Product Monograph - Alcaine
CONTRAINDICATIONS
- ALCAINE (proparacaine hydrochloride) ophthalmic solution is contraindicated in patients who are hypersensitive to proparacaine hydrochloride or to any ingredient in the formulation or component of the container.
- ALCAINE solution should never be prescribed for the patient’s own use.
WARNINGS
- ALCAINE (proparacaine hydrochloride) is for topical ophthalmic use only by health care professionals.
- Do not touch dropper tip to any surface as this may contaminate the solution.
- Prolonged use or abuse of topical ocular anesthetics, including ALCAINE, may lead to corneal epithelial toxicity and may manifest as epithelial defects, which may progress to permanent corneal damage, such as corneal opacification with accompanying loss of vision.
PRECAUTIONS:
General. Proparacaine hydrochloride should be used with caution in patients with known allergies, cardiac diseases, or hyperthyroidism.
Prolonged use of proparacaine hydrochloride may diminish the duration of anesthesia.
The long-term toxicity of proparacaine is not known; prolonged use may delay wound healing (see WARNINGS).
Ophthalmologic. ALCAINE solution contains benzalkonium chloride, which may cause eye irritation and is known to discolour soft contact lenses.
Protection of the eye from irritating chemicals, foreign bodies and rubbing during the period of anesthesia is very important. Patients should be advised to avoid touching the eye until the anesthesia has worn off. Additionally, contact lens wear is not recommended until the anesthetic has worn-off.
Skin. Proparacaine may cause allergic contact dermatitis. Avoid contact of ALCAINE (proparacaine hydrochloride) ophthalmic solution with the skin.
Carcinogenesis and Mutagenesis. Long-term studies in animals have not been performed to evaluate carcinogenic potential or mutagenicity.
Fertility. Long term studies in animals have not been performed to evaluate the effect of proparacaine on fertility in males or females.
Pregnant Women. Animal reproduction studies have not been conducted with ALCAINE solution. It is not known whether proparacaine hydrochloride can cause fetal harm when administered to a pregnant woman. ALCAINE solution is not recommended during pregnancy.
Nursing Women. It is not known whether ALCAINE solution is excreted in human milk; however, a risk to the child cannot be excluded. Because many drugs are excreted in human milk, caution should be exercised when proparacaine hydrochloride is administered to a nursing woman.
Pediatrics. Controlled clinical studies have not been performed with ALCAINE solution to establish safety and effectiveness in children. Proparacaine hydrochloride may be used as a topical ophthalmic anesthetic agent in children when benefit outweighs potential risks.
Ability to Drive and Use Machinery. Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs after administration, the patient should be advised to wait until vision clears before driving or using machinery.
ADVERSE REACTIONS:
Immune system disorders. Allergic contact dermatitis with drying and fissuring of the fingertips; hypersensitivity.
Nervous system disorders. Syncope; dizziness.
Eye disorders. Eye irritation, stinging, burning, eye pain or eye swelling; ocular discomfort; ocular hyperaemia; conjunctival redness; increased lacrimination; increased winking; corneal opacity; corneal oedema; keratitis; blurred vision; photophobia.
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.
Pupillary dilatation or cycloplegic effects have rarely been observed with proparacaine hydrochloride.
Softening and erosion of the corneal epithelium and conjunctival congestion and hemorrhage have been reported.
Misuse (e.g., uncontrolled use) or abuse of the product may lead to ocular lesions due to the toxic effects of the anesthetic to the corneal epithelium (see WARNINGS).
DRUG INTERACTIONS: No interaction studies have been performed; however, no clinically relevant interactions are expected.
DOSAGE AND ADMINISTRATION:
Deep anesthesia as in cataract extraction:
Instill 1 drop every 5 to 10 minutes for 5 to 7 doses.
Removal of sutures:
Instill 1 or 2 drops 2 or 3 minutes before removal of stitches.
Removal of foreign bodies:
Instill 1 or 2 drops prior to operating.
Tonometry:
Instill 1 or 2 drops immediately before measurement.
OVERDOSAGE:
In the event of overdose or accidental ingestion, systemic effects may manifest as central nervous system stimulation (which may include nervousness, tremors or convulsions) followed by central nervous system (CNS) and cardiovascular depression. CNS depression may result in loss of consciousness and respiratory depression.
For management of a suspected drug overdose, contact your regional Poison Control Centre.
HOW SUPPLIED: ALCAINE (proparacaine hydrochloride) ophthalmic solution is supplied in 15 mL DROP-TAINERTM dispensers.
STORAGE: Store at 2oC - 8oC. Keep refrigerated. Do not use if the solution is darker than a pale yellow.