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Adult Dose (adult + dose)

Distribution by Scientific Domains

Medical Sciences	71%

Selected Abstracts

Dosage regimens for inhaled therapy in children should be reconsidered

JOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 2 2002
JH Wildhaber
Abstract: In current asthma guidelines, dosage regimens for inhalation therapy in children are based on adult doses and are generally titrated per kilogram of bodyweight or per square metre of body surface area. However, these recommendations do not correspond well with current knowledge of aerosol therapy in childhood. Lung deposition of the aerosolised drug is the key determinant for clinical efficacy and for systemic side effects of inhalation therapy. Lung deposition increases with age, whereas lung deposition expressed as a percentage per kilogram bodyweight is age-independent. This finding is explained by the self-regulating effect of age-dependent airway anatomy on lung deposition. Therefore, it is more likely that adult doses translate into paediatric doses only by virtue of the differences in self-limiting pulmonary deposition when using the same absolute nominal doses of the medication. Adapting the adult dose to a paediatric dose calculated on body size might be unnecessary and could lead to insufficient pulmonary deposition of medication. These findings suggest that dosage regimens for inhalation therapy for children may have to be reconsidered, and should be determined from dose-ranging studies rather than calculated from adult doses based on body size. [source]

Longitudinal patterns of new Benzodiazepine use in the elderly,

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 10 2004
Gillian Bartlett PhD
Abstract Purpose To characterize longitudinal patterns of Benzodiazepine use in the elderly. Methods Prospective cohort of 78,367 community-dwelling Quebec residents aged 66 years or more who were new Benzodiazepine users, was followed for 5 years, 1989,1994. Data acquired from four population-based, provincial administrative databases were used to create time-dependent measures of change in dosage, switching or adding Benzodiazepines for 11 drugs listed in the provincial formulary. Subject-specific Spearman's rank correlation coefficients between dose and time were used to measure the tendency of increasing dose with consecutive periods of use. Multiple logistic regression and generalized estimating equations (GEE) models evaluated subject characteristics associated with increasing dose. Results The mean duration of uninterrupted Benzodiazepine use was 75.5 days. The mean daily dose was about half the recommended adult daily dose but 8.6% of subjects exceeded the recommended adult dose. Some of them (28.8%) switched medications at least once and 8.2% filled two or more prescriptions concurrently. For women, older age at date of first prescription was associated with increasing dose over time (odds ratio (OR) for 10 year age increase,=,1.23, p,<,0.001). Conclusion Long periods of Benzodiazepine use are frequent among Quebec elderly. The evidence of increasing dose, particularly for older women, and long-duration of use has important implications for clinicians. Copyright © 2003 John Wiley & Sons, Ltd. [source]

A Statistical Framework for Quantile Equivalence Clinical Trials with Application to Pharmacokinetic Studies that Bridge from HIV-Infected Adults to Children

BIOMETRICS, Issue 4 2008
Lixia Pei
Summary Bridging clinical trials are sometimes designed to evaluate whether a proposed dose for use in one population, for example, children, gives similar pharmacokinetic (PK) levels, or has similar effects on a surrogate marker as an established effective dose used in another population, for example, adults. For HIV bridging trials, because of the increased risk of viral resistance to drugs at low PK levels, the goal is often to determine whether the doses used in different populations result in similar percentages of patients with low PK levels. For example, it may be desired to evaluate that a proposed pediatric dose gives approximately 10% of children with PK levels below the 10th percentile of PK levels for the established adult dose. However, the 10th percentile for the adult dose is often imprecisely estimated in studies of relatively small size. Little attention has been given to the statistical framework for such bridging studies. In this article, a formal framework for the design and analysis of quantile-based bridging studies is proposed. The methodology is then developed for normally distributed outcome measures from both frequentist and Bayesian directions. Sample size and other design considerations are discussed. [source]

Desloratadine dose selection in children aged 6 months to 2 years: comparison of population pharmacokinetics between children and adults

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 2 2007
Samir K. Gupta
What is already known about this subject ,,According to recent literature, the pathophysiologies of allergic rhinitis and chronic idiopathic urticaria are thought to be similar in adults and children. In addition, the response to antihistamine treatment is similar in adults and children, suggesting a similar concentration-response relationship. ,,However, an appropriate dose selection and the pharmacokinetics of desloratadine in children of ,6 months,,2 years old have never been addressed in the literature. What this study adds ,,This study demonstrated that desloratadine syrup offers a safe treatment option for allergic conditions in young children. ,,A suitable dose for children aged ,6 months,<1 year is 1.0 mg, while the corresponding predicted dose for children aged ,1 year,,2 years is 1.25 mg. These paediatric doses yielded similar systemic desloratadine exposures (AUC) to those seen with a typical adult dose of 5.0 mg. Aims The aim of this study was to identify the dose of desloratadine in children aged ,6 months,,2 years that would yield a single-dose target exposure (AUC) comparable with that in adults taking 5 mg desloratadine as syrup. Methods In a phase 1, single-dose, open-label, pharmacokinetic study in 58 children aged ,6 months,<1 year and ,1 year,,2 years were randomly assigned to desloratadine syrup 0.625 mg (1.25 ml) and 1.25 mg (2.5 ml), respectively. Because the volume of blood that could be collected from individual subjects was limited, a population pharmacokinetic approach was used to estimate the pharmacokinetics of desloratadine. Safety was assessed based on results of screening and postdose physical examinations, laboratory safety tests, vital signs, and adverse events. Results The apparent clearance (CL/F) of desloratadine, population estimate (%CV), in children aged ,6 months,<1 year was 27.8 l h,1 (35) and corresponding values in children ,1 year,,2 years was 35.5 l h,1 (51), compared with 137 l h,1 (58) for adults. The CL/F ratios (children to adults) indicated that doses of 1 mg for ,6 months,<1 year and 1.25 mg for ,1 year,,2 years would result in similar systemic exposure to that observed in adults receiving the recommended 5 mg dose. Desloratadine was well tolerated with no safety issues. Conclusions Doses of 1.0 and 1.25 mg in children aged ,6 months,,2 years should result in an exposure to desloratadine similar to that of adults receiving doses of 5 mg. [source]

Underdosing of Midazolam in Emergency Endotracheal Intubation

ACADEMIC EMERGENCY MEDICINE, Issue 4 2003
Mark J. Sagarin MD
Objectives: To determine whether midazolam, when used as an induction agent for emergency department (ED) rapid-sequence intubation (RSI), is used in adequate and recommended induction doses (0.1 to 0.3 mg/kg), and to compare the accuracy of the dosing of midazolam for ED RSI with the accuracy of dosing of other agents. Methods: The authors conducted a systematic query of a prospectively collected database of ED intubations using the National Emergency Airway Registry data, gathered in 11 participating EDs over a 16-month period. A data form completed at the time of emergency department intubation (EDI) enabled analysis of patients' ages, weights, and indications for EDI, as well as the techniques and drugs used to facilitate EDI. Data were analyzed to determine whether midazolam is used in recommended doses during RSI. Patients intubated with midazolam alone were compared with patients who received other induction agents for RSI. Results: Of 1,288 patients entered in the study, 1,023 (79%) underwent RSI. Of the 888 RSI patients with an age recorded, midazolam was used as the sole induction agent in 140 (16%). The mean (±SD) dosages of midazolam used in RSI were 2.6 (±1.7) mg in children (age , 18) and 3.7 (±2.5) mg in adults (age ,19); the mean (±SD) dosages by weight were 0.08 (±0.04) mg/kg in children and 0.05 (±0.03) mg/kg in adults. More than half (56%) of the children, and nearly all (92%) of the adults, received dosages lower than the minimum recommended dosage (0.1 mg/kg). Of patients who received barbiturates, only 21% of children and 21% of adults received a dose lower than the minimum recommended. When combined with another induction agent, midazolam was dosed similarly to when it was used alone: mean adult doses were 3.1 (±1.2) mg and 0.04 (±0.02) mg/kg. Conclusions: Underdosing of midazolam during ED RSI is frequent, and appears to be related to incorrect dosage selection, rather than to a deliberate intention to reduce the dose used. [source]