Isopto Atropine

1 INDICATIONS AND USAGE ISOPTO ® Atropine 1% is indicated for: ISOPTO® Atropine 1% is a muscarinic antagonist indicated for: Mydriasis ( 1.1 ) Cycloplegia ( 1.2 ) Penalization of the healthy eye in the treatment of amblyopia ( 1.3 ) 1.1 Mydriasis 1.2 Cycloplegia 1.3 Penalization of the healthy eye in the treatment of amblyopia

2 DOSAGE AND ADMINISTRATION 2.1 In individuals from three (3) months of age or greater, 1 drop topically to the cul-de-sac of the conjunctiva, forty minutes prior to the intended maximal dilation time. 2.2 In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed. In individuals from three (3) months of age or greater 1 drop topically to the cul-de-sac of the conjunctiva, forty minutes prior to the intended maximal dilation time ( 2.1 ) In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed. ( 2.2 )

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

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 ) Increased adverse drug reaction susceptibility with certain central nervous system conditions ( 5.3 ) 5.1 Photophobia and Blurred Vision Photophobia and blurred vision due to pupil unresponsiveness and cycloplegia may last up to 2 weeks. 5.2 Elevation 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%. 5.3 Increased Adverse Drug Reaction Susceptibility with Certain Central Nervous System Conditions Individuals with Down syndrome, spastic paralysis, or brain damage are particularly susceptible to central nervous system disturbances, cardiopulmonary, and gastrointestinal toxicity from systemic absorption of atropine.

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

6 ADVERSE REACTIONS The following adverse reactions are described below and elsewhere in the labeling: Photophobia and Blurred Vision [see Warnings and Precautions (5.1) ] Elevation in Blood Pressure [see Warnings and Precautions (5.2) ] Increased Adverse Drug Reaction Susceptibility with Certain Central Nervous System Conditions [see Warnings and Precautions (5.3) ] The following adverse reactions have been identified following use of atropine sulfate ophthalmic solution. 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. The most common adverse reactions that have been reported are eye pain and stinging on administration, blurred vision, photophobia, superficial keratitis, decreased lacrimation, drowsiness, increased heart rate and blood pressure. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc., at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Ocular Adverse Reactions Eye pain and stinging occurs upon instillation of atropine sulfate ophthalmic solution. Other commonly occurring adverse reactions include blurred vision, photophobia, superficial keratitis and decreased lacrimation. Allergic reactions such as papillary conjunctivitis, contact dermatitis, and eyelid edema may also occur less commonly. 6.2 Systemic Adverse Reactions Systemic effects of atropine are related to its anti-muscarinic activity. Systemic adverse events reported include dryness of skin, mouth, and throat from decreased secretions from mucus membranes; drowsiness; restlessness, irritability or delirium from stimulation of the central nervous system; tachycardia; flushed skin of the face and neck.

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with ISOPTO® Atropine 1% administration in pregnant women to inform a drug-associated risk. Adequate animal development and reproduction studies have not been conducted with atropine sulfate. In humans, 1% atropine sulfate is systemically bioavailable following topical ocular administration [see Clinical Pharmacology (12.3) ] . ISOPTO® Atropine 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.