Mydcombi®
Tropicamide 1% / Phenylephrine 2.5% · ophthalmic spray
Mydriatics/Cycloplegics
Approved uses
Mydriasis for diagnostic procedures
One metered spray to the cornea of each eye to be dilated, repeated after 5 minutes.
Dilation begins in 15 to 30 minutes, is maximal at 20 to 90 minutes, and recovers in 3 to 8 hours.
Pupillary dilation in children
One metered spray per eye repeated after 5 minutes; younger than 1 year, one metered spray per eye to a maximum of 3 sprays per eye per day.
In children the spray widens pupils 2.48 mm, matching standard drops.
Contraindications
Known hypersensitivity to any component of the formulation.
Available FormsOne-cartridge carton, box with one cartridge plus one dispenser base, five-cartridge box, 2 mL cartridge holding approximately 180 metered sprays, tropicamide 1% / phenylephrine HCl 2.5%, 0.008 mL per spray delivering 0.08 mg and 0.2 mg respectively, cartridge works only with the matching dispenser base
Mechanism of ActionFixed combination of an anticholinergic, tropicamide, which blocks the response of the iris sphincter muscle to dilate the pupil, and an alpha-1 adrenergic agonist, phenylephrine, which contracts the iris dilator muscle. Onset 15 to 30 minutes, maximal mydriasis at 20 to 90 minutes, spontaneous recovery in 3 to 8 hours and up to 24 hours in some patients.
Warnings & Precautions
- Blood pressure elevation: Caution in pediatric patients under 5 years of age and in hyperthyroidism or cardiovascular disease; monitor post-treatment blood pressure in cardiac and endocrine disease and in anyone who develops symptoms.
- CNS disturbances: The tropicamide component may cause CNS disturbances that may be dangerous in pediatric patients, including psychotic reactions and behavioral disturbances from anticholinergic hypersensitivity.
- Intraocular pressure elevation: Mydriatics may produce a transient rise.
- Rebound miosis: Reported one day after an alpha-1 agonist ophthalmic solution, with a lesser mydriatic effect on re-administration.
- Pressor response interactions: Phenylephrine may enhance the pressor effect of atropine-like drugs and induce tachycardia, and may potentiate the cardiovascular depressant effects of some inhalation anesthetics.
- Cholinergic drug interference: May interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
- Route restriction: Topical ophthalmic use only, not for injection.
Common Side Effects
- Ocular, incidence under 2%: Transient blurred vision, reduced visual acuity, photophobia, mild eye discomfort.
- Ocular, additional: Superficial punctate keratitis; increased intraocular pressure reported following mydriatics.
- Systemic: Dry mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, CNS disturbances, muscle rigidity reported with tropicamide.
- Marked blood pressure increase: Reported with phenylephrine, particularly but not limited to low weight premature neonates, infants, and hypertensive patients.
- Anticholinergic class effects: Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children.
Pregnancy & LactationPregnancy: No data in pregnant women or in animals to inform drug-associated risk; give only if clearly needed.
Lactation: No data on presence in human milk, effects on the breastfed infant, or effects on milk production.
Pediatric UseLabeled dosing extends below 1 year of age (maximum 3 sprays per eye per day); rare CNS disturbances may be dangerous in children.