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Lidocaine and Prilocaine (Lidocaine / Prilocaine Topical) - Indications and Dosage

 
 



INDICATIONS & USAGE SECTION

Lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is 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.

lidocaine 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).

DOSAGE & ADMINISTRATION SECTION

Adult Patients-Intact Skin

A thick layer of lidocaine and prilocaine cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION).

Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of 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 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 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 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 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.

Adult Female Patients-Genital Mucous Membranes

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 to 10 grams) of lidocaine and prilocaine cream for 5 to 10 minutes.

Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the 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 lidocaine and prilocaine cream.

Pediatric Patients-Intact Skin

The following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream based on a child's age and weight:

Age and Body Weight
Requirements
Maximum Total
Dose of Lidocaine and
Prilocaine Cream
Maximum
Application Area
Maximum
Application Time
0 up to 3 months or < 5 kg 1 g 10 cm2 1 hour
3 up to 12 months and > 5 kg 2 g 20 cm2 4 hours
1 to 6 years and > 10 kg 10 g 100 cm2 4 hours
7 to 12 years and 20 kg 20 g 200 cm2 4 hours

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

Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine and prilocaine cream (see PRECAUTIONS).

When applying 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 lidocaine and prilocaine cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.

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 lidocaine and prilocaine 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 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 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).

HOW SUPPLIED SECTION

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:

NDC No. Strength Size
NDC 17478-190-05 5 gram/tube packed individually.
NDC 17478-190-55 5 gram/tube packed in 5.
NDC 17478-190-30 30 gram/tube packed individually, in a child-resistant tube.

NOT FOR OPHTHALMIC USE.

KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.

Storage: Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].

AKORN

Distributed by: Akorn, Inc.

Lake Forest, IL 60045

LN00N

Rev. 06/12

Principal Display Panel Text for Container Label:

NDC 17478-190-05 5 grams

Lidocaine 2.5% and

Prilocaine 2.5% Cream, USP

Rx only Akorn Logo

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