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warnings and cautions
5 WARNINGS AND PRECAUTIONS Not for Injection : Topical ophthalmic use ( 5.1 ) 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 ( 5.2 ) Central Nervous System Disturbances : Caution in pediatric patients where rare incidences of central nervous system disturbances have been reported ( 5.3 ) Intraocular Pressure : May produce a transient elevation ( 5.4 ) Rebound Miosis : Reported 1 day after administration ( 5.5 ) 5.1 Topical Ophthalmic Use MYDCOMBI is not indicated for injection. 5.2 Blood Pressure Elevation Caution should be exercised with the use of MYDCOMBI in pediatric patients less than 5 years of age and patients with hyperthyroidism, or cardiovascular disease. The post-treatment blood pressure of patients with cardiac and endocrine diseases and any patients who develop symptoms should be carefully monitored. 5.3 Central Nervous System Disturbances Tropicamide in MYDCOMBI may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered. 5.4 Intraocular Pressure Mydriatics may produce a transient elevation of intraocular pressure. 5.5 Rebound Miosis Rebound miosis has been reported one day after receiving phenylephrine hydrochloride ophthalmic solution, and re-administration of the drug produced a lesser mydriatic effect.
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (incidence < 2%) were transient blurred vision, reduced visual acuity, photophobia, and mild eye discomfort. 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 ( 6.1 ) 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 ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. at 1-833-393-6684 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Ocular Adverse Reactions Transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort may occur. Increased intraocular pressure has been reported following the use of mydriatics. 6.2 Systemic Adverse Reactions 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. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs. A marked increase in blood pressure has been reported with the use of phenylephrine, particularly, but not limited to, low weight premature neonates, infants, and hypertensive patients.