Isopto Atropine

ISOPTO^® Atropine 1% is indicated for:

Ophthalmic solution: 1% atropine sulfate (10mg/mL)

The following adverse reactions are described below and elsewhere in the labeling:

• Photophobia and Blurred Vision
  [see

  5.1 Photophobia and Blurred Vision

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

  ]
• Elevation in Blood Pressure
  [see

  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%.

  ]
• Increased Adverse Drug Reaction Susceptibility with Certain Central Nervous System Conditions
  [see

  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.

  ]

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.

ISOPTO® Atropine 1% is  a sterile topical ophthalmic solution. Each mL of ISOPTO® Atropine 1% contains 10 mg of atropine sulfate monohydrate equivalent to 9.7 mg/mL of atropine sulfate or 8.3 mg of atropine. Atropine sulfate monohydrate is designated chemically as benzeneacetic acid, α-(hydroxymethyl)-,8-methyl-8-aza-bicyclo-[3.2.1]oct-3-yl ester,

Atropine sulfate monohydrate is colorless crystals or white crystalline powder and has a molecular weight of 694.83.

ISOPTO® Atropine 1% has a pH of 3.5 to 6.0.

Active ingredient: atropine sulfate monohydrate 1.0%

Preservative: benzalkonium chloride 0.01%