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  • CLASSES

    Mydriatics and Cycloplegics

    DEA CLASS

    Rx

    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:
    - Avoid extreme temperatures
    - Do not refrigerate
    - Protect from freezing
    - Store between 46 to 80 degrees F
    Mydriacyl:
    - Avoid extreme temperatures
    - Do not refrigerate
    - Protect from freezing
    - Store between 46 to 80 degrees F
    Ocu-Tropic:
    - Avoid extreme temperatures
    - Do not refrigerate
    - Protect from freezing
    - Store between 46 to 80 degrees F
    Ophthalmicmyd:
    - Avoid extreme temperatures
    - Do not refrigerate
    - Protect from freezing
    - Store between 46 to 80 degrees F
    Tropicacyl :
    - Avoid extreme temperatures
    - Do not refrigerate
    - Protect from freezing
    - Store between 46 to 80 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.