Each mL contains: Active: Proparacaine Hydrochloride 5 mg.
Preservative: Benzalkonium Chloride 0.1 mg.
Inactives and Purified Water.
Proparacaine hydrochloride (ALCAINE*) is a topical anesthetic prepared as a sterile aqueous ophthalmic solution.
Pharmacology: Topical anesthetics stabilize the neuronal membrane and prevent the initiation and transmission of nerve impulses thereby effecting local anesthesia. The onset of anesthesia usually begins within 30 seconds and lasts a relatively short period of time.
For procedures in which a rapid and short-acting topical ophthalmic anesthetic is indicated such as in suture removal from the cornea or conjunctiva, tonometry, gonioscopy, removal of corneal foreign bodies, conjunctival scraping for diagnostic purposes, and other short corneal and conjunctival procedures.
For tonometry and other procedures of short duration, instill one or two drops just prior to evaluation. For minor surgical procedures such as foreign body or suture removal, instill one to two drops every five to ten minutes for one to three doses. For prolonged anesthesia instill one or two drops in the eye(s) every five to ten minutes for three to five doses.
In the event of overdose or accidental ingestion, systemic effects may manifest as central nervous system (CNS) stimulation and may include nervousness, tremors or convulsions; followed by depression in CNS which may result in loss of consciousness and respiratory depression.
Should not be used by the patient without physician supervision or in those persons showing hypersensitivity to the active substances or any of the excipients. This product should never be prescribed for the patient's own use.
FOR EXTERNAL USE ONLY-NOT FOR INJECTION.
Prolonged use of a topical ocular anesthetic may diminish duration of anesthesia, thus more and more medication is required to produce the desired anesthetic effect. This increased usage may result in subsequent corneal infection and/or corneal opacification with accompanying permanent visual loss or corneal perforation. Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage.
Local anaesthetics should be used with caution in patients with cardiac disease or hyperthyroidism. Prolonged use may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage. Advise patients that, due to the effect of the anesthetic, their eyes will be insensitive and that care should be taken to avoid accidental eye injuries. Proparacaine may cause allergic contact dermatitis. Avoid contact of PROPARACAINE hydrochloride (ALCAINE*) Sterile Ophthalmic Solution with the skin.
PROPARACAINE hydrochloride (ALCAINE*) Sterile Ophthalmic Solution contains benzalkonium chloride which may cause eye irritation and is known to discolor soft contact lenses. Additionally, contact lens wear is not recommended until the anesthetic effect has worn-off.
Patient should be advised not to touch or rub the eye(s) until the effect of the anesthetic has worn off. To prevent contamination of the dropper or solution, care should be taken not to touch the eyelids or surrounding area with the dropper tip. After cap is removed, if tamper evident snap collar is loose, remove before using product.
Effects on ability to drive and use machines: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs after administration, the patient must wait until the vision clears before driving or using machinery.
Fertility: Studies have not been performed to evaluate the effect of topical ocular administration of proparacaine on fertility.
Use in Pregnancy: There are no or limited amount of data from the use of ophthalmic proparacaine in pregnant women. PROPARACAINE hydrochloride (ALCAINE*) Sterile Ophthalmic Solution is not recommended during pregnancy.
Use in Lactation: It is unknown whether topical proparacaine/metabolites are excreted in human milk; however, a risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from PROPARACAINE hydrochloride (ALCAINE*) Sterile Ophthalmic Solution therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Transient symptoms (signs) such as stinging, burning, and conjunctival redness may occur.
A rare, severe, immediate type allergic corneal reaction characterized by acute diffuse epithelial keratitis with filament formation and/or sloughing of large areas of the necrotic epithelium, effuse stromal edema, descemetitis, and iritis has been reported.
The following adverse reactions have been reported following use of proparacaine topical ocular preparations.
Frequencies cannot be estimated from the available data. Within each System Organ Class, adverse reactions are presented in order of decreasing seriousness. (See table.)
Click on icon to see table/diagram/image
Additionally, uncontrolled use or abuse may lead to ocular lesions due to the toxic effects of the anesthetic to the epithelium.
No interaction studies have been performed; however, no clinically relevant interactions are to be expected.
Store refrigerated between 2-8°C. Do not use a discolored solution. Discard 28 days after opening.
Information to the Patient: After instillation of this product, the surface of the eye is insensitive and can be scratched without your feeling it.
Do not rube eye. Do not instill this product repeatedly because severe eye damage may occur.
S01HA04 - proxymetacaine ; Belongs to the class of local ophthalmologic anesthetics.