Description
NDC: 70069-121-01
Tropicamide 1% Ophthalmic Solution, 15 mL — Somerset Therapeutics
| Active ingredient | Tropicamide 1% |
| Dosage form | Ophthalmic solution |
| Route | Topical ophthalmic |
| Size | 15 mL |
| Manufacturer | Somerset Therapeutics |
| NDC | 70069-121-01 |
Indications and Usage
An anticholinergic agent indicated to produce mydriasis (pupil dilation) and cycloplegia for diagnostic ophthalmic procedures such as refraction and fundus examination.
Dosage and Administration
For refraction, instill one or two drops of the 1% solution in the eye(s), repeated in five minutes. If the patient is not examined within 20 to 30 minutes, an additional drop may be instilled to prolong the mydriatic effect. Individuals with heavily pigmented irides may require higher concentrations or repeat dosing.
Warnings and Precautions
- For topical ophthalmic use only; not for injection
- May cause transient elevation of intraocular pressure; use caution in patients predisposed to angle-closure glaucoma
- CNS disturbances, including psychotic reactions and behavioral changes, have been reported, particularly in children
- Remove contact lenses before instillation and observe for signs of systemic anticholinergic effects
Contraindications
Contraindicated in persons showing hypersensitivity to any component of this preparation, and in patients with untreated narrow-angle glaucoma or a narrow anterior chamber angle.
Adverse Reactions
Ocular effects include transient stinging, blurred vision, photophobia, and superficial punctate keratitis. Systemic anticholinergic effects such as dry mouth, tachycardia, headache, flushing, pallor, nausea, and vomiting may occur, most often in children.
Storage and Handling
Store at controlled room temperature; do not refrigerate. Protect from freezing and keep the container tightly closed.
How Supplied
Supplied as a sterile ophthalmic solution containing tropicamide 1% in a plastic dropper bottle of 15 mL.
Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.
