ATROPINE SULFATE
Generic: ATROPINE SULFATE
Basic Information
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ENDOTRACHEAL
FDA Set ID
e9fd624a-9abd-dfea-e053-2a95a90a8e9d
Indications & Usage
1 INDICATIONS & 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.
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.
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.