P-caine Ophthalmic Solution

P-caine sterile eye drops 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.

The main site of anesthetic action is the nerve cell membrane where proparacaine interferes with the large transient increase in the membrane permeability to sodium ions that is normally produced by a slight depolarization of the membrane. As the anesthetic action progressively develops in a nerve, the threshold for electrical stimulation gradually increases and the safety factor for conduction decreases; when this action is sufficiently well developed, block of conduction is produced. Several studies indicate that local anesthetics may limit sodium ion permeability by closing the pores through which the ions migrate in the lipid layer of the nerve cell membrane.

Deep anesthesia as in cataract extraction: Instill 1 drop to the eye every 5 to 10 minutes for 5 to 7 doses.

Removal of sutures: Instill 1 or 2 drops to the eye 2 or 3 minutes before removal of stitches.

Removal of foreign bodies: Instill 1 or 2 drops to the eye prior to operating.

Tonometry: Instill 1 or 2 drops to the eye immediately before measurement.

Proparacaine Hydrochloride sterile eye drops should be considered contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.

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.

Pregnancy Category C. Animal reproduction studies have not been conducted with Proparacaine Hydrochloride sterile eye drops 0.5%. It is also not known whether Proparacaine Hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Proparacaine Hydrochloride should be administered 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 Proparacaine Hydrochloride is administered to a nursing mother.

Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.

Pediatric Use: Safety and effectiveness of P-caine ophthalmic solution in pediatric patients have been established. Use of P-caine is supported by evidence from adequate and well-controlled studies in adults and children over the age of twelve, and safety information in neonates and other pediatric patients.

Geriatric Use: No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

Ocular perioperative drugs

Store bottles under refrigeration at 2° to 8°C & protect from light. It is desirable that the contents should not be used more than 4 weeks after first opening of the bottle. If solution shows more than a faint yellow color, it should not be used. Keep bottle tightly closed.