Lidotral Five Percent with Menthol

INDICATIONS For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation. This formulation can be 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 musculoligamentous strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, and other complex regional pains. If consulted by your physician, it may be used for other conditions as well. If consulted by your physician, it may be used for other conditions as well.

DOSAGE AND ADMINISTRATION Spray to the affected area two or three times daily or as directed by a physician. Apply Lidotral™ 5% with Menthol Spray to intact skin to cover the most painful area. Smaller areas of treatment are recommended in a debilitated patient, or a patient with impaired elimination. When Lidotral™ 5% with Menthol Spray is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

WARNINGS For external use only. Not for ophthalmic use. EXCESSIVE DOSING Excessive dosing by applying Lidotral™ 5% with Menthol Spray to larger areas or for longer than the recommended wearing time could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects (see ADVERSE REACTIONS, Systemic Reactions). Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 mcg/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, the average peak blood concentration is about 0.13 mcg/ mL, but concentrations higher than 0.25 mcg/mL have been observed in some individuals.

CONTRAINDICATIONS Lidotral™ 5% with Menthol Spray 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.

Drug Interactions Antiarrhythmic Drugs: Lidotral™ 5% with Menthol Spray should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics: When Lidotral™ 5% with Menthol Spray is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

Pregnancy Teratogenic Effects: Pregnancy Category B. Lidocaine has not been studied in pregnancy. Reproduction studies with lidocaine have been performed in rats at doses up to 30 mg/kg subcutaneously and have revealed no evidence of harm to the fetus due to lidocaine. There are, however, no adequate and well- controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, lidocaine should be used during pregnancy only if clearly needed. Labor and Delivery Lidocaine has not been studied in labor and delivery. Lidocaine is not contraindicated in labor and delivery. Should lidocaine be used concomitantly with other products containing lidocaine, total doses contributed by all formulations must be considered.

Nursing Mothers Lidocaine has not been studied in nursing mothers. Lidocaine is excreted in human milk, and the milk: plasma ratio of lidocaine is 0.4. Caution should be exercised when lidocaine is administered to a nursing woman.

ADVERSE REACTIONS ADVERSE REACTIONS Application Site Reactions Even though adverse reactions are rare, a very small percentage of patients experience an unpleasant burning sensation, redness, warmth, or stinging. It is advisable to apply a small amount on the forearm prior to first use. If any of these effects persists or worsens, contact your physician or pharmacist immediately. This medication is not absorbed systemically but if any serious side effects (i.e. rash, itching/swelling, severe dizziness) are experienced, discontinue use immediately and contact your pharmacist or physician. This is not a complete list of all side effects that may occur. You may report side effects to the FDA at 800-FDA-1088 or at http://www.fda.gov/medwatch. 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, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. Other Adverse Events Due to the nature and limitation of spontaneous reports in post marketing surveillance, causality has not been established for additional reported adverse events including: Asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor. Systemic (Dose-Related) Reactions Systemic adverse reactions following appropriate use of lidocaine is unlikely, due to the small dose absorbed (see CLINICAL PHARMACOLOGY, Pharmacokinetics). Systemic adverse effects of lidocaine are similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest. To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800- 272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.