Tetracaine (2 brand names, 2 dosage forms, 1 route)
Available dosage forms: PATCH, CREAM.
Routes of administration: TOPICAL.
Brand Names
- PLIAGLIS
- SYNERA
Indications and Usage
PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.
Contraindications
PLIAGLIS is contraindicated in patients with a known history of sensitivity to lidocaine or tetracaine, local anesthetics of the amide or ester type, or to any other component of the product [ see Warnings and Precautions (5.4) ]. PLIAGLIS is contraindicated in patients with para-aminobenzoic acid (PABA) hypersensitivity.
Adverse Reactions
The following adverse reactions are described elsewhere in the labeling: Methemoglobinemia [see Warnings and Precautions (5.1)] Overexposure [see Warnings and Precautions (5.2)] Risks of Secondary Exposure in Children and Pets [see Warnings and Precautions (5.3)] Anaphylactic Reactions [see Warnings and Precautions (5.4)] Eye Irritation [see Warnings and Precautions (5.5)]
Mechanism of Action
Lidocaine is an amide-type local anesthetic agent and tetracaine is an ester-type local anesthetic agent. Both lidocaine and tetracaine block sodium ion channels required for the initiation and conduction of neuronal impulses which, in certain instances, results in local anesthesia. When applied to intact skin, PLIAGLIS provides local dermal analgesia by the release of lidocaine and tetracaine from the peel into the skin.
Overdosage
Application of 59 g of PLIAGLIS over 400 cm 2(62 inch 2) for up to 120 minutes to adults produces peak plasma concentrations of lidocaine of 220 ng/mL. Toxic levels of lidocaine (>5000 ng/mL) cause CNS toxicity, including the risk of seizure. Signs of CNS toxicity may start at plasma concentrations of lidocaine as low as 1000 ng/mL, and the risk of seizures generally increases with increasing plasma levels. Very high levels of lidocaine can cause respiratory arrest, coma, decreases in cardiac output, total peripheral resistance and mean arterial pressure, ventricular arrhythmias and cardiac arrest. Tetracaine is associated with a profile of systemic CNS and cardiovascular adverse events similar to lidocaine, although toxicity associated with tetracaine is thought to occur at lower doses compared to lidocaine. The toxicity of co-administered local anesthetics is thought to be at least additive. In the absence of massive topical overdose or oral ingestion, other etiologies for the clinical effects or overdosage from other sources of lidocaine, tetracaine or other local anesthetics should be considered. The management of overdosage includes close monitoring, supportive care and symptomatic treatment. Dialysis is of negligible value in the treatment of acute overdosage of lidocaine or tetracaine.