Local Anaesthetic Cream 25g
Contains active ingredients including Amethocaine
Anethaine Local Anaesthetic Cream 25 g
Scheduling status: S1.Proprietary name (and dosage form):Anethaine® cream.Composition:Per 100 g:Amethocaine hydrochloride 1.0 g.Pharmacological classification:A 13.3 Surface anaesthetics.Pharmacological action:Anethaine cream contains a local anaesthetic, amethocaine hydrochloride.This compound exerts an effect within minutes of topical application and remains active for at least two hours.Indications:Relief of local pain and discomfort, e.g. in haemorrhoids, anal fissures, minor burns and scalds, boils, stings and certain skin infections. Useful lubricant in instrumentation.Identification:White cream with characteristic odour of bergamot oil.Presentation:Tubes of 25 g and 40 g. A suitable applicator nozzle is enclosed.Per 100 g.Amethocaine hydrochloride 1 g in a water-miscible base.Winthrop Pharmaceuticals.Sanofi Aventis Group.
Quantity in pack:
Anethaine®.Local anaesthetic cream.Haemorrhoids, minor burns, insect stings.25 g.
How to use
Store below 25 degrees C.
Contra-indications:Anethaine cream is contra-indicated in patients with a sensitivity to amethocaine hydrochloride or to related anaesthetics, PABA, parabens or paraphenylenediamine.All local anaesthetics are liable to cause sensitisation of the skin, and this risk is increased if the preparation is applied for prolonged periods and/or to broken skin. Anethaine cream should not be used on patients with eczema, or others having abnormal tendencies to develop sensitisation. Use of the cream must be stopped if there is any indication of development of dermatitis.Anethaine cream is also contra-indicated in cases of sunburn, except under medical supervision.Anethaine cream should not be given to patients with low plasma cholinesterase concentrations or to those receiving anti-cholinesterases.Side-effects and special precautions:Side-effects occur with excessive dosage or rapid absorption or may be due to idiosyncrasy, hypersensitivity or decreased patient tolerance. Swellings on the skin, burning, stinging, tenderness, contact dermatitis with a skin rash, redness and itching may occur after application. Should sensitisation occur, application should be discontinued.It should be given with caution to the elderly, the debilitated, children, to patients with epilepsy, impaired cardiac conduction, shock, liver damage, and myasthenia gravis.Local infection may alter the pH at the site of application, which may lead to a decrease or loss of local anaesthetic effect. Cross-sensitivity may occur between Anethaine cream and other ester-type local anaesthetics.Amethocaine should not be applied to inflamed, traumatised or highly vascular areas as this may increase the absorption of amethocaine, leading to increased risk of systemic toxicity.Absorption of amethocaine from mucous membranes is rapid and adverse reactions can occur abruptly without the appearance of prodromal signs or convulsions: fatalities have occurred.Drug interactions:Concurrent use of amethocaine and cholinesterase inhibitors may inhibit the metabolism of amethocaine, leading to an increased risk of systemic toxicity.Concurrent use of amethocaine and sulphonamides may antagonise the antibacterial activity of sulphonamides.Known symptoms of overdosage and particulars of its treatment:Overdosage with amethocaine occurs with excessive systemic absorption of large amounts through mucous membranes or damaged skin or from highly vascular areas. Systemic toxicity involves the central nervous system and the cardiovascular system. Excitation of the CNS may be manifested by restlessness, excitement, nervousness, dizziness, tinnitus, blurred vision, nausea and vomiting, muscle twitching and tremors, shivering or trembling, unusual anxiety, and convulsions.Excitation may be transient and followed by depression with drowsiness, unconsciousness, respiratory failure and coma. There may be simultaneous effects on the cardiovascular system with myocardial depression and peripheral vasodilatation resulting in hypotension and bradycardia; arrhythmias, unusual paleness, increased sweating and cardiac arrest may occur.When systemic reactions to amethocaine occur, steps should be taken to maintain the circulation and respiration and to control convulsions. A patent airway must be established and oxygen given, together with assisted ventilation if necessary. The circulation should be maintained with infusions of intravenous fluids, or administering a vasopressor. Convulsions may be controlled by the intravenous administration of diazepam or thiopentone sodium, but these agents may also depress respiration and circulation.Keep out of reach of children.For external use only.