DEXTROSE- dextrose monohydrate injection, solution United States - English - NLM (National Library of Medicine)

dextrose- dextrose monohydrate injection, solution

baxter healthcare corporation - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok) - dextrose monohydrate 50 g in 1000 ml - dextrose injection is indicated as source of water and calories. the use of dextrose injection is contraindicated in patients with: risk summary appropriate administration of dextrose injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. animal reproduction studies have not been conducted with injectable dextrose solutions. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. risk summary there are no data on the presence of dextrose in human milk, the effects on a breastfed infant, or the effects on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of dextrose injection to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dextrose injection and any potential adverse effects on the breastfed infant from dextrose injection or from the underlying maternal condition. the safety profile of dextrose injection in pediatric patients is similar to adults. neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects. closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. in very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and risk of intracerebral hemorrhage. children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see warnings and precautions (5.4)] . clinical studies of dextrose injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see warnings and precautions (5.4)] . other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. dextrose is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.