United States - English - NLM (National Library of Medicine)

exela pharma sciences, llc - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - bloxiverz, is a cholinesterase inhibitor, indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. bloxiverz is contraindicated in patients with: risk summary published studies and case reports over several decades about the use of neostigmine products, including neostigmine methylsulfate, in pregnant women have not identified any drug-associated risk for major birth defects and miscarriage. however, most of the available data are based on studies with exposure that occurred at the time of caesarean section or labor and delivery. these studies have not identified an adverse effect on maternal or infant outcomes. in animal reproduction studies, no adverse developmental effects were observed after administration of neostigmine methylsulfate to pregnant rats and rabbits during organogenesis with doses up to 0.1 and 0.2 times, respectively, the maximum recommended human dose (mrhd) of 5mg/60kg/person/day based on body surface area (mg/m2 ). the 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 the clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. data animal data in embryofetal development studies, rats and rabbits were administered neostigmine methylsulfate at human equivalent doses (hed, on a mg/m2 basis) of 1.6, 4 and 8.1 mcg/kg/day and 3.2, 8.1, and 13 mcg/kg/day, respectively, during the period of organogenesis (gestation days 6 through 17 for rats and gestation days 6 through 18 for rabbits). there was no evidence for a teratogenic effect in rats and rabbits up to hed 8.1 and 13 mcg/kg/day, which are approximately 0.097 times and 0.16 times the mrhd of 5 mg/60 kg, respectively in the presence of minimal maternal toxicity (tremors, ataxia, and prostration). the studies resulted in exposures in the animals well below predicted exposures in humans. in a pre- and postnatal development study in rats, neostigmine methylsulfate was administered to pregnant female rats at human equivalent doses (hed) of 1.6, 4 and 8.1 mcg/kg/day from day 6 of gestation through day 20 of lactation, with weaning on day 21. there were no adverse effects on physical development, behavior, learning ability, or fertility in the offspring at hed doses up to 8.1 mcg/kg/day which is 0.097 times the mrhd of 5 mg/60 kg on a mg/m2 basis in the presence of minimal maternal toxicity (tremors, ataxia, and prostration). the studies resulted in exposures in the animals well below predicted exposures in humans. risk summary published data from case reports are insufficient to determine the presence of neostigmine methylsulfate in human milk or the effects on the breastfed infant. there is no information on the effects of neostigmine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bloxiverz and any potential adverse effects on the breastfed infant from bloxiverz or from the underlying maternal condition. bloxiverz is approved for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery in pediatric patients of all ages. recovery of neuromuscular activity occurs more rapidly with smaller doses of cholinesterase inhibitors in infants and children than in adults. however, infants and small children may be at greater risk of complications from incomplete reversal of neuromuscular blockade due to decreased respiratory reserve. the risks associated with incomplete reversal outweigh any risk from giving higher doses of bloxiverz (up to 0.07 mg/kg or up to a total of 5 mg, whichever is less). the dose of bloxiverz required to reverse neuromuscular blockade in children varies between 0.03 mg - 0.07 mg/kg, the same dose range shown to be effective in adults, and should be selected using the same criteria as used for adult patients [see clinical pharmacology (12.3)] . since the blood pressure in pediatric patients, particularly infants and neonates, is sensitive to changes in heart rate, the effects of an anticholinergic agent (e.g., atropine) should be observed prior to administration of neostigmine to lessen the probability of bradycardia and hypotension. because elderly patients are more likely to have decreased renal function, bloxiverz should be used with caution and monitored for a longer period in elderly patients. the duration of action of neostigmine methylsulfate is prolonged in the elderly; however, elderly patients also experience slower spontaneous recovery from neuromuscular blocking agents. therefore, dosage adjustments are not generally needed in geriatric patients; however, they should be monitored for longer periods than younger adults to assure additional doses of bloxiverz are not required. the duration of monitoring should be predicated on the anticipated duration of action for the nmba used on the patient [see dosage and administration (2.3)] . elimination half-life of neostigmine methylsulfate was prolonged in anephric patients compared to normal subjects. although no adjustments to bloxiverz dosing appear to be warranted in patients with impaired renal function, they should be closely monitored to assure the effects of the neuromuscular blocking agent, particularly one cleared by the kidneys, do not persist beyond those of bloxiverz. in this regard, the interval for re-dosing the neuromuscular blocking agent during the surgical procedure may be useful in determining whether, and to what extent, post-operative monitoring needs to be extended. the pharmacokinetics of neostigmine methylsulfate in patients with hepatic impairment have not been studied. neostigmine methylsulfate is metabolized by microsomal enzymes in the liver. no adjustments to the dosing of bloxiverz appear to be warranted in patients with hepatic insufficiency. however, patients should be carefully monitored if hepatically cleared neuromuscular blocking agents were used during their surgical procedure as their duration of action may be prolonged by hepatic insufficiency whereas bloxiverz, which undergoes renal elimination, will not likely be affected. this could result in the effects of the neuromuscular blocking agent outlasting those of bloxiverz. this same situation may arise if the neuromuscular blocking agent has active metabolites. in this regard, the interval for re-dosing the neuromuscular blocking agent during the surgical procedure may be useful in determining whether, and to what extent, post-operative monitoring needs to be extended.

United States - English - NLM (National Library of Medicine)

exela pharma sciences, llc - potassium acetate (unii: m911911u02) (potassium cation - unii:295o53k152) - potassium acetate injection, usp (2 meq/ml) is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake. it is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. potassium administration is contraindicated in patients with severe renal insufficiency or adrenal insufficiency and in diseases where high potassium levels may be encountered.

United States - English - NLM (National Library of Medicine)

exela pharma sciences, llc - potassium acetate (unii: m911911u02) (potassium cation - unii:295o53k152) - potassium acetate 3.93 g in 20 ml - potassium acetate injection, usp is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake. it is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. potassium administration is contraindicated in patients with severe renal insufficiency or adrenal insufficiency and in diseases where high potassium levels may be encountered.

United States - English - NLM (National Library of Medicine)

exela pharma sciences, llc - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid in sodium chloride injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce the risk of hemorrhage during and following tooth extraction. tranexamic acid in sodium chloride injection is contraindicated: risk summary available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not identified a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. there are no reports regarding the use of tranexamic acid during the first trimester of pregnancy; therefore, there are no data regarding the risk of major birth defects with use of tranexamic acid during pregnancy. however, tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration (see data). reproduction studies performed in mice, rats, and rabbits have not revealed any adverse effects on the fet

United States - English - NLM (National Library of Medicine)

exela pharma sciences, llc - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - akovaz (ephedrine sulfate injection) is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none risk summary available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, there are clinical considerations due to underlying conditions (see clinical considerations) . in animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg/day). no malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the mrhd, respectively [see data] . the

United States - English - NLM (National Library of Medicine)

exela pharma sciences, llc - caffeine citrate (unii: u26eo4675q) (caffeine - unii:3g6a5w338e) - caffeine citrate 20 mg in 1 ml - caffeine citrate injection and caffeine citrate oral solution are indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age. caffeine citrate injection and caffeine citrate oral solution are contraindicated in patients who have demonstrated hypersensitivity to any of its components.

United States - English - NLM (National Library of Medicine)

exela pharma sciences, llc - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - bloxiverz is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. bloxiverz is contraindicated in patients with: risk summary there are no adequate or well-controlled studies of bloxiverz in pregnant women. it is not known whether bloxiverz can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. the incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited. all pregnancies, regardless of drug exposure, have a background risk of 2 to 4% for major birth defects, and 15 to 20% for pregnancy loss. no adverse effects were noted in rats or rabbits treated with human equivalent doses of neostigmine methylsulfate doses up to 8.1 and 13 mcg/kg/day, respectively, during organogenesis (0.1 to 0.2 times the maximum recommended human dose of 5 mg/60 kg person/day based on body surface area comparisons). anticholinesterase drugs, including neostigmin

United States - English - NLM (National Library of Medicine)

exela pharma sciences, llc - caffeine citrate (unii: u26eo4675q) (caffeine - unii:3g6a5w338e) - caffeine citrate 20 mg in 1 ml - caffeine citrate injection and caffeine citrate oral solution are indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age. caffeine citrate injection and caffeine citrate oral solution are contraindicated in patients who have demonstrated hypersensitivity to any of its components.

United States - English - NLM (National Library of Medicine)

exela pharma sciences, llc - sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - sodium bicarbonate injection, usp is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis - e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. but since an appreciable time int

United States - English - NLM (National Library of Medicine)

exela pharma sciences, llc - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - bloxiverz is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. bloxiverz is contraindicated in patients with: risk summary there are no adequate or well-controlled studies of bloxiverz in pregnant women. it is not known whether bloxiverz can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. the incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited. all pregnancies, regardless of drug exposure, have a background risk of 2 to 4% for major birth defects, and 15 to 20% for pregnancy loss. no adverse effects were noted in rats or rabbits treated with human equivalent doses of neostigmine methylsulfate doses up to 8.1 and 13 mcg/kg/day, respectively, during organogenesis (0.1 to 0.2 times the maximum recommended human dose of 5 mg/60 kg person/day based on body surface area comparisons). anticholinesterase drugs, including neostigmin