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Tropicamide 1% 15mL - Product image
Somerset Pharmaceuticals

Tropicamide 1% 15mL

SKU: RX-1022Medical Supplies

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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.

If you have any questions related to DSCSA compliance, transaction history, regulatory data or quality assurance, please contact our team at compliance@dryeyerescue.com for more information.

NDC
70069-121-01

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