Tropicamide 10 mg/mL
Tropicamide · SOLUTION/ DROPS · Bausch & Lomb Incorporated
Tropicamide is an eye drop medication that dilates your pupils and relaxes the focusing muscles in your eyes, allowing your eye doctor to examine the back of your eye more easily. It belongs to a class of drugs called anticholinergics and is used during eye exams and for certain eye conditions.
Key Facts
- Brand Name
- Tropicamide
- Generic Name
- Tropicamide
- NDC Code (Product)
24208-585- Manufacturer
- Bausch & Lomb Incorporated
- Strength
- 10 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA040064
- Drug Class
- Anticholinergic [EPC]
- Marketing Start
- 07/27/1994
Recall History
Imprimis NJOF, LLC
Sub-Potent Drug: Subpotent assay results during stability testing.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
US Compounding Inc
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Leiter's Compounding
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Specialty Medicine Compounding Pharmacy
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
KRS Global Biotechnology, Inc
Lack of Assurance of Sterility
Pharmacy Plus, Inc. dba Vital Care Compounder
Lack of Assurance of Sterility
KRS Global Biotechnology, Inc
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Specialty Medicine Compounding Pharmacy
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures.
Dosage & 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 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. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
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.
Contraindications
CONTRAINDICATIONS Contraindicated in persons showing hypersensitivity to any component of this preparation.
Adverse Reactions
ADVERSE REACTIONS 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 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 tropicamide. Psychotic reactions, behavioral disturbances, and vasomotor or cardio-respiratory collapse in children have been reported with the use of anticholinergic drugs.
Frequently Asked Questions
What is Tropicamide used for?
Tropicamide is an eye drop medication that dilates your pupils and relaxes the focusing muscles in your eyes, allowing your eye doctor to examine the back of your eye more easily. It belongs to a class of drugs called anticholinergics and is used during eye exams and for certain eye conditions.
Is Tropicamide a controlled substance?
Tropicamide is not classified as a controlled substance by the DEA.
What is the generic name for Tropicamide?
The generic name for Tropicamide is Tropicamide. There are 2 other brand versions of Tropicamide.
What is the NDC code for Tropicamide 10 mg/mL?
The NDC (National Drug Code) for Tropicamide 10 mg/mL is 24208-585, listed by Bausch & Lomb Incorporated.