether levetiracetam has lesser-degree antitremor efficacy was not addressed in this pilot study.
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Intravenous (IV) injection of lidocaine was used in patients with tinnitus for combined treatment with oral anticonvulsants carbamazepine (Tegretol) and primidone (Mysoline). In most cases, the high complication rate with these drugs precluded their long-term use. Tocainide hydrochloride (HCl), a primary amine analog of lidocaine, can be taken orally and was evaluated for the use in the treatment of tinnitus. A double-blind study in which one group received 200 mg tocainide HCl four times a day and one group received a placebo revealed no significant differences in tinnitus relief between the two groups. A single-blind study in which 600 mg tocainide HCl four times a day was administered showed 80% to 98% tinnitus relief in five of the six patients who tolerated the drug. Tocainide HCl treatment of tinnitus is promising.
The aim of the present paper is to provide information concerning the setting up and interpretation of therapeutic drug monitoring (TDM) for anti-epileptic drugs. The potential value of TDM for these drugs (including carbamazepine, clobazam, clonazepam, ethosuximide, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pheneturide, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, vigabatrin and zonisamide) is discussed in relation to their mode of action, drug interactions and their pharmacokinetic properties. The review is based upon available literature data and on observations from our clinical practice. Up until approximately 15 years ago anti-epileptic therapeutics were restricted to a very few drugs that were developed in the first half of the 20th century. Unfortunately, many patients were refractory to these drugs and a new generation of drugs has been developed, mostly as add-on therapy. Although the efficacy of the newer drugs is no better, there is an apparent improvement in drug tolerance, combined with a diminished potential for adverse drug interactions. All new anticonvulsant drugs have undergone extensive clinical studies, but information on the relationship between plasma concentrations and effects is scarce for many of these drugs. Wide ranges in concentrations have been published for seizure control and toxicity. Few studies have been undertaken to establish the concentration-effect relationship. This review shows that TDM may be helpful for a number of these newer drugs.
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The major established drugs used in the management of epilepsy are carbamazepine, valproic acid, phenytoin, phenobarbital, primidone, ethosuximide and benzodiazepine drugs. Carbamazepine and phenytoin are used mainly in the treatment of partial seizures and primarily or secondarily generalized tonic-clonic seizures. Valproic acid is effective against all types of seizures, but it is used most extensively in the management of generalized epilepsies. Ethosuximide is effective against absence seizures. Phenobarbital and primidone are effective against all types of seizures (except for absences) although they are less commonly used because of their sedative properties and adverse effects on cognition. Benzodiazepines are most valuable in the treatment of status epilepticus, but their long-term use is often associated with undesirable sedation and development of tolerance to their antiepileptic effect. Irrespective of the drug used, optimal clinical management requires individualization of dosage and dosing schedules based on careful evaluation of clinical response and sound knowledge of the pharmacokinetics and interaction potential of the individual compounds. Monitoring serum drug concentrations may provide a useful guide to dosage adjustments, particularly in the case of phenytoin, which shows dose-dependent kinetics within the therapeutic dosage range.
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Primidone, 25, 50, 100, and 150 mg/kg, was administered orally to mice of the I.C.I. strain from days 6-16 of pregnancy. The fetuses were removed by caesarian section on day 19 and examined by dissection and alizarin staining for gross structural and skeletal defects. The most common abnormalities found were palatal defects with full-length or submucosal clefts. In the controls--25, 50, 100, and 150 mg/kg groups--the incidence of palatal defects was 0/85, 16/84, 18/117, 19/102, and 17/92 fetuses, respectively. Essentially no other major or minor drug-related abnormalities were found. The metabolism of primidone in the pregnant and nonpregnant mouse was also studied and shown to be similar to that previously reported in the rat. Peak blood levels of primidone were obtained after 1 hr; they fell to very low levels by 6 hr. and were completely cleared by 24 hr. The metabolites produced, PEMA and phenobarbital, are similar to those produced in other species including man. Blood levels following single oral doses of 5 to 150 mg/kg were dose-related so that no explanation for the lack of dose-related teratogenic effect was found.
Hepatic function tests were performed on 48 dogs that had been given primidone, phenytoin, or a combination of anticonvulsant drugs for 6 months or longer. Except for histories of seizures, 44 of the dogs were healthy at the time the tests were performed. Abnormal test results were observed most frequently in dogs given only primidone and in dogs given combinations of anticonvulsant drugs. The test results that were abnormal most often were those for alanine transaminase and alkaline phosphatase activities, and sulfobromophthalein excretion. The dosage of anticonvulsant drug was found to modify certain test results. Statistically significant positive correlations were found between the dosage of primidone and serum alanine transaminase activity and between the dosage of phenytoin and serum alkaline phosphatase activity. Four of the dogs were examined because of signs of weakness and anorexia and 2 also had ascites. Three of the 4 dogs were euthanatized 2 to 49 days after admission with clinical signs compatible with hepatic failure, and cirrhosis of the liver was confirmed at necropsy. The fourth dog died at home and was not necropsied. Four of the remaining 44 dogs that apparently were healthy at the time of examination had abnormalities in hepatic biochemical test results that were comparable with those in the 4 dogs with clinical illness. We concluded that, although results of hepatic biochemical tests frequently may be abnormal in dogs given anticonvulsant drugs long-term, severe hepatic injury is observed less often.(ABSTRACT TRUNCATED AT 250 WORDS)
The anticonvulsant drug, primidone, was believed to be responsible for the development of hepatic cirrhosis in a 9-year-old German Shepherd Dog with idiopathic epilepsy. Marked increases in serum alanine aminotransferase, serum alkaline phosphatase, total bilirubin, and sulfobromophthalein retention, as well as decreases in albumin and BUN supported the diagnosis of hepatic failure. Biochemical abnormalities improved after primidone was discontinued. Previous reports indicated a poor prognosis for anticonvulsant-induced hepatic failure; however, this dog has remained stable for over a year after diagnosis and proper therapy.
The management of epilepsy or seizure disorder commonly includes drug therapy. Optimal treatment may involve single-drug regimens, but multiple agents are often required. Although any pharmacological agent can be involved in a drug interaction, anticonvulsants are often implicated. As more drugs are prescribed for the patient, the potential for drug interactions increases. This article reviews the background of anticonvulsant drug interactions, the most common interactions encountered, and nursing interventions useful in monitoring potential interactions. Suggestions for nursing research are given.
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Emerging organic contaminants (EOCs) are frequently detected in urban surface water and the adjacent groundwater and are therefore an increasing problem for potable water quality. River bank filtration (RBF) is a beneficial pretreatment step to improve surface water quality for potable use. Removal is mainly caused by microbial degradation of micropollutants, while sorption retards the transport. The quantification of biodegradation and adsorption parameters for EOCs at field scale is still scarce. In this study, the fate and behavior of a range of organic compounds during RBF were investigated using a two dimensional numerical flow- and transport model. The data base used emanated from a project conducted in Berlin, Germany (NASRI: Natural and Artificial Systems for Recharge and Infiltration). Oxygen isotope signatures and hydraulic head data were used for model calibration. Afterwards, twelve organic micropollutants were simulated with a reactive transport model. Three compounds (primidone, EDTA, and AMDOPH) showed conservative behavior (no biodegradation or sorption). For the nine remaining compounds (1.5 NDSA, AOX, AOI, MTBE, carbamazepine, clindamycin, phenazone, diclofenac and sulfamethoxazole), degradation and/or sorption was observed. 1.5 NDSA and AOX were not sorbed, but slightly degraded with model results for λ=2.25e(-3) 1/d and 2.4e(-3) 1/d. For AOI a λ=0.0106 1/d and R=1 were identified. MTBE could be characterized well assuming R=1 and a low 1st order degradation rate constant (λ=0.0085 1/d). Carbamazepine degraded with a half life time of about 66 days after a threshold value of 0.2-0.3 μg/L was exceeded and retarded slightly (R=1.7). Breakthrough curves of clindamycin, phenazone, diclofenac and sulfamethoxazole could be fitted less well, probably due to the dependency of degradation on temperature and redox conditions, which are highly transient at the RBF site. Conditions range from oxic to anoxic (up to iron-reducing), with the oxic and denitrifying zones moving spatially back and forth over time.
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Five biochemical variables, S-Ca, U-Ca, S-P, U-P and S-ALP, all involved in calcium metabolism, have been investigated in 86 epileptics on long-term medication. We found hypocalciuria in half of the epileptics and increased S-ALP in one third. In contrast to earlier reports there was no hypocalcemia, whereas hypercalcemia was found in 7 epileptics. We have previously reported a high frequency of fractures in these epileptics. An increased fracture rate was found in the 13 epileptics with both hypocalciuria and increased S-ALP, indicating osteomalacia.
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A method for the simultaneous determination of HEPP (D,L-3-hydroxy-3-ethyl-3-phenylpropionamide), a member of a new homologous series of phenylamide-derivative anticonvulsants, with six other antiepileptic drugs (ethosuximide, primidone, phenobarbital, phenytoin, carbamazepine and clonazepam) in plasma by high-performance liquid chromatography is described. These drugs are extracted from plasma by adding an equal volume of acetonitrile. An aliquot of the extract is then injected on a reversed-phase column with a acetonitrile-methanol-phosphate buffer mobile phase. The total time required for the whole analytical process, including the plasma pretreatment and chromatography, is approximately 30 min. The assay method is simple, rapid and reproducible, and therefore considered suitable for routine use in clinical investigations monitoring HEPP simultaneously with common antiepileptic drugs.
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Data on DDIs between anticancer drugs and AEDs were compiled from the British National Formulary, Drug Information Handbook, and Micromedex Healthcare Series version 5.1. Product information of the individual drugs, as well as literature on anticancer drug-AED interactions, was searched using PubMed (years: December 1970 to January 2008; search terms: anticancer, antiepileptic, chemotherapy regimen, drug interactions, and the generic names of the individual anticancer drugs and AEDs [acetazolamide, carbamazepine, ethosuximide, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, vigabatrin, and zonisamide]).
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The pharmacokinetics of antiepileptic drugs used for the treatment of human epilepsies is reviewed for dogs and cats. In dogs, especially phenobarbital and primidone must be regarded as useful drugs for chronic treatment on account of their elimination rate and bioavailability. Phenytoin, carbamazepine, valproic acid and benzodiazepines are eliminated so rapidly that a therapeutic value cannot be expected. In cats, phenytoin, phenobarbital, valproic acid and diazepam must be regarded as suited for chronic treatment, but there is a definite lack of clinical experience. Phenobarbital and primidone are useful for treatment of clonic-tonic generalized seizures (grand mal) in dogs. The effect of primidone depends mostly on its metabolite phenobarbital. Since primidone, given in high dosage for longer periods of time, gives rise to liver damage, phenobarbital is regarded as the drug of first choice. A status epilepticus may be treated by i.v. injection of diazepam, clonazepam, phenytoin or lidocaine. In cats with grand mal, treatment with daily doses of about 1 mg/kg diazepam may be tried. It proved effective for longer time periods without development of tolerance. There is no reliable clinical experience with other drugs in this species.
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A case of a patient with astrocytoma who showed somnolence and asterixis one month after tumour resection is presented. Although primidone had been prescribed preoperatively for five years and the same dose was maintained after the operation, the serum concentration of the primidone metabolite phenobarbital was elevated and she demonstrated hyperammonemic encephalopathy, which disappeared on withdrawal of the drug. A description of this seldom reported phenomenon during primidone therapy is given, with reference to valproate cases.
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Antiepileptic drug selection is based on efficacy for specific seizure types and epileptic syndromes. For idiopathic generalized epilepsies with absence, tonic-clonic, and myoclonic seizures, the drug of choice is valproate. Secondary generalized epilepsies with tonic, atonic, and other seizure types are difficult to treat with any single drug or combination of drugs. The drugs of choice for absence seizures are ethosuximide and valproate. For control of tonic-clonic seizures, any of the other major antiepileptic drugs can be effective. If valproate cannot be used, carbamazepine, phenobarbital, phenytoin, or primidone is effective, but ethosuximide or a benzodiazepine needs to be added to control associated absence or myoclonic seizures. The drugs of first choice for partial epilepsies with partial and secondarily tonic-clonic seizures are carbamazepine and phenytoin. Increasing evidence suggests that valproate may be a third alternative. Phenobarbital and primidone are second choice selections because of side effects. A combination of two of these five major antiepileptic drugs may be necessary for inadequately controlled patients. Other epilepsy syndromes such as neonatal and infantile epilepsies, febrile epilepsy, and alcoholic epilepsy require specific drug treatment. For all these seizure types and epilepsy syndromes, treatment ultimately must be selected to provide maximal efficacy and minimal adverse effect for each individual patient.
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This article reviews 119 papers published since 1964 on the pharmacokinetics of phenobarbital, primidone, valproic acid, ethosuximide and mesuximide (methsuximide) in paediatric patients. Particular attention has been paid to the role of age in determining the variability of pharmacokinetic parameters, but the effect of other factors, such as different formulations and routes of administration, concomitant treatments, gender and pathological conditions other than epilepsy, have also been considered. Mean phenobarbital terminal half-life (t1/2z) is very long in neonates (45 to 409 hours) and decreases with age. Therefore, a low dose per kilogram (dose/kg) is recommended during the neonatal period. The dose requirement decreases with increasing age, especially in children also taking valproic acid, which inhibits phenobarbital metabolism. Primidone is metabolised to phenobarbital and phenylethylmalonilamide; the metabolic conversion rate is increased by enzyme-inducing drugs and inversely correlated with age, being virtually absent in neonates. Valproic acid is extensively bound to plasma proteins, but there is a high interindividual and intraindividual diurnal variability in the binding, which depends on the concentration of binding proteins (i.e. albumin) and binding modulators (e.g. free fatty acids) but not on age (at least in those patients aged between 3 months and 65 years). The clearance (CL/F) of valproic acid positively correlates with the unbound concentrations and is strongly age-dependent, being low in neonates and high at the end of the first postnatal month, and progressively decreasing from 2 months to 14 years. The combination of these factors leads to a very poor correlation between plasma concentrations and dose/kg (C/D) and between plasma concentrations of total valproic acid and efficacy. Children also taking enzyme-inducing antiepileptic drugs require a larger valproic acid dose/kg, whereas the coadministration of aspirin (acetylsalicylic acid) may decrease the clearance of unbound drug (CLu/F), and thus require a decrease in the daily dose of valproic acid. Ethosuximide is well absorbed, minimally protein bound and slowly eliminated. Lower C/D ratios are reported in children younger than 10 years old than in older children and in individuals also taking enzyme-inducing drugs (i.e. primidone). According to the only available paper on mesuximide in paediatric patients, the C/D ratio is less sensitive to both age and associated therapy.
35 patients with a mean seizure frequency of 15 attacks per months were studied. 19 were taking a 2-drug combination, 13 a 3-drug combination and 3 patients a 4-drug combination. Treatment was reduced to monotherapy in 21 patients and to a 2-drug combination in 8 patients. There was an increase in seizure frequency in 6 patients taking a 2-drug combination when an attempt was made to reduce the treatment to monotherapy. Reduction in polypharmacy resulted in an improvement in seizure control in 54% of patients. Carbamazepine replaced polypharmacy as monotherapy in 19 patients and phenytoin and sodium valproate in 2 other patients. Improvement in seizure control was associated with optimal blood levels in 17 patients taking carbamazepine and in the 2 patients taking sodium valproate and phenytoin. Serum levels in all patients taking 2-drug combination were within the optimal range.
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A few reports have shown elevated fasting total plasma homocysteine (tHcy) in patients taking antiepileptic drugs (AEDs). In this study we determined the influence of AEDs on plasma tHcy levels prior to and following methionine loading.
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We included 23 professional musicians (4 female, 19 male; mean age 51.5 ± 11.4 years) with a TSTM. During anamnesis, clinical examination, by mail or via telephone patients were asked for epidemiological, phenomenological information, risk factors and treatments. We then compared our findings to primary writing tremor, the most common task specific tremor.
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We evaluated 138 patients with epilepsy, institutionalized at a facility that cares for 324 patients with multiple handicaps. Evaluation included EEG, MRI, and video-EEG monitoring. The medication regimen was changed according to seizure diagnosis and the status of seizure control. Follow-up was available for >or=6 months in 110 patients, 1 year for 89, and 1.5 years for 49 patients. We analyzed the seizure and epilepsy diagnosis in this population, as well as the seizure frequency after evaluation and treatment.
This paper consists of three parts. This second part reviews the foundations underlying the rational association of antiepileptic drugs.
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A crossover comparative study of valproate sodium and clonazepam in the treatment of 32 adult epileptic patients receiving multiple drug therapy is described. Serum concentrations of other anticonvulsant drugs were unchanged by the addition of clonazepam. However, patients receiving high doses of other anticonvulsant drugs had lower serum concentrations of clonazepam (p less than .01). With valproate sodium, phenobarbital concentrations increased (P less than .05) in patients receiving phenobarbital but not significantly in patients receiving primidone. Phenytoin concentrations were reduced (P less than .05) during treatment with valproate sodium. Both drugs significantly reduced the frequency of minor seizures, with valproate sodium having the greater effect. However, it is important to monitor serum concentrations of other anticonvulsant drugs during treatment with valproate sodium since changes in these may influence seizure control or cause side effects.
Tremor is a common problem for patients taking lithium, but little is known about its true prevalence, its effect on compliance, and effective treatments.
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The metabolism of the anticonvulsant drug primidone (PRM) was studied in the isolated perfused rat liver by a radiotracer methodology that permits nearly quantitative accounting of the dose as drug and identified metabolites. 14C-PRM and its metabolites were separated by thin-layer chromotography and quantitated by liquid-scintillation counting PRM was extensively converted to known active metabolites: phenobarbital (PB), 15%, and phenylethylmalonamide, 80%, in control livers during 120 minutes. Pretreatment of rats with PB greatly accelerated the rate of PRM metabolism, pretreatment with PRM only moderately so. There was no differential induction of the two metabolism pathways. Addition of phenylethylmalonamide to the perfusate reduced the rate of PRM metabolism but addition of PB did not. It is concluded that conversion of PRM to its active metabolites may be simultaneously influenced by the processes of metabolite induction (PB) and metabolite inhibition (phenylethylmalonamide).
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The authors prospectively followed 662 pregnancies in women with epilepsy who used enzyme-inducing AED. Of the 667 neonates, 463 were exposed to carbamazepine, 212 to phenytoin, 44 to phenobarbital, 11 to primidone, and 7 to oxcarbazepine. The control subjects were 1,324 nonepileptic pregnancies (1,334 neonates) matched for maternal age, parity, number of fetuses, and delivery date. None of the mothers received vitamin K(1) during pregnancy, but all infants received 1 mg vitamin K(1) intramuscularly at birth.