Lidocaine + Prilocaine

N/A

Indicated as a topical anesthetic for use on normal intact skin for local analgesia, genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia

N/A

Hypersensitivity to local anaesthetics of the amide type or to any other component of the product.

Lidocaine and prilocaine are local anaesthetic agents of the amide type. Both work by stabilising the neuronal membranes and inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby giving rise to the anaesthetic action.

Cream should be used with caution in patients receiving antiarrhythmic drugs, such as tocainide, since the toxic effects are additive.

Nervousness, dizziness, blurred vision, tremors, drowsiness, convulsions, unconsciousness, respiratory arrest, hypotension, myocardial depression, bradycardia, cardiac arrest and anaphylactoid reactions (cutaneous lesion, urticaria, oedema).

Toxic levels of lidocaine (>5 µg/ml) and/or prilocaine (>6 µg/ml) may decrease cardiac output, total peripheral resistance and mean arterial pressure. These changes are due to direct depressant effects of these local anaesthetic agents on the CVS.

There is no, or inadequate, evidence of safety of the drug in human pregnancy but it has been in wide use for many years without apparent ill consequence. If drug therapy is needed in pregnancy, this drug can be used if there is no safer alternative. Cream enters the mothers milk, but in such small quantities that there is generally no risk of affecting the child at therapeutic dose levels.

Absorption from wound surfaces and mucous membranes is relatively high, especially in the bronchial tree. This cream should be used with caution in patients with traumatised mucosa and/or sepsis in the region of the proposed application. If the dose or site of administration is likely to result in high blood levels, cream should be used cautiously in patients with epilepsy, impaired cardiac condition, bradycardia, impaired hepatic function and in severe shock. The use of oropharyngeal topical anesthetic agents may interfere with swallowing and thus enhance the danger of aspiration. This is particularly important in children because of their frequency of eating. Numbness of the tongue or buccal mucosa may increase the danger of biting trauma.