Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: Bausch & Lomb UK Limited, Bausch & Lomb House, 106 London Road, Kingston-Upon-Thames, Surrey, UK, KT2 6TN
Not to be used in patients with a known hypersensitivity to the product.
Tetracaine is hydrolysed in the body to p-amino-benzoic acid and should not therefore be used in patients being treated with sulphonamides.
In view of the immaturity of the enzyme system which metabolises the ester type local anaesthetics in premature babies, tetracaine should be avoided in these patients.
The anaesthetised eye should be protected from dust and bacterial contamination.
The cornea may be damaged by prolonged application of anaesthetic eye drops.
Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the naso lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)
Tetracaine should not be used in patients being treated with sulphonamides (see 4.3 above).
Safety for use in pregnancy and lactation has not been established, therefore, use only when considered essential by the physician.
May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery unless vision is clear.
Tetracaine may give rise to dermatitis in hypersensitive patients.
On instillation an initial burning sensation may be experienced. This may last for up to 30 seconds.
Corneal disorders such as superficial punctuate keratitis or edema may be observed following short-term application of Tetracaine (amethocaine) eye drops for topical anaesthesia.
The cornea may be damaged by prolonged application of anaesthetic eye drops.
None known.
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