RVP

Drug Catalog - Product Detail

TROPICAMIDE OPHTH SOL (TROPICACYL) SOL 0.01 15ML

NDC Mfr Size Str Form
17478-0102-12 AKORN 15 1% SOLUTION
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Description
DESCRIPTION: Tropicamide Ophthalmic Solution, USP is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the structural formula: C 17 H 20 N 2 O 2 MW=284.36 Established name: Tropicamide Chemical name: Benzeneacetamide, N- ethyl-α-(hydroxymethyl)- N- (4-pyridinylmethyl)-. Each mL contains: Active: Tropicamide 0.5% (5 mg) or 1% (10 mg). Inactives: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH), Water for Injection. pH range 4.0 to 5.8. Preservative: Benzalkonium Chloride 0.01%. Structural Formula
How Supplied
HOW SUPPLIED: Tropicamide Ophthalmic Solution USP, 0.5% and 1% are supplied as sterile solutions in plastic dropper bottles. 0.5% NDC 17478-101-12 (15 mL) 1% NDC 17478-102-12 (15 mL) 1% NDC 17478-102-20 (2 mL) STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not refrigerate or store at high temperatures. Keep container tightly closed. Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 TC00N Rev. 10/16
Indications & Usage
INDICATIONS AND USAGE: For mydriasis and cycloplegia for diagnostic procedures.
Dosage and Administration
DOSAGE AND ADMINISTRATION: For refraction, instill one or two drops of 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, instill one or two drops of 0.5% solution 15 to 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.