Pliaglis

Pliaglis

Pliaglis Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Pliaglis (lidocaine and tetracaine) Cream 7%/7% is a topical local anesthetic cream used 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. Common side effects include localized reactions such as hives, skin discoloration, swelling, rash, itching and dry skin.

For superficial dermatological procedures apply Pliaglis to intact skin for 20-60 minutes prior to the procedure. Time depends on the procedure and will be determined by your physician. Pliaglis may interact with antiarrhythmics, and other local anesthetics. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Pliaglis. Lidocaine passes into breast milk and it is unknown if tetracaine passes into breast milk. Consult your doctor before breastfeeding.

Our Pliaglis (lidocaine and tetracaine) Cream 7%/7% Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates 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.

PLIAGLIS Cream has been evaluated for safety in 2159 persons undergoing a superficial dermal procedure. PLIAGLIS Cream 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 Cream. Adverse reactions were assessed by collecting spontaneously reported adverse events, and observations made on formal evaluation of the skin for specific reactions.

Most common adverse events in clinical trials

Localized Reactions: During or immediately after treatment with PLIAGLIS Cream, 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%). 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 Cream -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 Cream and 4 with placebo. The frequency of systemic adverse events was greater for the PLIAGLIS Cream 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. 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 at 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.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of PLIAGLIS Cream. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Eye disorders: Eyelid swelling

Skin: Pruritus, Rash, Skin Burning Sensation, Erythema, Urticaria

Other: Drug ineffective

Read the entire FDA prescribing information for Pliaglis (Lidocaine and Tetracaine) »

A A A

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.


Women's Health

Find out what women really need.