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)

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

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)

ocusoft, inc. - homatropine hydrobromide (unii: bew7469qz0) (homatropine - unii:8qs6wcl55z) - a moderately long-acting mydriatic and cycloplegic for cycloplegic refraction and in the treatment of inflammatory conditions of the uveal tract. for pre and postoperative states when mydriasis is required. use as an optical aid in some cases of axial lens opacities. contraindicated in persons with primary glaucoma or a tendency toward glaucoma, e.g. narrow anterior chamber angle, and in those persons showing hypersensitivity to any component of this preparation.   homatropine should not be used during the first three months of life due to a possible association between the cycloplegia produced and the development of amblyopia. patient should be advised not to drive or engage in other hazardous activities while pupils are dilated. patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. parents should be warned not to get this preparation in their child’s mouth and to wash their own hands and the child's hands following administration. do not touch dropper

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

emd serono, inc. - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg in 3 ml - saizen (somatropin) is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone. saizen is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria: adult onset patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or childhood onset patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults. confirmation of the diagnosis of adult growth hormone deficiency in both groups invol

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

meridian medical technologies® llc - atropine (unii: 7c0697dr9i) (atropine - unii:7c0697dr9i) - atropine 2.1 mg in 0.7 ml - duodote is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds). none. risk summary atropine readily crosses the placental barrier and enters fetal circulation. there are no adequate data on the developmental risk associated with the use of atropine, pralidoxime, or the combination in pregnant women. adequate animal reproduction studies have not been conducted with atropine, pralidoxime, or the combination. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary atropine has been reported to be excreted in human milk. it is not known whether pralidoxime is excreted in human milk. there are no data on the effects of atropine or pralidoxime on the breastfed infant or the effects of the drugs on milk production. the developmental and health benefits

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

american regent, inc. - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate 1 mg in 1 ml - - in the treatment of parkinsonism. rigidity and tremor relieved by the apparently selective depressant action. - in the gastrointestinal tract to relieve pylorospasm, hypertonicity of the small intestine and the hypermotility of the colon. - to relieve hypertonicity of the uterine muscle. - to relax the spasm of biliary and uretered colic and bronchial spasm. - to diminish the tone of the detrusor muscle of the urinary bladder in the treatment of urinary tract disorders. - to control the crying and laughing episodes in patients with brain lesions. - in cases of closed head injuries which cause acetylcholine to be released or to be present in cerebrospinal fluid which in turn causes abnormal eeg patterns, stupor and neurological signs. - in the management of peptic ulcer. - in anesthesia to control excessive salivation and bronchial secretions. - to control rhinorrhea of acute rhinitis or hay fever. - as an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain species of aminata and

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

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

hf acquisition co llc, dba healthfirst - 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 drying effect