Usual Adult Dose for Anesthesia

Venipuncture and intravenous cannulation: 2.5 g (one-half of 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour.

Painful dermatologic procedure on a large skin area such as split thickness skin graft harvesting: 2 g per 10 cm2 of skin surface for at least 2 hours.

Genital skin (male): adjunct prior to local anesthetic infiltration, 1 g per 10 cm2 of skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after the removal of the 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.

Genital mucous membranes (female): 5 to 10 g for 5 to 10 minutes. Occlusion is not necessary for absorption. The procedure or the local anesthetic infiltration should be performed immediately after the removal of the cream.

Applied directly into periodontal pockets to provide localized anesthesia: Apply lidocaine-prilocaine liquid on the gingival margin around the selected teeth using the blunt tipped applicator included in the package. Wait 30 seconds, then fill the periodontal pockets with lidocaine-prilocaine liquid using the blunt tipped applicator until the gel becomes visible at the gingival margin. Wait another 30 seconds before starting treatment. A longer waiting time does not enhance the anesthesia. Anesthetic effect, as assessed by probing of pocket depths, has a duration of approximately 20 minutes. If the anesthesia starts to wear off, lidocaine-prilocaine liquid may be reapplied if needed. The maximum recommended dose of lidocaine-prilocaine liquid at one treatment session is 5 cartridges.

Usual Pediatric Dose for Anesthesia

Neonatal:
Topical:
Gestational Age (GA): Less than 37 weeks: 0.5 g/dose has been most frequently reported. One study of 30 preterm neonates (GA: greater than or equal to 30 weeks) showed application to the heel for 1 hour resulted in no measurable changes in methemoglobin levels; others have reported similar findings
GA: greater than or equal to 37 weeks:
Painful procedures (i.e.,, intramuscular injections): Apply 1 g/site for at least 60 minutes
Circumcision: Apply 1 to 2 g to prepuce and occlude for 60 to 90 minutes prior to procedure
Manufacturer recommended maximum dose and application area (based on application to intact skin): Weight less than 5 kg:
Maximum total dose of 1 g
Maximum application area: 10 cm2
Maximum application time: 1 hour

Dosage based on age, weight, application area, and application times - maximum recommended:
Less than or equal to 3 months (or less than 5 kg): 1 g, 10 cm2, 1 hour
Greater than 3 to less than or equal to 12 months: (and greater than 5 kg): 2 g, 20 cm2, 4 hours
1 to 6 years (and greater than 10 kg): 10 g, 100 cm2, 4 hours
7 to 12 years (and greater than 20 kg): 20 g, 200 cm2, 4 hours

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Patients with severe hepatic disease are at a greater risk of developing toxic plasma concentrations.

Dose Adjustments

In pediatric patients older than 3 months who do not meet the minimum weight requirement, the maximum total dose should be restricted to that which corresponds to the patient's weight.

Precautions

Lidocaine-prilocaine topical cream should not be used in neonates with a gestational age less than 37 weeks nor in infants younger than 12 months who are receiving treatment with methemoglobin-inducing agents.

Caution should be exercised when applying this cream over large areas or leaving it on for longer than 2 hours. The incidence of adverse effects can be expected to be directly proportional to the area and time of exposure.

Lidocaine-prilocaine is contraindicated in patients with a known history of sensitivity to amide-type local anesthetics.

Patients with congenital or idiopathic methemoglobinemia should not use lidocaine-prilocaine topical cream. Also, patients with glucose-6-phosphate dehydrogenase deficiencies and those taking drugs associated with drug-induced methemoglobinemia are at a greater risk of developing methemoglobinemia.

Neonates and infants up to 3 months should be monitored for methemoglobinemia levels before, during, and after the application of lidocaine-prilocaine topical cream.

Lidocaine-prilocaine topical cream should not be used in any clinical situation in which its penetration or migration beyond the tympanic membrane into the middle ear is possible. Studies in laboratory animals (guinea pigs) have shown an ototoxic effect when instilled into the middle ear. The animals exposed to the topical in the external auditory canal only, showed no abnormality.

Use cream with caution in patients who may be more sensitive to the systemic effects of lidocaine or prilocaine as a result of acute illness, debilitated, or the elderly.

Do not allow the cream to come into contact with the eye because animal studies have demonstrated severe eye irritation. Also, the loss of protective reflexes can permit corneal irritation and potential abrasion. If contact with the eye occurs, wash out the eye immediately with water or saline and protect the eye until sensation returns.

Patients with severe hepatic diseases are at a greater risk of developing toxic plasma concentrations of lidocaine and prilocaine.

Patients should be advised that a block of all sensations to the treated skin may occur and to avoid inadvertent trauma to the treated area.

Lidocaine-prilocaine topical cream should be used with caution in patients receiving Class I antiarrhythmic drugs since the toxic effects are additive and potentially synergistic.

For application to intact skin only.

Dialysis

Data not available