Pediatric population

El 1 Clinical Investigation of Medicinal Products in the Pediatric Population... 

There is a similar high prevalence of peripheral neuropathy (34%) in the pediatric population infected with HIV (Araujo et al. 2000). The frequency of IDP in the HIV-infected population is unknown but is thought to be rare (Wulff et al. 2000). In an outpatient population of HIV positive patients, mononeuritis multiplex and lumbosacral polyradiculopathy were found in less than 1% of patients with AIDS (Fuller et al. 1993). HIV-associated autonomic nervous system dysfunction is also not uncommon as up to 66% of patients have papillary involvement and 15% have sympathetic and parasympathetic involvement causing orthostatic hypotension and respiratory sinus arrhythmia (Gluck et al. 2000). 

Based primarily on the study protocol of the 1995 NINDS rt-PA study.Many centers would also exclude patients with known documented endocarditis or aortic dissection, and those with CT hypoattenuation in more than one third of the middle cerebral artery territory. There are insufficient data to support the use of rt-PA for ischemic stroke in pregnancy or in the pediatric population (age <18 years). 

IV rt-PA has been safely given in patients with cervical arterial dissection There are four reports of IV rt-PA use in pregnancy, with one case complicated by intrauterine hematoma,rt-PA should be used in this setting only after careful assessment of the risks and benefits. There is insufficient data to determine the benefit of rt-PA in the pediatric population, with no randomized trials. 

In its continuing effort to improve the safety and efficacy of drugs in the pediatric population, the U.S. Food and Drug Administration (FDA) has defined five subgroups of this population based on age. Each subgroup is not homogeneous but does contain similar characteristics that are considered milestones in growth in development. The FDA classifications are listed in Table 1. 

Age classifications do not provide an ill-inclusive method for establishing pediatric doses. Based on current knowledge, the most accurate pediatric doses are determined utilizing both weight and age. Dosing based on surface area has been shown to have no practical advantages for the general pediatric population [1]. 

Adverse reactions to drugs differ in both type and incidence in the pediatric population. Because of immature metabolic pathways, infants and children may have different metabolic patterns than adults. This at least partially explains why neonates require lower theophylline serum concentrations for the treatment of neonatal apnea and why the incidence of hepatotoxi-city following acetaminophen overdose is much lower in young children than in adults [44,45]. Antibiotic adverse effects unique to the pediatric population may... 

Because of the high incidence of lactose intolerance in the general population, lactose is not recommended as a sweetener for pediatric populations [70]. Aspartame, a phenylalanine derivative, is incorporated in many chewable tablets and sugar-free dosage forms. Aspartame-containing products should be avoided in children with autosomal recessive phenylketonuria [54]. 

No transdermal products have been marketed for use in the pediatric population. The development of transdermal products in pediatric doses could be very beneficial for children who are unable to tolerate oral medications. 

Before the start of any formal laboratory work, the characteristics of the drug and excipients to be used must be considered. When performing this evaluation, it is necessary to keep in mind all of the pharmacokinetic and physical changes experienced by the elderly and pediatric population. 

In children, entry of lead into the body occurs primarily by ingestion, although inhalation also contributes to body burden. Once lead intoxication proceeds to encephalopathy, the risk of death exists. Dose-response information on a pediatric population relating PbB levels with the occurrence of acute... 

The answer is b. (Katzung, p 41L) Severe hep at o toxicity of an idiosyncratic nature is associated with valproic acid The risk is very high in the pediatric population, particularly in patients below the age of two. Fatalities generally occur within four months of treatment Hepatotoxicity may be reversed in some individuals. 

Diagnosis of anemia in pediatric populations requires the use of age- and sex-adjusted norms for laboratory values. 

In the pediatric population, the daily dose of elemental iron, administered as iron sulfate, is 3 mg/kg for infants and 6 mg/kg for older children for 4 weeks. If response is seen, iron should be continued for 2 to 3 months to replace storage iron pools. The dose and schedule of vitamin B12 should be titrated according to clinical and laboratory response. The daily dose of folate is 1 to 3 mg. 

The present chapter deals with calculations associated with calories, nitrogen, protein-calorie percentage, parenteral hyperalimentation, and resting energy expenditure (REE) calculations including REE assessments for geriatric and pediatric populations. 

Body composition varies with age. The pediatric population has unique physiologic needs that make nutritional requirements distinctly different than adults. In children, caloric requirements per kilogram are higher because of their higher basal metabolic rate (BMR). BMR is approximately 50-55 kcal/ kg/day in infancy and declines to about 20-25 kcal/kg/day during adolescence. 

ICH Ell Qinical investigation of medicinal products in the pediatric population Step 5 (2000)... 

Children Safety and efficacy of dipyridamole and aspirin combination capsules in pediatric patients have not been studied. Because of the aspirin component, use of this product in the pediatric population is not recommended. 

Lactation It is not known whether dutasteride is excreted in human breast milk. Children Safety and effectiveness in the pediatric population have not been established. 

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