Tropicamide Ophthalmic Solution, USP

Rx only

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 ₁₇H ₂₀N ₂O 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%.

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 may be useful in producing mydriasis with only slight cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides.

For mydriasis and cycloplegia for diagnostic procedures.

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

For topical use only — not for injection.

This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered.

Mydriatics may produce a transient elevation of intraocular pressure.

Remove contact lenses before using.

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.

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)

DRUG: Tropicamide

GENERIC: Tropicamide

DOSAGE: SOLUTION/ DROPS

ADMINSTRATION: OPHTHALMIC

NDC: 70518-0744-0

PACKAGING: 15 mL in 1 BOTTLE, DROPPER

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

• Tropicamide 10mg in 1mL

INACTIVE INGREDIENT(S):

• benzalkonium chloride
• hydrochloric acid
• sodium hydroxide
• edetate disodium
• sodium chloride
• water

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