Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Lidocaine Patch 5% is available containing 140 mg of lidocaine, USP (50 mg per gram adhesive in polyisobutylene adhesive matrix). The rectangular patch consists of a pigmented backing film randomly printed with “Lidocaine Patch 5%” in brown ink, an adhesive matrix layer and a clear removable release liner. They are available as follows: NDC 0378-9055-93 carton containing 30 patches, packaged into individual child-resistant pouches Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX). Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 11/2018 LIDO:R4; PRINCIPAL DISPLAY PANEL - 5% NDC 0378-9055-93 Rx only Lidocaine Patch 5% 30 Patches 30 Pouches Containing 1 Patch Each Each adhesive patch contains: Lidocaine, USP 140 mg (50 mg per gram adhesive) in a polyisobutylene adhesive matrix. Usual Dosage: Apply up to 3 patches. See package insert for complete prescribing information. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] WARNING: Keep used and unused patches out of the reach of children, pets and others. DIRECTIONS FOR USE: Do not store patch outside of sealed pouch. • Cut the pouch at the top and both sides along the dotted lines. • Peel open the pouch and remove the patch with the transparent release liner. • Patches may be cut into smaller sizes with scissors prior to removal of the release liner. Safely discard the remaining unused pieces of cut patches where children and pets cannot get to them. • Remove the transparent release liner (clear plastic backing) before application of patch to the skin. • Apply immediately after removal from the protective pouch.. • Apply the prescribed number of patches, only once for up to 12 hours within a 24 hour period. Remove patches if irritation occurs. Placement of external heat sources, such as heating pads or electric blankets, over Lidocaine Patch 5% is not recommended Lidocaine Patch 5% may not stick if it gets wet. Avoid contact with water, such as bathing, swimming or showering. Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Mylan.com M9055:93:30C:R5 Directions For Use Lidocaine Patch 5% Carton Label
- HOW SUPPLIED Lidocaine Patch 5% is available containing 140 mg of lidocaine, USP (50 mg per gram adhesive in polyisobutylene adhesive matrix). The rectangular patch consists of a pigmented backing film randomly printed with “Lidocaine Patch 5%” in brown ink, an adhesive matrix layer and a clear removable release liner. They are available as follows: NDC 0378-9055-93 carton containing 30 patches, packaged into individual child-resistant pouches Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX). Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 11/2018 LIDO:R4
- PRINCIPAL DISPLAY PANEL - 5% NDC 0378-9055-93 Rx only Lidocaine Patch 5% 30 Patches 30 Pouches Containing 1 Patch Each Each adhesive patch contains: Lidocaine, USP 140 mg (50 mg per gram adhesive) in a polyisobutylene adhesive matrix. Usual Dosage: Apply up to 3 patches. See package insert for complete prescribing information. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] WARNING: Keep used and unused patches out of the reach of children, pets and others. DIRECTIONS FOR USE: Do not store patch outside of sealed pouch. • Cut the pouch at the top and both sides along the dotted lines. • Peel open the pouch and remove the patch with the transparent release liner. • Patches may be cut into smaller sizes with scissors prior to removal of the release liner. Safely discard the remaining unused pieces of cut patches where children and pets cannot get to them. • Remove the transparent release liner (clear plastic backing) before application of patch to the skin. • Apply immediately after removal from the protective pouch.. • Apply the prescribed number of patches, only once for up to 12 hours within a 24 hour period. Remove patches if irritation occurs. Placement of external heat sources, such as heating pads or electric blankets, over Lidocaine Patch 5% is not recommended Lidocaine Patch 5% may not stick if it gets wet. Avoid contact with water, such as bathing, swimming or showering. Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Mylan.com M9055:93:30C:R5 Directions For Use Lidocaine Patch 5% Carton Label
Overview
Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, USP, which is applied to a pigmented polyethylene/polyester backing film printed with brown ink and covered with a silicone coated polyester film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm × 14 cm. Lidocaine is chemically designated as 2-(Diethylamino)-2’,6’-acetoxylidide, has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure: Each adhesive patch contains 140 mg of lidocaine, USP (50 mg per gram adhesive) in a polyisobutylene adhesive matrix. Lidocaine Structural Formula
Indications & Usage
INDICATION AND USAGE Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin .
Dosage & Administration
Apply lidocaine patch 5% to intact skin to cover the most painful area. Apply the prescribed number of patches (maximum of 3), only once for up to 12 hours within a 24 hour period. Patches may be cut into smaller sizes with scissors prior to removal of the release liner. (See HANDLING AND DISPOSAL ) 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(es) and do not reapply until the irritation subsides. When lidocaine patch 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Lidocaine patch 5% may not stick if it gets wet. Avoid contact with water, such as bathing, swimming or showering.
Warnings & Precautions
WARNINGS Risk of Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue lidocaine patch 5% and any other oxidizing agents. Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. Accidental Exposure in Children Even a used lidocaine patch 5% contains a large amount of lidocaine (at least 115 mg). The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used lidocaine patch 5%, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of lidocaine patch 5% out of the reach of children, pets and others . (See HANDLING AND DISPOSAL ) Excessive Dosing Excessive dosing by applying lidocaine patch 5% 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 of lidocaine patch 5%, 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
Lidocaine patch 5% 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.
Adverse Reactions
Application Site Reactions During or immediately after treatment with lidocaine patch 5%, the skin at the site of application may develop blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. 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 postmarketing 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 patch 5% are 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.
Drug Interactions
Antiarrhythmic Drugs Lidocaine patch 5% 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 lidocaine patch 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Drugs That May Cause Methemoglobinemia When Used with Lidocaine Patch 5% Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine
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