Description
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.