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

general injectables and vaccines, inc - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate 1 mg in 1 ml - neostigmine methylsulfate injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (nmba) after surgery.  neostigmine is contraindicated in patients with: - known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis).  - peritonitis or mechanical obstruction of the urinary or intestinal tracts. pregnancy risk summary there are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women.  it is not known whether neostigmine methylsulfate injection 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 e

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

fresenius kabi usa, llc - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate 0.5 mg in 1 ml - neostigmine methylsulfate injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (nmba) after surgery.  neostigmine is contraindicated in patients with: - known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis).  - peritonitis or mechanical obstruction of the urinary or intestinal tracts. risk summary there are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women.  it is not known whether neostigmine methylsulfate injection 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, h

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - neostigmine methylsulfate, quantity: 2.5 mg - injection, solution - excipient ingredients: water for injections; sodium chloride - neostigmine is indicated for:,? reversal of the effects of non-depolarising neuromuscular blocking agents.,? prophylaxis and treatment of post-operative intestinal atony and urinary retention.,? treatment of myasthenia gravis during acute exacerbations, when the condition is severe or in neonates.

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - neostigmine methylsulfate, quantity: 500 microgram - injection, solution - excipient ingredients: sodium chloride; monobasic sodium phosphate; dibasic sodium phosphate dodecahydrate; water for injections - neostigmine is indicated for:,? reversal of the effects of non-depolarising neuromuscular blocking agents.,? prophylaxis and treatment of post-operative intestinal atony and urinary retention.,? treatment of myasthenia gravis during acute exacerbations, when the condition is severe or in neonates.

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

remedyrepack inc. - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate 1 mg in 1 ml

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

fresenius kabi usa, llc - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (nmba) after surgery.  neostigmine is contraindicated in patients with: - known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis).  - peritonitis or mechanical obstruction of the urinary or intestinal tracts. risk summary there are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women.  it is not known whether neostigmine methylsulfate injection 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, h

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

par pharmaceutical, inc. - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non‑depolarizing neuromuscular blocking agents after surgery. neostigmine methylsulfate injection is contraindicated in patients with: - known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis). - with peritonitis or mechanical obstruction of the intestinal or urinary tract. risk summary there are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women. it is not known whether neostigmine methylsulfate injection 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

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

medical purchasing solutions, llc - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non‑depolarizing neuromuscular blocking agents after surgery. neostigmine methylsulfate injection is contraindicated in patients with: - known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis). - with peritonitis or mechanical obstruction of the intestinal or urinary tract. risk summary there are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women. it is not known whether neostigmine methylsulfate injection 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

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

amneal pharmaceuticals llc - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. neostigmine methylsulfate is contraindicated in patients with: - known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis). - peritonitis or mechanical obstruction of the intestinal or urinary tract. risk summary there are no adequate or well-controlled studies of neostigmine methylsulfate in pregnant women. it is not known whether neostigmine methylsulfate 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 neostigmine, may cause uterine irritability and induce premature labor when administered to pregnant women near term. neostigmine methylsulfate should be given to a pregnant woman only if clearly needed. 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 neostigmine methylsulfate has not been studied in lactating women. it is not known whether neostigmine methylsulfate is present in human milk, or if neostigmine methylsulfate has effects on milk production or the breastfed child. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s need for neostigmine methylsulfate and any potential adverse effects on the breastfed child from neostigmine methylsulfate or from the underlying maternal condition. neostigmine methylsulfate 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 neostigmine methylsulfate (up to 0.07 mg/kg or up to a total of 5 mg, whichever is less). the dose of neostigmine methylsulfate required to reverse neuromuscular blockade in children varies between 0.03 mg to 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, neostigmine methylsulfate 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 neostigmine methylsulfate 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 neostigmine methylsulfate 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 neostigmine methylsulfate. 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 neostigmine methylsulfate 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 neostigmine methylsulfate, which undergoes renal elimination, will not likely be affected. this could result in the effects of the neuromuscular blocking agent outlasting those of neostigmine methylsulfate. 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)

fresenius kabi usa, llc - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (nmba) after surgery. neostigmine is contraindicated in patients with: - known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis). - peritonitis or mechanical obstruction of the urinary or intestinal tracts. risk summary there are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women. it is not known whether neostigmine methylsulfate injection 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 neostigmine may cause uterine irritability and induce premature labor when administered to pregnant women near term. neostigmine methylsulfate injection should be given to a pregnant woman only if clearly needed. data animal data it is not known whether neostigmine methylsulfate injection is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions from neostigmine methylsulfate injection in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. data from published literature support the intravenous use of neostigmine methylsulfate for reversal of nondepolarizing neuromuscular blocking agents in all pediatric age groups. 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 neostigmine methylsulfate (up to 0.07 mg/kg or up to a total of 5 mg, whichever is lower). the dose of neostigmine methylsulfate required to reverse neuromuscular blockade in children varies between 0.03 mg to 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. elderly patients are likely to have decreased renal function, which may prolong the duration of action of neostigmine methylsulfate. however, elderly patients also experience slower spontaneous recovery from neuromuscular blocking agents. therefore, dosage adjustments are generally not needed in geriatric patients; however, they should be monitored for longer periods than younger adults to assure additional doses of neostigmine methylsulfate injection are not required. the duration of monitoring should be predicated on the anticipated duration of action for the neuromuscular blocking agents used on the patient. elimination half-life of neostigmine was prolonged in anephric patients compared to normal subjects, so neostigmine concentration may increase in patients with impaired renal functions. although no adjustments to neostigmine methylsulfate injection dosing appear to be warranted in patients with impaired renal function, they should be closely monitored for a longer period of time. to assure the effects of the neuromuscular blocking agent, particularly one cleared by the kidneys, do not persist beyond those of neostigmine methylsulfate injection, 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 is metabolized by microsomal enzymes in the liver so neostigmine concentration may increase in patients with impaired hepatic functions. although no adjustments to the dosing of neostigmine methylsulfate injection appear to be warranted in patients with hepatic insufficiency, patients should be carefully monitored for a longer period of time. if hepatically cleared neuromuscular blocking agents were used during the surgical procedure, their duration of action may also be prolonged by hepatic insufficiency. this could result in the effects of the neuromuscular blocking agent outlasting those of neostigmine methylsulfate injection. 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. instructions for use figure 1: outer packaging and prefilled syringe notes: - inspect the outer packaging (blister pack) to confirm the integrity of the packaging. do not use if the blister pack or the prefilled syringe has been damaged. - remove the syringe from the outer packaging. (see figure 2) figure 2 remove the syringe from the outer packaging. (see figure 2) figure 2 - visually inspect the syringe. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. visually inspect the syringe. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. - twist off the syringe tip cap. do not remove the label around the luer lock collar. (see figure 3) figure 3 twist off the syringe tip cap. do not remove the label around the luer lock collar. (see figure 3) figure 3 - expel air bubble(s). adjust the dose (if applicable). - administer the dose ensuring that pressure is maintained on the plunger rod during the entire administration. - discard the used syringe into an appropriate receptacle. for more information concerning this drug, please call fresenius kabi usa, llc at 1-800-551-7176. to report suspected adverse reactions, contact fresenius kabi usa, llc at 1-800-551-7176 or fda at 1-800-fda-1088 or www.fda.gov/medwatch. u.s. patents 9,731,082 and 10,661,018 lake zurich, il 60047 www.fresenius-kabi.com/us 451585b