Menthol 5%, Lidocaine 4%
FDA Drug Information • Also known as: Lidothol Es
- Brand Names
- Lidothol Es
- Drug Class
- Amide Local Anesthetic [EPC], Antiarrhythmic [EPC]
- Route
- TRANSDERMAL
- Dosage Form
- SYSTEM
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
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). The chemical name is (1R,2S,5R)-2-isopropyl-5-methylcyclohexanol. The empirical formula for menthol is C10H20O with a molecular weight of 156.27 g/mol. Lidothol® ES consists of a Drug-in-Adhesive System containing lidocaine 4% and menthol 5%, applied to flexible woven polyester backing and protected by a plastic film. The protective film is removed prior to application to the skin. The size of the system is 10 cm x 14 cm. Lidocaine is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide, has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure: Menthol is chemically designated as 2-Isopropyl-5-methylcyclohexanol. It contains colorless, hexagonal crystals, usually needle-like; fused masses or crystalline powder with a pleasant, peppermint-like odor. It has a melting point between 31°C to 36°C. Menthol has the following structure: Each system contains:Lidocaine: 373.5 mg (45 mg per gram adhesive) in an anhydrous base. Menthol: 415 mg (50 mg per gram adhesive) in an anhydrous base. It also contains the following inactive ingredients: acrylate copolymer PSA adhesives, alpha-tocopherol (vitamin E) lidocaine menthol
What Is Menthol 5%, Lidocaine 4% Used For?
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.
Dosage and Administration
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. If irritation or a burning sensation occurs during application, remove the system and do not reapply until the irritation subsides. When Lidothol® ES is used concurrently with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
Side Effects (Adverse Reactions)
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. Serious adverse experiences are generally systemic in nature. During or immediately after treatment with Lidothol® ES, the skin at the site of application may develop redness, blisters, bruising, burning sensation, depigmentation, dermatitis, or mild irritation.
Drug 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 table
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.
Overdosage
OVERDOSAGE There have been no reports of overdosage with Lidothol® ES. Signs of overdosage would include vomiting, drowsiness, coma, respiratory depression, and seizures. In the case of overdosage, discontinue the product immediately, treat the patient symptomatically, and institute supportive measures.
How Supplied
HOW SUPPLIED Lidothol ES is supplied in the following dosage form: 15 Systems: 1 per pouch, 15 pouches | NDC 80425-0561-01
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.