Atropine Sulfate

Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for: Atropine is an anticholinergic indicated in adults and pediatric patients aged three (3) months and older for: Cycloplegia ( 1.1 ) Mydriasis ( 1.2 ) Penalization of the healthy eye in the treatment of amblyopia ( 1.3 )

1.1 Cycloplegia .

1.2 Mydriasis .

1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia .

Hypersensitivity or allergic reaction to any ingredient in formulation ( 4.1 )

4.1Hypersensitivity

Atropine sulfate ophthalmic solution 1% is contraindicated in patients who have demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation.

Photophobia and blurred vision due to pupil unresponsiveness and cycloplegia may last up to 2 weeks. ( 5.1 ) Risk of blood pressure increase from systemic absorption. ( 5.2 )

5.1Photophobia and Blurred Vision Photophobia

and blurred vision due to pupil unresponsiveness and cycloplegia may last up to 2 weeks.

5.2Elevation of Blood Pressure Elevation

in blood pressure from systemic absorption has been reported following conjunctival instillation of recommended doses of atropine sulfate ophthalmic solution, 1%.