A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Emla Indications, Dosage, Storage, Stability - Lidocaine and Prilocaine
Emla Indications, Dosage, Storage, Stability - Lidocaine and Prilocaine
INDICATIONS
EMLA (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.
EMLA is not recommended for use on mucous membranes because limited
studies show much greater
absorption of lidocaine
and prilocaine than through intact skin. Safe dosing recommendations
for use on mucous membranes
cannot be made because it has not been studied adequately.
EMLA is not recommended in any clinical situation in which 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
EMLA Cream and Anesthetic Disc
A thick layer of EMLA
Cream is applied to intact skin
and covered with an occlusive
dressing, or alternatively, an EMLA
Anesthetic Disc is applied to intact skin:
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, or 1 EMLA Anesthetic
Disc (1g over 10 cm2) 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.
EMLA Cream
A thick layer of EMLA
Cream is applied to intact skin
and covered with an occlusive
dressing:
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.
Pediatric Patients
The following are the maximum
recommended doses and areas of application for EMLA
based on a child's age and
weight:
Age and Body Weight
Requirements |
Maximum Total
Dose of EMLA |
Maximum
Application Area** |
| 1 to 3 months or < 5 kg |
1 g |
10 cm2 |
| 4 to 12 months and > 5 kg |
2 g |
20 cm2 |
| 1 to 6 years and >10 kg |
10 g |
100 cm2 |
| 7 to 12 years and >20 kg |
20 g |
200 cm2 |
Please note: If a patient
greater than 3 months old does not meet the minimum
weight requirement, the
maximum total dose of EMLA
should be restricted to that which corresponds to the patient's
weight.
Practitioners should carefully instruct caregivers to avoid application
of excessive amounts of EMLA
(see Precautions).
When applying EMLA to
the skin of young children,
care must be taken to maintain careful observation of the child
to prevent accidental ingestion
of EMLA, the occlusive
dressing, or the anesthetic disc. A secondary
protective covering
to prevent inadvertent disruption of the application site
may be useful.
EMLA should not be used in infants under the age
of one month nor in infants under the age
of twelve months who are receiving treatment
with methemoglobin-inducing agents (see WARNINGS:
Methemoglobinemia).
When EMLA (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 is determined by
the area over which it
is applied and the duration
of application under occlusion
(see CLINICAL PHARMACOLOGY: CLINICAL
STUDIES - Individualization of Dose: Table 2, ** footnote).
Although the incidence
of systemic adverse reactions with EMLA
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 CLINICAL
PHARMACOLOGY: CLINICAL STUDIES - Individualization
of Dose).
HOW SUPPLIED
EMLA Cream is available as the following:
NDC 0186-1515-015 gram
tube,box of 1,contains 2 Tegaderm® dressings (6 cm
× 7 cm)
NDC 0186-1515-035 gram
tube,box of 5,contains 12 Tegaderm® dressings (6
cm x 7 cm)
NDC 0186-1516-0130 gram
tube,box of 1
EMLA Anesthetic Disc is available in the following: NDC 0186-1512-701
gram Anesthetic Disc,box of 2NDC 0186-1512-711 gram
Anesthetic Disc,box of 10
NOT FOR OPHTHALMIC USE.
KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.
Store at controlled room
temperature 15°30°C (59°86°F).
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