Plasma Concentrations of Protriptyline and Clinical Effects in Depressed Women

1976 ◽  
Vol 128 (4) ◽  
pp. 384-390 ◽  
Author(s):  
S. F. Whyte ◽  
A. J. Macdonald ◽  
G. J. Naylor ◽  
J. P. Moody
Keyword(s):  
Side Effects ◽  
Plasma Levels ◽  
Side Effect ◽  
Plasma Concentrations ◽  
Clinical Effects ◽  
Drug Plasma ◽  
Pre Treatment ◽  
Positive Correlations ◽  
Drug Plasma Levels ◽  
The Relationship

SummaryWe studied the relationship between side effects, clinical outcome and the drug plasma levels in 28 female depressed patients treated with protriptyline. After 3½ weeks treatment, patients with plasma levels within a median range (630 to 900 nmol/1) showed better responses to the drug than patients with plasma levels outside this range.There were no statistically significant correlations between plasma levels and side effect scores or ‘corrected’ side effect scores (scores after subtracting pre-treatment values) for the group at any time after starting the treatment. But we found positive correlations between plasma levels and ‘corrected’ side effect scores for the neurotic subgroup after 14 and 21 days of treatment. Other correlations between plasma levels and side effect scores were non-significant.

Sulpiride and Haloperidol in Schizophrenia: A Double-blind Cross-over Study of Therapeutic Effect, Side Effects and Plasma Concentrations

1985 ◽  
Vol 147 (3) ◽  
pp. 283-288 ◽  
Author(s):  
Jes Gerlach ◽  
Kirsten Behnke ◽  
Jon Heltberg ◽  
Ebbe Munk-Andersen ◽  
Henrik Nielsen
Keyword(s):  
Side Effects ◽  
Plasma Concentrations ◽  
Clinical Effects ◽  
Median Dose ◽  
Double Blind ◽  
Day Range ◽  
Daily Dose ◽  
Schizophrenic Patients ◽  
High Doses ◽  
Therapeutic Profile

SummaryIn a double-blind cross-over trial, 20 chronic schizophrenic patients were treated with sulpiride and haloperidol in two 12-week periods. The final median dose of sulpiride was 2000 mg/day (range 800–3200) and of haloperidol 12 mg/day (range 6–24). Sulpiride had an antipsychotic effect and therapeutic profile not significantly different from that of haloperidol. In spite of the high doses of sulpiride, extrapyramidal side-effects were seen less frequently during the first four weeks of the sulpiride period than during the corresponding haloperidol period (P < 0.05), whereas autonomic side-effects were equally rare for both drugs. A positive correlation was found between daily dose and plasma concentration of both sulpiride (P < 0.001) and haloperidol (P < 0.05), but no correlation could be established between clinical effects and plasma levels of either neuroleptic.

Noncompliance Contributing to Apparent Drug Failure in Status Epilepticus

PEDIATRICS ◽  
1974 ◽  
Vol 53 (6) ◽  
pp. 938-940
Author(s):  
John T. Wilson
Keyword(s):  
Status Epilepticus ◽  
Plasma Levels ◽  
Seizure Activity ◽  
Drug Level ◽  
Continuous Control ◽  
Drug Plasma ◽  
Intravenous Diazepam ◽  
Grand Mal ◽  
History Of ◽  
Drug Plasma Levels

The case to be described illustrates apparent drug failure because of noncompliance in the drug delivery system, and the sequelae of this mishap. In connection with investigation of this case further occurrences of noncompliance were found. This incident also brings into focus the importance of plasma drug level determinations for effective application of therapy. CASE REPORT A 7-year-old, 26-kg, black girl was admitted with a 16-month history of nonprogressive neurologic disease accompanied by clinical and EEG evidence of petit mal and grand mal epilepsy which responded to diphenylhydantoin (DPH), phenobarbital or ethosuximide (Zarontin) treatment. Generalized convulsions had been infrequent for four months, but, before the present admission, a marked increase in grand mal seizures was noted. On the day of admission (day 1), recurrent generalized seizure activity progressed to status epilepticus within six hours. Intravenous diazepam (Valium [0.18/mg/kg]) controlled the seizures. Primidone (Mysoline), 250 mg tid, and ethosuximide, 500 mg tid were prescribed as maintenance anticonvulsants in an attempt to allay further progression to status epilepticus. For the next several days her seizures could be controlled only with paraldehyde (0.36 mg/kg intravenously), although administration of other drugs was continued. Assays of drug plasma levels did not become available until day 6. They disclosed that plasma levels of diazepam and demethyldiazepam were high (289 and 50 ng/ml, respectively) one hour after dosing with 0.18 mg/kg. This indicated that diazepam was not effective for continuous control of seizures, but this information was not acted upon immediately. The most striking finding was that primidone was not detected in plasma, although the prescibed dosage was 250 mg tid.

Ibuprofen: Plasma Concentrations in Man

1985 ◽  
Vol 13 (1) ◽  
pp. 68-73 ◽  
Author(s):  
G M E Janssen ◽  
J F Venema
Keyword(s):  
Side Effects ◽  
Crossover Study ◽  
Plasma Levels ◽  
Healthy Subjects ◽  
Peak Plasma ◽  
Plasma Concentrations ◽  
Repeated Dose ◽  
Similar Range ◽  
The Mean ◽  
Peak Value

The plasma levels of Ibuprofen were measured in five healthy subjects who took 600 mg tablets of Ibuprofen twice daily, three times daily and four times daily in a crossover study. Peak plasma levels were obtained 1 hour after the first dose in all but one subject (slow absorber), the mean peak value being 51·3 μg.ml−1 (range 39·4–63·7 μg.ml−1). After the repeated dose regimens of two, three or four times daily of ibuprofen, the peak levels achieved were in a similar range to those seen after the first dose: Twice daily 39·4–66·4 μg.ml−1 Three times daily 43·6–63·3 μg.ml−1 Four times daily 44·1–58·4 μg.ml−1 There was no evidence of accumulation of the drug and no side-effects occurred during the trial.

Five-year administration of fenretinide: pharmacokinetics and effects on plasma retinol concentrations.

1993 ◽  
Vol 11 (10) ◽  
pp. 2036-2042 ◽  
Author(s):  
F Formelli ◽  
M Clerici ◽  
T Campa ◽  
M G Di Mauro ◽  
A Magni ◽  
...  
Keyword(s):  
Plasma Levels ◽  
High Performance ◽  
Plasma Concentrations ◽  
Nipple Discharge ◽  
Treatment Interruption ◽  
Phase Iii ◽  
Breast Cancer Patients ◽  
Plasma Retinol ◽  
Drug Plasma Levels ◽  
Level Reduction

PURPOSE Monitoring of fenretinide (4HPR) levels, kinetics, and effects on retinal was performed in patients who participated in a phase I trial and who continued to be treated for 5 years as phase III trial patients. Accumulation of 4HPR in the breast was also assessed. PATIENTS AND METHODS Plasma concentrations of 4HPR, of its main metabolite N-(4-methoxyphenyl)retinamide (4MPR), and of retinol were assayed by high-performance liquid chromatography (HPLC) in breast cancer patients treated orally with 4HPR 200 mg/d for 5 years with a 3-day drug interruption at the end of each month. RESULTS 4HPR, at 200 mg/d, resulted in average 4HPR plasma levels of approximately 1 mumol/L, which remained steady and caused steady retinol level reduction; 4MPR levels, similar to those of 4HPR, slightly but significantly increased during the first 35 months, but at 5 years they were similar to those at 5 months. During daily treatment, baseline retinol concentrations were reduced by 71%; after a 3-day drug interruption, all patients recovered and the mean reduction was 38%. After discontinuation of 5-year treatment, 4HPR and 4MPR half-lives (t1/2 beta) were 27 and 54 hours, respectively, similar to those reported after 28 daily treatments. After 6 and 12 months, the concentrations of 4HPR were at the limit of detectability (0.01 mumol/L), whereas those of 4MPR were five times higher. Baseline retinol concentrations were already recovered after 1 month. Accumulation of this retinoid in the breast was evidenced by concentrations of 4HPR and 4MPR in nipple discharge and in breast biopsies that were 10 and 20 times higher, respectively, than those found in plasma. CONCLUSION 4HPR, at 200 mg/d for 5 years, resulted in constant drug plasma levels and constant retinol level reduction. After treatment interruption, 4HPR plasma concentrations decreased at the limit of detectability at 6 months and baseline retinol plasma concentrations were recovered after 1 month.

Hostility Conflict and Reporting of Side Effects by Psychiatric Outpatients

1980 ◽  
Vol 47 (1) ◽  
pp. 319-324 ◽  
Author(s):  
Robert W. Downing ◽  
Karl Rickels
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Self Report ◽  
Partial Replication ◽  
Drug Trials ◽  
Psychiatric Outpatients ◽  
Double Blind ◽  
The Relationship ◽  
Report Measure

The Irritability, Indirect Hostility, Verbal Hostility, and Resentment scales from the Buss-Durkee Hostility Inventory, along with a newly constructed scale intended as a self-report measure of Hostility Conflict, were administered to 84 non-psychotic, primarily anxious psychiatric outpatients receiving an active anxiolytic and participating in one of several 4-wk. double-blind drug trials. Patients who complained of one or more side effects after 2 wk. of treatment were classified as side reactors; the remaining patients, as non-side reactors. Compared to non-side reactors, the side reactors obtained higher hostility conflict scores and lower scores on the Irritability and Indirect Hostility scales. Also, the relationship between side effect status and hostility conflict was stronger in those patients who obtained higher scores on the Irritability, Indirect Hostility, and Verbal Hostility scales and among patients obtaining lower scores on the Resentment scale. Findings were regarded as providing partial replication of and further verification of earlier results.

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