Proparacaine Hydrochloride 5 mg/mL
Proparacaine Hydrochloride · SOLUTION/ DROPS · Bausch & Lomb Incorporated
Proparacaine Hydrochloride is a local anesthetic eye drop used to numb the surface of the eye for medical procedures and examinations. It works by blocking pain signals in the eye to provide temporary relief during diagnostic tests or minor eye surgeries.
Key Facts
- Brand Name
- Proparacaine Hydrochloride
- Generic Name
- Proparacaine Hydrochloride
- NDC Code (Product)
24208-730- Manufacturer
- Bausch & Lomb Incorporated
- Strength
- 5 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA040074
- Marketing Start
- 09/29/1995
Recall History
Akorn, Inc.
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Akorn, Inc.
CGMP Deviations:
Altaire Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Altaire Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Akorn, Inc.
CGMP Deviations:
Mckesson Medical-Surgical Inc. Corporate Office
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Proparacaine hydrochloride ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.
Dosage & Administration
DOSAGE AND ADMINISTRATION Usual Dosage: Removal of foreign bodies and sutures, and for tonometry: 1 to 2 drops (in single instillations) in each eye before operating. Short corneal and conjunctival procedures: 1 drop in each eye every 5 to 10 minutes for 5 to 7 doses. NOTE: Proparacaine hydrochloride ophthalmic solution should be clear to straw-color. If the solution becomes darker, discard the solution.
Warnings
WARNINGS NOT FOR INJECTION - FOR TOPICAL OPHTHALMIC USE ONLY. Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.
Contraindications
CONTRAINDICATIONS Proparacaine hydrochloride ophthalmic solution should be considered contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.
Adverse Reactions
ADVERSE REACTIONS Occasional temporary stinging, burning and conjunctival redness may occur with the use of proparacaine. A rare, severe, immediate-type, apparently hyperallergic corneal reaction characterized by acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and, sometimes, iritis with descemetitis has been reported. Allergic contact dermatitis from proparacaine with drying and fissuring of the fingertips has also been reported.
Frequently Asked Questions
What is Proparacaine Hydrochloride used for?
Proparacaine Hydrochloride is a local anesthetic eye drop used to numb the surface of the eye for medical procedures and examinations. It works by blocking pain signals in the eye to provide temporary relief during diagnostic tests or minor eye surgeries.
Is Proparacaine Hydrochloride a controlled substance?
Proparacaine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Proparacaine Hydrochloride?
The generic name for Proparacaine Hydrochloride is Proparacaine Hydrochloride. There are 4 other brand versions of Proparacaine Hydrochloride.
What is the NDC code for Proparacaine Hydrochloride 5 mg/mL?
The NDC (National Drug Code) for Proparacaine Hydrochloride 5 mg/mL is 24208-730, listed by Bausch & Lomb Incorporated.