Lidotral Five Percent With Menthol

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.

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. 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.

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).

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.

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.