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Fast Acting1,2,3
Medicated
Numbing Prescription Relief
Odor Free

Lidocaine Patch 5%

For relief of pain associated with post-herpetic neuralgia.

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Lidocaine Patch 5% is comprised of an adhesive material which is applied to a non-woven polyester felt backing and a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10cm x 14cm.

Lidocaine Patch 5% is an amide-type local anesthetic agent, suggested to stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses. Lidocaine Patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. Each adhesive patch contains 700 mg of lidocaine. Be sure to apply the prescribed number of patches (maximum of 3x per day), to intact skin, for up to 12-hours within a 24-hour period.

Dosage Administration:

  • Lidocaine Patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.
  • Lidocaine Patch 5% may be cut into smaller sizes with scissors prior to the removal of the release liner.
  • Clothing may be worn over the area of application. Smaller areas of treatment are recommended for a debilitated patient, or a patient with impaired elimination.
  • The absorption 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.1

Inactive Ingredients:
There are 15 inactive ingredients that will be found in the compound of the Lidocaine Patch 5%, which includes water, glycerin, sorbitol, polyacrylic acid, Sodium polyacrylate, Propylene glycol, urea, kaolin, tartaric acid, polyvinyl alcohol, dihydroxy aluminum amino acetate, edetate disodium, methylparaben, propylparaben, carboxymethylcellulose sodium, and gelatin.

Prescribing Information
Indication and Important Safety Information

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References:

  1. Lidocaine Patch 5% [package insert]. Parsippany, NJ: YARAL Pharma Inc; 2021.
  2. Beecham GB, Nessel TA, Goyal A. Lidocaine. [Updated 2022 Dec 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan. Available from: https://www.ncbi.nlm.nih.gov/books/NBK539881/.
  3. Rowbotham MC, Davies PS, Verkempinck C, Galer BS. Lidocaine patch: double-blind controlled study of a new treatment method for post-herpetic neuralgia. Pain. 1996 Apr;65(1):39-44. doi:10.1016/0304-3959(95)00146-8. PMID: 8826488.

LIDODERM® is a registered trademark of Hind Health Care, Inc.

General Information About Lidocaine Patch 5%

Using Lidocaine Patch 5%

Handling and Disposal of Lidocaine Patch 5%

Possible Side Effects of Lidocaine Patch 5%

  INDICATION & IMPORTANT SAFETY INFORMATION for Lidocaine Patch 5%

INDICATION
Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin. 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Lidocaine patch 5% 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. All patients are at risk for met­hemoglobinemia.
  • If local anesthetics must be used in 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, close monitoring for symptoms and signs of methemoglobinemia is recommended as these patients are more susceptible to developing clinical manifestations of the condition.
  • Signs of methemoglobinemia, including cyanotic skin discoloration and/or abnormal coloration of the blood may occur immediately or may be delayed some hours after exposure. Methemoglobin levels may continue to rise which may lead to more serious central nervous system and cardiovascular adverse effects, including sei­zures, coma, arrhythmias, and death. Discontinue lidocaine patch 5% and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care or may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

ACCIDENTAL EXPOSURE IN CHILDREN

  • Small children or pets could suffer serious adverse effects from chewing or ingesting a new or used lidocaine patch 5%.  Store and dispose of lidocaine patch 5% properly and keep out of reach of children, pets and others.

EXCESSIVE DOSING AND OVERDOSE

  • Excessive dosing could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects, including lidocaine toxicity.  Longer duration  of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increased blood concentration levels of lidocaine.
  • Apply the prescribed number of patches (maximum of 3), only once for up to 12 hours within a 24-hour period. If lidocaine overdose is suspected, check blood concentration. Management of overdose includes close monitoring, supportive care, and symptomatic treatment.

PRECAUTIONS

  • HEPATIC DISEASE: Patients with severe hepatic disease are at greater risk of devel­oping toxic blood concentrations of lidocaine.
  • ALLERGIC REACTIONS: Lidocaine patch 5% should be used with cau­tion in patients allergic to PABA derivatives or with a history of drug sensitivities, especially if the etiologic agent is uncertain.
  • NON-INTACT SKIN: Apply lidocaine patch 5% on intact skin only. Application to broken or inflamed skin may result in higher blood concentrations of lidocaine from increased absorption.
  • EXTERNAL HEAT SOURCES: Placement of external heat sources, such as heating pads or elec­tric blankets, over lidocaine patch 5% is not recommended and may increase plasma lidocaine levels.
  • EYE EXPOSURE: Avoid contact of lidocaine patch 5% with eyes.  If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.

ADVERSE REACTIONS

  • APPLICATION SITE REACTION: Side effects of lidocaine patch 5% include application site reactions such as 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, such as angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngo­spasm, pruritus, shock, and urticaria, can occur and should be managed by conventional means.
  • SYSTEMIC REACTIONS: Systemic adverse reactions following appropriate use of lidocaine patch 5% are unlikely and are similar in nature to those observed with other amide local anesthetic agents.

DRUG INTERACTIONS

  • ANTIARRHYTHMIC DRUGS: Lidocaine patch 5% should be used with caution with Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.
  • LOCAL ANESTHETICS: When lidocaine patch 5% 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 LIDOCAINE PATCH 5%: Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarial, anticonvulsants, acetaminophen and other drugs associated with the risk of methemoglobinemia.

USE IN SPECIFIC POPULATIONS

  • LACTATION: Use of lidocaine patch 5% during lactation should be used with caution as lidocaine is excreted in breast milk.
  • PREGNANCY: Lidocaine patch 5% has not been studied in pregnancy or in labor and delivery and therefore should be used only if clearly needed and total doses contributed by all formulations must be considered.
  • PEDIATRICS: Safety and effectiveness in pediatric patients have not been established.

These are not all of the adverse reactions that may occur with use of lidocaine patch 5%.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088, or contact Yaral Pharma, Inc. at 1-866-218-9009.

Please see Full Prescribing Information for Lidocaine patch 5% at: www.yaralpharma.com/lidocaine-pi.

REF-1490-v1

INDICATION & IMPORTANT SAFETY INFORMATION for Lidocaine Patch 5%

  INDICATION & IMPORTANT SAFETY INFORMATION for Lidocaine Patch 5%

INDICATION
Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin. 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Lidocaine patch 5% 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. All patients are at risk for met­hemoglobinemia.
  • If local anesthetics must be used in 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, close monitoring for symptoms and signs of methemoglobinemia is recommended as these patients are more susceptible to developing clinical manifestations of the condition.
  • Signs of methemoglobinemia, including cyanotic skin discoloration and/or abnormal coloration of the blood may occur immediately or may be delayed some hours after exposure. Methemoglobin levels may continue to rise which may lead to more serious central nervous system and cardiovascular adverse effects, including sei­zures, coma, arrhythmias, and death. Discontinue lidocaine patch 5% and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care or may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

ACCIDENTAL EXPOSURE IN CHILDREN

  • Small children or pets could suffer serious adverse effects from chewing or ingesting a new or used lidocaine patch 5%.  Store and dispose of lidocaine patch 5% properly and keep out of reach of children, pets and others.

EXCESSIVE DOSING AND OVERDOSE

  • Excessive dosing could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects, including lidocaine toxicity.  Longer duration  of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increased blood concentration levels of lidocaine.
  • Apply the prescribed number of patches (maximum of 3), only once for up to 12 hours within a 24-hour period. If lidocaine overdose is suspected, check blood concentration. Management of overdose includes close monitoring, supportive care, and symptomatic treatment.

PRECAUTIONS

  • HEPATIC DISEASE: Patients with severe hepatic disease are at greater risk of devel­oping toxic blood concentrations of lidocaine.
  • ALLERGIC REACTIONS: Lidocaine patch 5% should be used with cau­tion in patients allergic to PABA derivatives or with a history of drug sensitivities, especially if the etiologic agent is uncertain.
  • NON-INTACT SKIN: Apply lidocaine patch 5% on intact skin only. Application to broken or inflamed skin may result in higher blood concentrations of lidocaine from increased absorption.
  • EXTERNAL HEAT SOURCES: Placement of external heat sources, such as heating pads or elec­tric blankets, over lidocaine patch 5% is not recommended and may increase plasma lidocaine levels.
  • EYE EXPOSURE: Avoid contact of lidocaine patch 5% with eyes.  If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.

ADVERSE REACTIONS

  • APPLICATION SITE REACTION: Side effects of lidocaine patch 5% include application site reactions such as 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, such as angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngo­spasm, pruritus, shock, and urticaria, can occur and should be managed by conventional means.
  • SYSTEMIC REACTIONS: Systemic adverse reactions following appropriate use of lidocaine patch 5% are unlikely and are similar in nature to those observed with other amide local anesthetic agents.

DRUG INTERACTIONS

  • ANTIARRHYTHMIC DRUGS: Lidocaine patch 5% should be used with caution with Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.
  • LOCAL ANESTHETICS: When lidocaine patch 5% 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 LIDOCAINE PATCH 5%: Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarial, anticonvulsants, acetaminophen and other drugs associated with the risk of methemoglobinemia.

USE IN SPECIFIC POPULATIONS

  • LACTATION: Use of lidocaine patch 5% during lactation should be used with caution as lidocaine is excreted in breast milk.
  • PREGNANCY: Lidocaine patch 5% has not been studied in pregnancy or in labor and delivery and therefore should be used only if clearly needed and total doses contributed by all formulations must be considered.
  • PEDIATRICS: Safety and effectiveness in pediatric patients have not been established.

These are not all of the adverse reactions that may occur with use of lidocaine patch 5%.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088, or contact Yaral Pharma, Inc. at 1-866-218-9009.

Please see Full Prescribing Information for Lidocaine patch 5% at: www.yaralpharma.com/lidocaine-pi.

REF-1490-v1

INDICATION
Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin. 

CONTRAINDICATIONS
Lidocaine patch 5% 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.

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