미국 - 영어 - 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

미국 - 영어 - 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

미국 - 영어 - NLM (National Library of Medicine)

american regent, 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. 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-sustai

미국 - 영어 - 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.

미국 - 영어 - 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

미국 - 영어 - 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.

미국 - 영어 - 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.

미국 - 영어 - NLM (National Library of Medicine)

sparhawk laboratories, inc. - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate 15 mg in 1 ml - for use as an antidote in the treatment of organophosphate insecticide poisoning of cattle, horses and sheep.

미국 - 영어 - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - 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. pregnancy category c: there are no adequate and well-controlled studies of atropine sulfate in pregnant women. animal development and reproduction studies have not been conducted with atropine sulfate. since it is not known whether topically administered atropine sulfate can cause fetal harm, atropine sulfate ophthalmic solution, 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. traces of atropine have been found in human milk following administration of atropine solution for injection. because some systemic absorption occurs from topical administration, caution should be exercised when atropine sulfate ophthalmic solution, 1% is administered to a nursing woman. due to the potential for systemic absorption of atropine sulfate ophthalmic solution, the use of atropine sulfate ophthalmic solution, 1% in children under the age of 3 months is not recommended and the use in children under 3 years of age should be limited to no more than one drop per eye per day. no overall differences in safety and effectiveness have been observed between elderly and younger adult patients.

미국 - 영어 - NLM (National Library of Medicine)

avpak - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - for mydriasis and/or cycloplegia. for cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract. this product should not be used in patients with primary glaucoma or a predisposition to narrow anterior chamber angle glaucoma. this product should not be used in pediatric patients who have previously had a severe systemic reaction to atropine. this product should not be used in those persons showing hypersensitivity to any component of this preparation.