Tropi-Storz

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Tropi-Storz uses


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 reaction and behavioral disturbance due to hypersensitivity to anticholinergic drugs should be considered.

Mydriatics may produce a transient elevation of intraocular pressure.

Remove contact lenses before using.

PRECAUTIONS

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

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 dropper tip to any surface, as this may contaminate the solution. Patients should be advised not to drive or engage in potentially hazardous activities while pupils are dilated. Patients 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 wash their own hands and the child's hands following administration.

Drug Interactions

Tropi-Storz 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 Tropi-Storz in animals to evaluate carcinogenic potential.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Tropi-Storz. It is also not known whether Tropi-Storz can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tropi-Storz 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 Tropi-Storz is administered to a nursing woman.

Pediatric Use

Tropi-Storz 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. Keep this and all medications out of the reach of children.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS

Ocular

Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of Tropi-Storz. Increased intraocular pressure has been reported following the use of mydriatics.

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 Tropi-Storz. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

Tropi-Storz Ophthalmic Solution, USP 1% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following sizes:

2 mL - NDC 24208-585-59

15 mL - NDC 24208-585-64

Tropi-Storz Ophthalmic Solution, USP 0.5% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following size:

15 mL - NDC 24208-590-64

Storage: Store at 20° to 25C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)

.

Keep container tightly closed.

DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW IS NOT INTACT.

KEEP OUT OF REACH OF CHILDREN.

Revised: July 2016

Bausch + Lomb, a division of

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

©Bausch & Lomb Incorporated

9115805 (folded)

9115905 (flat)

symbol

NDC 24208-590-64

Tropi-Storz

Ophthalmic

Solution, USP

0.5% (Sterile)

FOR TOPICAL

OPHTHALMIC

USE ONLY

Rx only

15 mL

BAUSCH + LOMB

Carton5mexico.jpg

NDC 24208-590-64

Tropi-Storz

Ophthalmic

Solution, USP

0.5% (Sterile)

FOR TOPICAL

OPHTHALMIC

USE ONLY

Rx only

15 mL

BAUSCH + LOMB

Carton5japan.jpg

NDC 24208-585-64

Tropi-Storz

Ophthalmic

Solution, USP

1% (Sterile)

FOR TOPICAL

OPHTHALMIC

USE ONLY

Rx only

15 mL

BAUSCH + LOMB

Carton1mexico.jpg

NDC 24208-585-64

Tropi-Storz

Ophthalmic

Solution, USP

1% (Sterile)

FOR TOPICAL

OPHTHALMIC

USE ONLY

Rx only

15 mL

BAUSCH + LOMB

Carton1japan.jpg

Tropi-Storz pharmaceutical active ingredients containing related brand and generic drugs:


Tropi-Storz available forms, composition, doses:


Tropi-Storz destination | category:


Tropi-Storz Anatomical Therapeutic Chemical codes:


Tropi-Storz pharmaceutical companies:


References

  1. Dailymed."TROPICAMIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "tropicamide". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Tropi-Storz?

Depending on the reaction of the Tropi-Storz after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Tropi-Storz not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Tropi-Storz addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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