VallaDerm-90 Dosage

Adult Patients-Intact Skin
A thick layer of Lidocaine and Prilocaine Cream USP, 2.5%/2.5% 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 USP, 2.5%/2.5% (1/2 the 5 g tube) over 20 to 25 cm 2 of skin surface for at least 1 hour. In controlled clinical trials using Lidocaine and Prilocaine Cream USP, 2.5%/2.5%, 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 USP, 2.5%/2.5% per 10 cm 2 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 USP, 2.5%/2.5% (1 g/10 cm 2 ) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of Lidocaine and Prilocaine Cream USP, 2.5%/2.5%.

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 acuminate, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of Lidocaine and Prilocaine Cream USP, 2.5%/2.5% 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 USP, 2.5%/2.5% 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 USP, 2.5%/2.5%.

Pediatric Patients-Intact Skin
The following are the maximum recommended doses, application areas and application times for Lidocaine and Prilocaine Cream USP, 2.5%/2.5% based on a child's age and weight:

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 USP, 2.5%/2.5% 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 USP, 2.5%/2.5% (see PRECAUTIONS).

When applying Lidocaine and Prilocaine Cream USP, 2.5%/2.5% 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 USP, 2.5%/2.5% or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.

Lidocaine and prilocaine cream, 2.5%/2.5% 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 USP, 2.5%/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 USP, 2.5%/2.5% 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 USP, 2.5%/2.5% 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).