Label: LIDOCAN VII- lidocaine 5% patch
- NDC Code(s): 59088-900-54, 59088-900-84
- Packager: PURETEK CORPORATION
- This is a repackaged label.
- Source NDC Code(s): 82347-0505
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 9, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
DESCRIPTION
Lidocan™ VII is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release ...
-
CLINICAL PHARMACOLOGY
Pharmacodynamics - Lidocaine is an amide-type local anesthetic agent and is suggested to stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction ...
-
CLINICAL STUDIES
Single-dose treatment with lidocaine patch 5% was compared to treatment with vehicle patch (without lidocaine), and to no treatment (observation only) in a double-blind, crossover clinical trial ...
-
INDICATIONS AND USAGE
Lidocan™ VII is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.
-
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.
-
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 ...
-
PRECAUTIONS
General - Hepatic Disease - Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize lidocaine ...
-
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 ...
-
OVERDOSAGE
Lidocaine overdose from cutaneous absorption is rare, but could occur. If there is any suspicion of lidocaine overdose (see ADVERSE REACTIONS, Systemic Reactions), drug blood concentration should ...
-
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 ...
-
HANDLING AND DISPOSAL
Hands should be washed after the handling of - Lidocan™ VII, and eye contact with - Lidocan™ VII should be avoided. Do not store patch outside the sealed envelope. Apply immediately after ...
-
HOW SUPPLIED
Lidocan™ VII is available as the following: Package of 30 patches.................................................................................... NDC 59088-900-54 - (packaged into ...
-
Lidocan™ VII
-
INGREDIENTS AND APPEARANCEProduct Information