Synera Generic Name & Formulations
Legal Class
Rx
General Description
Lidocaine 70mg, tetracaine 70mg; topical patch.
Pharmacological Class
Topical anesthetic.
How Supplied
Patches—1, 10
Manufacturer
Generic Availability
NO
Synera Indications
Indications
For local dermal analgesia for superficial venous access and superficial dermatological procedures (eg, excision, electrodessication, shave biopsy of skin lesions).
Synera Dosage and Administration
Adults and Children
<3yrs: see full labeling. Apply to intact skin. ≥3yrs: Prior to venipuncture or IV cannulation: apply for 20–30mins. Superficial dermatological procedures (eg, excision, shave biopsy): apply for 30mins prior to procedure. Remove patch if irritation or burning sensation occurs. Do not cut patches or remove top cover (may cause thermal injury). Do not cover holes on top side of patch.
Synera Contraindications
Not Applicable
Synera Boxed Warnings
Not Applicable
Synera Warnings/Precautions
Warnings/Precautions
Risk of methemoglobinemia (esp. in G6PD deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants <6 months of age, concurrent exposure to oxidizing agents or metabolites); monitor. Avoid simultaneous or sequential application or for longer than recommended. Remove before undergoing MRI (contains iron powder). Avoid eyes, mucous membranes, broken or inflamed skin, inadvertent trauma (eg, scratching, rubbing, exposure to extreme temperatures). Effect on intradermal live vaccines undetermined. Severe hepatic disease or pseudocholinesterase deficiency. Acutely ill or debilitated. Elderly. Pregnancy. Nursing mothers: avoid direct infant exposure.
Synera Pharmacokinetics
See Literature
Synera Interactions
Interactions
Increased risk of methemoglobinemia when concurrently exposed to nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, others. Toxicity may be potentiated by Class I antiarrhythmics (eg, tocainide, mexiletine). Additive effects with other products containing local anesthetics.
Synera Adverse Reactions
Adverse Reactions
Local reactions (eg, erythema, blanching, edema), anaphylactoid reactions.
Synera Clinical Trials
See Literature
Synera Note
Not Applicable
Synera Patient Counseling
See Literature