Included as part of the "PRECAUTIONS" Section
Photophobia And Blurred Vision
Photophobia and blurred vision due to pupil unresponsiveness and cycloplegia may last up to 2 weeks.
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
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.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Atropine sulfate was negative in the Salmonella/microsome mutagenicity test. Studies to evaluate carcinogenicity and impairment of fertility have not been conducted.
Use In Specific Populations
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]. ISOPTO® Atropine 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
There is no information to inform risk regarding the presence of atropine in human milk following ocular administration of ISOPTO® Atropine 1% to the mother. The effects on breastfed infants and the effects on milk production are also unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ISOPTO® Atropine 1% and any potential adverse effects on the breastfed child from ISOPTO® Atropine 1%.
Due to the potential for systemic absorption of atropine sulfate ophthalmic solution the use of ISOPTO® Atropine 1% in children under the age of 3 months is not recommended and the use in children under 3 years of age should be limited to no more than one drop per eye per day. Safety and efficacy in children above the age of 3 months has been established in adequate and well controlled trials.
No overall differences in safety or effectiveness have been observed between elderly and adult patients.