LIDOTHOL

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: 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 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 lidocaine menthol

: 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.

: 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.

: 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.

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.

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

HANDLING AND DISPOSAL: Wash hands immediately after applying or removing Lidothol. Eye contact with Lidothol should be avoided. Do not store patch outside the sealed envelope. Apply immediately after removal from the protective envelope. Fold used patches so the adhesive side sticks to itself, then safely discard used patches or pieces of cut patches where children and pets cannot access them. Lidothol should be kept out of reach of children. STORAGE: Store at room temperature of 65˚F to 75˚F (18˚C to 24˚C). Keep away from heat or sunlight. Protect from excessive moisture. The product can be considered safe and effective to use when maintained under these recommended conditions within the posted expiration date.