Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TETRACAINE HYDROCHLORIDE
Bausch & Lomb UK Limited
S01HA03
TETRACAINE HYDROCHLORIDE
0.5 %w/v
Eye Drops Solution
Product subject to prescription which may not be renewed (A)
tetracaine
Marketed
1980-04-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minims Tetracaine Hydrochloride 0.5% w/v Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains Tetracaine hydrochloride 0.5% w/v solution. Each unit (0.5ml) contains Tetracaine hydrochloride 2.5mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution Clear, colourless, aqueous, sterile, single dose eye drop solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ocular anaesthetic for topical instillation into the conjunctival sac. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children One drop or as required. Each Minims unit should be discarded after use. 4.3 CONTRAINDICATIONS 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. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The anaesthetised eye should be protected from dust and bacterial contamination. Use with caution in an inflamed eye, as hyperaemia greatly increases the rate of systemic absorption through the conjunctiva. 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. 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 nasolacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.) H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Read the complete document