AMETOP^◊

Indications 

Topical anaesthetic for dermal analgesia.  

Contraindications 

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.

Precautions 

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.

Adverse effects 

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 

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.

Supplied 

Each gram of white, opalescent gel contains 40 mg of tetracaine base. Available in tubes of 1.5 grams.  

Storage 

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.  

Ordering codes 

PROPER USE OF THIS MEDICATION

Administration
Apply the contents of the tube to the skin starting from the center of the site where the skin is to be punctured by a needle and cover with an occlusive dressing.

The contents from one tube (approximately 1g) are sufficient to cover and anesthetize an area of up to 30cm2 (6 x 5 cm). Smaller areas of anaesthetized skin may be adequate.

Adequate anesthesia can usually be achieved for getting a needle or having blood taken following a thirty minute application time, and for inserting an intravenous drip 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 4% for longer than the above recommended times and anesthesia is maintained for 4 to 6 hours in most patients after a single application.

Usual dose
Adults (including the elderly): No more than the contents of 1 tube (approximately 1g) should be applied per site where a needle or an intravenous drip is to be inserted. In certain circumstances anesthesia of more than one site may be necessary.  In such cases, a maximum of 5 sites may be anesthetized at the outset of a course of treatment, if required to ensure that a series of sites are available in the event that venous access cannot be achieved at the first site.

The maximum cumulative dose in a 24 hour period should not exceed 7 tubes.

Children (over 1 month of age)
No more than 1 tube should be applied in a single application.

The maximum cumulative dose in a 24 hour period should not exceed 2 tubes.

Overdose
In case of AMETOP Gel 4% overdose or if you think you or anyone else are experiencing any of the side effects described below, telephone your doctor or go to the nearest hospital right away.

HOW TO STORE IT
Keep refrigerated at 2° to 8° C. Do not freeze. Protect from heat.

PDF Documents

AMETOP - Instructions for Use