TROPICAMIDE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TROPICAMIDE (UNII: N0A3Z5XTC6) (TROPICAMIDE - UNII:N0A3Z5XTC6)

Available from:

REMEDYREPACK INC.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For mydriasis and cycloplegia for diagnostic procedures. Contraindicated in persons showing hypersensitivity to any component of this preparation.

Product summary:

Tropicamide ophthalmic solution, USP, 0.5% is supplied in an LDPE plastic bottle with a dropper tip as: NDC: 70518-2759-00 PACKAGING: 1 in 1 CARTON, 15 mL in 1 BOTTLE PLASTIC TYPE 0 STORAGE Store at 8° to 25°C (46° to 77°F). Do not refrigerate or store at high temperatures. Keep container tightly closed. After opening, this product can be used until the expiration date on the bottle. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TROPICAMIDE- TROPICAMIDE SOLUTION/ DROPS
REMEDYREPACK INC.
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TROPICAMIDE OPHTHALMIC SOLUTION, USP
RX ONLY
DESCRIPTION
Tropicamide Ophthalmic Solution, USP, 0.5% is an anticholinergic
prepared as a sterile
topical ophthalmic solution. The active ingredient is represented by
the chemical
structure:
Established name: Tropicamide ophthalmic solution
Chemical name: Benzeneacetamide, _N_-ethyl-α-(hydroxymethyl)-
_N_-(4-pyridinylmethyl)-.
EACH ML CONTAINS: ACTIVE: tropicamide 0.5%. PRESERVATIVE: benzalkonium
chloride
0.01%. INACTIVES: sodium chloride, edetate disodium, hydrochloric acid
and/or sodium
hydroxide (to adjust pH), purified water. pH 4.0 - 5.8.
CLINICAL PHARMACOLOGY
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 to
30 minutes, and the duration of activity is approximately 3 to 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.
INDICATIONS AND USAGE
For mydriasis and cycloplegia for diagnostic procedures.
CONTRAINDICATIONS
Contraindicated in persons showing hypersensitivity to any component
of this
preparation.
WARNINGS
For topical ophthalmic 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.
PRECAUTIONS
GENERAL
The lacrimal sac should be compressed by digital pressure for two to
three minutes
after instillation to reduce excessive systemic absorption.
INFORMATION FOR PATIENTS
Do not touch