Ametop (Tetracaine HCl)


Smith & Nephew

Tetracaine HCl

Topical Anesthetic

Action And Clinical Pharmacology: Tetracaine is a local anesthetic of the ester type (para-amino benzoic acid derivative). Ametop has been formulated as the free base to allow the tetracaine to diffuse across the skin barrier and reach the pain receptors (nociceptors) located just below the stratum corneum.

It acts by inhibiting sodium ion flux across the axon membrane thus preventing the nociceptors signalling pain to the CNS.

Indications And Clinical Uses: Topical anesthetic for dermal analgesia.

Contra-Indications: Premature babies or full-term infants less than 1 month of age, in whom the metabolic pathway for tetracaine may not be fully developed.

Known hypersensitivity to local anesthetics of the ester type.

Do not apply gel to broken skin, mucous membranes or to the eyes or ears.

Do not use prior to immunization.

Manufacturers’ Warnings In Clinical States: If accidentally ingested, systemic toxicity may occur and signs will be similar to those observed after other local anesthetics.

As tetracaine can cause contact sensitization reactions, particularly with repeated exposure, healthcare professionals should take care to minimize contact with the gel during application and removal.

Precautions: Only apply to intact, unbroken skin. Not to be taken internally. Tetracaine gel, like other local anesthetics may be ototoxic and should not be instilled into the middle ear or used for procedures which might involve penetration into to the middle ear. Repeated exposure to tetracaine gel may increase the risk of sensitization reactions to tetracaine.

Pregnancy and Lactation: 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 Reactions: 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 anesthetized area.

Slight edema or itching are less frequently seen at the site of application.

More severe erythema, edema and/or itching have rarely been reported.

Dosage And Administration: Adults (including geriatrics) and children over 1 month of age: Apply the contents of the tube to the skin starting from the centre of the area to be anesthetized and cover wih an occlusive dressing. The contents expellable from 1 tube (approximately 1 g) are sufficient to cover and anesthetize an area of up to 30 cm(6´5 cm). Smaller areas of anesthetized skin may be adequate in infants and small children.

Adequate anesthesia can usually be achieved for venepuncture following a 30-minute application time, and for venous cannulation following a 45-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 tetracaine gel for longer than the above recommended times and anesthesia is maintained for 4 to 6 hours in most patients after a single application.

SuppliedSupplied: Each g of white, opalescent gel contains: tetracaine base 40 mg (4% w/w) (as tetracaine HCI). Nonmedicinal ingredients: purified water, potassium phosphate, sodium chloride, sodium hydroxide, sodium methyl-p-hydroxybenzoate, sodium propyl-p-hydroxybenzoate and xanthan gum. Tubes of 1.5 g. Keep refrigerated at 2 to 8°C. Within the shelf life of 2 years, the product may be stored after dispensing for up to 1 month at 25°C.

AMETOP™ Smith & Nephew Tetracaine HCl Topical Anesthetic

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