Statele Unite ale Americii - engleză - 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.

Statele Unite ale Americii - engleză - 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.

Canada - engleză - Health Canada

laboratoire aguettant - atropine sulfate - solution - 0.5mg - atropine sulfate 0.5mg - antimuscarinics antispasmodics

Canada - engleză - Health Canada

laboratoire aguettant - atropine sulfate - solution - 1mg - atropine sulfate 1mg - antimuscarinics antispasmodics

Canada - engleză - Health Canada

laboratoire aguettant - atropine sulfate - solution - 3mg - atropine sulfate 3mg - antimuscarinics antispasmodics

Canada - engleză - Health Canada

hikma canada limited - atropine sulfate - solution - 0.4mg - atropine sulfate 0.4mg - antimuscarinics antispasmodics

Canada - engleză - Health Canada

hikma canada limited - atropine sulfate - solution - 0.6mg - atropine sulfate 0.6mg - antimuscarinics antispasmodics

Regatul Unit - engleză - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - atropine sulfate - eye drops - 5mg/1ml

Regatul Unit - engleză - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance healthcare (distribution) ltd - atropine sulfate - eye drops - 5mg/1ml

Regatul Unit - engleză - MHRA (Medicines & Healthcare Products Regulatory Agency)

waymade healthcare plc - atropine sulfate - eye drops - 5mg/1ml