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Tropicamide: Pediatric drug information

Tropicamide: Pediatric drug information
(For additional information see "Tropicamide: Drug information" and see "Tropicamide: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Mydriacyl
Brand Names: Canada
  • Minims Tropicamide;
  • Mydriacyl;
  • Odan-Tropicamide
Therapeutic Category
  • Ophthalmic Agent, Mydriatic
Dosing: Neonatal

Note: Individuals with heavily pigmented eyes may require higher strength or additional doses.

Mydriasis

Mydriasis: Ophthalmic: (0.5%): Instill 1 drop 15 to 20 minutes prior to exam

Dosing: Pediatric

Note: Individuals with heavily pigmented eyes may require higher strength or additional doses.

Cycloplegia

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

Mydriasis: Infants, Children, and Adolescents: Ophthalmic (0.5%): Instill 1 to 2 drops (0.5%) 15 to 20 minutes before exam

Dosing: Kidney 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.

Dosing: Adult

(For additional information see "Tropicamide: Drug information")

Note: Individuals with heavily pigmented eyes may require higher strength or additional doses. Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.

Cycloplegia

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

Mydriasis: Ophthalmic: Instill 1 to 2 drops (0.5%) in the eye(s) 15 to 20 minutes before exam.

Dosing: Kidney 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.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Postmarketing:

Cardiovascular: Tachycardia

Dermatologic: Pallor

Gastrointestinal: Nausea, vomiting, xerostomia

Hypersensitivity: Anaphylaxis (Sefi-Yurdakul 2021), hypersensitivity reaction

Nervous system: Central nervous system dysfunction, headache

Neuromuscular & skeletal: Muscle rigidity

Ophthalmic: Blurred vision, photophobia, stinging of eyes (transient), superficial punctate keratitis

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).

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.

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).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic:

Mydriacyl: 1% (15 mL)

Generic: 0.5% (15 mL); 1% (2 mL, 3 mL, 15 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Mydriacyl Ophthalmic)

1% (per mL): $8.01

Solution (Tropicamide Ophthalmic)

0.5% (per mL): $1.67 - $1.78

1% (per mL): $2.38 - $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.

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 (edta) disodium]

Generic: 1% (0.5 mL, 15 mL)

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 (Ref). Wash hands following administration.

Administration: Adult

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.

Storage/Stability

Store at 8°C to 27°C (46°F to 80°F). Do not refrigerate or store at high temperatures. Avoid freezing.

Use

For mydriasis and cycloplegia in diagnostic procedures (FDA approved in pediatric patients [age not specified] and adults)

Metabolism/Transport Effects

None known.

Drug Interactions

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.

Carbachol: Tropicamide may diminish the therapeutic effect of Carbachol. Risk C: Monitor therapy

Echothiophate Iodide: Tropicamide may diminish the therapeutic effect of Echothiophate Iodide. Risk C: Monitor therapy

Pilocarpine (Ophthalmic): Tropicamide may diminish the therapeutic effect of Pilocarpine (Ophthalmic). Risk C: Monitor therapy

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).

Monitoring Parameters

Ophthalmic exam, intraocular pressure, CNS reactions (especially in pediatric patients)

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.

Pharmacokinetics (Adult Data Unless Noted)

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Mydriacyl | Mydriaticum;
  • (AR) Argentina: Alcon mydril | Midriaticum;
  • (AT) Austria: Mydriaticum;
  • (AU) Australia: Mydriacyl;
  • (BD) Bangladesh: Camide | Eyetrop | Mydriacyl | Mydriaticum | Mydrimide | Stamide | Tropicamin | Tropigen | Trusil;
  • (BE) Belgium: Mydriacyl | Tropicol;
  • (BG) Bulgaria: Mydrum | Tropicamid vision | Unitropic;
  • (BR) Brazil: Ciclomidrin | Mydriacyl | Tropinom;
  • (CL) Chile: Isopto Mydriacyl;
  • (CN) China: Mydrin-m | Run zheng | Shuang xing ming | Tropicamide co.;
  • (CO) Colombia: Mydriacyl | Oftamida;
  • (CZ) Czech Republic: Mydriacyl | Mydrum | Unitropic;
  • (DE) Germany: Mydriaticum stulln | Mydrum;
  • (DO) Dominican Republic: Mydriacyl;
  • (EC) Ecuador: Mydryacil | Tropicamida;
  • (EE) Estonia: Mydriacyl | Mydriaticum agepha | Tropicamid | Unitropic;
  • (EG) Egypt: Medrapide | Mydrapid | Mydriacyl | Mydriamex;
  • (ES) Spain: Colircusi Tropicamida;
  • (ET) Ethiopia: Mydriacyl | Tropicil top;
  • (FI) Finland: Oftan-tropicamid;
  • (FR) France: Mydriaticum;
  • (GB) United Kingdom: Mydriacyl;
  • (GR) Greece: Tropixal;
  • (HK) Hong Kong: Mydriacyl;
  • (HU) Hungary: Mydriacyl | Mydrum | Unitropic;
  • (ID) Indonesia: Midric | Mydriacil | Mydriatyl;
  • (IE) Ireland: Mydriacyl;
  • (IL) Israel: Mydramide;
  • (IN) India: Ahlmide | Meptrop | Optimide | Picamid | Tmide | Triocyl | Tromide | Tropac | Trophtha | Tropia | Tropicacyl | Tropicamet | Tropicon | Tropind;
  • (IT) Italy: Tropimil | Visumidriatic;
  • (JO) Jordan: Mydriacyl;
  • (JP) Japan: Mydrin-m | Sandol | Sandol my;
  • (KE) Kenya: Mydriacyl;
  • (KR) Korea, Republic of: Mydriacyl | Ocutropic;
  • (KW) Kuwait: Mydriacyl | Mydriaticum;
  • (LB) Lebanon: Miotrop | Mydriacyl | Mydriaticum | Tropicil top;
  • (LT) Lithuania: Mydriacyl | Mydrum | Tropicacyl | Tropicamid;
  • (LU) Luxembourg: Tropicol;
  • (LV) Latvia: Mydriacyl | Mydriaticum stulln | Mydrum | Tropicamidum wzf | Tropicil top;
  • (MX) Mexico: Icafrine | Myriacyl alcon | Tropicamida;
  • (MY) Malaysia: Colircusi Tropicamida | Mydriacyl;
  • (NO) Norway: Mydriacyl | Mydrian | Mydrum | Tropikamid minims | Visumidriatic;
  • (NZ) New Zealand: Mydriacyl;
  • (PE) Peru: Midilar t | Mydriacyl | Tropicacyl | Tropicamida;
  • (PH) Philippines: Mydriacyl;
  • (PK) Pakistan: Mydolate | Mydrex | Mydriacyl | Mydriaticum | Mydromide | Mydropic | Oculacil | Ophth-Dilate | Tromid | Tropic | Tropicafin | Tropix;
  • (PL) Poland: Mydriacyl | Mydrum | Tropicamidum;
  • (PR) Puerto Rico: Mydriacyl | Tropicacyl;
  • (PT) Portugal: Tropicil;
  • (PY) Paraguay: Alcon mydril;
  • (QA) Qatar: Minims Tropicamide | Mydriacyl;
  • (RO) Romania: Tropicamida | Tropicamida rompharm | Tropixal;
  • (RU) Russian Federation: Midriatikum stulln pu | Mydriacyl | Mydrum | Tropicam | Tropicamid | Tropicamide solopharm;
  • (SA) Saudi Arabia: Eymid | Mydriacyl | Mydriaticum;
  • (SE) Sweden: Mydriacyl;
  • (SG) Singapore: Minims tropicamide | Mydriacyl | Triacyl;
  • (SI) Slovenia: Mydriacyl | Tropicil top | Unitropic;
  • (SK) Slovakia: Mydriacyl | Mydrum | Unitropic;
  • (TH) Thailand: Mydriacyl;
  • (TN) Tunisia: Mydriaticum | Mydricol;
  • (TR) Turkey: Mydriacyl | Tropamid;
  • (TW) Taiwan: Better | Losemin | Mydriacyl | Mydrin-m | Picon | Sintropic | Stomide | Stropin | Topimide | Tropin;
  • (UA) Ukraine: Mydriacyl | Tropicamet | Tropicamid | Unitropic;
  • (UY) Uruguay: Alcon mydril;
  • (VE) Venezuela, Bolivarian Republic of: Mydriacyl | Mydrox;
  • (ZA) South Africa: Mydriacyl | Mydriaticum;
  • (ZM) Zambia: Mydriacyl
  1. 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):166-173. [PubMed 15977870]
  2. Mydriacyl (tropicamide) [prescribing information]. Fort Worth, TX: Alcon Laboratories Inc; April 2018.
  3. Mydriacyl (tropicamide) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; November 2017.
  4. Samples JR, Meyer SM. Use of Ophthalmic Medications in Pregnant and Nursing Women. Am J Ophthalmol. 1988;106(5):616-623. [PubMed 2903673]
  5. Sefi-Yurdakul N, Sancakli Ö. Tropicamide and anaphylaxis: a case report. Saudi J Ophthalmol. 2021;35(1):71-72. doi:10.4103/1319-4534.325779 [PubMed 34667937]
  6. Tropicamide 0.5% and 1% ophthalmic solution [prescribing information]. Bridgewater, NJ: Bausch & Lomb Inc; July 2016.
  7. Tropicamide 1% ophthalmic solution [prescribing information]. Hollywood, FL: Somerset Therapeutics LLC; August 2019.
  8. Urtti A, Salminen L. Minimizing systemic absorption of topically administered ophthalmic drugs. Surv Ophthalmol. 1993;37(6):435-456. [PubMed 8100087]
  9. 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]
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