atropine sulfate
Generic: ATROPINE SULFATE
Basic Information
Manufacturer
Amneal Pharmaceuticals LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
80a31286-a741-4440-b200-290c08925d06
Indications & Usage
1 INDICATIONS AND USAGE 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.
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 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.
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 Amneal Pharmaceuticals LLC at 1-877-835-5472 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.
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 Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.