Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2018 Publisher: Pharmaco (NZ) Ltd, 4 Fisher Crescent, Mount Wellington, Auckland 1060, New Zealand. PO Box 4079, Auckland 1140, New Zealand. Free Phone: 0800 804 079.
Alcaine is contraindicated in patients with known hypersensitivity to proxymetacaine hydrochloride or any of the excipients listed under section 6.1.
NOT FOR INJECTION INTO THE EYE.
Prolonged use of a topical ocular anaesthetic may produce a diminished duration of the effect, thus more and more of the medication is required to produce the desired anaesthetic effect. Prolonged use or abuse may result in corneal epithelial toxicity and may manifest as epithelial defects, subsequent corneal damage, corneal infection, corneal perforation and/or corneal opacification with accompanying permanent loss of vision. The long term toxicity of proxymetacaine hydrochloride is unknown; prolonged use may possibly delay wound healing. Although exceedingly rare with ophthalmic application of local anaesthetics, it should be borne in mind that systemic toxicity (manifested by central nervous system stimulation followed by depression) may occur.
Local anaesthetics should be used cautiously and sparingly in patients with known allergies, epilepsy, cardiac disease, hyperthyroidism or in patients with respiratory problems. Patients who suffer from myasthenia gravis are particularly sensitive to the effects of anaesthetics. Patients with a low amount of acetylcholinesterase in the plasma, and patients being treated with cholinesterase inhibitors exhibit an increased risk for systemic side effects during topical application of ester-type anaesthetics.
Protection of the eyes from irritating chemicals, foreign bodies and rubbing during the period of anaesthesia is very important. Tonometers soaked in sterilising or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use.
Advise patients that, due to the effect of the anaesthetic, their eyes will be insensitive and that care should be taken to avoid accidental eye injuries.
Alcaine Eye drops may cause allergic contact dermatitis. Avoid contact with the skin.
Controlled clinical studies have not been performed with Alcaine Eye Drops to establish safety and effectiveness in children, however, the literature cites the use of proxymetacaine hydrochloride as a topical ophthalmic anaesthetic agent in children.
There is no information available for use in patients above 65 years of age.
The safety and efficacy of proxymetacaine ophthalmic solution in patients with hepatic or renal impairment have not been established.
Alcaine contains the preservative benzalkonium chloride which may cause eye irritation, discolour and be deposited in soft (hydrophilic) contact lenses. Contact lens wear is not recommended until the anaesthetic effect has worn-off
The metabolism of local anaesthetics derived from esters may be inhibited by anticholinesterases thus increasing the risk of systemic toxicity.
Category B2.
Animal reproduction studies have not been conducted with Alcaine Eye Drops. It is not known whether proxymetacaine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Proxymetacaine hydrochloride should be administrated to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk however, a risk to the suckling child cannot be excluded. Because many drugs are excreted in human milk, caution should be exercised when proxymetacaine hydrochloride is administered to a breastfeeding woman.
Use only when considered essential by the physician.
No study has been conducted to determine the possible adverse effects of proxymetacaine hydrochloride on fertility.
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.
Pupillary dilatation or cycloplegic effect have rarely been observed with proxymetacaine hydrochloride. The drug appears to be safe for use in patients sensitive to other local anaesthetics, but local or systemic sensitivity occasionally occurs. Instillation of proxymetacaine in the eye at recommended concentration and dosage usually produces little or no initial irritation, stinging, burning, conjunctival redness, lacrimation or increased winking. However, some local irritation and stinging may occur several hours after instillation.
Rarely, a severe, immediate-type, apparently hyperallergic corneal reaction may occur which include acute, intense and diffuse epithelial keratitis; a grey, ground-glass appearance; sloughing of large areas of necrotic epithelium; corneal filaments and, sometimes, iritis and descemetitis.
Allergic contact dermatitis with drying and fissuring of the fingertips has been reported. Softening and erosion of the corneal epithelium and conjunctival congestion and haemorrhage have been reported.
The following adverse reactions have been reported following use of proxymetacaine 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.
Immune system disorders: Hypersensitivity.
Nervous system disorders: Syncope.
Eye disorders: Corneal erosion, corneal opacity, keratitis, vision blurred, photophobia, mydriasis, eye pain, eye irritation, eye swelling, ocular discomfort, ocular hyperaemia, lacrimation increased.
Additionally, overuse, uncontrolled use or abuse of the product may lead to ocular lesions due to the toxic effects of the anaesthetic to the epithelium.
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting.
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