ZTLIDO

ZTLIDO has different bioavailability compared to Lidoderm. In a single-dose, crossover study conducted in 53 healthy volunteers, ZTLIDO (lidocaine topical system) 1.8% demonstrated equivalent exposure (AUC) and peak concentration (C max ) of lidocaine to Lidoderm (lidocaine patch 5%).

AbsorptionThe amount of lidocaine systemically absorbed from ZTLIDO is directly related to both the duration of application and the surface area over which it is applied. In a pharmacokinetic study, three ZTLIDO t...

Single-dose treatment with lidocaine patch (currently preferred dosage form term for a patch is topical system) was compared to treatment with vehicle patch (without lidocaine), and to no treatment (observation only) in a double-blind, crossover clinical trial with 35 post-herpetic neuralgia patients. Pain intensity and pain relief scores were evaluated periodically for 12 hours. Lidocaine patch performed statistically better than vehicle patch in terms of pain intensity from 4 to 12 hours. Multiple-dose, two-week treatment with lidocaine patch was compared to vehicle patch (without lidocaine)...

The following serious adverse reactions are described elsewhere in the labeling: Excessive Dosing/Overexposure to Lidocaine [see Warnings and Precautions (5.2) ] Methemoglobinemia [see Warnings and Precautions (5.3) ] Application Site Reactions [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Eye Irritation [see Warnings and Precautions (5.6) ] The following adverse reactions from voluntary reports or clinical studies have been reported with ...

ZTLIDO is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. ZTLIDO is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. ( 4 )

Accidental Exposure : Even a used ZTLIDO topical system contains residual lidocaine after use. It is important for patients to store and dispose of ZTLIDO properly and keep out of the reach of children, pets, and others. ( 5.1 ) Excessive Dosing/Overexposure : Applying ZTLIDO to larger surface areas or for a longer duration than recommended could lead to increased absorption and high blood concentrations of lidocaine, leading to adverse effects. ( 5.2 ) Increased Absorption on Non-Intact Skin : ...

7 DRUG INTERACTIONS Class I Antiarrhythmic Drugs: When ZTLIDO is used in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) the toxic effects are additive and potentially synergistic. Consider risk/benefit before concomitant use. ( 7.2 ) Local Anesthetic Agents: When ZTLIDO is used concomitantly with other products containing local anesthetic agents, the effects are...