"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
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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 (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 AND ADMINISTRATION
Adult Patients - Intact Skin
A thick layer of EMLA (lidocaine and prilocaine) Cream is applied to intact skin and covered with an occlusive dressing (see Instruction For Application).
Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of EMLA (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 EMLA (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 EMLA (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 EMLA (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 EMLA (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 (5-10 grams) of EMLA (lidocaine and prilocaine) Cream for 5 to 10 minutes.
a href="/script/main/art.asp?articlekey=24885">Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the EMLA (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 EMLA (lidocaine and prilocaine) Cream.
Pediatric Patients - Intact Skin
The following are the maximum recommended doses, application areas and application times for EMLA (lidocaine and prilocaine) 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 (lidocaine and prilocaine) Cream should be restricted to that which corresponds to the patient's weight. (see Instruction For Application).
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of EMLA Cream (see PRECAUTIONS).
When applying EMLA (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 EMLA (lidocaine and prilocaine) Cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
EMLA (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 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 (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 EMLA (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).
Instruction For Application
To measure 1 gram of EMLA (lidocaine and prilocaine) , 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 (lidocaine and prilocaine) cream should be contained within the lines of the diagram shown below.
≈1 g strip
1.5 X 0.2 inches
Use the number of strips that equals your dose, like the examples in the table below.
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 (lidocaine and prilocaine) Cream, which can be harmful, if applied over too much skin at one time in young children.
When applying EMLA (lidocaine and prilocaine) 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® (lidocaine and prilocaine) 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® (lidocaine and prilocaine) Cream, 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.
- Do not apply near eyes or on open wounds.
- Keep out of reach of children.
- If your child becomes very dizzy, excessively sleepy, or develops duskiness of the face or lips after applying EMLA (lidocaine and prilocaine) Cream, remove the cream and contact the child's physician at once.
EMLA (lidocaine and prilocaine) Cream is available as the following:
NDC 0186-1515-01..............................5 gram tube, box of 1
Product No. 0186-1515-03..............................5 gram tube, box of 5
NDC 0186-1516-01..............................30 gram tube box of 1, the 30 gram tube of EMLA (lidocaine and prilocaine) Cream is packaged in a child resistant tube.
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).
AstraZeneca LP, Wilmington, DE 19850. FDA Rev date: 04/27/06
Last reviewed on RxList: 8/13/2008
This monograph has been modified to include the generic and brand name in many instances.
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