Atropine (ophthalmic)

FDA label, Alcon Laboratories, Inc., ophthalmic, effective 2026-03-13. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Drug interactions

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Label text (2 paragraphs)

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.

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 )

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with Atropine Sulfate Ophthalmic Solution, 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 )] . Atropine Sulfate Ophthalmic Solution, 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Lactation

8.2 Lactation There is no information to inform risk regarding the presence of atropine in human milk following ocular administration of Atropine Sulfate Ophthalmic Solution, 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 Atropine Sulfate Ophthalmic Solution, 1% and any potential adverse effects on the breastfed child from Atropine Sulfate Ophthalmic Solution, 1%.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

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