Version May 2024
Note: Individuals with heavily pigmented eyes may require additional doses. Mydriasis will reverse spontaneously with time, typically in 3 to 8 hours; however, in some cases, complete recovery may take up to 24 hours.
Mydriasis: Ophthalmic: Instill 1 spray into the cornea(s); repeat in 5 minutes.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Tropicamide and phenylephrine: Pediatric drug information")
Mydriasis:
Infants: Ophthalmic: Administer 1 spray to the cornea of each eye to be dilated; may repeat if indicated; time to repeat dosing is not defined; in children and adolescents, a dose may be repeated after 5 minutes; maximum daily dose: 3 sprays per eye/day.
Children and Adolescents: Ophthalmic: Administer 1 spray to the cornea of each eye to be dilated; repeat after 5 minutes.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see individual agents.
1% to 10%: Ophthalmic: Decreased visual acuity (<2%), eye discomfort (<2%), photophobia (<2%), transient blurred vision (<2%)
Hypersensitivity to tropicamide, phenylephrine, or any component of the formulation.
Concerns related to adverse effects:
• Increased intraocular pressure: May cause a transient increase in intraocular pressure.
• Rebound miosis: Has been reported 1 day after phenylephrine treatment; reinstallation of the drug produced a lesser effect.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with cardiovascular disease; may elevate BP.
• Hyperthyroidism: Use with caution in patients with hyperthyroidism; may elevate BP.
Special populations:
• Pediatric: Use with caution in infants and children; may cause potentially dangerous CNS disturbances. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs. Use with caution in patients <5 years of age; may elevate BP.
Other warnings/precautions:
• Appropriate use: For topical ophthalmic use only. Not for injection.
May cause a significant increase in blood pressure; the risk is increased in pediatric patients <5 years and in patients with hyperthyroidism or cardiovascular disease. Use with caution in these patient groups and monitor closely.
Mydcombi: FDA approved May 2023; anticipated availability currently unknown.
Ophthalmic: For topical ophthalmic use only; not for injection. Load the dispenser by depressing the fill button once. Hold the dispenser with thumb over mist button, while wrapping fingers around the base. Bring dispenser to patient's eye with mirror facing the patient; the dispenser should be as close as the patient's nose; gently pull lower eyelid down to prevent blinking. Align the mist opening with the center of the eye then press and release the mist button.
Ophthalmic spray: Topical: For topical ophthalmic use only; not for injection into the eye. If soft contacts are worn, remove ≥10 minutes before administering dose. Do not administer artificial tears within 10 minutes of administration.
Mydcombi: See instructions for use in manufacturer's labeling for details on assembling dispenser, cleaning procedure, and mist test. Wash hands prior to use. The exterior of the dispenser should be cleaned using 70% isopropyl alcohol prior to each use. A mist test should be performed daily before dosing begins. Press the fill button down to load drug solution into the dispenser. Once loaded, position the mist opening at the center of the eye making sure the alignment marks align with the center of the eye and the lower eyelid is positioned to avoid blinking; see manufacturer's labeling for detailed instructions. Once alignment has been confirmed, firmly press and release mist button. Repeat process for contralateral eye if it is to be dilated. If a second dose is indicated, wait 5 minutes and repeat process.
Mydriasis: To induce mydriasis for diagnostic procedures and conditions where short-term pupil dilation is desired.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Risk C: Monitor therapy
Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Atropine (Systemic): May enhance the hypertensive effect of Alpha1-Agonists. Risk C: Monitor therapy
Bromocriptine: May enhance the hypertensive effect of Alpha1-Agonists. Management: Consider alternatives to this combination when possible. If combined, monitor for hypertension and tachycardia, and do not coadminister these agents for more than 10 days. Risk D: Consider therapy modification
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Carbachol: Tropicamide may diminish the therapeutic effect of Carbachol. Risk C: Monitor therapy
Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider therapy modification
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy
Echothiophate Iodide: Tropicamide may diminish the therapeutic effect of Echothiophate Iodide. Risk C: Monitor therapy
Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): May enhance the vasoconstricting effect of Alpha1-Agonists. Risk X: Avoid combination
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy
Inhalational Anesthetics: Phenylephrine (Ophthalmic) may enhance the adverse/toxic effect of Inhalational Anesthetics. Specifically, the cardiovascular depressant effects of inhalational anesthetics may be increased. Risk C: Monitor therapy
Iobenguane Radiopharmaceutical Products: Alpha1-Agonists may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination
Levothyroxine: May enhance the adverse/toxic effect of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Levothyroxine may enhance the therapeutic effect of Sympathomimetics. Sympathomimetics may enhance the therapeutic effect of Levothyroxine. Risk C: Monitor therapy
Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider therapy modification
Lisuride: May enhance the hypertensive effect of Alpha1-Agonists. Risk X: Avoid combination
Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Alpha1-Agonists. While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Risk X: Avoid combination
Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy
Pergolide: May enhance the hypertensive effect of Alpha1-Agonists. Risk C: Monitor therapy
Pilocarpine (Ophthalmic): Tropicamide may diminish the therapeutic effect of Pilocarpine (Ophthalmic). Risk C: Monitor therapy
Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Tricyclic Antidepressants: May enhance the therapeutic effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the therapeutic effect of Alpha1-Agonists. Risk C: Monitor therapy
Animal reproduction studies have not been conducted.
Refer to individual monographs.
It is not known if tropicamide or phenylephrine are present in breast milk following ophthalmic administration.
According to the manufacturer, the decision to breastfeed should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Refer to individual monographs.
Ophthalmic exam, intraocular pressure, CNS reactions (especially in pediatric patients); BP post administration in patients with cardiac or endocrine disease or patients who develop symptoms.
Tropicamide: Prevents the sphincter muscle of the iris and the muscle of the ciliary body from responding to cholinergic stimulation; produces dilation and prevents accommodation.
Phenylephrine: Potent, direct-acting alpha-adrenergic agonist with virtually no beta-adrenergic activity; produces local vasoconstriction. When applied topically to the eye, phenylephrine stimulates the dilator muscle of the iris, resulting in mydriasis.
Note: Also see individual agents. Onset of action and duration of effect are partially dependent upon eye pigment; dark eyes have a prolonged onset of action and shorter duration than blue eyes.
Onset: 15 to 30 minutes; maximal mydriasis 20 to 90 minutes.
Duration: 3 to 8 hours.
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