Lidothol Patch
FDA Drug Information • Also known as: Lidothol Patch
- Brand Names
- Lidothol Patch
- Drug Class
- Amide Local Anesthetic [EPC], Antiarrhythmic [EPC]
- Route
- TOPICAL
- Dosage Form
- PATCH
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
Lidothol is a prescription topical patch, packaged with 15 medicated patches: 5 per re-sealable pouch, 3 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 1% 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 (Lidocaine 4% / Menthol 1% Patch) consists of an adhesive hydrogel containing Lidocaine 4% and Menthol 1%, 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 patch is 12cm x 8cm. Lidocaine is chemically designated as 2-‐(diethylamino)-‐N-‐(2,6-‐dimethylphenyl), has an octanol: water partition ration of 43 at pH 7.4, and has the following structure: [lidocaine] 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: [menthol] Each adhesive patch contains 76.5mg of Lidocaine and 85mg of Menthol. It also contains the following inactive ingredients: dihydroxyaluminum aminoacetate, glycerol, methylparaben, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, water
What Is Lidothol Patch Used For?
Lidothol 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
Apply Lidothol to intact skin to cover the most painful area. Apply no more than four patches per day. Each patch should not be applied for more than 12 hours in a given 24-‐ hour period. Patches may be cut into smaller sizes with scissors prior to removal of the protective film. Clothing may be worn over the area of application. Smaller areas of treatment are recommended in a debilitated patient, or a patient with impaired elimination. If irritation or a burning sensation occurs during application, remove the patch and do not reapply until the irritation subsides. When Lidothol is used concurrently with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Lidothol may not stick if it gets wet. Avoid contact with water, such as bathing, swimming or showering
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 are similar in nature to those observed in other amide 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, the skin at the site of application may develop redness, blisters, bruising, burning sensation, depigmentation, dermatitis, or mild irritation. Allergic Reactions Allergic and anaphylactoid reactions associated with Lidocaine, although rare, can occur. They are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria. If they occur, consult your doctor.
Warnings and Precautions
Excessive dosage or short interval between doses can result in high plasma levels and serious adverse effects. Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen or other resuscitative drugs. Accidental Exposure in Children Even a used Lidothol patch contains a large amount of Lidocaine. The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used Lidothol patch, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of Lidothol beyond the reach of children, pets and others. (See HANDLING AND DISPOSAL) Excessive Dosing Excessive dosing by applying Lidothol to larger areas for longer than the recommended wearing time could result in increased absorption of Lidocaine and high blood concentrations, leading to serious adverse effects. Lidocaine toxicity could be expected at Lidocaine blood concentrations above 5 µg/mL. The blood concentration of Lidocaine is determined by the rate of systemic absorption and elimination. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of Lidocaine. With recommended dosing of Lidothol, the average blood concentration is about 0.13 µg/mL, but concentration higher than 0.25 µg/mL have been observed in some patients.
Drug Interactions
Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents Class Nitrates/Nitrites Local Anesthetics Antineoplastic agents Antibiotics Antimalarials Anticonvulsants Other drugs Examples nitroglycerin, nitroprusside, nitric oxide, nitrous oxide benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea dapsone, sulfonamides, nitrofurantoin, para-aminosalicyclic acid chloroquine, primaquine phenytoin, sodium valproate, phenobarbital acetaminophen, metoclopramide, sulfa drugs (i.e., sulfasalazine), quinine
Contraindications
Lidothol 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
There have been no reports of over-‐dosage with Lidothol. 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
Lidothol is supplied in the following dosage form: 15 Patches: 5 per re-‐sealable pouch, 3 pouches NDC 72189-0553-15 Manufactured For: Clinic Pharma Las Vegas, NV 89121
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.