Chemical formula: C₁₆H₂₆N₂O₃ Molecular mass: 294.389 g/mol PubChem compound: 4935
Category B2.
Safety for use in pregnancy has not been established, therefore, use only when considered essential by the physician.
Animal reproduction studies have not been conducted with proxymetacaine eye drops. It is not known whether proxymetacaine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Proxymetacaine should be administrated to a pregnant woman only if clearly needed.
Safety for use in lactation has not been established, therefore, use only when considered essential by the physician.
No study has been conducted to determine the possible adverse effects of proxymetacaine on fertility.
May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery unless vision is clear.
Pupillary dilatation or cycloplegic effect have rarely been observed with proxymetacaine. 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.
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