Overview
Description: Lidothol® ES is a prescription drug-in-adhesive system, packaged with 15 systems: 1 per pouch, 15 pouches. Lidocaine is present in a 4% concentration (w/w). It is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide and has an empirical formula of C14H22N2O. The molecular weight of lidocaine is 234.34 g/mol. Menthol is present in a 5% concentration (w/w).
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacodynamics Menthol works by targeting the κ-opioid receptor on the TRPM8 neuron. The TRPM8 neuron is normally activated at temperatures between 46.4–82.4 °F (8–28 °C). Menthol causes the neuron to fire at temperatures above normal activation, which triggers the characteristic cooling sensation. Also, because of menthol’s specific targeting of the κ-opioid receptor, it is endowed with analgesic properties. Lidocaine is an amide-type local anesthetic agent and is suggested to stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses.
Indications
- INDICATIONS AND USAGE Lidothol® ES is a formulation used to assist patients in the treatment of mild to moderate acute or chronic aches or pain. Muscle or joint pain can be due to muscle or ligament strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post-herpetic neuralgia, and other complex regional pains. It can also be used to help with certain types of headaches, but use with caution when applying in order to avoid eye contact. Other uses may be considered if deemed clinically relevant.
Common Doses
- Refer to label
Dosage
DOSAGE AND ADMINISTRATION Apply Lidothol® ES to intact skin to cover the most painful area. Apply no more than two systems per day. Each system should not be applied for more than 12 hours in a given 24-hour period. Lidothol® ES may be cut into smaller sizes with scissors prior to the removal of the protective film. Clothing may be worn over the area of application. Smaller treatment areas are recommended for debilitated patients or those with impaired elimination.
Contraindications
- CONTRAINDICATIONS Lidothol® ES 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.
Side Effects
- ADVERSE REACTIONS The most common adverse reactions occur at the application site, including dermatitis, itching, or scaling. These tend to be dose-limiting and diminish with time. Serious adverse experiences following the administration of Lidothol® ES are similar in nature to those observed in other amide local anesthetic-containing agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient.
Interactions
- DRUG INTERACTIONS Antiarrhythmic Drugs Lidothol® ES should be used with caution in patients receiving Class 1 antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics When Lidothol® ES is used concurrently with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Methemoglobinemia Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: a di...