BONDLIDO

Bioavailability for topical systems such as BONDLIDO is dependent on multiple factors, including formulation, and does not necessarily correlate with dosage strength. In a single-dose, crossover study conducted in 32 healthy volunteers, BONDLIDO (lidocaine topical system 10%) demonstrated equivalent systemic exposure (AUC) and peak concentration (C max ) of lidocaine to a lidocaine topical system 5%.

AbsorptionThe amount of lidocaine systemically absorbed from BONDLIDO topical system is directl...

Single-dose treatment with a different lidocaine topical system was compared to treatment with vehicle system (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 topical system performed statistically better than vehicle system in terms of pain intensity from 4 to 12 hours. Multiple-dose, two-week treatment with a different lidocaine topical system was also compared to vehicle system (without lidocaine) in a doub...

The following serious adverse reactions are described elsewhere in the labeling: Accidental Exposure [see Warnings and Precautions (5.1) ] 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 associate...

BONDLIDO 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. BONDLIDO 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 : A used BONDLIDO topical system contains residual lidocaine after use. It is important for patients to store and dispose of BONDLIDO out of the reach of children, pets, and others (5.1). Excessive Dosing : Applying BONDLIDO to larger surface areas or for a longer duration than recommended could result in increased absorption and high blood concentrations of lidocaine, leading to serious adverse effects ( 5.2 ). Non-Intact Skin : May result in higher blood concentrations of l...

7 DRUG INTERACTIONS Antiarrhythmic Drugs: When BONDLIDO is used in patients receiving Class I antiarrhythmic drugs (such as tocainide or mexiletine), the toxic effects are additive and potentially synergistic. Consider risk/benefit during concomitant use ( 7.1 ). Local Anesthetics: When BONDLIDO is used concomitantly with other products containing local anesthetic agents, the effects are additive....