Indication

MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1% / 2.5% ophthalmic spray is indicated to induce mydriasis for routine diagnostic procedures and in conditions where short-term pupil dilation is desired.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: Known hypersensitivity to any component of the formulation

WARNINGS AND PRECAUTIONS

Not for Injection: Topical ophthalmic use

Significant Elevations in Blood Pressure: Caution in pediatric patients less than 5 years of age, and in patients with cardiovascular disease or hyperthyroidism. In patients at high risk, monitor blood pressure post treatment

Central Nervous System Disturbances: Caution in pediatric patients where rare incidences of central nervous system disturbances have been reported

Intraocular Pressure: May produce a transient elevation

Rebound Miosis: Reported 1 day after administration

DRUG INTERACTIONS

Atropine-like Drugs: May exaggerate the adrenergic pressor response

Cholinergic Agonists and Ophthalmic Cholinesterase Inhibitors: May interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors

Potent Inhalation Anesthetic Agents: May potentiate cardiovascular depressant effects of some inhalation anesthetic agents

ADVERSE REACTIONS

• Most common ocular adverse reactions include transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort. Increased intraocular pressure has been reported following the use of mydriatics
• Systemic adverse reactions including dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide

To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 www.fda.gov/medwatch