International reference: 3 US FDA recalls for this ingredient
Sub-Potent Drug: Subpotent assay results during stability testing. (proparacaine)
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. (proparacaine)
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penici (proparacaine)
US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Rwanda.
AUROCAINE
Proparacaine Hydrochloride Ophthalmic solution USP 0.5% w/v
What it does
Proparacaine is a local anesthetic used to numb the eye for medical procedures.
Commonly used for: eye surgery, diagnostic eye tests
Read more in plain English ↓Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.
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Sourcing - Kenya onlyRegistration & product details
Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:21 · updated 2026-09-21 02:30:20
About this medicine
Proparacaine is a local anesthetic used to numb the eye for medical procedures.
What it treats
- eye surgery
- diagnostic eye tests
How it works
Proparacaine blocks nerve signals in the area it is applied, which helps prevent pain during procedures.
Who it's for
Proparacaine is for people needing numbing of the eye for medical reasons.
AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.
Clinical monograph: proparacaine
BNF-referencedProparacaine is a local anesthetic commonly used in ophthalmology for ocular procedures. It acts by blocking nerve impulses, providing temporary loss of sensation in the cornea and conjunctiva to facilitate various eye examinations and surgeries.
Indications
- Ophthalmic procedures
- Corneal anesthesia
- Eye examinations
Dosage
Children: Refer to BNF for Children for specific dosing guidelines.
Adults: Instill 1-2 drops into the affected eye(s) as needed, not exceeding 2-3 times per procedure.
Mechanism of action
The exact mechanism whereby proparacaine and other local anesthetics influence the permeability of the cell membrane is unknown; however, several studies indicate that local anesthetics may limit sodium ion permeability through the lipid layer of the nerve cell membrane. Proparacaine may alter epithelial sodium channels through interaction with channel protein residues. This limitation prevents the fundamental change necessary for the generation of the action potential.
Pharmacodynamics
Proparacaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. More specifically, proparacaine appears to bind or antagonize the function of voltage gated sodium channels.
Pharmacokinetics
Proparacaine is rapidly absorbed through the corneal epithelium and has a quick onset of action, typically within 10-20 seconds of application. The duration of effect is usually around 15-30 minutes. Metabolism primarily occurs in the liver, and elimination is through renal excretion.
Adverse effects
- Burning or stinging at the application site
- Corneal epithelial toxicity
- Allergic reactions
- Systemic toxicity in cases of overdose
Precautions
- Use with caution in patients with a history of hypersensitivity to local anesthetics
- Monitor for signs of systemic absorption leading to CNS or cardiovascular toxicity
Pregnancy
Proparacaine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Breast-feeding
It is not known whether proparacaine is excreted in human milk. Caution should be exercised when administering to a nursing mother.
Storage
Store at room temperature, away from light and moisture. Do not freeze.
Formulations
- 0.5% ophthalmic solution
AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.
Molecular reference: proparacaine
PubChem CID 4935Molecular formula: C16H26N2O3
Mechanism of action
The exact mechanism whereby proparacaine and other local anesthetics influence the permeability of the cell membrane is unknown; however, several studies indicate that local anesthetics may limit sodium ion permeability through the lipid layer of the nerve cell membrane. Proparacaine may alter epithelial sodium channels through interaction with channel protein residues. This limitation prevents the fundamental change necessary for the generation of the action potential.
Pharmacodynamics
Proparacaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses thereby effecting local anesthetic action. More specifically, proparacaine appears to bind or antagonize the function of voltage gated sodium channels.
Biological pathways
Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.