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Lidoderm
Overview
What is Lidoderm?
LIDODERM (lidocaine patch 5%) 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 × 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:
dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin,
methylparaben, polyacrylic acid, polyvinyl alcohol, propylene glycol,
propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol,
tartaric acid, and urea.
What does Lidoderm look like?
What are the available doses of Lidoderm?
Sorry No records found.
What should I talk to my health care provider before I take Lidoderm?
Sorry No records found
How should I use Lidoderm?
LIDODERM is indicated for relief of pain associated with post-herpetic
neuralgia. It should be applied only to .
Apply LIDODERM to intact skin to cover the most painful area.
Apply up to three patches, 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 )
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 LIDODERM is used concomitantly with other products containing local
anesthetic agents, the amount absorbed from all formulations must be considered.
What interacts with Lidoderm?
LIDODERM 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.
What are the warnings of Lidoderm?
Rare reports exist of severe hepatic reactions including encephalopathy, fulminant hepatic necrosis and death in patients receiving propylthiouracil. Symptoms suggestive of hepatic dysfunction (anorexia, pruritus, right upper quadrant pain, etc.) should prompt evaluation of liver function. Treatment with propylthiouracil should be discontinued promptly in the event of clinically significant evidence of liver abnormality, including hepatic transaminases in excess of 3 times the upper limit of normal.
Even a LIDODERM patch 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 LIDODERM patch, although the risk with this formulation has not been
evaluated. It is important for patients to (See )
Excessive dosing by applying LIDODERM 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
).
Lidocaine toxicity could be expected at lidocaine blood concentrations above 5
µg/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 LIDODERM, the average peak blood
concentration is about 0.13 µg/mL, but concentrations higher than 0.25 µg/mL
have been observed in some individuals.
What are the precautions of Lidoderm?
Hepatic Disease:
Allergic Reactions:
Non-intact Skin:
External Heat Sources:
Eye Exposure:
Antiarrhythmic Drugs:
Local Anesthetics:
Carcinogenesis:
Mutagenesis:
Impairment of Fertility:
Teratogenic Effects: Pregnancy Category
B.
LIDODERM has not been studied in labor and delivery. Lidocaine is
not contraindicated in labor and delivery. Should LIDODERM be used concomitantly
with other products containing lidocaine, total doses contributed by all
formulations must be considered.
LIDODERM has not been studied in nursing mothers. Lidocaine is
excreted in human milk, and the milk:plasma ratio of lidocaine is 0.4. Caution
should be exercised when LIDODERM is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been
established.
What are the side effects of Lidoderm?
During or immediately after treatment with LIDODERM (lidocaine
patch 5%), 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 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.
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 adverse reactions following appropriate use of LIDODERM
are unlikely, due to the small dose absorbed (see ). Systemic
adverse effects of lidocaine are similar in nature to those observed with other
amide local anesthetic agents, including CNS excitation and/or depression (light
headedness, 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.
What should I look out for while using Lidoderm?
LIDODERM 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.
Even a LIDODERM patch 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 LIDODERM patch, although the risk with this formulation has not been
evaluated. It is important for patients to (See )
Excessive dosing by applying LIDODERM 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
).
Lidocaine toxicity could be expected at lidocaine blood concentrations above 5
µg/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 LIDODERM, the average peak blood
concentration is about 0.13 µg/mL, but concentrations higher than 0.25 µg/mL
have been observed in some individuals.
What might happen if I take too much Lidoderm?
Lidocaine overdose from cutaneous absorption is rare, but could
occur. If there is any suspicion of lidocaine overdose (see ), 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 of lidocaine HCl is 459 (346-773) mg/kg
(as the salt) in non-fasted female rats and 214 (159-324) 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.
How should I store and handle Lidoderm?
Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.LIDODERM (lidocaine patch 5%) is available as the following:Carton of 30 patches, packaged into individual child-resistant envelopes. NDC 54868-4146-03 Cartons of 30 patches, packaged into individual child-resistant envelopes.NDC 54868-4146-1 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Manufactured for: Chadds Ford, Pennsylvania 19317LIDODERM is a Registered Trademark of Hind Health Care, Inc.© 2010 Endo Pharmaceuticals6524-12/March 2010LIDODERM (lidocaine patch 5%) is available as the following:Carton of 30 patches, packaged into individual child-resistant envelopes. NDC 54868-4146-03 Cartons of 30 patches, packaged into individual child-resistant envelopes.NDC 54868-4146-1 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Manufactured for: Chadds Ford, Pennsylvania 19317LIDODERM is a Registered Trademark of Hind Health Care, Inc.© 2010 Endo Pharmaceuticals6524-12/March 2010LIDODERM (lidocaine patch 5%) is available as the following:Carton of 30 patches, packaged into individual child-resistant envelopes. NDC 54868-4146-03 Cartons of 30 patches, packaged into individual child-resistant envelopes.NDC 54868-4146-1 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Manufactured for: Chadds Ford, Pennsylvania 19317LIDODERM is a Registered Trademark of Hind Health Care, Inc.© 2010 Endo Pharmaceuticals6524-12/March 2010LIDODERM (lidocaine patch 5%) is available as the following:Carton of 30 patches, packaged into individual child-resistant envelopes. NDC 54868-4146-03 Cartons of 30 patches, packaged into individual child-resistant envelopes.NDC 54868-4146-1 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Manufactured for: Chadds Ford, Pennsylvania 19317LIDODERM is a Registered Trademark of Hind Health Care, Inc.© 2010 Endo Pharmaceuticals6524-12/March 2010LIDODERM (lidocaine patch 5%) is available as the following:Carton of 30 patches, packaged into individual child-resistant envelopes. NDC 54868-4146-03 Cartons of 30 patches, packaged into individual child-resistant envelopes.NDC 54868-4146-1 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Manufactured for: Chadds Ford, Pennsylvania 19317LIDODERM is a Registered Trademark of Hind Health Care, Inc.© 2010 Endo Pharmaceuticals6524-12/March 2010LIDODERM (lidocaine patch 5%) is available as the following:Carton of 30 patches, packaged into individual child-resistant envelopes. NDC 54868-4146-03 Cartons of 30 patches, packaged into individual child-resistant envelopes.NDC 54868-4146-1 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Manufactured for: Chadds Ford, Pennsylvania 19317LIDODERM is a Registered Trademark of Hind Health Care, Inc.© 2010 Endo Pharmaceuticals6524-12/March 2010LIDODERM (lidocaine patch 5%) is available as the following:Carton of 30 patches, packaged into individual child-resistant envelopes. NDC 54868-4146-03 Cartons of 30 patches, packaged into individual child-resistant envelopes.NDC 54868-4146-1 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Manufactured for: Chadds Ford, Pennsylvania 19317LIDODERM is a Registered Trademark of Hind Health Care, Inc.© 2010 Endo Pharmaceuticals6524-12/March 2010LIDODERM (lidocaine patch 5%) is available as the following:Carton of 30 patches, packaged into individual child-resistant envelopes. NDC 54868-4146-03 Cartons of 30 patches, packaged into individual child-resistant envelopes.NDC 54868-4146-1 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Manufactured for: Chadds Ford, Pennsylvania 19317LIDODERM is a Registered Trademark of Hind Health Care, Inc.© 2010 Endo Pharmaceuticals6524-12/March 2010
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 LIDODERM
is sufficient to produce an analgesic effect, but less than the amount necessary
to produce a complete sensory block.
Absorption
When LIDODERM 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 µg/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
Distribution:
Metabolism:
Excretion:
Non-Clinical Toxicology
LIDODERM 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.Even a LIDODERM patch 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 LIDODERM patch, although the risk with this formulation has not been evaluated. It is important for patients to (See )
Excessive dosing by applying LIDODERM 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 ). Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 µg/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 LIDODERM, the average peak blood concentration is about 0.13 µg/mL, but concentrations higher than 0.25 µg/mL have been observed in some individuals.
Anticoagulants (Oral): The activity of anticoagulants may be potentiated by anti-vitamin-K activity attributed to propylthiouracil.
β-Adrenergic Blocking Agents: Hyperthyroidism may cause an increased clearance of beta blockers with a high extraction ratio. A dose reduction of beta-adrenergic blockers may be needed when a hyperthyroid patient becomes euthyroid.
Digitalis Glycosides: Serum digitalis levels may be increased when hyperthyroid patients on a stable digitalis glycoside regimen become euthyroid; a reduced dosage of digitalis glycosides may be required.
Theophylline: Theophylline clearance may decrease when hyperthyroid patients on a stable theophylline regimen become euthyroid; a reduced dose of theophylline may be needed.
Hepatic Disease:
Allergic Reactions:
Non-intact Skin:
External Heat Sources:
Eye Exposure:
Antiarrhythmic Drugs:
Local Anesthetics:
Carcinogenesis:
Mutagenesis:
Impairment of Fertility:
Teratogenic Effects: Pregnancy Category B.
LIDODERM has not been studied in labor and delivery. Lidocaine is not contraindicated in labor and delivery. Should LIDODERM be used concomitantly with other products containing lidocaine, total doses contributed by all formulations must be considered.
LIDODERM has not been studied in nursing mothers. Lidocaine is excreted in human milk, and the milk:plasma ratio of lidocaine is 0.4. Caution should be exercised when LIDODERM is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
During or immediately after treatment with LIDODERM (lidocaine patch 5%), 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 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.
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 adverse reactions following appropriate use of LIDODERM are unlikely, due to the small dose absorbed (see ). Systemic adverse effects of lidocaine are similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light headedness, 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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