Isopto Atropine Ophthalmic Solution

ISOPTO® Atropine 1% is indicated for:

Mydriasis

Cycloplegia

Penalization of the healthy eye in the treatment of amblyopia

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.

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.

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.

Monoamine Oxidase Inhibitors

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

ISOPTO® Atropine 1% is supplied sterile in low-density polyethylene plastic DROP-TAINER® dispensers with low-density polyethylene tips and red polypropylene caps as follows:

• 5 mL filled in 8-mL bottles             NDC 0065-0303-55
• 15 mL filled in 15-mL bottles         NDC 0065-0303-15

Storage: Store ISOPTO® Atropine 1% at 2–25°C (36–77°F).