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does levonorgestrel cause weight gain
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does levonorgestrel cause weight gain
Generic Name: Lidocaine HCl and Epinephrine Iontophoretic Patch
Date of Approval: May 10, 2004
Company: Vyteris, Inc.
Treatment for: Localized Pain Treatment

The United States Food and Drug Administration (FDA) has approved LidoSite TopicalSystem.
The system has been approved for use on normal intact skin to provide a localanalgesia that numbs the skin prior to the administration of superficial dermatologicalprocedures such as venipuncture (drawing blood with a needle from a vein usuallyin the forearm), intravenous cannulation (administration of fluids and/or medications),and laser ablation (high power laser pulses) of superficial skin lesions does levonorgestrel cause weight gain. Theproduct is approved for use on patients five-years-of-age and older does levonorgestrel cause weight gain.

LidoSite uses an active transdermal delivery technology known as iontophoresis,which administers medications through the skin via a mild electric current does levonorgestrel cause weight gain. The LidoSite system administers lidocaine and epinepherine using a patentedelectrotransport technology that enables the controlled delivery of medicationover a predetermined period of time, from minutes to days does levonorgestrel cause weight gain. Topical anestheticcreams and patches can take up to an hour to numb the skin, while LidoSite worksin 10 minutes does levonorgestrel cause weight gain. This product has successfully completed clinical trials and hasbeen found to significantly decrease pain from needle injections and similarprocedures in both adults and children does levonorgestrel cause weight gain. Lidosite is intended to also addressa strong need in adult applications does levonorgestrel cause weight gain. Its major impact is expected to be in thepediatric population, where pain associated with needlesticks, blood-draw proceduresand immunizations is a major issue for the clinician, child and parent.

Studies Demonstrate Safety and Efficacy
More than 1,000 adults and children (ages 5 to 17 years) participated in clinicalstudies evaluating the safety and efficacy of the Vyteris system in providingtopical anesthesia does levonorgestrel cause weight gain. Two pivotal studies compared the system (administering lidocaine10% and epinephrine 0.1%) with placebo for use prior to needle injections orintravenous (IV) insertions does levonorgestrel cause weight gain. Additional studies evaluated the efficacy of thesystem for use prior to the removal of surface skin lesions (via incision orlaser treatment) does levonorgestrel cause weight gain. Patients treated with Vyteris' LidoSite system experiencedsignificantly less pain associated with needlestick procedures compared withsubjects treated with the placebo system does levonorgestrel cause weight gain. Consequently, fewer patients in theactive group reported experiencing severe pain and most reported feeling littleor no pain in contrast to patients in the placebo group does levonorgestrel cause weight gain. In these studies, thepatients were evaluated using established pain assessment tools including theFacial Affective Scale (FAS) (A = no pain, I = maximal pain) or the Visual AnalogueScale (VAS) (0 = no pain, 10 = maximal pain) methods does levonorgestrel cause weight gain. Evaluations were takenimmediately following patch removal and at 24 hours for side effects does levonorgestrel cause weight gain. Pain scoreevaluations from both scales resulted in statistically significantly less painfor those who used the Vyteris' LidoSite system, as compared to placebo does levonorgestrel cause weight gain. Inthese studies, the most common side effect was mild erythema (skin redness),which disappeared for most patients within 24-hours.
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