HomeNDC LookupIngredientsLidocaine 5% › 59088-0900-54
Lidocan VII Lidocaine 5% 50 mg/g Patch — NDC 59088-0900-54 package photo

Lidocan VII Lidocaine 5% 50 mg/g Patch

by PURETEK CORPORATION · 30 POUCH in 1 PACKAGE (59088-900-54) / 14 g in 1 POUCH (59088-900-84)
NDC 59088-0900-54
🏷️ FDA NDC (as labeled) 59088-900-54 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 59088-900-54
Product NDC 59088-900
11-digit billing NDC 59088090054
NCPDP billing unit EA — each (per item)
RxCUI 1745091, 2642344
UNII 98PI200987
Application # ANDA209190
SPL Set ID 1f33d51c-168c-55f2-e063-6394a90a8905
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-06-15
Route TOPICAL
Dosage form PATCH
Substance LIDOCAINE
GPI-14 90850060005930
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 59088-900-54 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59088-0900-54. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPURETEK CORPORATION
Application holderIBSA INSTITUT BIOCHIMIQUE SA
FDA applicationANDA209190 (ANDA)
Labeler code59088
First marketedJun 2023
Product typeHuman Prescription Drug
Portfolio178 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Prescription lidocaine transdermal (Dermalid, Lidoderm, Ztildo) is used to relieve the pain of post-herpetic neuralgia (PHN; burning, stabbing pains, or aches that may last for months or years after a shingles infection). Nonprescription (over-the-counter) lidocaine (Absorbine Jr, Aspercreme, Lidocare, Salonpas, others) is also available to relieve minor pain in shoulders, arms, neck and legs in adults and children 12 years of age and older. Lidocaine is in a class of medications called local anesthetics. It works by stopping nerves from sending pain signals.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's best to avoid using two lidocaine products at the same time unless your doctor says it's okay. When you use multiple products containing a local anesthetic, the total amount a...
  • Can I use a lidocaine patch and a lidocaine cream at the same time?
  • No — please don't do this. Heat significantly increases how much lidocaine is absorbed through your skin, which can push drug levels in your blood higher than they should be. Stick...
  • Can I put a heating pad on the area where I applied a lidocaine patch?
📖 Read our full Lidocaine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII DO250MG0W6
    A mineral compound containing aluminum that acts as an antacid and buffering agent. It helps neutralize stomach acid and is used as a pH buffer to stabilize the medicine's formulation.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 24H4NWX5CO
    Kaolin is a naturally occurring clay mineral. It's used in tablets and capsules as a filler and absorbent to add bulk, improve texture, and help bind ingredients together.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 73861X4K5F
    A synthetic polymer used as a binder and thickening agent in tablets and capsules. It helps hold ingredients together and can modify how quickly the medicine dissolves and is absorbed in your body.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 285CYO341L
    Sodium polyacrylate is a synthetic polymer that absorbs and holds water. In medicines, it acts as a disintegrant, helping tablets break apart quickly in the stomach, and as a binder, holding tablet ingredients together.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII W4888I119H
    Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
  • UNII 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

16 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lidocaine 5% 50 mg/g 82347-0505-05 YARAL 30 patches $1.915 AB FDA listed
Lidocaine 50 mg/g 00591-2679-30 Actavis 30 pouches $2.031 AB Availability likely
Lidocaine 50 mg/g 00591-3525-30 Actavis 30 pouches $2.031 AB Availability likely
Lidocaine 50 mg/g 00603-1880-16 Par 30 pouches $2.031 AB Availability likely
Lidocan IV 50 mg/g 59088-0910-54 PURETEK 30 pouches $2.031 AB Availability likely
Lidocaine 700 mg 65162-0791-08 Amneal 30 patches $2.031 AB Availability likely
Tridacaine XL 50 mg/g 73352-0845-30 Trifluent 30 packets $2.031 AB Availability likely
Lidocaine 700 mg 42291-0477-30 AvKARE 30 patches AB FDA listed
Lidocaine 50 mg/g 42291-0495-30 AVKARE 30 pouches AB FDA listed
Lidocaine 50 mg/g 50090-1359-02 A-S 30 pouches AB FDA listed
Lidocaine 5% 50 mg/g 50090-7857-02 A-S 30 pouches AB FDA listed
Lidocaine 700 mg 50090-7894-02 A-S 30 patches AB FDA listed
Lidocaine 50 mg/g 51407-0827-30 Golden 30 pouches AB FDA listed
Lidocaine 50 mg/g 55154-2665-05 Cardinal 5 pouches AB FDA listed
Lidocaine 50 mg/g 55154-7228-05 Cardinal 5 patches AB FDA listed
Lidocaine 50 mg/g 55700-0142-30 Quality 30 pouches AB FDA listed
LidoPure Patch 59088-0712-00 PureTek 1 kit FDA listed
Lidoxryl 59088-0722-00 PureTek 1 kit FDA listed
Lidocan VII 50 mg/gthis 59088-0900-54 PURETEK 30 pouches AB FDA listed
Lidocan 700 mg 59088-0905-54 PURETEK 30 patches AB FDA listed
Lidocan III 50 mg/g 59088-0907-54 PURETEK 30 patches AB FDA listed
Lidocan V 50 mg/g 59088-0909-54 PURETEK 30 pouches AB FDA listed
Lidocan VI 50 mg/g 59088-0911-54 PURETEK 30 pouches AB FDA listed
Lidocaine 5% 50 mg/g 60760-0657-05 St. 5 patches AB FDA listed
Lidocaine 50 mg/g 60760-0880-05 St. 5 pouches AB FDA listed
Lidocaine 50 mg/g 61919-0588-30 DIRECT 1 g AB FDA listed
Lidoderm 700 mg 61959-0001-30 TPU 30 patches AB FDA listed
Lidocaine 50 mg/g 63629-5094-01 Bryant 30 pouches AB FDA listed
Lidocaine 50 mg/g 63629-7059-01 Bryant 30 pouches AB FDA listed
Lidocaine 50 mg/g 63629-8755-01 Bryant 30 pouches AB FDA listed
Lidocaine 5% 700 mg 68071-3620-03 NuCare 30 patches AB FDA listed
Lidocaine 50 mg/g 68788-7159-03 Preferred 30 pouches AB FDA listed
Lidocaine 700 mg 68788-8344-03 Preferred 30 patches AB FDA listed
Lidocaine 50 mg 70518-0566-00 REMEDYREPACK 30 patches AB FDA listed
Lidocaine 5% 50 mg/g 70518-4487-00 REMEDYREPACK 30 pouches AB FDA listed
Lidocaine 50 mg/g 70518-4502-00 REMEDYREPACK 30 pouches AB FDA listed
Lidocaine 50 mg/g 71335-1934-01 Bryant 30 pouches AB FDA listed
Lidocaine 700 mg 71335-1971-01 Bryant 30 patches AB FDA listed
Lidocaine 700 mg 72162-2085-03 Bryant 30 patches AB FDA listed
Lidocaine Patch 700 mg 72189-0387-30 Direct_Rx 30 patches AB FDA listed
Tridacaine III 50 mg/g 73352-0835-15 Trifluent 15 packets AB FDA listed
Lidocaine 50 mg/g 76420-0037-30 Asclemed 30 pouches AB FDA listed
Lidocaine 50 mg/g 76420-0887-30 Asclemed 30 pouches AB FDA listed
Lidocaine 5% 50 mg/g 76420-0899-30 Asclemed 30 pouches AB FDA listed
Lidocaine 700 mg 80425-0325-01 Advanced 30 patches AB FDA listed
Lidocaine 50 mg/g 80425-0404-01 Advanced 30 pouches AB FDA listed
Lidocaine 5% Patch 700 mg 82461-0611-15 Medcore 15 patches AB FDA listed
Lidocaine 50 mg/g 85509-2880-03 PHOENIX 30 pouches AB FDA listed
Lidocaine 50 mg/g 85766-0169-30 Sportpharm 30 pouches AB FDA listed
Lidocaine 700 mg 85766-0170-30 Sportpharm 30 patches AB FDA listed
Lidox 5 Patch 50 mg/g 87234-0505-03 Injecta 30 pouches AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Lidocaine 5% — the ingredient across all brands.

Top reported reactions

Nausea42
Pain30
Headache28
Dizziness26
Fatigue24
Vomiting24
Hypotension22

Reporter sex

0 reports

Serious outcomes

Hospitalization181
Life-threatening59
Death43
Disabling28
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 54 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59088-0900-54 You're viewing this 30 POUCH in 1 PACKAGE (59088-900-54) / 14 g in 1 POUCH (59088-900-84) 2024-08-08 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 59088-900-54, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 59088-0900-54, written without dashes as 59088090054. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 59088-0900-54, the first segment (59088) is the labeler code FDA assigned to PURETEK CORPORATION; the middle segment (0900) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (54) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by PURETEK CORPORATION. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PURETEK CORPORATION is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 23 words

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 and Administration 142 words

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.

Contraindications 28 words

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 ~2 min read

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, 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 665 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 Lidocan™ VII out of the reach of children, pets, and others (see HANDLING AND DISPOSAL). Excessive Dosing - Excessive dosing by applying Lidocan™ VII 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 Lidocan™ VII , 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.

🤒 Adverse Reactions ~1 min read

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, 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 Lidocan™ VII 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 (lightheadedness, 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 101 words

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

🤰 Pregnancy 76 words

Pregnancy Teratogenic Effects Pregnancy Category B. Lidocan™ VII has not been studied in pregnancy. Reproduction studies with lidocaine have been performed in rats at doses up to 30 mg/kg subcutaneously and have revealed no evidence of harm to the fetus due to lidocaine.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Lidocan™ VII should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 12 words

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 153 words

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 be checked. The management of overdose includes close monitoring, supportive care, and symptomatic treatment.

Dialysis is of negligible value in the treatment of acute overdose with lidocaine. In the absence of massive topical overdose or oral ingestion, evaluation of symptoms of toxicity should include consideration of other etiologies for the clinical effects, or overdosage from other sources of lidocaine or other local anesthetics. The oral LD 50 of lidocaine HCl is 459 (346 to 773) mg/kg (as the salt) in non-fasted female rats and 214 (159 to 324) mg/kg (as the salt) in fasted female rats, which are equivalent to roughly 4000 mg and 2000 mg, respectively, in a 60 to 70 kg man based on the equivalent surface area dosage conversion factors between species.

🧬 Clinical Pharmacology ~3 min read

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 of impulses. The penetration of lidocaine into intact skin after application of a lidocaine patch 5% is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block. Pharmacokinetics Absorption The amount of lidocaine systemically absorbed from lidocaine patch 5% is directly related to both the duration of application and the surface area over which it is applied.

In a pharmacokinetic study, three lidocaine patches were applied over an area of 420 cm 2 of intact skin on the back of normal volunteers for 12 hours. Blood samples were withdrawn for determination of lidocaine concentration during the application and for 12 hours after removal of patches. The results are summarized in Table 1.

Table 1 Absorption of lidocaine from Lidocaine Patch Normal volunteers (n=15, 12-hour wearing time) Lidocaine Patch 5% Application Site Area (cm 2 ) Dose Absorbed (mg) C max (mcg/mL) T max (hr) 3 patches (2100 mg) Back 420 64 ± 32 0.13 ± 0.06 11 hr When Lidocan™ VII is used according to the recommended dosing instructions, only 3 ± 2% of the dose applied is expected to be absorbed. At least 95% (665 mg) of lidocaine will remain in a used patch. Mean peak blood concentration of lidocaine is about 0.13 mcg/mL (about 1/10 of the therapeutic concentration required to treat cardiac arrhythmias).

Repeated application of three patches simultaneously for 12 hours (recommended maximum daily dose), once per day for three days, indicated that the lidocaine concentration does not increase with daily use. The mean plasma pharmacokinetic profile for the 15 healthy volunteers is shown in Figure 1. Figure 1 Mean lidocaine blood concentrations after three consecutive daily applications of three lidocaine patches simultaneously for 12 hours per day in healthy volunteers (n = 15).

Distribution When lidocaine is administered intravenously to healthy volunteers, the volume of distribution is 0.7 to

2.7L/kg (mean 1.5 ±

0.6SD, n = 15). At concentrations produced by application of lidocaine patch 5%, lidocaine is approximately 70% bound to plasma proteins, primarily alpha-1-acid glycoprotein. At much higher plasma concentrations (1 to 4 mcg/mL of free base), the plasma protein binding of lidocaine is concentration dependent.

Lidocaine crosses the placental and blood brain barriers, presumably by passive diffusion. Metabolism It is not known if lidocaine is metabolized in the skin. Lidocaine is metabolized rapidly by the liver to a number of metabolites, including monoethylglycinexylidide (MEGX) and glycinexylidide (GX), both of which have pharmacologic activity similar to, but less potent than that of lidocaine.

A minor metabolite, 2,6-xylidine, has unknown pharmacologic activity but is carcinogenic in rats. The blood concentration of this metabolite is negligible following application of lidocaine patch 5%. Following intravenous administration, MEGX and GX concentrations in serum range from 11 to 36% and from 5 to 11% of lidocaine concentrations, respectively.

Excretion Lidocaine and its metabolites are excreted by the kidneys. Less than 10% of lidocaine is excreted unchanged. The half-life of lidocaine elimination from the plasma following IV administration is 81 to 149 minutes (mean 107 ± 22 SD, n = 15).

The systemic clearance is 0.33 to

0.90L/min (mean 0.64 ±

0.18SD, n = 15). graphs

📦 How Supplied / Storage and Handling 49 words

HOW SUPPLIED Lidocan™ VII is available as the following: Package of 30 patches .................................................................................... NDC 59088-900-54 (packaged into individual child-resistant envelope) Single patch ............................................................................................. NDC 59088-900-84 (packaged into individual child-resistant envelope) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

📋 Description 126 words

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 liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm.

Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure: Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben. molecule

💬 Information for Patients 64 words

Information for Patients Methemoglobinemia Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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