Lidocan VII 50 mg/g

Lidocaine 5% · PATCH · PURETEK CORPORATION

No Recall HistoryCurrently in Shortage

Plain English

Lidocan VII is a prescription patch containing 5% lidocaine that you apply directly to your skin to relieve localized pain and discomfort. This topical anesthetic works by numbing the area where it's applied and is commonly used for conditions like post-herpetic neuralgia and other localized pain conditions.

Key Facts

Brand Name: Lidocan VII
Generic Name: Lidocaine 5%
NDC Code (Product): 59088-900
Manufacturer: PURETEK CORPORATION
Strength: 50 mg/g
Dosage Form: PATCH
Route: TOPICAL
Marketing Status
Application #: ANDA209190
Drug Class: Amide Local Anesthetic [EPC]; Antiarrhythmic [EPC]
Marketing Start: 06/15/2023

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Lidocan™ VII is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.

Dosage & Administration

DOSAGE AND ADMINISTRATION Apply Lidocan™ VII 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 Lidocan™ VII is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered . Lidocan™ VII may not stick if it gets wet. Avoid contact with water, such as bathing, swimming, or showering.

Warnings

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 Lidocan™ VII and any other oxidizing agents. Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy…

Contraindications

CONTRAINDICATIONS Lidocan™ VII 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

Drug Interactions Antiarrhythmic Drugs - Lidocan™ VII 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 Lidocan™ VII 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 Lidocan™ VII 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: Drug

Adverse Reactions

ADVERSE REACTIONS Application Site Reactions During or immediately after treatment with Lidocan™ VII , 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,…

Frequently Asked Questions

What is Lidocan VII used for?

Is Lidocan VII a controlled substance?

Lidocan VII is not classified as a controlled substance by the DEA.

What is the generic name for Lidocan VII?

The generic name for Lidocan VII is Lidocaine 5%. There are 12 other brand versions of Lidocaine 5%.

What is the NDC code for Lidocan VII 50 mg/g?

The NDC (National Drug Code) for Lidocan VII 50 mg/g is 59088-900, listed by PURETEK CORPORATION.

Product NDC

59088-900

Package NDC

59088-900-54

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)