Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2024
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LidoSite (Patch)
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LidoSite���Controller can only be used with the LidoSite���Patch as the complete LidoSite���System, and LidoSite���Patches should only be used with a LidoSite���Controller. LidoSite���System should be applied only by a health care practitioner in a health care setting. One LidoSite���Patch is to be used with one LidoSite���Controller. Do not use a damaged or altered patch. To administer, see the���LidoSite���Topical System Instructions���contained in this package insert. Following iontophoresis and patch removal, the treatment site should be cleansed according to standard practice prior to the medical procedure. Disinfecting agents containing heavy metal ions (mercury, zinc, copper, etc.) should not be used for skin disinfection prior to iontophoresis as they have been associated with swelling and edema. LidoSite���Controller should not be subjected to any sterilization procedure. LidoSite���Controller should be disposed of in a trash receptacle.
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LidoSite���System is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, sulfites, or to any other component of the product . LidoSite���System is contraindicated for use in patients with electrically-sensitive devices (e.g., pacemakers).
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dailymed-ingredient:2-phenoxyethanol,_methyl-,_ethyl-,_propyl-,_butyl-_and_isobutyl-p-h...,
dailymed-ingredient:citric_acid,
dailymed-ingredient:edetate_disodium,
dailymed-ingredient:glycerin,
dailymed-ingredient:monbasic_sodium_phosphate,
dailymed-ingredient:polyvinylpyrrolidone_(PVP)_hydrogel,
dailymed-ingredient:sodium_chloride,
dailymed-ingredient:sodium_metabisulfite
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| dailymed-instance:precautio... |
General: Since amide-type local anesthetics are metabolized by the liver, LidoSite���System should be used with caution in patients with hepatic disease. Patients with severe hepatic disease normally are at a greater risk of developing toxic plasma concentrations. LidoSite���System should be used with caution in persons with known drug sensitivities. Patients allergic to para-amino-benzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine. Nevertheless, LidoSite���System should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain. Lidocaine and epinephrine should be used with caution in patients with impaired cardiovascular function since they may be less able to compensate for changes in cardiac conduction, contractility, and oxygen demand that may be caused by systemic exposure to these drugs. LidoSite���System should be applied only by a health care practitioner in a health care setting. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use when LidoSite���System is administered. . The intended treatment site should not be covered with excessive hair, as that may affect patch adhesion. The LidoSite���System has not been tested for safety or effectiveness in the head and neck areas, over-damaged or denuded skin, or on mucous membranes. The safety of LidoSite���System has not been tested in patients who have received long-term treatment with corticosteroids. Clinical judgment should be exercised when considering the use of LidoSite���System in these patients, as they may be more susceptible to skin injury from LidoSite���System. The LidoSite���Patch reservoirs must remain in complete contact with the skin during treatment. Therefore, restricting motion is recommended for those application sites where movement could release the patch from the skin. Following iontophoresis and patch removal, the treatment site should be cleansed according to standard practice prior to starting the medical procedure. Non-intact skin: Application to broken or inflamed skin, may result in local tissue injury or higher blood concentrations of lidocaine from increased absorption. LidoSite���System is only recommended for use on intact skin. Eye exposure: The contact of LidoSite���Patch with eyes, should be avoided based on the findings of severe eye irritation with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns. Repeated application of LidoSite���System may increase blood levels of lidocaine. LidoSite���System should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine, including acutely ill, debilitated, or elderly patients. Lidocaine has been shown to inhibit viral and bacterial growth. The effect of LidoSite���Patch on intradermal injections of live vaccines has not been determined. Information For Patients: When LidoSite���System is used, the patient should be aware that block of all sensations in the treated skin may occur. For this reason, the patient should avoid inadvertent trauma to the treated area by scratching, rubbing or exposure to extreme hot or cold temperatures until complete sensation has returned. Diminished sensation may persist for an hour or more . Patients should be advised to monitor the treated area for the return of sensation. The appearance of the treated area may appear to be blanched or red which are normal reactions and usually disappear within 24 hours. Patients should be instructed to monitor the site and report persistent pain, redness and other skin abnormalities based upon directions provided by the health care professional. Clinically Significant Drug Interactions: Monoamine Oxidase Inhibitors: The administration of local anesthetics containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe prolonged hypertension. Antiarrhythmic Drugs: LidoSite���System should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the systemic toxic effects are thought to be additive and potentially synergistic. Local Anesthetics: When LidoSite���System is used concomitantly with other products containing local anesthetic agents, the systemic exposure from all formulations must be considered.<br/>CARCINOGENESIS, MUTAGENESIS AND IMPAIRMENT OF FERTILITY: Carcinogenesis: Long-term studies to evaluate the carcinogenic potential of lidocaine in animals have not been conducted. Mutagenesis: The mutagenic potential of lidocaine HCl has been tested in the Ames Salmonella/Mammalian Microsome Test, by analysis of structural chromosome aberrations in human lymphocytes in vitro, and by the mouse micronucleus test in vivo. There was no indication of any mutagenic effects in these tests. Impairment of Fertility: Studies to evaluate the effects of lidocaine on fertility in animals have not been conducted. Use in Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 500 mg/kg/day, s.c. (6.6 times the human injected dose) via mini-osmotic pumps and have revealed no significant adverse reproductive or teratogenic effects attributable 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, this drug should be used during pregnancy only if clearly needed. Nursing Mothers: Lidocaine is excreted in human milk. The milk to plasma ratio of systemically administered lidocaine is 0.4. Caution should be exercised when LidoSite���System is administered to a nursing woman. Pediatric Use: The safety and effectiveness of the LidoSite���System have been established in pediatric patients five years and older based on adequate and well-controlled studies . The recommended dose for pediatric patients five years and older is the same as for adults. Safety and effectiveness in pediatric patients below the age of five years have not been established. Geriatric Use: In the clinical studies, there were sixty patients over 65 years of age and thirty-one patients over 75 years of age. No overall differences in safety or efficacy were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger patients. However, greater sensitivity of individual patients greater than 65 years of age cannot be ruled out. In clinical studies of intravenously administered lidocaine, the elimination half-life of lidocaine was statistically significantly longer in elderly patients (2.5 hours) than in younger patients (1.5 hours) . Labor and Delivery: The effects of LidoSite���System on the mother and fetus, on the duration of labor or delivery, and on neonatal outcome and maturation have not been studied. Should LidoSite���System be used concomitantly with other products containing lidocaine and/or epinephrine, total doses contributed by all formulations must be considered .
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Lidocaine hydrochloride and Epinephrine bitartrate
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| dailymed-instance:fullName |
LidoSite (Patch)
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Rx Only DANGER-EXPLOSIVE HAZARD: This product could serve as an ignition source and should not be used in the presence of flammable anesthetics. Accidental Exposure in Children: Even a used LidoSite���Patch contains a large amount of lidocaine (up to 100 mg). The potential exists for a small child to suffer serious adverse effects from chewing or ingesting a new or used LidoSite���Patch. Children should be closely observed when treated with the LidoSite���System, and LidoSite���Patches should be stored and disposed of in the proper manner. Skin Reactions: Iontophoresis can cause skin irritation, burning sensation and/or burns. Patients should be warned of the possibilities and alerted to early signs such as itching or warmth. Patients should be instructed to notify appropriate personnel as soon as symptoms are detected. Longer than recommended durations of application, repeat applications or continued application after the occurrence of symptoms may increase the risk of local skin irritation or injury. Iontophoresis with the LidoSite���Patch may cause transient, local blanching or erythema in the dermis under the patch. The redness under the elongated reservoir is normally uniform in color, while under the circular reservoir the color may be mottled. Sulfite Allergy: LidoSite���Patch contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms, and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. Vasoconstriction Related to Epinephrine: Since the LidoSite���Patch contains a vasoconstrictor, it should not be used on areas of the body supplied by end arteries or having otherwise compromised blood supply. Repeated applications should not be made to the same site. Patients with peripheral vascular disease and those with hypertensive vascular disease may exhibit an exaggerated vasoconstrictor response. LidoSite���System should be used with caution in patients with severe coronary artery disease, hypertension or cardiac disrhythmias or in patients who are currently taking monoamine oxidase (MAO) inhibitors or tricyclic antidepressants.
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| dailymed-instance:indicatio... |
LidoSite���System is a topical local anesthetic delivery system indicated for use on normal intact skin to provide local analgesia for superficial dermatological procedures such as venipuncture, intravenous cannulation, and laser ablation of superficial skin lesions. LidoSite���System is indicated for use on patients 5 years of age and older.
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LidoSite
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