Classes
DEA Class; Rx
Common Brand Names; Synera, Pliaglis
- Anesthetics, Topical
Description
Local anesthetics for topical administration; available as a patch that becomes warm once the outer packaging is removed and as a cream that forms a pliable peel on the skin when exposed to air.
Indications
Indicated for use as local anesthesia to provide topical anesthesia to normal intact skin.
Contraindications
Hypersensitivity to components, amide-type local anesthetics
Adverse Effects
Localized erythema (71%)
Localized blanching (12%)
Localized edema (12%)
Other application site reactions (contact dermatitis, rash, skin discoloration) (<4%)
Rash
Application site reactions
Pruritus
Dizziness
Headache
Pain
Contact dermatitis
Infection
Skin discoloration
Somnolence
Allergic reaction
Blister
Paresthesia
Urticaria
Vesiculobullous rash
Warnings
Severe hepatic or pseudocholinesterase deficiency
Do not use on broken skin or mucous membranes
Use caution if applied for longer period than recommended
Produces mild localized warming of skin to facilitate drug absorption
Simultaneous/successive patches not recommended due to risk of serious adverse effects caused by increased systemic absorption
Do not apply near eyes as loss of protective reflexes can permit corneal irritation and potential abrasion
Severe hepatic or pseudocholinesterase deficiency due to increased risk of toxic plasma concentrations of lidocaine/tetracaine
Lidocaine and prilocaine have been shown to inhibit viral and bacterial growth
Integrated heating component contains iron; remove patch prior to MRI
Instruct patient to avoid irritating or exposing treated area to extreme temperatures until complete sensation has returned
Pregnancy and Lactation
There are no available data on use in pregnant women to determine drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
There are no data on presence of tetracaine in human milk, effects on a breastfed infant, or on milk production
Maximum Dosage
1 patch on the body at any given time; maximal application area of the cream should not exceed 62 inch2.
1 patch on the body at any given time; maximal application area of the cream should not exceed 62 inch2.
1 patch on the body at any given time; safety and efficacy of the cream have not been established.
3 years and older: 1 patch on the body at any given time; safety and efficacy of the cream have not been established.
Younger than 3 years: Safety and efficacy have not been established.
How supplied
Lidocaine/tetracaine
transdermal patch
- 70mg/70mg (Synera)
topical cream
- 7%/7% (Pliaglis)