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

sandoz inc - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride 20 mg in 1 ml - anectine is indicated in adults and pediatric patients: anectine is contraindicated in patients with: hyperkalemia, which may result in cardiac arrest [see warnings and precautions (5.4)] risk summary available data from published literature from case reports and case series over decades of use with succinylcholine during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. succinylcholine is used commonly during delivery by caesarean section to provide muscle relaxation. if succinylcholine is used during labor and delivery, there is a risk for prolonged apnea in some pregnant women (see clinical considerations). animal reproduction studies have not been conducted with succinylcholine chloride. 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 clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations maternal adverse reactions plasma cholinesterase levels are decreased by approximately 24% during pregnancy and for several days postpartum which can prolong the effect of anectine. therefore, some pregnant or newly postpartum patients may experience prolonged apnea following administration of anectine. fetal/neonatal adverse reactions apnea and flaccidity may occur in the newborn after repeated high doses to, or in the presence of atypical plasma cholinesterase in the mother. labor or delivery succinylcholine is commonly used to provide muscle relaxation during delivery by caesarean section. succinylcholine is known to cross the placental barrier in an amount that is dependent on the concentration gradient between the maternal and fetal circulation. risk summary there are no data on the presence of succinylcholine or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for anectine and any potential adverse effects on the breastfed infant from anectine or from the underlying maternal condition. safety and effectiveness of succinylcholine chloride have been established in pediatric patients age groups, neonate to adolescent. since there is a risk of ventricular dysrhythmias, cardiac arrest, and death from hyperkalemic rhabdomyolysis in pediatric patients, reserve the use of anectine in pediatric patients for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible [see warnings and precautions (5.1)] . intravenous bolus administration of anectine in infants or pediatric patients may result in profound bradycardia or, rarely, asystole. the incidence and severity of bradycardia is higher in pediatric patients than adults [see warnings and precautions (5.6)] . the effective dose of anectine in pediatric patients may be higher than that predicted by body weight dosing alone [see dosage and administration (2.3)] . clinical studies of succinylcholine chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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.

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

sandoz inc - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - anectine is indicated in adults and pediatric patients: anectine is contraindicated in patients with: risk summary available data from published literature from case reports and case series over decades of use with succinylcholine during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. succinylcholine is used commonly during delivery by caesarean section to provide muscle relaxation. if succinylcholine is used during labor and delivery, there is a risk for prolonged apnea in some pregnant women (see clinical considerations). animal reproduction studies have not been conducted with succinylcholine chloride. 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 clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations maternal adverse reactions plasma cholinesterase levels are decreased by approximately 24% during pregnancy and for several days postpartum which can prolong the effect of anectine. therefore, some pregnant or newly postpartum patients may experience prolonged apnea following administration of anectine. fetal/neonatal adverse reactions apnea and flaccidity may occur in the newborn after repeated high doses to, or in the presence of atypical plasma cholinesterase in, the mother. labor or delivery succinylcholine is commonly used to provide muscle relaxation during delivery by caesarean section. succinylcholine is known to cross the placental barrier in an amount that is dependent on the concentration gradient between the maternal and fetal circulation. risk summary there are no data on the presence of succinylcholine or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for anectine and any potential adverse effects on the breastfed infant from anectine or from the underlying maternal condition. safety and effectiveness of succinylcholine chloride have been established in pediatric patients age groups, neonate to adolescent. since there is a risk of ventricular dysrhythmias, cardiac arrest, and death from hyperkalemic rhabdomyolysis in pediatric patients, reserve the use of anectine in pediatric patients for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible [see warnings and precautions (5.1)] . intravenous bolus administration of anectine in infants or pediatric patients may result in profound bradycardia or, rarely, asystole. the incidence and severity of bradycardia is higher in pediatric patients than adults [see warnings and precautions (5.6)] . the effective dose of anectine in pediatric patients may be higher than that predicted by body weight dosing alone [see dosage and administration (2.3)] . clinical studies of succinylcholine chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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.

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

civica, inc. - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - anectine is indicated in adults and pediatric patients: anectine is contraindicated in patients with: risk summary available data from published literature from case reports and case series over decades of use with succinylcholine during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. succinylcholine is used commonly during delivery by caesarean section to provide muscle relaxation. if succinylcholine is used during labor and delivery, there is a risk for prolonged apnea in some pregnant women (see clinical considerations). animal reproduction studies have not been conducted with succinylcholine chloride. 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 clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations maternal adverse reactions plasma cholinesterase levels are decreased by approximately 24% during pregnancy and for several days postpartum which can prolong the effect of anectine. therefore, some pregnant or newly postpartum patients may experience prolonged apnea following administration of anectine. fetal/neonatal adverse reactions apnea and flaccidity may occur in the newborn after repeated high doses to, or in the presence of atypical plasma cholinesterase in the mother. labor or delivery succinylcholine is commonly used to provide muscle relaxation during delivery by caesarean section. succinylcholine is known to cross the placental barrier in an amount that is dependent on the concentration gradient between the maternal and fetal circulation. risk summary there are no data on the presence of succinylcholine or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for anectine and any potential adverse effects on the breastfed infant from anectine or from the underlying maternal condition. safety and effectiveness of succinylcholine chloride have been established in pediatric patients age groups, neonate to adolescent. since there is a risk of ventricular dysrhythmias, cardiac arrest, and death from hyperkalemic rhabdomyolysis in pediatric patients, reserve the use of anectine in pediatric patients for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible [see warnings and precautions (5.1)] . intravenous bolus administration of anectine in infants or pediatric patients may result in profound bradycardia or, rarely, asystole. the incidence and severity of bradycardia is higher in pediatric patients than adults [see warnings and precautions (5.6)] . the effective dose of anectine in pediatric patients may be higher than that predicted by body weight dosing alone [see dosage and administration (2.3)] . clinical studies of succinylcholine chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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.

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

sandoz inc - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. succinylcholine is contraindicated in persons with personal or familial history of malignant hyperthermia, skeletal muscle myopathies, and known hypersensitivity to the drug. it is also contraindicated in patients after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, because succinylcholine administered to such individuals may result in severe hyperkalemia which may result in cardiac arrest (see warnings ). the risk of hyperkalemia in these patients increases over time and usually peaks at 7 to 10 days after the injury. the risk is dependent on the extent and location of the injury. the precise time of onset and the duration of the risk period are not known.

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

delpharm boucherville canada inc. - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. anectine is contraindicated in patients with: • known or suspected genetic susceptibility to malignant hyperthermia (see  warnings; malignant hyperthermia, clinical pharmacology; pharmacogenomics ) • skeletal muscle myopathies • known hypersensitivity to succinylcholine (see warnings; anaphylaxis) • after the acute phase of injury following major burns, multiple trauma, extensive denervation of the skeletal muscle, or upper neuron injury because succinylcholine administered to such individuals may result in severe hyperkalemia, which may result in cardiac arrest (see warnings; hyperkalemia )

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

delpharm boucherville canada inc. - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. anectine is contraindicated in patients with: • known or suspected genetic susceptibility to malignant hyperthermia (see  warnings; malignant hyperthermia, clinical pharmacology; pharmacogenomics ) • skeletal muscle myopathies • known hypersensitivity to succinylcholine (see warnings; anaphylaxis) • after the acute phase of injury following major burns, multiple trauma, extensive denervation of the skeletal muscle, or upper neuron injury because succinylcholine administered to such individuals may result in severe hyperkalemia, which may result in cardiac arrest (see warnings; hyperkalemia )

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - suxamethonium chloride - solution for inj/inf - 50 mg/ml - choline derivatives

Malta - English - Medicines Authority

the wellcome foundation - suxamethonium chloride 500 mg/ml - solution for injection

Ireland - English - HPRA (Health Products Regulatory Authority)

aspen pharma trading limited - suxamethonium chloride - solution for injection/infusion - 50 milligram(s)/millilitre - choline derivatives; suxamethonium

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

aspen pharma trading ltd - suxamethonium chloride - solution for injection - 50mg/1ml