Pliaglis (lidocaine and tetracaine) has been evaluated for safety in 2159 persons undergoing a superficial dermal procedure. Pliaglis (lidocaine and tetracaine) was studied in 11 placebo-controlled and 1 active-controlled trials, and in open-label safety trials. All 2159 persons were exposed to only a single application of Pliaglis (lidocaine and tetracaine) .
Adverse reactions were assessed by collecting spontaneously reported adverse events, and observations made on formal evaluation of the skin for specific reactions.
Because clinical trials are conducted under widely varying conditions, the frequencies of adverse reactions observed in the clinical trials of a drug may not reflect the frequencies observed in practice. However, the adverse reaction information from clinical trials does provide a basis for identifying the adverse events that appear to be related to drug use and for approximating their incidence in clinical practice.
Most common adverse events in clinical trials
Localized Reactions: During or immediately after treatment with Pliaglis (lidocaine and tetracaine) , the skin at the site of treatment may develop erythema, blanching or edema. In clinical studies, the most common local reactions were erythema (47%), skin discoloration (e.g., blanching, ecchymosis, and purpura) (16%), and edema (14%). These reactions were generally mild and transient, resolving spontaneously soon after treatment. There were no serious adverse events. However, one patient withdrew due to burning pain at the treatment site.
Other Localized Reactions: The following dermal adverse events occurred in 1% or less of Pliaglis (lidocaine and tetracaine) -treated patients: ecchymosis, petechial rash, vesiculobullous rash, perifollicular erythema, perifollicular edema, pruritus, rash, maculopapular rash, dry skin, contact dermatitis, and acne.
Systemic (Dose-Related) Reactions: Across all trials, 19 subjects experienced a systemic adverse event, 15 of who were treated with Pliaglis (lidocaine and tetracaine) and 4 with placebo. The frequency of systemic adverse events was greater for the Pliaglis (lidocaine and tetracaine) group (1%) than the placebo group (0.3%). The most common systemic adverse events were headache, vomiting, dizziness, and fever, all of which occurred with a frequency of < 1%. Other systemic reactions were syncope, nausea, confusion, dehydration, hyperventilation, hypotension, nervousness, paresthesia, pharyngitis, stupor, pallor, and sweating.
Overall, systemic adverse reactions following appropriate use of Pliaglis (lidocaine and tetracaine) are unlikely, due to the small dose absorbed (see CLINICAL PHARMACOLOGY, Pharmacokinetics). Systemic adverse effects of lidocaine and tetracaine are similar in nature to those observed with other amide and ester local anesthetic agents, including CNS excitation and/or depression (light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensation of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Signs of CNS toxicity may start at plasma concentrations of lidocaine as low as 1000 ng/mL. The plasma concentrations at which tetracaine toxicity may occur are less well characterized; however, systemic toxicity with tetracaine is thought to occur with much lower plasma concentrations compared with lidocaine. The toxicity of co-administered local anesthetics is thought to be at least additive. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.
Read the Pliaglis (lidocaine and tetracaine) Side Effects Center for a complete guide to possible side effects
Antiarrhythmic Drugs: Pliaglis (lidocaine and tetracaine) should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the systemic toxic effects are thought to be additive and potentially synergistic with lidocaine and tetracaine.
Local Anesthetics: When Pliaglis (lidocaine and tetracaine) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations should be considered since the systemic toxic effects are thought to be additive and potentially synergistic with lidocaine and tetracaine.
Read the Pliaglis Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 1/16/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Pliaglis Information
- Pliaglis Drug Interactions Center: lidocaine-tetracaine top
- Pliaglis Side Effects Center
- Pliaglis FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.