Tropicamide 1% Ophthalmic Solution, 15mL – Bausch + Lomb

Tropicamide 1% Ophthalmic Solution, 15mL – Bausch + Lomb

Tropicamide 1% Ophthalmic Solution, 15mL – Bausch + Lomb is a fast-acting, short-duration mydriatic and cycloplegic agent specifically formulated for efficient ophthalmic diagnostics. This prescription eye drop is extensively utilized by healthcare professionals to achieve effective pupil dilation (mydriasis) and temporary paralysis of accommodation (cycloplegia). It is essential for various diagnostic evaluations, refraction tests, and a range of ophthalmic procedures.

Key Features:

• Active Ingredient: Tropicamide 10 mg/mL (1%)
• Purpose: Induces temporary pupil dilation (mydriasis) and accommodation paralysis (cycloplegia)
• Fast-Acting: Effects manifest within 15-30 minutes
• Short-Lasting: Effects typically wear off within 3-8 hours
• Ideal For: Retinal examinations, refraction testing, and surgical preparation
• Manufacturer: Bausch + Lomb, a trusted leader in ophthalmic care
• Prescription Required: Yes (Rx Only)
• Bottle Size: 15mL
• NDC Code: 24208-585-64 (1% solution, 15mL)

Indications for Use:

Tropicamide 1% is clinically indicated for:

• Retinal and fundus examinations
• Refraction testing (paralyzes eye focusing for accurate vision assessment)
• Pre-surgical preparation requiring pupil dilation
• General ophthalmic diagnostic procedures

Dosage & Administration:

• For Refraction: Instill 1-2 drops of the 1% solution, repeating after five minutes if necessary.
• For Retinal Examination: Administer 1-2 drops 15-20 minutes before the procedure.
• Additional Dosing: Patients with heavily pigmented irides may require additional drops for full dilation.
• Mydriasis Reversal: The effects typically subside within 4 to 8 hours, but in some cases, full recovery may take up to 24 hours.

Clinical Pharmacology:

Tropicamide is classified as an anticholinergic agent that inhibits cholinergic stimulation of the iris sphincter muscle and ciliary muscle, resulting in temporary pupil dilation and loss of accommodation (cycloplegia). The 1% formulation provides both mydriasis and cycloplegia, while the 0.5% formulation primarily induces pupil dilation with minimal accommodation paralysis.

Contraindications & Warnings:

• Contraindicated in patients with hypersensitivity to tropicamide or its components.
• For ophthalmic use only – not for injection or systemic use.
• Potential for temporary elevation of intraocular pressure (IOP).
• Use caution in pediatric patients due to possible CNS effects and behavioral changes.
• Remove contact lenses prior to application to avoid absorption of preservative (benzalkonium chloride).
• Store at room temperature (68°F-77°F) and keep the container tightly closed.

Possible Side Effects:

Common ocular side effects may include:

• Temporary stinging
• Blurred vision
• Photophobia
• Increased intraocular pressure

Systemic effects may involve:

• Dry mouth
• Headache
• Nausea
• Rare reactions in pediatric patients

How Supplied:

• Tropicamide Ophthalmic Solution, USP 1%: 15mL bottle with red cap and controlled dropper tip, NDC Code: 24208-585-64
• Tropicamide Ophthalmic Solution, USP 0.5%: 15mL bottle with red cap and controlled dropper tip, NDC Code: 24208-590-64

Storage & Handling:

Store between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Maintain container tightly closed and out of reach of children.

Manufacturer:

Distributed by: Bausch & Lomb Americas Inc., Bridgewater, NJ 08807 USA
Manufactured by: Bausch & Lomb Incorporated, Tampa, FL 33637 USA
Revised: September 2023

Reporting Adverse Reactions:

Contact Bausch & Lomb at 1-800-553-5340 or report to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Order Now:

Choose Tropicamide 1% by Bausch + Lomb for an effective solution for your ophthalmic diagnostics needs, delivering reliable pupil dilation and cycloplegia with a rapid onset and predictable duration.