Pediatric studies dosing

The pathogenesis of glucocorticoid-induced glaucoma is still unknown, but there is reduced outflow, and excessive accumulation of mucopolysaccharides may be a major factor. An association with cataract and papilledema has often been observed. The rise in intraocular pressure is variable in the pediatric study of low dose cited above there was a reversible effect in only two of 23 subjects compared with controls, but in other studies serious increases in pressure have occurred, with a risk of blindness. 

In the future, the FDA will require pediatric studies if the drug product will be widely used in the claimed indication and the absence of adequate pediatric labeling could pose significant risks to pediatric patients. Studies will also be required if the drug product is indicated for a very significant or life-threatening illness, but additional dosing or safety information is needed to permit its safe and effective use in pediatric patients. 

Pediatric studies of pharyngitis and tonsillitis showed that azithromycin was not as effective as a 10-day course of penicillin V. However, it was felt that part ol the problem could be attributed to the presence of macrolide resistance (17% in one study) [184-187]. At least two large double-blind, multicenter studies using a higher dose of azithromycin for 5 days in children with streptococcal pharyngitis have shown that azithromycin was clinically superior to a 10-day course ol penicillin V [187, 188]. We have no clinical evidence of the efficacy of azithromycin in prevention of rheumatic fever. 

Pediatric studies often have failed to show superiority of antidepressant drugs over placebo, particularly with older antidepressants but also with most SSRls, and the future of tricyclic antidepressant use in children is uncertain. Finally, evidence concerning clinical dose-response and dose-risk relationships is especially limited with the newer antidepressant drugs. Despite lack of consistency and convincingly demonstrated efficacy, the modern antidepressants have largely replaced the tricyclics as first-line options in children, adolescents, and the elderly, largely owing to their relative safety. 

Higher dose amoxicillin, amoxicillin-davulanate (eg., 90 mg/kg/day) is used for penicillin-resistant Streptococcus pneumoniae fluoroquinolones are avoided in pediatric patients because of the potential for cartilage damage however, their use in pediatrics is emerging. Doses shown are extrapolated from adults and will require further study. 

The AEGL-1 concentration was based on a 1-hour (h) no-effect concentration of 8,000 parts per million (ppm) in healthy human subjects (Emmen et al. 2000). This concentration was without effects on pulmonary function, respiratory parameters, the eyes (irritation), or the cardiovascular system. Because this concentration is considerably below that causing any adverse effect in animal studies, an intraspecies uncertainty factor (UF) of 1 was applied. The intraspecies UF of 1 is supported by the absence of adverse effects in therapy tests with patients with severe chronic obstructive pulmonary disease and adult and pediatric asthmatics who were tested with metered-dose inhalers containing HFC-134a as the propellant. Because blood concentrations in this study approached equilibrium following 55 minutes (min) of exposure and effects are determined by blood concentrations, the value of 8,000 ppm was made equivalent across all time periods. The AEGL-1 of 8,000 ppm is supported by the absence of adverse effects in experimental animals that inhaled considerably higher concentrations. No adverse effects were observed in rats exposed at 81,000 ppm for 4 h (Silber and Kennedy 1979) or in rats exposed... 

The database for HFC-134a is extensive it contains studies with both human subjects and animal models. Potentially sensitive populations, including patients with COPD and adult and pediatric asthmatic patients, were tested with direct inhalation of HFC-134a from metered-dose inhalers. The response of these groups was no different than that of healthy adults. The animal studies covered acute, subchronic, and chronic exposure durations and addressed systemic toxicity as well as neurotoxicity, reproductive and developmental effects, cardiac sensitization, genotoxicity, and carcinogenicity. The metabolism of HFC-134a is well understood, and the relationship of exposure con... 

Children 6 years of age and older- 0.2 mg/kg once per day as monotherapy. Doses above 0.6 mg/kg (or in excess of 40 mg daily) have not been studied in pediatric patients. 

Children - Studies suggest the following starting doses in pediatric patients 1 to 16 years of age. 

Powder for oral suspension The recommended dosage in pediatric patients is 14 mg/kg, up to a maximum dose of 600 mg/day. Once daily dosing for 10 days is as effective as twice-daily dosing. Once-daily dosing has not been studied in skin infections therefore, administer oral suspension twice daily in this infection. Oral suspension may be administered without regard to meals. 

Children Two hundred fifty-one patients 4 years of age and above have received amprenavir as single or multiple doses in studies. An adverse event profile similar to that seen in adults was seen in pediatric patients. The safety, efficacy, and pharmacokinetics of amprenavir capsules have not been evaluated in pediatric patients below 4 years of age. 

Because of the ready availability of parents, pediatric psychopharmacology is in an advantageous position to conduct family-based association studies. The use of standardized assessment instruments and systematic dosing regimens are of obvious importance. The creation of genetic archives would allow subsequent test-... 

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