Neonates adverse reactions

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... 

Nine randomized, controlled studies of the use of diuretics in pre-eclampsia have been analysed (145). There were almost 7000 subjects in whom thiazides had been compared with placebo or no treatment. In the pooled analysis, diuretic treatment was associated with a nonsignificant reduction in perinatal mortahty (about 10%) and stillbirths (about 33%). There was no excess of serious adverse reactions, either in the mothers or the neonates. These findings thus give no support to the belief that diuretics are harmful in pregnancy. It should not be concluded that diuretics ought to be used in pre-eclampsia in preference to other well-established agents, but they certainly can be used with confidence when they are really needed, for example in patients with severe hypertension that predates pregnancy and in heart failure. 

Berger I, Steinberg A, Schlesinger Y, Seelenfreund M, Schimmel MS. Neonatal mydriasis intravenous lidocaine adverse reaction. J Child Neurol 2002 17(5) 400-1. 

Adverse reactions involving the kidneys occur in about 20% of patients receiving polymyxins (10). The potential for kidney damage seems to be related to age. Whereas in neonates and young infants colistimethate 20 mg/kg may be well tolerated, children over 2 years should not receive more than 10 mg/kg/day and adults even less. 

Although widely used as an antimicrobial preservative, benzyl alcohol has been associated with some fatal adverse reactions when administered to neonates. It is now recommended that parenteral products preserved with benzyl alcohol, or other antimicrobial preservatives, should not be used in newborn infants if at all possible see Section 14. 

Povidone-Iodine Adverse Reactions Adverse reactions associated with povidone-iodine appHcation include unpleasant odor, skin irritation and allergic reactions. Systemic absorption through topical appHcation may result in metabohc acidosis, hypothyroidism (neonates), hyperthyroidism, electrolyte disturbances and kidney dysfunction (Wax, 2006). Several case reports by Marks (1982),... 

Susceptibflity factors Age The use of remifentanil in neonates and premature infants has been reviewed. Adverse reactions were similar to other opioids (bradycardia, hypotension, respiratory depression, chest waU rigidity, nausea, and vomiting) but were less frequent and less severe [177 ]. 

Susceptibility factors Children Adverse reactions to caspofungin in five clinical registration studies in 171 children have been analysed [87 ]. The median age of the caspofungin recipients was 6.0 years (range 1 week to 17 years). Most (77%) were taking a maintenance dose of 50 mg/m /day. The rest took 1 mg/kg/day (9 patients), 25 mg/ m /day (18 neonates or infants under months of age), or 70 mg/m /day (12 patients). The maximum absolute dose in all cases was 70 mg/day. The median duration of treatment was 9 (range 1-87) days... 

In a placebo-controlled study of 26 neonates who underwent cardiac surgery, aprotinin was not efficacious and had no deleterious effect on renal function the authors suggested that it is unclear whether adverse reactions data on aprotinin from studies in adults are relevant to neonates [204 ]. Similarly, in a controlled study in 31 patients who underwent neuromuscular scoliosis surgery, aprotinin reduced total blood loss and did not cause renal impairment. However, these studies were too small to draw any conclusions. 

Melatonin has been used in neonates at pharmacological doses without apparent adverse reactions, although studies are usually small [26 ]. 

Observational studies Fluconazole is increasingly used to treat fungal infections in neonatal and paediatric populations. Common adverse reactions described include hepatotoxicity and gastrointestinal symptoms, but these two have not been thoroughly evaluated in neonates and other paediatric age groups. 

Many of these reactions are related to the quantity of excipient found in a dosage form. Benzyl alcohol benzalkonium chloride, propylene glycol, lactose, and polysorbates are all associated with dose-related toxic reactions [52-54], Large-volume parenterals containing 1.5% benzyl alcohol as a preservative have caused metabolic acidosis, cardiovascular collapse, and death in low birth weight premature neonates and infants. The cumulative dose of benzyl alcohol ranged from 99 to 234 mg/kg per day in these patients [55,56], Dose-related adverse effects to excipients are of particular concern in the preterm, low birth weight infant because... 

The answer is c. (Hardman, pp 1134-1135.) Hematologic toxicity is by far the most important adverse effect of chloramphenicol The toxicity consists of two types (1) bone marrow depression (common) and (2) aplastic anemia (rare) Chloramphenicol can produce a potentially fatal toxic reaction, the gray baby syndrome, caused by diminished ability of neonates to conjugate chloramphenicol with resultant high serum concentrations. Tetracyclines produce staining of the teeth and phototoxicity... 

Knight M. Adverse drug reactions in neonates. J Clin Pharmacol 1994 34 128-35. 

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