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.
|
