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
Tetracaine hydrochloride is used as a local anaesthetic which acts by reversibly blocking the propagation and conduction of nerve impulses along nerve axons. Tetracaine stabilises the nerve membrane, preventing the increase in sodium permeability necessary for the production of an action potential.
Tetracaine is a weak base (pKa 8.5), therefore, significant changes in the rate of ionised lipid soluble drug uptake may occur with changes in the acid base balance.
In vitro studies have shown that tetracaine has a high affinity for melanin, therefore, differences in duration of action may be expected between deeply pigmented eyes and less pigmented eyes.
The primary site of metabolism for tetracaine is the plasma. Pseudocholinesterases in the plasma hydrolyse tetracaine to 4-aminobenzoic acid. Unmetabolised drug is excreted in the urine.
No adverse safety issues were detected during the development of this formulation. The active ingredient is well established in clinical ophthalmology.
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