Liprikaine Cream

[Catherine Nicolo]

Liprikainelidocaine and prilocaine) Cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).

Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of Liprikaine (lidocaine and prilocaine) Cream (1/2 the 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using Liprikaine (lidocaine and prilocaine) Cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.

Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of Liprikaine (lidocaine and prilocaine) Cream per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.

Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of Liprikaine (lidocaine and prilocaine) Cream (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of Liprikaine (lidocaine and prilocaine) Cream.

Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.

For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5-10 grams) of Liprikaine (lidocaine and prilocaine) Cream for 5 to 10 minutes.

a href="/script/main/art.asp?articlekey=24885">Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the Liprikaine (lidocaine and prilocaine) Cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of Liprikaine (lidocaine and prilocaine) Cream.

Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of Liprikaine (lidocaine and prilocaine) Cream should be restricted to that which corresponds to the patient's weight. (see Instruction For Application).

When applying Liprikaine (lidocaine and prilocaine) Cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of Liprikaine (lidocaine and prilocaine) Cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.

Liprikaine (lidocaine and prilocaine) Cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).

When Liprikaine Cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of Liprikaine (lidocaine and prilocaine) Cream is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).

Although the incidence of systemic adverse reactions with Liprikaine (lidocaine and prilocaine) Cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).

To measure 1 gram of Liprikaine (lidocaine and prilocaine) , the Cream should be gently squeezed out of the tube as a narrow strip that is 1.5 inches (3.8 cm) long and 0.2 inches (5 mm) wide. The strip of Liprikaine (lidocaine and prilocaine) cream should be contained within the lines of the diagram shown below.

If your child is below the age of 3 months or small for their age, please inform your doctor before applying Liprikaine (lidocaine and prilocaine) Cream, which can be harmful, if applied over too much skin at one time in young children.

When applying Liprikaine (lidocaine and prilocaine) to the intact skin of young children, it is important that they be carefully observed by an adult in order to prevent the accidental ingestion of or eye contact with Liprikaine Cream.

Liprikaine (lidocaine and prilocaine) Cream must be applied to intact skin at least 1 hour before the start of a routine procedure and for 2 hours before the start of a painful procedure. A protective covering of the Cream is not necessary for absorption but may be helpful to keep the cream in place.

If using a protective covering, your doctor will remove it, wipe off the Liprikaine (lidocaine and prilocaine) Cream, clean the entire area with an antiseptic solution before the procedure. The duration of effective skin anesthesia will be at least 1 hour after removal of the protective covering.

Liprikaine Cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

Application of Liprikaine (lidocaine and prilocaine) Cream to larger areas or for longer times than those recommended could result in sufficient absorption of lidocaine and prilocaine resulting in serious adverse effects (see Individualization of Dose).

Patients treated with class III anti-arrhythmic drugs (eg, amiodarone, bretylium, sotalol, dofetilide) should be under close surveillance and ECG monitoring considered, because cardiac effects may be additive.

Studies in laboratory animals (guinea pigs) have shown that Liprikaine (lidocaine and prilocaine) Cream has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to Liprikaine (lidocaine and prilocaine) Cream only in the external auditory canal, showed no abnormality. Liprikaine (lidocaine and prilocaine) Cream should not be used in any clinical situation when its penetration or migration beyond the tympanic membrane into the middle ear is possible.

Methemoglobinemia: Liprikaine (lidocaine and prilocaine) Cream should not be used in those rare patients with congenital or idiopathic methemoglobinemia and in infants under the age of twelve months who are receiving treatment with methemoglobin-inducing agents.

Patients taking drugs associated with drug-induced methemoglobinemia such as sulfonamides, acetaminophen, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine, are also at greater risk for developing methemoglobinemia.

There have been reports of significant methemoglobinemia (20-30%) in infants and children following excessive applications of Liprikaine (lidocaine and prilocaine) Cream. These cases involved the use of large doses, larger than recommended areas of application, or infants under the age of 3 months who did not have fully mature enzyme systems. In addition, a few of these cases involved the concomitant administration of methemoglobin-inducing agents. Most patients recovered spontaneously after removal of the cream. Treatment with IV methylene blue may be effective if required.

Physicians are cautioned to make sure that parents or other caregivers understand the need for careful application of Liprikaine (lidocaine and prilocaine) Cream, to ensure that the doses and areas of application recommended in Table 2 are not exceeded (especially in children under the age of 3 months) and to limit the period of application to the minimum required to achieve the desired anesthesia.

Neonates and infants up to 3 months of age should be monitored for Met-Hb levels before, during, and after the application of Liprikaine (lidocaine and prilocaine) Cream, provided the test results can be obtained quickly.

Repeated doses of Liprikaine Cream may increase blood levels of lidocaine and prilocaine. Liprikaine (lidocaine and prilocaine) Cream should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine and prilocaine including acutely ill, debilitated, or elderly patients.

Care should be taken not to allow Liprikaine (lidocaine and prilocaine) Cream to come in contact with the eye because animal studies have demonstrated severe eye irritation. Also the loss of protective reflexes can permit corneal irritation and potential abrasion. Absorption of Liprikaine (lidocaine and prilocaine) Cream in conjunctival tissues has not been determined. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.

Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine; however, Liprikaine (lidocaine and prilocaine) Cream should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.

Lidocaine and prilocaine have been shown to inhibit viral and bacterial growth. The effect of Liprikaine (lidocaine and prilocaine) Cream on intradermal injections of livevaccines has not been determined.

Metabolites of prilocaine have been shown to be carcinogenic in laboratory animals. In the animal studies reported below, doses or blood levels are compared with the Single Dermal Administration (SDA) of 60 g of Liprikaine (lidocaine and prilocaine) Cream to 400 cm2 for 3 hours to a small person (50 kg). The typical application of Liprikaine (lidocaine and prilocaine) Cream for one or two treatments for venipuncture sites (2.5 or 5 g) would be 1/24 or 1/12 of that dose in an adult or about the same mg/kg dose in an infant.

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