Atropine Sulfate
Generic: ATROPINE SULFATE INJECTION
Basic Information
Manufacturer
ProPharma Distribution
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
3eeed115-0e17-c4b2-e063-6294a90a29b7
Indications & Usage
1 INDICATIONS AND USAGE 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.
These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively.
See full prescribing information for ATROPINE SULFATE INJECTION.
ATROPINE SULFATE injection, for intravenous use Initial U.S.
Approval: 1960
These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively.
See full prescribing information for ATROPINE SULFATE INJECTION.
ATROPINE SULFATE injection, for intravenous use Initial U.S.
Approval: 1960
Adverse Reactions
6 ADVERSE REACTIONS 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 in elderly patients.
Occasional hypersensitivity reactions have been observed, especially skin rashes which in some instances progressed to exfoliation.
To report SUSPECTED ADVERSE REACTIONS, contact Medefil, Inc.
at 630-682-4600, 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 in elderly patients.
Occasional hypersensitivity reactions have been observed, especially skin rashes which in some instances progressed to exfoliation.
To report SUSPECTED ADVERSE REACTIONS, contact Medefil, Inc.
at 630-682-4600, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch