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Emla (Prilocaine / Lidocaine Topical) - Indications and Dosage

 
 



INDICATIONS AND USAGE

EMLA 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.


EMLA 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 AND ADMINISTRATION

Adult Patients−Intact Skin

A thick layer of EMLA 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 EMLA 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 EMLA 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 EMLA 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 EMLA Cream (1 g/10 cm2) to the skin surface for 15 minutes.  Local anesthetic infiltration should be performed immediately after removal of EMLA 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 EMLA 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 EMLA Cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of EMLA Cream.

Pediatric Patients−Intact Skin

The following are the maximum recommended doses, application areas and application times for EMLA Cream based on a child’s age and weight:

Age and Body Weight
Requirements
Maximum Total
Dose of EMLA 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 EMLA 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 EMLA Cream (see PRECAUTIONS ).


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


EMLA 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 EMLA 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 EMLA 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 EMLA 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 ).

INSTRUCTIONS FOR APPLICATION:

To measure 1 gram of EMLA, 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 EMLA cream should be contained within the lines of the diagram shown below. 


     1.5 x 0.2 inches


Use the number of strips that equals your dose, like the examples in the table below.


                                                         Dosing Information

                                                             1 gram = 1 strip

                                                            2 grams = 2 strips

                                                        2.5 grams = 2.5 strips


For adult and pediatric patients, apply ONLY as prescribed by your physician.


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


When applying EMLA 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 EMLA Cream.


EMLA 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 EMLA Cream, and 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.


Precautions

1. Do not apply near eyes or open wounds.

2. Keep out of the reach of children.

3. If your child becomes very dizzy, excessively sleepy, or develops duskiness of the face or lips after applying EMLA Cream, remove the cream and contact the child’s physician at once.


HOW SUPPLIED

EMLA Cream is available as the following:


Product
No. 
NDC
No. 
Strength Size
278905 63323-289-05 5 gram/tube packaged individually.
278955     63323-289-55  5 gram/tube  packaged in 5. 
279030  63323-290-30  30 gram/tube  packaged individually,  in a child-resistant tube. 

NOT FOR OPHTHALMIC USE.

 

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

 

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

 

Manufactured for:

451096A

Revised: November 2008

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