Lidocaine Patch 5%
Criteria for Use in Neuropathic Pain
April 2012
VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives
The following recommendations are based on medical evidence, clinician input, and expert opinion. The content of the document is dynamic and will be revised as new information becomes available. The purpose of this document is to assist practitioners in clinical decision-making, to standardize and improve the quality of patient care, and to promote cost-effective drug prescribing. THE CLINICIAN SHOULD UTILIZE THIS GUIDANCE AND INTERPRET IT IN THE CLINICAL CONTEXT OF THE INDIVIDUAL PATIENT. INDIVIDUAL CASES THAT ARE EXCEPTIONS TO THE EXCLUSION AND INCLUSION CRITERIA SHOULD BE ADJUDICATED AT THE LOCAL FACILITY ACCORDING TO THE POLICY AND PROCEDURES OF ITS P&T COMMITTEE AND PHARMACY SERVICES.
The Product Information should be consulted for detailed prescribing information. For further information, see the VA National PBM-MAP-VPE supporting literature review for these criteria at www.pbm.va.gov or http://vaww.pbm.va.gov.
Exclusion Criteria If the answer to ANY item below is met, then the patient should NOT receive lidocaine patch.
 Sensitivity to amide-type local anesthetics or any other component of the product.
 Area of application includes non-intact skin
 Severe hepatic disease
 Concomitant use of oral Class I antiarrhythmic drugs (e.g., mexiletine)
Inclusion Criteria One of the following criterion must be fulfilled for prescription benefit coverage.
 Moderate to severe localized postherpetic neuralgia (PHN).
 Other types of moderate to severe localized neuropathic pain with an unsatisfactory response, intolerance, contraindication, or risk factor(s) for potentially serious adverse effects to two of the following agents from different drug classes:
Capsaicin cream 0.075%
Tricyclic antidepressant (e.g., one of the following: amitriptyline, clomipramine, desipramine, or nortriptyline)
Gabapentinoid (gabapentin or pregabalin)
Serotonin-norepinephrine reuptake inhibitor (e.g., for painful diabetic neuropathy, venlafaxine or duloxetine)
Opioid (tramadol or other opioid; Schedule II–IV opioids not recommended, but if patient has already taken at least one of these, he/she meets criteria.) See Issues for Consideration items 1, 5 and 7.
Dosage and Administration
For postherpetic neuralgia: Apply up to a maximum of three lidocaine patches (2100 mg) to intact skin only over the most painful area once for up to 12 hours per 24-hour period.
Patches may be cut (before removing the release liner) to fit the size and shape of the affected area.
In debilitated patients or those with impaired drug elimination, smaller areas of application are recommended.
If lidocaine patch is being applied to the face, avoid contact with the eyes.
Renewal Criteria
Documented benefit and tolerability at least 2 weeks after initiation of treatment and every year thereafter. Discontinue lidocaine patch in patients who have no beneficial response within 2 weeks after initiation or experience spontaneous resolution of postherpetic neuralgia pain.
Monitoring
Lidocaine toxicity resulting from transcutaneous absorption is rare but possible. On average, only about 3% of the dose (64 ± 32 mg of 2100 mg [3 patches]) is absorbed when lidocaine patches are applied as recommended. If there is suspicion of lidocaine-related systemic toxicity, check lidocaine blood concentrations.
Symptoms of systemic lidocaine toxicity include CNS excitation and/or depression, such as nervousness, confusion, dizziness, tinnitus, blurred or double vision, vomiting, twitching, tremors, seizures, unconsciousness, respiratory depression, bradycardia, hypotension, and cardiopulmonary arrest.
Factors that may increase absorption of lidocaine from the patch and lead to systemic toxicity include excessive dosing (application to larger areas [more than 3 patches], or for longer