Jepang - Inggris - すりの適正使用協議会 RAD-AR Council, Japan

nichi-iko pharmaceutical co.,ltd - amezinium metilsulfate - white tablet, diameter: 6.0 mm, thickness: 2.5 mm

Amerika Serikat - Inggris - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate injection, usp is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. neostigmine methylsulfate injection, usp 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 injection, usp in pregnant women. it is not known whether neostigmine methylsulfate injection, usp 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, usp 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 prenatal 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 injection, usp 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 injection, usp (up to 0.07 mg/kg or up to a total of 5 mg, whichever is less). the dose of neostigmine methylsulfate injection, usp 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, neostigmine methylsulfate injection, usp 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 injection, usp 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 injection, usp 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 injection, usp. 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 injection, usp 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 injection, usp, 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 injection, usp. 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.

Malaysia - Inggris - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pharm-d sdn. bhd. - galsulfase -

Panama - Inggris - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

biomarin international limited - elosulfasa alfa - elosulfasa alfa....5mg/5ml

Selandia Baru - Inggris - Medsafe (Medicines Safety Authority)

boucher & muir (nz) ltd t/a mercury pharma (nz) - glycopyrronium bromide 0.5 mg/ml; neostigmine metilsulfate 2.5 mg/ml - solution for injection - active: glycopyrronium bromide 0.5 mg/ml neostigmine metilsulfate 2.5 mg/ml excipient: citric acid citric acid monohydrate dibasic sodium phosphate dodecahydrate sodium hydroxide water for injection - reversal of residual non-depolarising (competitive) neuromuscular block.

Kanada - Inggris - Health Canada

pharmascience inc - neostigmine methylsulfate - liquid - .5mg - neostigmine methylsulfate .5mg - parasympathomemetic (cholinergic) agents

Kanada - Inggris - Health Canada

pharmascience inc - neostigmine methylsulfate - liquid - 1mg - neostigmine methylsulfate 1mg - parasympathomemetic (cholinergic) agents

Kanada - Inggris - Health Canada

sandoz canada incorporated - neostigmine methylsulfate - solution - 0.5mg - neostigmine methylsulfate 0.5mg - parasympathomemetic (cholinergic) agents

Kanada - Inggris - Health Canada

sandoz canada incorporated - neostigmine methylsulfate - liquid - 1mg - neostigmine methylsulfate 1mg - parasympathomemetic (cholinergic) agents

Kanada - Inggris - Health Canada

sandoz canada incorporated - neostigmine methylsulfate - solution - 2.5mg - neostigmine methylsulfate 2.5mg - parasympathomemetic (cholinergic) agents