DailyMed Label: Tropicamide

DailyMed Label: Tropicamide

2023

DailyMed Prescription

Tropicamide

Tropicamide

Bausch & Lomb Incorporated

NDC: 24208-590

NDC: 24208-585

NDC: 24208-590

NDC: 24208-590

NDC: 24208-585

NDC: 24208-585

Tropicamide ophthalmic solution, USP is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the following chemical structure: Chemical name: Benzeneacetamide, N -ethyl-α-(hydroxymethyl)- N -(4-pyridinylmethyl)- Each mL contains: Active: tropicamide 5 mg (0.5%) or 10 mg (1%); Inactives: boric acid, hydrochloric acid, edetate disodium dihydrate, purified water. Sodium hydroxide and/or hydrochloric acid (to adjust pH) pH range 4.0 - 5.8. Preservative: benzalkonium chloride 0.01%. ChemStructure-Tropicamide.jpg

For mydriasis and cycloplegia for diagnostic procedures.

For refraction, one or two drops of the 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect. For examination of fundus, one or two drops of the 0.5% solution 15 or 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses. Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.

Contraindicated in persons showing hypersensitivity to any component of this preparation.

Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Tropicamide ophthalmic solution USP, 1% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following sizes: NDC 24208-585-59: 2 mL in a 7.5 mL bottle NDC 24208-585-64: 15 mL in a 15 mL bottle   Tropicamide ophthalmic solution USP, 0.5% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following size: NDC 24208-590-64: 15 mL in a 15 mL bottle Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Keep out of reach of children. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: September 2023 9115807 (Folded) 9115907 (Flat) donotuse

This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, dilating the pupil [mydriasis]. The stronger preparation (1%) also paralyzes accommodation. This preparation acts in 15-30 minutes, and the duration of activity is approximately 3-8 hours. Complete recovery from mydriasis in some individuals may require 24 hours. The weaker strength (0.5%) may be useful in producing mydriasis with only slight cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides.

NDC 24208-590-64 Tropicamide Ophthalmic Solution, USP 0.5% (Sterile) FOR TOPICAL OPHTHALMIC USE ONLY Rx only 15 mL BAUSCH + LOMB 9052002 AB07311 carton-mexico 0.5 15ml