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

remedyrepack inc. - 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. 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)

accord healthcare, inc., - 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 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. risk summary limited available data with atropine sulfate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes (see data). there are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see clinical considerations).   animal reproduction studies have not been conducted with atropine sulfate injection. 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 defect

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

hikma pharmaceuticals usa inc. - 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. risk summary limited available data with atropine sulfate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes (see data) . there are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see clinical considerations) . animal reproduction studies have not been conducted with atropine sulfate injection. 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 t

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

henry schein, inc. - 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 d

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

henry schein, inc. - 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)

henry schein, inc. - 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 d

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)

alcon laboratories, inc. - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate ophthalmic solution, 1% is indicated for: atropine sulfate ophthalmic solution 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 with atropine sulfate ophthalmic solution, 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, 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. there is no information to inform risk regarding the presence of atropine in human milk following ocular administration of atropine sulfate ophthalmic solution, 1% to the mother. the effects on breas

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