Lidocaine is excreted in human milk, and the milk:plasma ratio of lidocaine is 0. 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. 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. Lidocaine overdose from cutaneous absorption is rare, but could occur. 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. 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. 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.
Avoid contact with water, such as bathing, swimming or showering. Do not store patch outside the sealed envelope. Apply immediately after removal from the protective envelope. Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. Carton of 30 patches, packaged into individual child-resistant envelopes NDC Manufactured for: Endo Pharmaceuticals Inc.
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Drug Label Info. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. 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.
Do not apply it more or less often than prescribed by your doctor. It is applied up to 3 times daily and for no more than 8 hours per application. Use nonprescription lidocaine patches exactly as directed. Do not use more or less of it or use it more often or for a longer period of time than directed by the package instructions. Your doctor will tell you how many lidocaine patches or topical systems you may use at one time and the length of time you may wear the patches.
Applying too many patches or topical systems or leaving them on for too long may cause serious side effects. Apply the lidocaine patch or topical system to clean, dry, intact skin as directed.
Choose an area where the patch will not be rubbed by tight clothing. Do not apply the patch or topical system to an open wound or cut, to skin that is irritated or red, or to skin that is affected by a rash, burn, or other skin problem.
If irritation or a burning sensation occurs during lidocaine application, remove the lidocaine patch or system and do not reapply it until the irritation is gone. Prescription patches and topical systems may be cut into smaller sizes with scissors prior to removal of the release liner.
Be sure to remove the current patch before you apply a new one. Do not let lidocaine transdermal come in contact with your eyes. If lidocaine transdermal does touch your eye, immediately wash the eye with water or saline and protect the eye until sensation returns. While you are wearing a lidocaine transdermal patch or system, protect the treated area from direct heat such as heating pads or electric blankets.
You can apply the lidocaine 1. Do not bandage the affected area tightly. If you are using the prescription lidocaine 1. If the lidocaine 1. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. This medication is usually used as needed. If your doctor has told you to use lidocaine patches or topical systems regularly, apply the missed patch or topical system as soon as you remember it. However, if it is almost time for the next dose, skip the missed patch and continue your regular dosing schedule.
Do not apply a double dose to make up for a missed one. Lidocaine transdermal may cause other side effects. Call your doctor if you have any unusual problems while using this medication. 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.
Mean peak blood concentration of lidocaine is about 0. 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. Distribution: When lidocaine is administered intravenously to healthy volunteers, the volume of distribution is 0.
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. Excretion: Lidocaine and its metabolites are excreted by the kidneys. The systemic clearance is 0.
Single-dose treatment with lidocaine patch was compared to treatment with vehicle patch without lidocaine , and to no treatment observation only in a double-blind, crossover clinical trial with 35 post-herpetic neuralgia patients.
Pain intensity and pain relief scores were evaluated periodically for 12 hours. Lidocaine patch performed statistically better than vehicle patch in terms of pain intensity from 4 to 12 hours. Multiple-dose, two-week treatment with lidocaine patch was compared to vehicle patch without lidocaine in a double-blind, crossover clinical trial of withdrawal-type design conducted in 32 patients, who were considered as responders to the open-label use of lidocaine patch prior to the study.
The constant type of pain was evaluated but not the pain induced by sensory stimuli dysesthesia. Statistically significant differences favoring lidocaine patch were observed in terms of time to exit from the trial 14 versus 3. About half of the patients also took oral medication commonly used in the treatment of post-herpetic neuralgia.
The extent of use of concomitant medication was similar in the two treatment groups. It should be applied only to intact skin. Even a used lidocaine patch contains a large amount of lidocaine at least 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, although the risk with this formulation has not been evaluated.
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.
Hepatic Disease: Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize lidocaine normally. Allergic Reactions: Patients allergic to para-aminobenzoic acid derivatives procaine, tetracaine, benzocaine, etc.
Non-intact Skin: Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of lidocaine from increased absorption. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
Carcinogenesis: A minor metabolite, 2,6-xylidine, has been found to be carcinogenic in rats. Teratogenic Effects: Pregnancy Category B. There are, however, no adequate and well-controlled studies in pregnant women. Lidocaine is not contraindicated in labor and delivery. Lidocaine is excreted in human milk, and the milk:plasma ratio of lidocaine is 0.
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.
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