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Tropicamide Ophthalmic Solution, USP | Tropicamide

05:56 EDT 27th August 2014 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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:

CHNO         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%.

IMAGE tro00-0001-01.jpg

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.

General: The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to avoid excessive systemic absorption.

Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in potentially hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration.

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

Carcinogenesis, Mutagenesis, Impairment of Fertility: There have been no long-term studies done using tropicamide in animals to evaluate carcinogenic potential.

Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with tropicamide. It is also not known whether tropicamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tropicamide should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tropicamide is administered to a nursing woman.

Pediatric Use: Tropicamide may rarely cause CNS disturbances which may be dangerous in pediatric patients. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs (See WARNINGS). Keep this and all medications out of the reach of children.

Ocular: Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydri-atics.

Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.

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.

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 60045TC00N Rev. 06/11

Principal Display Panel Text for Container Label:

NDC 17478-101-12

Tropicamide

Ophthalmic

Solution, USP

0.5%

15 mL

Sterile

Rx only [Akorn logo]

For Topical Ophthalmic Use Only

IMAGE tro00-0001-02.jpg

Principal Display Panel Text for Carton Label:

NDC 17478-101-12

Tropicamide

Ophthalmic

Solution, USP

0.5%

For Topical Ophthalmic

Use only.

15 mL

Sterile

Rx only [Akorn logo]

IMAGE tro00-0001-03.jpg

Principal Display Panel Text for Container Label:

NDC 17478-102-12

Tropicamide

Ophthalmic

Solution, USP

1%

15 mL

Sterile

Rx only [Akorn logo]

For Topical Ophthalmic Use Only

IMAGE tro00-0001-04.jpg

Principal Display Panel Text for Carton Label:

NDC 17478-102-12

Tropicamide

Ophthalmic

Solution, USP

1%

For Topical Ophthalmic

Use only.

15 mL

Sterile

Rx only [Akorn logo]

IMAGE tro00-0001-05.jpg

Manufacturer

Akorn, Inc.

Active Ingredients

Source

Drugs and Medications [6 Associated Drugs and Medications listed on BioPortfolio]

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Tropicamide Ophthalmic Solution, USP

Mydriacyl [Alcon Laboratories, Inc.]

Mydriacyl (tropicamide ophthalmic solution, USP)

Mydriacyl [Alcon Laboratories, Inc.]

Mydriacyl (tropicamide ophthalmic solution, USP)

Paremyd [Akorn, Inc.]

PAREMYD

Clinical Trials [7 Associated Clinical Trials listed on BioPortfolio]

Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation

The purpose of this study is to compare the efficacy on pupillary dilation between the single dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular exami...

Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

The purpose is to determine if an intracameral solution of 0.2% tropicamide and 2% phenylephrine can dilate the pupil for cataract surgery as well as pre-operative topical 1% tropicamide a...

CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment

Pupillary dilation to perform a fundus in premature newborns and neonates is often difficult to obtain, because of the non mature iris sphincter. The fundus is essential to detect retinal ...

Medications Effect on Lenstar Measurements

Prior to cataract surgery the lens must be calculated to appropriately fit a patient for the intraocular lens implant. Lenstar is an optical biometer that calculates the axial length, kera...

Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients

The primary goal of the study is to evaluate the safety and potential efficacy of intra-oral dissolvable NH004 films to improve the short-term symptoms of sialorrhea (drooling) in Parkinso...

PubMed Articles [3 Associated PubMed Articles listed on BioPortfolio]

Cubic liquid crystalline nanoparticles: optimization and evaluation for ocular delivery of tropicamide.

The purpose of this study was to investigate the potential of cubic liquid crystalline nanoparticles for ocular delivery of tropicamide. Ultrasound-assisted fragmentation of cubic liquid crystalline b...

Higher-Order Aberrations After Cyclopentolate, Tropicamide, and Artificial Tear Drops Application in Normal Eyes.

To determine the effect of cyclopentolate, tropicamide, and artificial tear drops on higher-order aberrations (HOAs) in normal eyes with OPD-Scan III (Nidek Inc., Tokyo, Japan).

Pupil Dilation with Intracameral Epinephrine Hydrochloride during Phacoemulsification and Intraocular Lens Implantation.

Objective. To investigate mydriatic effect of intracamerally injected epinephrine hydrochloride during phacoemulsification and intraocular lens (IOL) implantation. Methods. Eighteen cataract patients ...

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