Embedded Files
Pharmacologic Category
Dosing: Adult
Note: Individuals with heavily pigmented eyes may require higher strength or additional doses:
Cycloplegia: Ophthalmic: Instill 1 to 2 drops (1%) in the eye(s); repeat in 5 minutes. If the patient is not examined within 20 to 30 minutes, instill an additional drop to prolong effect.
Mydriasis: Ophthalmic: Instill 1 to 2 drops (0.5%) in the eye(s) 15 to 20 minutes before exam
* See Dosage and Administration in AHFS Essentials for additional information.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
There are no dosage adjustments provided in the manufacturer’s labeling.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments provided in the manufacturer’s labeling.
Dosing: Pediatric
Note: Individuals with heavily pigmented eyes may require higher strength or additional doses.
Cycloplegia: Infants, Children, and Adolescents: Ophthalmic (1%): Instill 1 to 2 drops; repeat in 5 minutes. If the patient is not examined within 20 to 30 minutes, instill an additional drop to prolong effect.
Mydriasis: Infants, Children, and Adolescents: Ophthalmic (0.5%): Instill 1 to 2 drops (0.5%) 15 to 20 minutes before exam
Dosing: Renal Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling.
Use: Labeled Indications
Mydriasis/Cycloplegia: For mydriasis and cycloplegia in diagnostic procedures
* See Uses in AHFS Essentials for additional information.
Class and Related Monographs
Administration: Ophthalmic
For topical ophthalmic use only. Remove contact lenses prior to instillation. To avoid excessive systemic absorption, apply gentle finger pressure to lacrimal sac for 2 to 3 minutes following application. Do not touch dropper tip to eyelids or any surface. Wash hands following administration.
Administration: Pediatric
Ophthalmic: For topical ophthalmic use only. Remove contact lenses prior to instillation. Do not touch dropper tip to eyelids or any surface. Apply gentle pressure to lacrimal sac during and immediately following instillation (1 minute) or instruct patient to gently close eyelid after administration, to decrease systemic absorption of ophthalmic drops (Urrti 1993; Zimmerman 1982). Wash hands following administration.
Storage/Stability
Store at 8°C to 27°C (46°F to 80°F). Do not refrigerate or store at high temperatures.
Medication Patient Education with HCAHPS Considerations
What is this drug used for?
• It is used before an eye exam.
Frequently reported side effects of this drug
• Stinging
• Eye irritation
• Blurred vision
• Sensitivity to lights
• Dry mouth
• Headache
• Vomiting
• Nausea
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
• Eye pain
• Fast heartbeat
• Mood changes
• Behavioral changes
• Pale skin
• Stiff muscles
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Contraindications
Hypersensitivity to tropicamide or any component of the formulation.
Canadian labeling: Additional contraindications (not in US labeling): Known or suspected narrow angle glaucoma; small infants (<3 months of age).
Documentation of allergenic cross-reactivity for belladonna alkaloids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Warnings/Precautions
Concerns related to adverse effects:
• CNS effects: May cause drowsiness and/or blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).
• Increased intraocular pressure: May cause a transient increase in intraocular pressure.
Special populations:
• Contact lens wearers: Contains benzalkonium chloride, which may be absorbed by soft contact lenses; remove lenses prior to administration.
• 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.
Other warnings/precautions:
• Appropriate use: For topical ophthalmic use only. Remove contact lenses prior to administration. To avoid excessive systemic absorption, apply gentle finger pressure to lacrimal sac for 2 to 3 minutes following application. Do not touch dropper tip to eyelids or any surface.
* See Cautions in AHFS Essentials for additional information.
Warnings: Additional Pediatric Considerations
May cause increased blood pressure in premature neonates: The use of tropicamide 1% solution in combination with phenylephrine has been associated with significant increases in mean blood pressure (Chew 2005).
Pregnancy Considerations
Animal reproduction studies have not been conducted. If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples 1988).
Breast-Feeding Considerations
It is not known if tropicamide is excreted in breast milk. The manufacturer recommends that caution be used if administered to nursing women.
Briggs' Drugs in Pregnancy & Lactation
Adverse Reactions
Frequency not defined.
Cardiovascular: Central nervous system dysfunction, tachycardia
Central nervous system: Headache
Dermatologic: Pallor
Gastrointestinal: Nausea, vomiting, xerostomia
Hypersensitivity: Hypersensitivity reaction
Neuromuscular & skeletal: Muscle rigidity
Ophthalmic: Blurred vision, photophobia, stinging of eyes (transient), superficial punctate keratitis
* See Cautions in AHFS Essentials for additional information.
Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects
None known.
Drug Interactions Open Interactions
There are no known significant interactions.
Monitoring Parameters
Ophthalmic exam, intraocular pressure, CNS reactions (especially in pediatric patients).
Dosage Forms: US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Ophthalmic:
Mydriacyl: 1% (3 mL [DSC], 15 mL)
Generic: 0.5% (15 mL); 1% (2 mL, 3 mL, 15 mL)
Dosage Forms: Canada
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic:
Mydriacyl: 0.5% (15 mL); 1% (15 mL) [contains benzalkonium chloride, edetate disodium]
Generic: 0.5% (15 mL); 1% (0.3 mL, 0.5 mL, 15 mL)
Anatomic Therapeutic Chemical (ATC) Classification
- S01FA06
Generic Available (US)
Yes
Pricing: US
Solution (Mydriacyl Ophthalmic)
1% (per mL): $6.70
Solution (Tropicamide Ophthalmic)
0.5% (per mL): $0.67 - $1.78
1% (per mL): $0.71 - $3.17
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Mechanism of Action
Prevents the sphincter muscle of the iris and the muscle of the ciliary body from responding to cholinergic stimulation; produces dilation and prevents accommodation.
Pharmacodynamics/Kinetics
Onset of action: Cycloplegic effect: Peak: 20 to 35 minutes; Mydriatic effect: ~20 to 40 minutes
Duration: Cycloplegic effect: <6 hour; Mydriatic effect: ~6 to 7 hours
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Dryness of mouth.
Effects on Bleeding
No information available to require special precautions
Index Terms
Bistropamide
FDA Approval Date
August 09, 1982
References
Caputo AR and Schnitzer RE, “Systemic Response to Mydriatic Eyedrops in Neonates: Mydriatics in Neonates,” J Pediatr Ophthalmol Strabismus, 1978, 15(2):109-22.[PubMed 368306]
Chew C, Rahman RA, Shafie SM, et al, "Comparison of Mydriatic Regimens Used in Screening for Retinopathy of Prematurity in Preterm Infants With Dark Irides," J Pediatr Ophthalmol Strabismus, 2005, 42(3):166-73.[PubMed 15977870]
Mydriacyl (tropicamide) [prescribing information]. Fort Worth, TX: Alcon Laboratories Inc; April 2018.
Mydriacyl (tropicamide) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; November 2017.
Samples JR and Meyer SM, "Use of Ophthalmic Medications in Pregnant and Nursing Women," Am J Ophthalmol, 1988, 106(5):616-23.[PubMed 2903673]
Tropicamide [prescribing information]. Princeton, NJ: Sandoz Inc; November 2011.
Tropicamide ophthalmic solution [prescribing information]. Lake Forest, IL: Akorn, Inc.; April 2012.
Urtti A, Salminen L. Minimizing systemic absorption of topically administered ophthalmic drugs. Surv Ophthalmol. 1993;37(6):435-456.[PubMed 8100087]
Zimmerman TJ, Kooner KS, Kandarakis AS, Ziegler LP. Improving the therapeutic index of topically applied ocular drugs. Arch Ophthalmol. 1984;102(4):551-553.[PubMed 6704011]
Brand Names: International
Alcon-Mydril (AR, PY, UY); Colircusi Tropicamida (ES); Dilate (BD); Eyetrop (BD); Losemin (TW); Midric (ID); Minims Tropicamide (GB); Mydramide (IL); Mydrapid (EG); Mydriacyl (AE, AU, BB, BE, BF, BH, BJ, BR, CI, CL, CO, CY, DK, EE, EG, ET, GB, GH, GM, GN, HK, HU, IQ, IR, IS, JO, KE, KR, KW, LB, LK, LR, LT, LV, LY, MA, ML, MR, MT, MU, MW, MY, NE, NG, NZ, OM, PE, PH, PK, PL, QA, RO, RU, SA, SC, SD, SE, SG, SI, SL, SN, SY, TH, TN, TW, TZ, UG, VE, VN, YE, ZA, ZM, ZW); Mydriaticum (AT, CH, DE, FR, LU, NL); Mydrin-M (JP); Mydromide (LK); Mydrum (CZ, HN, HU); Oftan Mydrin (PL); Oftan-tropicamid (FI); Runzheng (CN); Sintropic (TW); Topimide (TW); Tropamid (TR); Tropicam (BD); Tropicamet (IN); Tropicamid (BG); Tropicamidum (PL); Tropicil (LB); Tropicil Top (ET); Tropicol (BE, LU, PT); Tropikacil (PE); Tropikamid (HR, NO); Tropimil (IT, MT); Tropixal (GR, JO); Trusil (BD); Visumidriatic (IT)
Last Updated 3/24/20
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