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

genus lifesciences inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), homatropine methylbromide (unii: 68jrs2hc1c) (methylhomatropine - unii:p97ogj7l1l) - hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. limitations of use: - not indicated for pediatric patients under 18 years of age [see use in specific populations (8.4)]. - contraindicated in pediatric patients less than 6 years of age [see contraindications (4)]. - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. hydrocodone bitartrate and homatropine methylbromide is contraindicated for: - all pediatric patients younger than 6 years of age [see warnings and precautions (5.2, 5.3), use in specific populations (8.4)]. - significant respiratory depression [see warnings and precautions (5.2)]

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

sandoz inc - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg in 1.5 ml - omnitrope (somatropin) injection is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (gh). omnitrope (somatropin) injection is indicated for the treatment of pediatric patients who have growth failure due to prader-willi syndrome (pws). the diagnosis of pws should be confirmed by appropriate genetic testing [see contraindications (4) and warnings and precautions (5.2)] . omnitrope (somatropin) injection is indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to manifest catch-up growth by age 2 years. omnitrope (somatropin) injection is indicated for the treatment of growth failure associated with turner syndrome. omnitrope (somatropin) injection is indicated for the treatment of idiopathic short stature (iss), also called non-growth hormone-deficient short stature, defined by height standard deviation score (sds) ≤ -2.25, and associated with growth rates unlikely to permit attainment of adul

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

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)

a-s medication solutions - 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. 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

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratoire aguettant - atropine sulfate monohydrate - solution for injection in pre-filled syringe - 0.1 milligram(s)/millilitre - belladonna alkaloids, tertiary amines; atropine - belladonna alkaloids, tertiary amines - atropine sulfate aguettant 0.1 mg/ml, solution for injection in pre-filled syringe is indicated in adults and in paediatric population from birth, but with a body weight superior to 3 kg - as a pre-anaesthetic medication to prevent vagal reactions associated with tracheal intubation and surgical manipulation, - to limit the muscarinic effects of neostigmine, when given postsurgically to counteract non-depolarising muscle relaxants - treatment of hemodynamically compromising bradycardia and/ or atrioventricular block due to excessive vagal tone in emergency situation - cardiopulmonary resuscitation: to treat symptomatic bradycardia and av block - as antidote following overdosage or poisoning with acetylcholinesterase-inhibitors e.g. anticholinesterases, organophosphorus, carbamates and muscarinic mushrooms

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

a-s medication solutions - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate injection, usp, may be given parenterally as a pre-anesthetic medication in surgical patients to reduce salivation and bronchial secretions. it may also be used to suppress vagal activity associated with the use of halogenated hydrocarbons during inhalation anesthesia and reflex excitation arising from mechanical stimulation during surgery. the antispasmodic action of atropine is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. for ureteral and biliary colic, atropine concomitantly with morphine may be indicated. atropine relaxes the upper gi tract and colon during hypotonic radiography. in poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare nerve gases, large doses of atropine relieve the muscarine-like symptoms and some of the central nervous system manifestations. it is also used as an antidote for mushroom poisoning due to muscarine in certain species such as amanita muscaria . atropine sulfate

Israel - English - Ministry of Health

teva israel ltd - atropine sulfate - solution for injection - atropine sulfate 20 mg / 10 ml - atropine - atropine - preanesthetic medication to decrease excessive salivation and secretions of the respiratory tract. treatment of sinus bradycardia, particularly if complicated by hypotension. antidote in poisoning by organophosphorus.

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

medical purchasing solutions, 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