Indications
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
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 )
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 )
5.1Photophobia 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%.
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.
Interactions
The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis. ( 7 )
At a glance
- Brand name
- Isopto Atropine
- Active substance
- atropine sulfate
- Route
- Eye
- Dosage form
- Solution/drops
- Applicant
- Alcon Labs Inc
- Status
- Prescription
- FDA approval
- 1 Dec 2016
- Application
- NDA208151-001



