NEODOSE

FDA APPROVED INDICATION

Topical anesthetic for use on normal intact skin for local analgesia and genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Not recommended for any clinical situation where penetration or migration beyond the tympanic membrane into the middle ear is possible due to risk of ototoxic effects. Evaluated in 105 full-term neonates for blood drawing and circumcision procedures. Studies have not demonstrated efficacy for heel lancing.

CONTRAINDICATIONS

Hypersensitivity to local amide-type anesthetics or to any component of the product.

PRECAUTIONS

• Concomitant Use:
  • with class III anti-arrhythmic drugs (e.g. amiodarone, bretylium, sotalol, dofetilide) may result in additive cardiac effects; monitoring recommended.
• Dermatologic:
  • Increased risk for systemic absorption and toxicity with covering of application site, large doses and/or treatment areas, skin temperature increases, and with irritated, broken skin, or wounds; potentially resulting in life-threatening side effects.
• Hematologic:
  • Methemoglobinemia has been reported with use of local anesthetics; increased risk in patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites and other drugs associated with methemoglobinemia; if use is required in at-risk patients monitoring is recommended; medical management and discontinuation of therapy is required.
• Hepatic:
  • Risk of toxic plasma concentrations in patients with severe hepatic disease.
• Immunologic:
  • Use with caution in patients with history of allergies to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.).
  • Has been shown to inhibit viral and bacterial growth, effect on intradermal injections of live vaccines has not been determined.
• Ophthalmic:
  • Avoid contact with eyes due to risk of severe irritation and loss of protective reflexes.
• Otic:
  • Ototoxic effects possible when drug penetrates beyond the tympanic membrane into the middle ear.
• Special Populations:
  • Acutely ill or debilitated patients; increased sensitivity to systemic effects.

ADVERSE EFFECTS

Blanching and redness resolve without treatment. When measured, blood levels of methemoglobin in neonates after the application of 1 g of EMLA cream have been well below toxic levels. Two cases of methemoglobinemia in infants occurred after greater than 3 g of EMLA cream was applied; in 1 of these cases, the infant also was receiving sulfamethoxazole. EMLA cream should not be used in neonates with congenital or idiopathic methemoglobinemia, or who are receiving other drugs known to induce methemoglobinemia: sulfonamides, acetaminophen, nitrates, nitroglycerin, nitroprusside, phenobarbital, and phenytoin.

MONITORING

Blood methemoglobin concentration if concerned about toxicity.