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SYNERA
Topical pain relief
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Drug Name:

SYNERA Rx

Generic Name and Formulations:
Lidocaine 70mg, tetracaine 70mg; topical patch.

Company:
Galen US Inc.

Therapeutic Use:

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.

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 (Cat.B). Nursing mothers.

Pharmacological Class:

Topical anesthetic.

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.

Adverse Reactions:

Local reactions (eg, erythema, blanching, edema), anaphylactoid reactions.

Generic Availability:

NO

How Supplied:

Patches—1, 10

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