Rx Item-Ztlido 1.8 % 30 Lidocaine Topical Adh. Patch 1.8 % By Scilex Pharma

For: Postherpetic Neuralgia

ZTlido (lidocaine topical system 1.8%) is a transdermal anesthetic formulation for the treatment of pain associated with postherpetic neuralgia
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ZTLIDO� (lidocaine topical system) 1.8% safely and effectively. See full prescribing information for ZTLIDO�.







ZTLIDO� (lidocaine topical system)



Initial U.S. Approval: 1953
RECENT MAJOR CHANGES
Warnings and Precautions, Methemoglobinemia ( 5.3) 11/2018

INDICATIONS AND USAGE
ZTLIDO contains lidocaine, an amide local anesthetic, and is indicated for relief of pain associated with post-herpetic neuralgia (PHN) ( 1).

DOSAGE AND ADMINISTRATION
Because of the difference in bioavailability of ZTLIDO compared to Lidoderm�, a different dosage strength is required to be administered to the patient. One ZTLIDO (lidocaine topical system) 1.8% provides equivalent lidocaine exposure to one Lidoderm (lidocaine patch 5%) ( 2.1).
Apply ZTLIDO to intact skin to cover the most painful area. Apply the prescribed number of topical systems (up to three) only once for up to 12 hours in a 24-hour period. ZTLIDO may be cut into smaller sizes prior to removal of the release liner. Debilitated patients or those with impaired elimination should use smaller areas of treatment ( 2.2).
DOSAGE FORMS AND STRENGTHS
ZTLIDO 1.8% is available as a single-dose topical system ( 3).

CONTRAINDICATIONS
ZTLIDO 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 ( 4).

WARNINGS AND PRECAUTIONS
Accidental Exposure: Even a used ZTLIDO topical system contains residual lidocaine after use. It is important for patients to store and dispose of ZTLIDO properly and keep out of the reach of children, pets, and others ( 5.1).
Excessive Dosing/Overexposure: Applying ZTLIDO to larger surface areas or for a longer duration than recommended could lead to increased absorption and high blood concentrations of lidocaine, leading to adverse effects ( 5.2).
Increased Absorption on Non-Intact Skin: May result in higher blood concentrations of lidocaine ( 5.2).
Risk of Overexposure with External Heat Sources: Applying external heat sources to ZTLIDO may result in increased drug exposure ( 5.2).
Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use ( 5.3).
Application Site Reactions: During or immediately after treatment with ZTLIDO, application site reactions may develop ( 5.4).
Hypersensitivity Reactions: Cross sensitivity to ZTLIDO in patients with a history of drug sensitivity to para-aminobenzoic acid (PABA) derivatives is possible ( 5.5).
Eye Exposure: Immediately wash out the eye with water or saline and protect the eye until sensation returns ( 5.6).
ADVERSE REACTIONS
Common adverse reactions are application site reactions such as irritation, erythema, and pruritus ( 6).



To report SUSPECTED ADVERSE REACTIONS, contact Scilex Pharmaceuticals Inc. at 1-866-SCILEX3 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS
Class I Antiarrhythmic Drugs: When ZTLIDO is used in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) the toxic effects are additive and potentially synergistic. Consider risk/benefit before concomitant use ( 7.2).
Local Anesthetic Agents: When ZTLIDO is used concomitantly with other products containing local anesthetic agents, the effects are additive. Consider the amount of drug absorbed from all formulations when local anesthetics are administered concomitantly ( 7.3).
USE IN SPECIFIC POPULATIONS
Lactation: Lidocaine is excreted into human milk. Caution should be exercised when ZTLIDO is administered to a nursing mother, especially when administered with other local anesthetics ( 8.2).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 11/2018

ZTLIDO 1.8 % PAT 30 lidocaine
Item No.:Rx788398 788398 NDC No.69557-0111-30 69557-111-30 UPC No.:3-69557-11130-1 NDC No.69557011130 6955711130 UPC/GTIN No..369557-111301 369557111301 MPN 11130

Lidocaine 5% Patch 30 By Actavis(Teva) G
BRAND: LIDOCAINE NDC: 00591-3525-30,591352530 UPC: 3-05913-52530-6,305913525306

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ZTLIDO 1.8 % PAT 30 lidocaine
Item No.:Rx788398 788398 NDC No.69557-0111-30 69557-111-30 UPC No.:3-69557-11130-1 NDC No.69557011130 6955711130 UPC/GTIN No..369557-111301 369557111301 MPN 11130

00591-3525-30
Lidocaine Paatches by Actavis(Teva)