AMETOP Gel 4%
Topical anaesthetic for dermal analgesia.
Use in premature babies or full term infants less than one month of age, in whom the metabolic pathway for tetracaine may not be fully developed. Known hypersensitivity to local anaesthetics of the ester type. Do not apply AMETOP Gel to broken skin, mucous membranes or to the eyes or ears. Do not use prior to immunisation.
Only apply to intact, unbroken skin. Not to be taken internally. AMETOP Gel, like other local anaesthetics may be ototoxic and should not be instilled into the middle ear or used for procedures which might involve penetration into the middle ear. Repeated exposure to AMETOP Gel may increase the risk of sensitisation reactions to tetracaine. There is no specific information as to the safety of tetracaine in pregnancy. It is not known whether tetracaine or its metabolites are secreted in breast milk. Therefore the product is not recommended for use by pregnant women or by breast-feeding mothers.
Slight erythema is frequently seen at the site of application and is due to the pharmacological action of tetracaine dilating capillary vessels. This may help in delineating the anaesthetised area. Slight oedema or itching are less frequently seen at the site of application. More severe erythema, oedema and/or itching have rarely been reported. In very rare instances, blistering of the skin at the site of application may be apparent - in these cases, remove the gel immediately and treat the affected area symptomatically.
Dosage and administration
Adults (including the elderly) and children over one month of age: Apply the contents of the tube to the skin starting from the center of the area to be anaesthetised and cover with an occlusive dressing. The contents expellable from one tube (approximately one gram) are sufficient to cover and anaesthetise an area of up to 30 cm 2 (6 X 5 cm). Smaller areas of anaesthetised skin may be adequate in infants and small children. Adequate anaesthesia can usually be achieved for venepuncture following a thirty-minute application time, and for venous cannulation following a forty-five minute application time; after which the gel should be removed with a gauze swab and the site prepared with an antiseptic wipe in the normal manner. It is not necessary to apply AMETOP Gel for longer than the above recommended times and anaesthesia is maintained for 4 to 6 hours in most patients after a single application.
Overdosage with AMETOP gel is unlikely to result from application to intact skin. If accidentally ingested systemic toxicity may occur, and signs will be similar to those observed after administration of other local anaesthetics.
Each gram of white, opalescent gel contains 40 mg of tetracaine base. Available in tubes of 1.5 grams.
Keep refrigerated at 2º to 8º C. Within the shelf life of 2 years, the product may be stored after dispensing for up to one month at 25º C.