Generic Name and Formulations:
Lidocaine 70mg, tetracaine 70mg; topical patch.
Galen US Inc.
Indications for SYNERA:
For local dermal analgesia for superficial venous access and superficial dermatological procedures (eg, excision, electrodessication, shave biopsy of skin lesions).
Adults and Children:
<3yrs: see full labeling. Apply to intact skin. ≥3yrs: Prior to venipuncture or IV cannulation: apply for 20–30 mins. Superficial dermatological procedures (eg, excision, shave biopsy): apply for 30 mins 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.
Avoid simultaneous or sequential application or for longer than recommended. Severe hepatic disease or pseudocholinesterase deficiency. Avoid eyes, mucous membranes, broken or inflamed skin, inadvertent trauma (eg, scratching, rubbing, exposure to extreme temperatures). Remove before undergoing MRI (contains iron powder). Effect on intradermal live vaccines unknown. Congenital or idiopathic methemoglobinemia. Acutely ill or debilitated. Elderly. Pregnancy (Cat.B). Nursing mothers.
Toxicity potentiated by Class I antiarrhythmics (eg, tocainide, mexiletine), other local anesthetics.
Local reactions (eg, erythema, blanching, edema), anaphylactoid reactions.
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