Tropicamide Ophthalmic Solution, USP 1% (15mL), (Mydriacyl) - Somerset

Tropicamide Ophthalmic Solution, USP 1% (15mL), (Mydriacyl) - Somerset

Tropicamide Ophthalmic Solution, USP 1% (15mL), (Mydriacyl) - Somerset is a specialized prescription eye drop tailored for effective and rapid pupil dilation during ophthalmic examinations. This fast-acting mydriatic agent is essential for healthcare professionals, enabling precise assessments of vision and comprehensive evaluations of ocular health.

Key Features:

• Active Ingredient: Tropicamide 10 mg/mL (1%)
• Purpose: Induces temporary pupil dilation (mydriasis) and accommodation paralysis (cycloplegia)
• Fast-Acting: Effects commence within 15-30 minutes
• Short-Lasting: Dilatory effects typically wear off within 3-8 hours
• Ideal for: Retinal exams and refractive testing
• Manufactured by: Bausch + Lomb, a trusted leader in ophthalmic care
• Prescription Required: (Rx Only)
• Bottle Size: 15mL
• NDC Codes: 24208-585-64 (1% solution, 15mL)

Indications for Use:

Tropicamide Ophthalmic Solution is prescribed for:

• Retinal and fundus examinations
• Refraction testing to ensure accurate vision assessments
• Pre-surgical preparation requiring pupil dilation
• General ophthalmic diagnostic procedures

Dosage & Administration:

For optimal results, administer Tropicamide as follows:

• For Refraction: Instill 1-2 drops of the 1% solution, repeating after five minutes if necessary.
• For Retinal Examination: Instill 1-2 drops of the 0.5% solution 15-20 minutes prior to the procedure.
• Additional Dosing: Patients with heavily pigmented irides may require extra drops for complete dilation.
• Mydriasis Reversal: Effects typically subside within 4 to 8 hours, with full recovery possibly taking up to 24 hours.

Clinical Pharmacology:

Tropicamide acts as an anticholinergic agent, blocking cholinergic stimulation of the iris sphincter and ciliary muscles. This results in temporary pupil dilation and loss of accommodation (cycloplegia). The 1% formulation effectively provides both mydriasis and cycloplegia.

Contraindications & Warnings:

• Contraindicated in patients with hypersensitivity to tropicamide or any of its components.
• For ophthalmic use only – not for injection or systemic administration.
• May cause a temporary increase in intraocular pressure (IOP).
• Use caution in pediatric patients due to potential CNS effects and behavioral disturbances.
• Remove contact lenses before use to prevent preservative absorption.
• Store at room temperature (68°F-77°F) and keep container tightly closed.

Possible Side Effects:

Potential side effects may include:

• Ocular: Temporary stinging, blurred vision, photophobia, superficial punctate keratitis, and increased IOP.
• Systemic: Dry mouth, tachycardia, headache, nausea, vomiting, CNS disturbances, and behavioral changes (rare).

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 at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Ensure the container is 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:

Ensure precise diagnostic outcomes with Tropicamide Ophthalmic Solution, USP 1% (15mL), (Mydriacyl) - Somerset, a trusted option for ophthalmic diagnostics, providing effective pupil dilation and cycloplegia with rapid onset and predictable duration.