CLASSES
Mydriatics and Cycloplegics
DESCRIPTION
Ophthalmic cycloplegic and mydriatic agent
Used for cycloplegic refraction and for dilating the pupil for diagnostic purposes
Contraindicated for use in glaucoma
COMMON BRAND NAMES
Mydral, Mydriacyl, Ocu-Tropic, Ophthalmicmyd, Tropicacyl
HOW SUPPLIED
Mydral/Mydriacyl/Ocu-Tropic/Ophthalmicmyd/Tropicacyl/Tropicamide Ophthalmic Sol: 0.5%, 1%
DOSAGE & INDICATIONS
For cycloplegia induction for refraction.
NOTE: Heavily pigmented irises may require larger doses than lightly pigmented irises.
Ophthalmic dosage
Adults, Adolescents, and Children
Instill 1 or 2 drops of a 1% solution into the eye(s), then repeat in 5 minutes. If the patient has not been seen within 20 to 30 minutes, an additional drop to prolong mydriasis may be used.
For mydriasis induction for examination of the fundus.
NOTE: Heavily pigmented irises may require larger doses than lightly pigmented irises.
Ophthalmic dosage
Adults, Adolescents, and Children
Instill 1 or 2 drops of a 0.5% solution 15 to 20 minutes before examination.
MAXIMUM DOSAGE
Adults
1% solution: 5 drops/day/eye.
0.5% solution: 2 drops/day/eye
Geriatric
1% solution: 5 drops/day/eye.
0.5% solution: 2 drops/day/eye
Adolescents
1% solution: 5 drops/day/eye.
0.5% solution: 2 drops/day/eye
Children
1% solution: 5 drops/day/eye.
0.5% solution: 2 drops/day/eye
Infants
Safety and efficacy have not been established.
Neonates
Safety and efficacy have not been established.
DOSING CONSIDERATIONS
Hepatic Impairment
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Renal Impairment
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
STORAGE
Mydral:
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Mydriacyl:
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Ocu-Tropic:
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Ophthalmicmyd:
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Tropicacyl :
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
CONTRAINDICATIONS / PRECAUTIONS
General Information
Tropicamide is contraindicated in patients with a hypersensitivity to any component of the formulation. Hypersensitivity to anticholinergics may result in behavioral disturbances and psychotic reactions.
Tropicamide ophthalmic solution is for topical use only and should never be injected.
Closed-angle glaucoma, glaucoma
Tropicamide is contraindicated in patients with primary glaucoma or a tendency toward narrow angle glaucoma (closed-angle glaucoma). An estimation of the depth of the angle of the anterior chamber should be made prior to the administration of tropicamide to avoid inducing closed-angle glaucoma.[42357]
Contact lenses
Tropicamide contains benzalkonium chloride, which may be absorbed by contact lenses. Users of soft contact lenses should not administer tropicamide while wearing these lenses.
Geriatric
No differences in safety or efficacy have been identified between geriatric and younger patients. However, increased intraocular pressure may be present in the elderly.
Children, infants, neonates
Use tropicamide cautiously in children. The risk of precipitating CNS disturbances in children is possible with the use of tropicamide. Psychotic reactions, behavioral disturbances, and cardiorespiratory collapse have been reported in children being treated with anticholinergics. The safety and efficacy of tropicamide have not been established in infants and neonates.[42357]
Pregnancy
It is unknown if tropicamide can cause fetal harm when administered during pregnancy or if it can affect reproductive capacity. Therefore, administer tropicamide to a pregnant woman only if clearly needed.
Breast-feeding
It is not known whether tropicamide is excreted in human milk.[42356] Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
ADVERSE REACTIONS
Severe
keratitis / Delayed / Incidence not known
Moderate
photophobia / Early / Incidence not known
blurred vision / Early / Incidence not known
sinus tachycardia / Rapid / Incidence not known
Mild
headache / Early / Incidence not known
xerostomia / Early / Incidence not known
pallor / Early / Incidence not known
vomiting / Early / Incidence not known
nausea / Early / Incidence not known
DRUG INTERACTIONS
There are no drug interactions associated with Tropicamide products.
PREGNANCY AND LACTATION
Pregnancy
It is unknown if tropicamide can cause fetal harm when administered during pregnancy or if it can affect reproductive capacity. Therefore, administer tropicamide to a pregnant woman only if clearly needed.
It is not known whether tropicamide is excreted in human milk.[42356] Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
MECHANISM OF ACTION
Tropicamide has an anticholinergic effect that blocks the responses of the iris sphincter muscle and the ciliary body muscle to cholinergic stimulation, resulting in mydriasis. The 0.5% solution may be useful for producing mydriasis with little cycloplegia. Administration of the 1% solution also paralyzes accommodation.[42357]
PHARMACOKINETICS
Tropicamide is administered ophthalmically.
Other Route(s)
Ophthalmic route The 1% tropicamide solution has a rapid onset of action producing the maximum mydriatic and cycloplegic effects within 15-60 minutes following topical application to the eye. The duration of both effects is normally 3-8 hours. However, mydriasis may persist for 24 hours in selected patients.