SYNERA (lidocaine and tetracaine) Topical Patch is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures.
SYNERA is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine, local anesthetics of the amide or ester type, or any other component of the product and in patients with para-aminobenzoic acid (PABA) hypersensitivity. Keeping a patch on longer than recommended or applying multiple patches simultaneously or sequentially could result in systemic absorption sufficient to result in serious adverse effects that are typical of drugs in this class.
Used SYNERA patches contain a large amount of lidocaine and tetracaine (at least 90% of the initial amount). Chewing or ingesting a new or used SYNERA patch may result in serious adverse effects. Store and dispose of SYNERA out of the reach of children and pets.
SYNERA should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine and tetracaine, particularly the acutely ill, the debilitated, and those with compromised hepatic function. Patients with severe hepatic disease or pseudocholinesterase deficiency are at greater risk of developing toxic plasma concentrations.
SYNERA should be used with caution in patients with a history of methemoglobinemia (see complete prescribing information).
Do not use on mucous membranes or on areas with a compromised skin barrier. Application to broken or inflamed skin may result in toxic blood concentrations of lidocaine and tetracaine.
Allergic or anaphylactoid reactions (urticaria, angioedema, bronchospasm, and shock) to the active or inactive components of SYNERA can occur and should be managed by conventional means.
Avoid contact of SYNERA with the eyes due to potential irritation or abrasion. If contact occurs, immediately wash out the eye with water or saline, and protect it until sensation returns.
Simultaneous or sequential application of more than two SYNERA patches to children is not recommended as it has not been adequately studied.
Safety and effectiveness of SYNERA have been established in patients 3 years and older.
Lidocaine has been shown to inhibit viral and bacterial growth. The effect of SYNERA on intradermal injections of live vaccines has not been determined.
The heating component contains iron powder, and the patch must be removed before magnetic resonance imaging.
SYNERA may lead to diminished or blocked sensation in the treated skin; therefore, patients should avoid inadvertent trauma (rubbing, scratching, or exposure to heat or cold) before complete sensation returns.
SYNERA should be used with caution in patients receiving class I antiarrhythmics and/or other local anesthetics, because the systemic toxic effects may be additive and potentially synergistic with lidocaine and tetracaine.
In clinical studies, the most common local reactions were erythema (71%), blanching (12%), and edema (12%); these reactions were generally mild, resolving spontaneously soon after patch removal.
Do not cut or remove the top cover of the patch as this could result in thermal injury.
Please refer to complete prescribing information including Instructions For Use before using SYNERA.