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We studied 21 patients with complex partial seizures during phenobarbital (PB) or primidone withdrawal. Blood levels were measured daily, and seizure frequency was monitored by nursing staff and EEG-video telemetry. Patients were monitored for one week of baseline and for five weeks after PB tapering was initiated (withdrawal). Most were observed for at least one week after levels were undetectable. When ranked seizure counts were averaged, there was a tendency for seizure rates to be highest as PB levels passed through the range 15 to 20 mg/l, compared with rates at higher or lower PB levels. There was little or no relation between the rate of PB withdrawal, other drug therapy, or initial PB level and the ratio of highest seizure frequency to mean seizure frequency. Patients withdrawing from PB may be most likely to experience an increase in seizure frequency when their PB blood level falls below 20 mg/l.
Primidone represents a possible adjuvant therapy in theophylline-resistant apnea of prematurity. Caution is advised, because of primidone's complex pharmacologic characteristics, until there are further controlled prospective studies.
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We reported a child with refractory partial seizures successfully managed by clinical desensitization to phenytoin. The patient had ischemic brain lesions due to cardiopulmonary arrest at 39 weeks of corrected age. He had complex partial seizures refractory to several antiepileptic drugs since 4 years of age. At 8 years 1 month of age, phenytoin was first administered. Fever and maculopapular rashes appeared at 10 days after phenytoin initiation, and then the drug was discontinued. At 8 years 8 months of age, desensitization was attempted because of refractoriness of seizures to drugs other than phenytoin. Desensitization was started at 1mg daily, and then the dose was doubled every week. His seizures were controlled by 150mg/day of phenytoin in combination with primidone. No problems have been observed during desensitization.
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We compared a gas-chromatographic method for determination of phenytoin with a high-pressure liquid chromatographic technique and with enzyme immunoassay by three instrumental procedures. More than 100 sera from patients being treated with this drug were assayed by all these techniques. The coefficient of variation was the lowest (4.0%) with liquid chromatography, but all methods gave a CV of less than 10%. The correlation coefficients for all methods exceeded 0.97 when compared to gas chromatography. Operation costs varied with the number of tests per batch, reagent costs, and operator labor costs. All assays gave comparable values for the therapeutic range, so it would be plausible to use more than one method in a situation where (e.g.) satellite laboratories handle different quantities of assays. In any of these techniques, interferences from carbamazepine, mephenytoin, phenobarbital, and primidone were negligible.
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Relationship between steady-state plasma concentrations of phenobarbitone (PB), phenytoin (PHT), primidone (PRM), carbamazepine (CBZ) and sodium valproate (VPA) and their efficacy and toxicity, were studied in 392 pediatric outpatients, long-term treated in monotherapy for epileptic seizures or febrile convulsions, in order to establish "target" values which may be used, as reference, in clinical practice. The concentration-efficacy and toxicity curves suggest target values of 20, 15, 9, 10, 6 and 70 mg/l for PB, PB derived from PRM, PRM, PHT, CBZ and VPA respectively. Above 25 mg/l of PB, 20 of PHT and 100 of VPA, markedly decreased the probability of response in refractory patients, and a clear increase in toxicity was shown. Above 7 mg/l of CBZ a decrease in the percentage of seizure-free patients was observed, without an increase of toxicity. For PRM no efficacy "ceiling" was found but side effects increased. The target values proposed may be helpful as a reference for the initial dosage of antiepileptic drugs in children, during monotherapy. Nevertheless, final doses should be adjusted according to clinical response of each patient.
Simultaneous nitrification/denitrification and trace organic contaminant (TrOC) removal during wastewater treatment by an integrated anoxic-aerobic MBR was examined. A set of 30 compounds was selected to represent TrOCs that occur ubiquitously in domestic wastewater. The system achieved over 95% total organic carbon (TOC) and over 80% total nitrogen (TN) removal. In addition, 21 of the 30 TrOCs investigated here were removed by over 90%. Low oxidation reduction potential (i.e., anoxic/anaerobic) regimes were conducive to moderate to high (50% to 90%) removal of nine TrOCs. These included four pharmaceuticals and personal care products (primidone, metronidazole, triclosan, and amitriptyline), one steroid hormone (17β-estradiol-17-acetate), one industrial chemical (4-tert-octylphenol) and all three selected UV filters (benzophenone, oxybenzone, and octocrylene). Internal recirculation between the anoxic and aerobic bioreactors was essential for anoxic removal of remaining TrOCs. A major role of the aerobic MBR for TOC, TN, and TrOC removal was observed.
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Only one study met the inclusion criteria for the review. In this open study, 180 patients with newly-diagnosed, untreated epilepsy were randomised to treatment with the antiepileptic drug selected by their physician either with or without therapeutic drug serum level monitoring as an aid to dosage adjustments. The antiepileptic drugs used were carbamazepine, valproate, phenytoin, phenobarbital and primidone. A 12-month remission from seizures was achieved by 60% of the patients randomised to therapeutic drug monitoring (intervention group) and by 61% in the control group. A total of 56% in the intervention group and 58% in the control group were seizure free during the last 12 months of follow up. Adverse effects were reported by 48% in the intervention group and 47% of the control group patients. Of those randomised to therapeutic drug monitoring, 62% completed the two-year follow up compared with 67% of the control group.
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Nicotinamide is a ligand of the benzodiazepine receptor and has been reported to have anticonvulsant activity. In addition, our previous clinical experience has raised the possibility that it may also potentiate the action of barbiturates. Therefore, we have examined the anticonvulsant activity and neurotoxicity of nicotinamide alone and in combination with phenobarbital in mice. Nicotinamide had its maximal anticonvulsant effect 15 min and its maximal sedative effect 45 min after intraperitoneal injection. At 15 min, the median effective dose was 586.5 mg/kg against bicuculline and 2,019 mg/kg against pentylenetetrazol. Nicotinamide was ineffective against maximal electroshock. It had a sedative effect, with a median toxic dose of 874.8 mg/kg by the Rotorod Toxicity Test at 45 min. At doses that were ineffective by themselves (0.01 effective dose) nicotinamide potentiated the anticonvulsant activity of phenobarbital against bicuculline and pentylenetetrazol, but the toxicity was not potentiated and therefore the therapeutic index of phenobarbital was improved by nicotinamide. These results suggest that nicotinamide may be useful as a therapeutic adjunct for the treatment of epilepsy with phenobarbital or primidone.
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gamma-Aminobutyric acid (GABA) levels were determined in cisternal cerebrospinal fluid (CSF) of 19 epileptic dogs with generalized tonic-clonic (grand mal) seizures using a radioreceptor assay. Thirty-four healthy age-matched dogs served as controls. The average CSF GABA level in epileptic dogs (40 pmol/ml) was significantly lower than that determined in controls (66 pmol/ml). Treatment with phenobarbital or primidone seemed not to affect CSF GABA levels.
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1. The pharmacokinetics and metabolism of primidone at steady-state were studied in 10 elderly patients aged 70-81 years and eight control subjects aged 18-26 years. 2. Primidone half-lives and clearance values (mean +/- s.d.) were similar in the elderly and in the young (12.1 +/- 4.6 vs 14.7 +/- 3.5 h and 34.8 +/- 9.0 vs 33.2 +/- 7.2 ml h-1 kg-1 respectively. 3. The serum concentrations of the metabolites phenylethylmalonamide (PEMA) and phenobarbitone relative to those of parent drug were higher in the elderly than in the young, the difference being significant (P less than 0.01) in the case of PEMA. 4. The renal clearances of primidone, phenobarbitone and PEMA were moderately decreased in the elderly but this reduction was statistically significant only for PEMA. Elderly patients excreted a reduced proportion of unchanged primidone and an increased proportion of PEMA in urine. 5. Ageing is associated with a greater accumulation of PEMA, which is unlikely to have a major clinical significance.
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To report the novel finding of a significant improvement in essential tremor symptoms with oxcarbazepine in a patient with a suboptimal response to propranolol.
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Nine of 13 patients included in our study experienced a good response. A positive response was understood as a decrease on the limitation of daily activities and an improvement on neurological examination. Zonisamide was well tolerated and no patient abandoned the study for this reason.
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The antiepileptic activity of oral frusemide (120 mg daily) was compared with that of an identical placebo in a double-blind crossover trial in fourteen patients with severe focal epilepsy who were receiving long-term therapy with established antiepileptic drugs. A statistically significant reduction in the frequency of focal fits was seen with the active drug. Marked drowsiness occurred in three patients during frusemide therapy, causing their withdrawal from the trial. A slight, but significant, rise in serum phenobarbitone concentrations was observed during frusemide therapy, but no change was seen in serum primidone or phenytoin concentrations. Frusemide significantly lowered plasma sodium and potassium concentrations, and increased plasma bicarbonate.
25 microliters plasma, 25 microliters internal standard and 5 microliters sodium dihydrogenphosphate solution are extracted with 100 microliters ethyl acetate. 40 microliters of the extract are mixed with 10 microliters trimethyl-phenyl-ammoniumhydroxide (0.1 mol/l methanol). 3 microliters of this solution are injected for gas chromatography using a nitrogen-specific detector. Trimethyl-phenyl-ammoniumacetate appears to be a satisfactory methylating agent for these drugs in the injection port of the gas chromatograph.
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The story began on 11th May 1857 when Charles Locock commented in the Lancet on his use of potassium bromide in 15 cases of "hysterical" epilepsy in young women. The next development was the serendipitous discovery of the anticonvulsant properties of phenobarbital by Alfred Hauptmann in 1912. This predated by more than 20 years the screening of potential therapeutic agents against "electrical seizures" in cats by Houston Merritt and Tracy Putnam. The result was the launching of phenytoin in 1938. Next came primidone, ethosuximide, carbamazepine and valproic acid, all of which can be regarded as first generation antiepileptic drugs (AEDs). Shortly after their synthesis, the benzodiazepines were rapidly recognised as having anticonvulsant activity. The modern era focused on the systematic screening of many thousands of compounds against rodent seizure models under the Anticonvulsant Drug Development Program in the US. This resulted in the global licensing, in chronological order, of vigabatrin, zonisamide, oxcarbazepine, lamotrigine, felbamate, gabapentin, topiramate, tiagabine, levetiracetam, pregabalin and lacosamide. Rufinamide is available in the US and Europe for Lennox-Gastaut syndrome and stiripentol has been made available for Dravet syndrome under the European orphan drug scheme. Eslicarbazepine can be prescribed in Europe for partial seizures, but not in the US. Has all this activity improved the lives of people with epilepsy? The short answer is-probably yes, but not by very much! This paper will conclude with a précis of the views of a selected group of paediatric and adult epileptologists on the advances in pharmacological management achieved over the last 20 years.
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4 cases from the authors' experiences are added to the list of women who became pregnant during oral contraception while taking other drugs. 2 were 24- and 28-year-old epileptics taking Stediril and Mysoline, or primidone, a deoxybarbiturate. The 3rd was a 32-year-old woman who had forgotten 1 Stediril pill and taken 2 the next day, while taking 75 mg phenobarbital for a homeopathic regime. The 4th had been using Stediril for 5 years and had stopped for 2 months, and conceived during her 1st cycle after resuming the pill. She was taking drugs for migraine headaches, Nivaprine to prevent malaria, tetracyclines and trisulfazine for diarrhea. It is emphasized that when the usual pill side effects or regular withdrawal bleeding are absent in women on other medications, physicians should be alerted that the contraceptive action of the pill may be compromised.
A multi-residue method was developed that allows for the simultaneous determination of psychoactive compounds such as opioids, tranquilizers, antiepileptics (primidone, carbamazepine plus two metabolites),the cocaine metabolite benzoylecgonine, the antidepressant doxepin, as well as the calcium channel blocker verapamil in raw and treated wastewater, surface water, groundwater, and drinking water. After solid-phase extraction with Oasis HLB at neutral pH, the analytes were detected by LC electrospray tandem MS in the positive ion mode. With a few exceptions relative recoveries of the analytes exceeded 70%. The limits of quantification were in the low ng/L range. Matrix effects were compensated by using appropriate deuterated or 13C-15N-labeled surrogate standards. For raw and treated wastewater, concentration factors were lowered to reduce matrix effects. Most analytes (15 of 20) were found in raw and treated wastewater as well as in surface water, and hence, are presumably ubiquitously present in the environment. Antiepileptics, the opium alkaloids morphine and codeine, dihydrocodeine, the two tranquilizers oxazepam and temazepam, the opioid tramadol, doxepin, and verapamil were detected in STP discharges and German rivers at concentrations up to the microg/L range. In drinking water, only carbamazepine, its metabolite 10,11-dihydroxy-10,11-dihydrocarbamazepine, and primidone were present at concentrations up to 0.020 microg/L.
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A rapid method for simultaneously determining the anticonvulsant drugs carbamazepine, ethosuximide, phenobarbitone, phenytoin, primidone, and valproic acid is described. Blank plus single-point calibration gives reliable quantitation from therapeutic to high fatal concentrations, except for ethosuximide, for which it gives semiquantitative results. Whole blood and liver tissue samples containing deuterated internal standards were extracted using Bond Elut Certify columns. Butyl derivatives were formed using n-iodobutane and TMAH under mild conditions and were extracted into ethyl acetate as a cleanup step. Recoveries were greater than 50%, except for valproic acid (42%). Sample preparation time was less than 2 h, and the GC run time was less than 20 min per injection. At least two ion pairs formed by electron impact ionization were monitored for each drug. Intraday CVs were less than 6.28% (4.20%) and interday CVs less than 14.1% (for midtherapeutic concentrations in blood [liver], except for ethosuximide). Linearity was observed from subtherapeutic to high fatal levels for all drugs. This method has been applied to forensic cases and has significantly reduced analytical time while improving case-work quality. Results of a case study involving anticonvulsant drugs are given.
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The effectiveness and toxicity of phenobarbital (PB), primidone (PRM), and sodium valproate (VPA), used exclusively in monotherapy, were compared in 95 children affected with febrile convulsions. Treatment was restricted to either complicated or simple febrile convulsions with risk factors. The effectiveness and toxicity of each drug were related to the daily dose and the steady-state plasma levels. PB (4.8 +/- 0.7 mg/kg/day) achieved plasma levels of 16.4 +/- 2.8 micrograms/ml and prevented febrile convulsions in 80% of the patients. Side effects were observed in 76.7% of the patients, a change in dose being required only in 13.3%. PRM (17.8 mg/kg/day) yielded PB plasma levels of 14.1 +/- 3.7 micrograms/ml and was effective in 88.2% of the patients. The incidence of side effects was 53%, but no change in treatment was required. VPA (35.2 +/- 5.9 mg/kg/day) achieved plasma levels of 57.2 +/- 15.3 micrograms/ml (measured before the first dose in the morning) and was effective in 91.7% of the patients. Side effects were detected in 45% (significantly lower than after PB, p less than 0.01), and required a change in treatment in 14.3%. No differences in doses and plasma levels were found between patients with or without recurrence of febrile convulsions and with or without side effects; an exception was the higher doses of VPA administered to patients who showed side effects. It is concluded that PRM and VPA were at least as effective and well tolerated as PB. Because the plasma levels of the three drugs were near the lower limit of the therapeutic range, it remains to be elucidated whether higher doses may increase the benefit without adding unacceptable toxicity.
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A 40-year-old woman with a history of substance abuse complicated by essential tremor and neuropathic pain was admitted to our addictions unit with altered mental state due to escalating use of alprazolam. Alprazolam had been prescribed several months prior to admission for treatment of anxiety. The doses had risen to 5-10 mg/day during that period. Apparently, her essential tremor had responded inadequately to propranolol, but had responded well to alprazolam. She was started on a sedative/hypnotic withdrawal protocol, but did not require treatment with phenobarbital. She subsequently rated her tremor as "moderately severe." On discontinuation of the withdrawal protocol, oxcarbazepine 450 mg twice daily was initiated to treat her neuropathic pain, and the tremor improved, with a clinically significant reduction in tremor and a decreased pain score.