Atropine Sulfate

1. INDICATIONS AND USAGE Atropine sulfate ophthalmic solution, 1% is indicated for: Atropine is an anti-muscarinic agent indicated 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

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

4.1Hypersensitivity

to any Component of this Medication Atropine sulfate ophthalmic solution should not be used in anyone who has demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation because it may recur.

5. WARNINGS AND PRECAUTIONS 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%.

7. DRUG INTERACTIONS The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis. ( 7 )

Monoamine oxidase inhibitors (MAOI) The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis.