Atropine Sulfate
Generic: ATROPINE SULFATE
Basic Information
Manufacturer
ProPharma Distribution
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ENDOTRACHEAL
FDA Set ID
38404931-980b-0019-e063-6394a90a933f
Indications & Usage
1 INDICATIONS AND USAGE 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.
Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life threatening muscarinic effects.
( 1 )
Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life threatening muscarinic effects.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in labeling: Hypersensitivity (5.1) Worsening of Ischemic Heart Disease (5.2) Acute Glaucoma (5.3) Pyloric Obstruction (5.4) Complete Urinary Retention (5.5) Viscid Plugs (5.6) The following adverse reactions have been identified during post-approval use of atropine sulfate.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Most of the side effects of atropine are directly related to its antimuscarinic action.
Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur.
Anhidrosis can produce heat intolerance.
Constipation and difficulty in micturition may occur.
Occasional hypersensitivity reactions have been observed, including serious skin rashes.
Paralytic ileus may occur.
Exacerbation of reflux has been reported.
Larger or toxic doses may produce such central effects as restlessness, tremor, fatigue, locomotor difficulties, delirium, followed by hallucinations, depression, and ultimately, medullary paralysis and death.
Large doses can also lead to circulatory collapse.
In such cases, blood pressure declines and death due to respiratory failure may ensue following paralysis and coma.
Most adverse reactions are directly related to atropine’s antimuscarinic action.
Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur with chronic administration of therapeutic doses.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Most of the side effects of atropine are directly related to its antimuscarinic action.
Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur.
Anhidrosis can produce heat intolerance.
Constipation and difficulty in micturition may occur.
Occasional hypersensitivity reactions have been observed, including serious skin rashes.
Paralytic ileus may occur.
Exacerbation of reflux has been reported.
Larger or toxic doses may produce such central effects as restlessness, tremor, fatigue, locomotor difficulties, delirium, followed by hallucinations, depression, and ultimately, medullary paralysis and death.
Large doses can also lead to circulatory collapse.
In such cases, blood pressure declines and death due to respiratory failure may ensue following paralysis and coma.
Most adverse reactions are directly related to atropine’s antimuscarinic action.
Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur with chronic administration of therapeutic doses.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.