Pliaglis Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Pliaglis FDA Prescribing Information: Side Effects
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 entire FDA prescribing information for Pliaglis (Lidocaine and Tetracaine) »
Additional Pliaglis Information
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