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

bausch & lomb incorporated - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate ophthalmic solution, usp 1% is indicated for: atropine sulfate ophthalmic solution, usp 1% should not be used in anyone who has demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation because it may recur. risk summary there are no adequate and well-controlled studies of atropine sulfate ophthalmic solution, usp 1% administration in pregnant women to inform a drug-associated risk. adequate animal development and reproduction studies have not been conducted with atropine sulfate. in humans, 1% atropine sulfate is systemically bioavailable following topical ocular administration [see clinical pharmacology (12.3)] . atropine sulfate ophthalmic solution, usp 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. risk summary there is no information to inform risk regarding the presence of atropine in human milk following ocular administrations of atropine sulfate ophthalmic solution, usp 1% to th

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

hf acquisition co llc, dba healthfirst - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia. none. 8.1 pregnancy risk summary 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. clinical considerations disease-associated maternal and/or embryo/fetal risk severe or life-threatening muscarinic events such as acute organophosphate poisoning and symptomatic bradycardia are medical emergencies in pregnancy which can be fatal if left untreated. life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of atropine on the fetus. data human data no adequate and well-controlled studies are available regarding use of atropine in pregnant women. in a cohort study of 401 pregnancies in the first trimester and 797 pregnancies in the second or third trimester, atropine use was not associated with an increased risk of congenital malformation. in a surveillance study, 381 newborns were exposed to atropine during the first trimester; 18 major birth defects were observed when 16 were expected. no specific pattern of major birth defects was identified. in another surveillance study of 50 pregnancies in the first trimester, atropine use was not associated with an increased risk of malformations. methodological limitations of these observational studies including the inability to control for the dosage and timing of atropine exposure, underlying maternal disease, or concomitant maternal drug use, cannot definitively establish or exclude any drug- associated risk during pregnancy. 8.2 lactation risk summary trace amounts of atropine have been reported in human milk after oral intake. there are no available data on atropine levels in human milk after intravenous injection, the effects on the breastfed infant, or the effects on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of atropine to an infant during lactation. clinical considerations minimizing exposure the elimination half-life of atropine is more than doubled in children less than 2 years of age [see clinical pharmacology (12.3)]. to minimize potential infant exposure to atropine sulfate injection, a woman may pump and discard her milk for 24 hours after use before resuming to breastfeed her infant. 8.5 geriatric use an evaluation of current literature revealed no clinical experience identifying differences in response between 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)

bausch & lomb americas inc. - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate ophthalmic solution, usp 1% is indicated for: atropine sulfate ophthalmic solution, usp 1% should not be used in anyone who has demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation because it may recur. risk summary there are no adequate and well-controlled studies of atropine sulfate ophthalmic solution, usp 1% administration in pregnant women to inform a drug-associated risk. adequate animal development and reproduction studies have not been conducted with atropine sulfate. in humans, 1% atropine sulfate is systemically bioavailable following topical ocular administration [see clinical pharmacology (12.3)] . atropine sulfate ophthalmic solution, usp 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. risk summary there is no information to inform risk regarding the presence of atropine in human milk following ocular administrations of atropine sulfate ophthalmic solution, usp 1% to th

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

hf acquisition co llc, dba healthfirst - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate injection, usp, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. none. 8.1 pregnancy pregnancy risk summary there are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see clinical considerations). available data from published observational studies on atropine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). animal reproduction studies have not been conducted with atropine. clinical considerations disease-associated maternal and/or embryo/fetal risk severe or life-threatening muscarinic events such as acute organophosphate poisoning and symptomatic bradycardia are medical emergencies in pregnancy which can be fatal if left untreated. life-sustaining therapy for the pregnant woman should not be withheld because of concerns regarding the effects of atropine on the fetus. data human data atropine crosses the placenta [see clinical pharmacology (12.3)]. no adequate and well-controlled studies are available regarding use of atropine in pregnant women. in a cohort study of 401 pregnancies in the first trimester and 797 pregnancies in the second or third trimester, atropine use was not associated with an increased risk of congenital malformation. in a surveillance study, 381 newborns were exposed to atropine during the first trimester; 18 major birth defects were observed when 16 were expected. no specific pattern of major birth defects was identified. in another surveillance study of 50 pregnancies in the first trimester, atropine use was not associated with an increased risk of malformations. methodological limitations of these observational studies including the inability to control for the dosage and timing of atropine exposure, underlying maternal disease, or concomitant maternal drug use, cannot definitively establish or exclude any drug associated risk during pregnancy. 8.2 lactation risk summary trace amounts of atropine have been reported in human milk after oral intake. there are no available data on atropine levels in human milk after intravenous injection, the effects on the breastfed infant, or the effects on milk production. clinical considerations minimizing exposure the elimination half-life of atropine is more than doubled in children less than 2 years of age [see clinical pharmacology (12.3)]. to minimize potential infant exposure to atropine sulfate injection, a woman may pump and discard her milk for 24 hours after use before resuming to breastfeed her infant. 8.4 pediatric use recommendations for use in pediatric patients are not based on clinical trials. 8.5 geriatric use an evaluation of current literature revealed no clinical experience identifying differences in response between 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)

hf acquisition co llc, dba healthfirst - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate injection, usp, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. none. 8.1 pregnancy pregnancy risk summary there are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see clinical considerations). available data from published observational studies on atropine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). animal reproduction studies have not been conducted with atropine. clinical considerations disease-associated maternal and/or embryo/fetal risk severe or life-threatening muscarinic events such as acute organophosphate poisoning and symptomatic bradycardia are medical emergencies in pregnancy which can be fatal if left untreated. life-sustaining therapy for the pregnant woman should not be withheld because of concerns regarding the effects of atropine on the fetus. data human data atropine crosses the placenta [see clinical pharmacology (12.3)]. no adequate and well-controlled studies are available regarding use of atropine in pregnant women. in a cohort study of 401 pregnancies in the first trimester and 797 pregnancies in the second or third trimester, atropine use was not associated with an increased risk of congenital malformation. in a surveillance study, 381 newborns were exposed to atropine during the first trimester; 18 major birth defects were observed when 16 were expected. no specific pattern of major birth defects was identified. in another surveillance study of 50 pregnancies in the first trimester, atropine use was not associated with an increased risk of malformations. methodological limitations of these observational studies including the inability to control for the dosage and timing of atropine exposure, underlying maternal disease, or concomitant maternal drug use, cannot definitively establish or exclude any drug associated risk during pregnancy. 8.2 lactation risk summary trace amounts of atropine have been reported in human milk after oral intake. there are no available data on atropine levels in human milk after intravenous injection, the effects on the breastfed infant, or the effects on milk production. clinical considerations minimizing exposure the elimination half-life of atropine is more than doubled in children less than 2 years of age [see clinical pharmacology (12.3)]. to minimize potential infant exposure to atropine sulfate injection, a woman may pump and discard her milk for 24 hours after use before resuming to breastfeed her infant. 8.4 pediatric use recommendations for use in pediatric patients are not based on clinical trials. 8.5 geriatric use an evaluation of current literature revealed no clinical experience identifying differences in response between 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)

hf acquisition co llc, dba healthfirst - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate injection, usp, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. none. 8.1 pregnancy animal reproduction studies have not been conducted with atropine. it also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. 8.3 nursing mothers trace amounts of atropine was found in breast milk. the clinical impact of this is not known. 8.5 geriatric use an evaluation of current literature revealed no clinical experience identifying differences in response between 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)

hf acquisition co., llc, dba health first - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate injection, usp, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. none. 8.1 pregnancy animal reproduction studies have not been conducted with atropine. it also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. 8.3 nursing mothers trace amounts of atropine was found in breast milk. the clinical impact of this is not known. 8.4 pediatric use recommendations for use in pediatric patients are not based on clinical trials. 8.5 geriatric use an evaluation of current literature revealed no clinical experience identifying differences in response between 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)

amneal pharmaceuticals llc - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate injection is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning and to treat bradyasystolic cardiac arrest. none. animal reproduction studies have not been conducted with atropine. it also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. trace amounts of atropine was found in breast milk. the clinical impact of this is not known. recommendations for use in pediatric patients are not based on clinical trials. an evaluation of current literature revealed no clinical experience identifying differences in response between 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)

medical purchasing solutions, llc - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate injection, usp, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. none. pregnancy category c animal reproduction studies have not been conducted with atropine. it also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. trace amounts of atropine was found in breast milk. the clinical impact of this is not known. an evaluation of current literature revealed no clinical experience identifying differences in response between 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)

medical purchasing solutions, llc - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate is given parenterally as a preanesthetic medication to decrease salivation and bronchial secretions. it is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. for ureteral and biliary colic, atropine sulfate given with morphine may be indicated. atropine sulfate is indicated for relaxation of the upper gastrointestinal tract and colon during hypotonic radiography. atropine is used as an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain species of aminata and in poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare “nerve gases”. large doses relieve the muscarine-like symptoms and some of the central nervous system manifestations. conditions at which inhibition of postganglionic cholinergic nerves are undesirable, such as glaucoma and tachycardia. also contraindicated in asthma, because the parenteral dose which might relieve asthma would have an excessive dryi