MINIMS TETRACAINE HYDROCHLORIDE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TETRACAINE HYDROCHLORIDE

Available from:

Bausch & Lomb UK Limited

ATC code:

S01HA03

INN (International Name):

TETRACAINE HYDROCHLORIDE

Dosage:

1.0 %w/v

Pharmaceutical form:

Eye Drops Solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

tetracaine

Authorization status:

Marketed

Authorization date:

1980-04-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Tetracaine Hydrochloride 1% w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Tetracaine hydrochloride 1% w/v solution.
Each unit (0.5ml) contains Tetracaine hydrochloride 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.)
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