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Michael Chez - One of the best experts on this subject based on the ideXlab platform.
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Pediatric safety of tizanidine: clinical adverse event database and retrospective chart assessment.
Pediatric Drugs, 2012Co-Authors: Henry R. Henney, Michael ChezAbstract:Background: Tizanidine is an imidazoline with central α2-adrenoceptor agonist activity at both spinal and supraspinal levels, which is indicated as a Short-Acting Drug for the management of spasticity. Despite being used in pediatric populations, there is no adequate information or well controlled studies to document the safety and efficacy of tizanidine in this group.
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Pediatric Safety of Tizanidine
Pediatric Drugs, 2009Co-Authors: Henry R. Henney, Michael ChezAbstract:Background: Tizanidine is an imidazoline with central α_2-adrenoceptor agonist activity at both spinal and supraspinal levels, which is indicated as a Short-Acting Drug for the management of spasticity. Despite being used in pediatric populations, there is no adequate information or well controlled studies to document the safety and efficacy of tizanidine in this group. Objective: To evaluate the safety of tizanidine in the pediatric population. Methods: We compared spontaneous adverse event reports in the Acorda Therapeutics worldwide clinical adverse event database for children (≤16 years; n = 99) and adults (>16 years; n= 1153) who had received tizanidine and for whom at least one adverse event was reported, and performed a retrospective chart review of the safety of tizanidine in children (≤16 years; n = 76) at a large US pediatric neurology practice. Causality of adverse events in our worldwide clinical adverse event database were neither assessed nor assigned by the company. Results: When adverse events from the clinical adverse event database were collapsed into the 25 Medical Dictionary for Regulatory Activities (MedDRA; version 9.0) organ system classes, five classes were more frequent in adults (general disorders and administration site conditions [p = 0.0006], hepatobiliary disorders [p = 0.0031], nervous system disorders [p = 0.0108], skin and subcutaneous disorders [p = 0.0063], and vascular disorders [p = 0.0029]), while one class was more frequent in children (psychiatric disorders [p < 0.0001]). The most common adverse event classes in children were psychiatric disorders (52.5%) followed by nervous system disorders (29.3%), and gastrointestinal disorders (16.2%), whereas the most common adverse event classes in adults were nervous system disorders (42.4%), general disorders and administration site conditions (28.6%), and gastrointestinal disorders (21.3%). Serious adverse events were substantially less frequent in children than adults (19.2% vs 45.9%) in the clinical adverse event database. In the pediatric practice chart review, the incidence of adverse events in the MedDRA psychiatric disorders class was very similar (52.6%) to that for children in the clinical adverse event database, while the next most common classes were gastrointestinal disorders (14.5%), and nervous system disorders (13.2%). There were three deaths in children across the databases, including one from accidental exposure and two from cardiac events; the relationship of cardiac events in relation to tizanidine or other causes was difficult to assess with the limited available information. The major causes of death in adults were related to suicide or overdose. Minor, transient liver transaminase increases were occasionally reported; the effect of tizanidine could not be ruled out. Conclusion: The overall safety of tizanidine in the pediatric group appeared good; however, the adverse event profile differed from that in adults. This difference most likely reflects the off-label use of tizanidine as adjunctive treatment for attention disorders and autism. The frequency and nature of adverse events in adults were consistent with the tizanidine prescribing information as reported for its approved indication, i.e. management of spasticity.
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Pediatric safety of tizanidine: Clinical adverse event database and retrospective chart assessment
Pediatric Drugs, 2009Co-Authors: Henry R. Henney, Michael ChezAbstract:BACKGROUND: Tizanidine is an imidazoline with central alpha(2)-adrenoceptor agonist activity at both spinal and supraspinal levels, which is indicated as a Short-Acting Drug for the management of spasticity. Despite being used in pediatric populations, there is no adequate information or well controlled studies to document the safety and efficacy of tizanidine in this group. OBJECTIVE: To evaluate the safety of tizanidine in the pediatric population. We compared spontaneous adverse event reports in the Acorda Therapeutics worldwide clinical adverse event database for children (< or = 16 years; n = 99) and adults (>16 years; n = 1153) who had received tizanidine and for whom at least one adverse event was reported, and performed a retrospective chart review of the safety of tizanidine in children (< or = 16 years; n = 76) at a large US pediatric neurology practice. Causality of adverse events in our worldwide clinical adverse event database were neither assessed nor assigned by the company. RESULTS: When adverse events from the clinical adverse event database were collapsed into the 25 Medical Dictionary for Regulatory Activities (MedDRA; version 9.0) organ system classes, five classes were more frequent in adults (general disorders and administration site conditions [p = 0.0006], hepatobiliary disorders [p = 0.0031], nervous system disorders [p = 0.0108], skin and subcutaneous disorders [p = 0.0063], and vascular disorders [p = 0.0029]), while one class was more frequent in children (psychiatric disorders [p < 0.0001]). The most common adverse event classes in children were psychiatric disorders (52.5%) followed by nervous system disorders (29.3%), and gastrointestinal disorders (16.2%), whereas the most common adverse event classes in adults were nervous system disorders (42.4%), general disorders and administration site conditions (28.6%), and gastrointestinal disorders (21.3%). Serious adverse events were substantially less frequent in children than adults (19.2% vs 45.9%) in the clinical adverse event database. In the pediatric practice chart review, the incidence of adverse events in the MedDRA psychiatric disorders class was very similar (52.6%) to that for children in the clinical adverse event database, while the next most common classes were gastrointestinal disorders (14.5%), and nervous system disorders (13.2%). There were three deaths in children across the databases, including one from accidental exposure and two from cardiac events; the relationship of cardiac events in relation to tizanidine or other causes was difficult to assess with the limited available information.The major causes of death in adults were related to suicide or overdose. Minor, transient liver transaminase increases were occasionally reported; the effect of tizanidine could not be ruled out. CONCLUSION: The overall safety of tizanidine in the pediatric group appeared good; however, the adverse event profile differed from that in adults. This difference most likely reflects the off-label use of tizanidine as adjunctive treatment for attention disorders and autism. The frequency and nature of adverse events in adults were consistent with the tizanidine prescribing information as reported for its approved indication, i.e. management of spasticity.
Henry R. Henney - One of the best experts on this subject based on the ideXlab platform.
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Pediatric safety of tizanidine: clinical adverse event database and retrospective chart assessment.
Pediatric Drugs, 2012Co-Authors: Henry R. Henney, Michael ChezAbstract:Background: Tizanidine is an imidazoline with central α2-adrenoceptor agonist activity at both spinal and supraspinal levels, which is indicated as a Short-Acting Drug for the management of spasticity. Despite being used in pediatric populations, there is no adequate information or well controlled studies to document the safety and efficacy of tizanidine in this group.
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Pediatric Safety of Tizanidine
Pediatric Drugs, 2009Co-Authors: Henry R. Henney, Michael ChezAbstract:Background: Tizanidine is an imidazoline with central α_2-adrenoceptor agonist activity at both spinal and supraspinal levels, which is indicated as a Short-Acting Drug for the management of spasticity. Despite being used in pediatric populations, there is no adequate information or well controlled studies to document the safety and efficacy of tizanidine in this group. Objective: To evaluate the safety of tizanidine in the pediatric population. Methods: We compared spontaneous adverse event reports in the Acorda Therapeutics worldwide clinical adverse event database for children (≤16 years; n = 99) and adults (>16 years; n= 1153) who had received tizanidine and for whom at least one adverse event was reported, and performed a retrospective chart review of the safety of tizanidine in children (≤16 years; n = 76) at a large US pediatric neurology practice. Causality of adverse events in our worldwide clinical adverse event database were neither assessed nor assigned by the company. Results: When adverse events from the clinical adverse event database were collapsed into the 25 Medical Dictionary for Regulatory Activities (MedDRA; version 9.0) organ system classes, five classes were more frequent in adults (general disorders and administration site conditions [p = 0.0006], hepatobiliary disorders [p = 0.0031], nervous system disorders [p = 0.0108], skin and subcutaneous disorders [p = 0.0063], and vascular disorders [p = 0.0029]), while one class was more frequent in children (psychiatric disorders [p < 0.0001]). The most common adverse event classes in children were psychiatric disorders (52.5%) followed by nervous system disorders (29.3%), and gastrointestinal disorders (16.2%), whereas the most common adverse event classes in adults were nervous system disorders (42.4%), general disorders and administration site conditions (28.6%), and gastrointestinal disorders (21.3%). Serious adverse events were substantially less frequent in children than adults (19.2% vs 45.9%) in the clinical adverse event database. In the pediatric practice chart review, the incidence of adverse events in the MedDRA psychiatric disorders class was very similar (52.6%) to that for children in the clinical adverse event database, while the next most common classes were gastrointestinal disorders (14.5%), and nervous system disorders (13.2%). There were three deaths in children across the databases, including one from accidental exposure and two from cardiac events; the relationship of cardiac events in relation to tizanidine or other causes was difficult to assess with the limited available information. The major causes of death in adults were related to suicide or overdose. Minor, transient liver transaminase increases were occasionally reported; the effect of tizanidine could not be ruled out. Conclusion: The overall safety of tizanidine in the pediatric group appeared good; however, the adverse event profile differed from that in adults. This difference most likely reflects the off-label use of tizanidine as adjunctive treatment for attention disorders and autism. The frequency and nature of adverse events in adults were consistent with the tizanidine prescribing information as reported for its approved indication, i.e. management of spasticity.
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Pediatric safety of tizanidine: Clinical adverse event database and retrospective chart assessment
Pediatric Drugs, 2009Co-Authors: Henry R. Henney, Michael ChezAbstract:BACKGROUND: Tizanidine is an imidazoline with central alpha(2)-adrenoceptor agonist activity at both spinal and supraspinal levels, which is indicated as a Short-Acting Drug for the management of spasticity. Despite being used in pediatric populations, there is no adequate information or well controlled studies to document the safety and efficacy of tizanidine in this group. OBJECTIVE: To evaluate the safety of tizanidine in the pediatric population. We compared spontaneous adverse event reports in the Acorda Therapeutics worldwide clinical adverse event database for children (< or = 16 years; n = 99) and adults (>16 years; n = 1153) who had received tizanidine and for whom at least one adverse event was reported, and performed a retrospective chart review of the safety of tizanidine in children (< or = 16 years; n = 76) at a large US pediatric neurology practice. Causality of adverse events in our worldwide clinical adverse event database were neither assessed nor assigned by the company. RESULTS: When adverse events from the clinical adverse event database were collapsed into the 25 Medical Dictionary for Regulatory Activities (MedDRA; version 9.0) organ system classes, five classes were more frequent in adults (general disorders and administration site conditions [p = 0.0006], hepatobiliary disorders [p = 0.0031], nervous system disorders [p = 0.0108], skin and subcutaneous disorders [p = 0.0063], and vascular disorders [p = 0.0029]), while one class was more frequent in children (psychiatric disorders [p < 0.0001]). The most common adverse event classes in children were psychiatric disorders (52.5%) followed by nervous system disorders (29.3%), and gastrointestinal disorders (16.2%), whereas the most common adverse event classes in adults were nervous system disorders (42.4%), general disorders and administration site conditions (28.6%), and gastrointestinal disorders (21.3%). Serious adverse events were substantially less frequent in children than adults (19.2% vs 45.9%) in the clinical adverse event database. In the pediatric practice chart review, the incidence of adverse events in the MedDRA psychiatric disorders class was very similar (52.6%) to that for children in the clinical adverse event database, while the next most common classes were gastrointestinal disorders (14.5%), and nervous system disorders (13.2%). There were three deaths in children across the databases, including one from accidental exposure and two from cardiac events; the relationship of cardiac events in relation to tizanidine or other causes was difficult to assess with the limited available information.The major causes of death in adults were related to suicide or overdose. Minor, transient liver transaminase increases were occasionally reported; the effect of tizanidine could not be ruled out. CONCLUSION: The overall safety of tizanidine in the pediatric group appeared good; however, the adverse event profile differed from that in adults. This difference most likely reflects the off-label use of tizanidine as adjunctive treatment for attention disorders and autism. The frequency and nature of adverse events in adults were consistent with the tizanidine prescribing information as reported for its approved indication, i.e. management of spasticity.
David Wheatley - One of the best experts on this subject based on the ideXlab platform.
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Prescribing Short-Acting hypnosedatives : current recommendations from a safety perspective
Drug Safety, 1992Co-Authors: David WheatleyAbstract:The duration of action of hypnosedative Drugs is mainly determined by their pharmacokinetic properties. The ideal Drug should induce sleep within 30 min and maintain a normal pattern of sleep for 6 to 8h, with little or no residual effects the next morning. Clinically, 4 types of insomnia can be distinguished: prolonged latency, 1 to 2 long periods of wakefulness, frequent Short awakenings, and early morning awakening. An ultra-Short-Acting Drug (2 to 3h), such as triazolam, is useful for prolonged latency. Temazepam, lormetazepam and loprazolam provide more prolonged effects (8 to 10h). These benzodiazepines are not free of daytime adverse effects, particularly drowsiness, dependency potential, rebound insomnia and habituation to the Drug effect.
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Prescribing Short-Acting Hypnosedatives
Drug Safety, 1992Co-Authors: David WheatleyAbstract:The duration of action of hypnosedative Drugs is mainly determined by their pharmacokinetic properties. The ideal Drug should induce sleep within 30 min and maintain a normal pattern of sleep for 6 to 8h, with little or no residual effects the next morning. Clinically, 4 types of insomnia can be distinguished: prolonged latency, 1 to 2 long periods of wakefulness, frequent Short awakenings, and early morning awakening. An ultra-Short-Acting Drug (2 to 3h), such as triazolam, is useful for prolonged latency. Temazepam, lormetazepam and loprazolam provide more prolonged effects (8 to 10h). These benzodiazepines are not free of daytime adverse effects, particularly drowsiness, dependency potential, rebound insomnia and habituation to the Drug effect. Zopiclone and zolpidem are new nonbenzodiazepine hypnotics that are as effective as benzodiazepines but without the problems associated with the latter. They produce a more normal electroencephalogram sleep pattern and so would seem to approach to the ideal hypnosedative for the future. However, only further clinical trials and widespread use in practice will determine whether they will live up to this potential.
Hans H Maurer - One of the best experts on this subject based on the ideXlab platform.
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The breast feeding mother and xenon anaesthesia: four case reports. Breast feeding and xenon anaesthesia
BMC Anesthesiology, 2010Co-Authors: Ralph Stuttmann, Claudia Schäfer, Peter Hilbert, Markus R Meyer, Hans H MaurerAbstract:Background Four nursing mothers consented to anaesthesia for urgent surgery only on condition that their ability to breast feed would not be impaired. Methods Following induction of general anaesthesia with propofol and remifentanil, 65-69% xenon supplemented with remifentanil was used as an inhalational anaesthetic for maintenance. Results After finishing surgery the women could be extubated between 2:52 and 7:22 minutes. The women were fully alert just minutes after extubation and spent about 45 minutes in the recovery room before discharge to a regular ward. They resumed regular breast feeding some time later. The propofol concentration in the blood was measured after 0, 30, 90, and 300 minutes and in the milk after 90 and 300 minutes. Just 90 minutes after extubation, the concentration of propofol in the milk was limited (> 3 mg/l) so that pharmacological effects on the babies were excluded after oral intake. Also, no traces of xenon gas were found in the maternal milk at any time. After propofol induction and maintenance of anaesthesia with xenon in combination with a water-soluble Short-Acting Drug like remifentanil, the concentration of propofol in maternal milk is low (> 3 mg/l 90 min after anesthesia) and harmless after oral intake. Conclusions These results, as well as the rapid elimination and absence of metabolism of xenon, are of great interest to nursing mothers. General anaesthesia with propofol for induction only, combined with remifentanil and xenon for maintenance, has not yet been described in breast feeding mothers.
Hayder Eltaher Sulaiman - One of the best experts on this subject based on the ideXlab platform.
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THE EFFECT OF ETHANOLIC EXTRACT OF SOLANUM DUBIUM IN GLUCOSE INTRA-PERITONIALLY LOADED RATS (in-vivo) AND GLUCOSE UPTAKE IN ISOLATED RAT HEMIDIAPHRAGM (in-vitro)
2017Co-Authors: Hayder Eltaher SulaimanAbstract:ABSTRACT: Thirty westar albino rats of either sexes weighing 120gm to 250gm were divided into five groups to test three different doses of ethanolic extract of solanum dubium for its blood glucose lowering activity in comparison with glibenclamide as a positive control and distilled water as a negative control group. Blood glucose in the rats was evaluated in the first, second and fourth hour. The first and second hour the extract lowered blood glucose level potently to a decrement value of 25% in comparison to 17% decrement in the group administered glibenclamide. At the fourth hour the extract showed no effect on blood glucose level, nevertheless, it start rising, the fact that reveals it as a Short Acting Drug. Using rat hemidiaphragm to check the potential of solanum extract in enhancing re-uptake of glucose by tissues, it showed good synergistic activity when administered with insulin. Key words: solanum dubium , glibenclamide, ethanolic, hypoglycemic, hemidiaphragm.