Flector transdermal patch, voltaren gel diclofenac topical. A topical patch containing the epolamine salt form of the nonsteroid antiinflammatory drug nsaid diclofenac, with antiinflammatory, antipyretic and analgesic activities. This monograph also contains information on diclofenac potassium, diclofenac sodium chemical name. Flector patch can be used in attempts to treat conditions that have not been validated by the fda. Flector diclofenac epolamine patch ibsa institut biochimique sa flector patch diclofenac epolamine topical patch 1. Flector patch contains diclofenac epolamine, a nonsteroidal antiinflammatory drug nsaid, and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. Jan 19, 2012 each individual patch is embossed with flector patch diclofenac epolamine topical patch 1. Wo2010069397a1 process for the preparation of diclofenac.
Flector patch diclofenac transdermal uses, side effects. Diclofenac is a nonsteroidal antiinflammatory drug nsaids. Diclofenac epolamine is a nonopioid analgesic chemically designated as 22,6dichlorophenyl aminobenzeneacetic acid, 2pyrrolidin1yl ethanol salt, with a molecular formula of c 20 h 24 cl 2 n 2 o 3 molecular weight 411. Diclofenac topical for the skin is used to treat joint. Diclofenac topical system patch is used to treat pain caused by minor sprains, strains, or bruising. It works by reducing substances in the body that cause pain and inflammation. Jun 18, 2019 flector patches contain diclofenac epolamine, a nonsteroidal antiinflammatory drug nsaid.
Overall, the most common adverse events associated with flector patch diclofenac epolamine topical patch treatment were skin reactions at the site of treatment. Nov 09, 2018 diclofenac is a nonsteroidal antiinflammatory drug nsaid. Flector transdermal patch, voltaren gel diclofenac. Diclofenac sodium definition of diclofenac sodium by. When applied topically in a patch, diclofenac epolamine produces consistent and sustained drug release for 12 hours, with systemic drug exposure being. Improvements in pain typically occur within half an hour and last for as much as eight hours. Nov 16, 2017 flector patch diclofenac epolamine patch is a nonsteroidal antiinflammatory drug, available for topical application. Safety and efficacy of generic diclofenac epolamine acute. Indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. Each patch contains 180 mg of diclofenac epolamine and mg of diclofenac epolamine per gram of adhesive. Apr 11, 2019 what is diclofenac topical system flector patch. Ndc proprietary name nonproprietary name dosage form route name company name product type. Flector patch is contraindicated in patients who have experienced asthma, urticaria, or. Flector patch diclofenac epolamine contains a nonsteroidal antiinflammatory medication used as a pain reliver indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.
This is further supported by an apparent plasma diclofenac halflife of 912 hours after patch application, which implies the presence of a tissue reservoir, as the halflife after oral intake of diclofenac is 12 hours. Flector patch side effects, flector patch generic, dosage. Eye contact rinse thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids. Diclofenac dye kloe fen ak is a nonsteroidal antiinflammatory drug nsaid. Use lowest effective dosage for shortest duration consistent with individual patient treatment goals. Table 1 lists all adverse events, regardless of causality, occurring in. Apply a patch as soon as you remember, and wear it for 12 hours before applying a new one. Product name diclofenac epolamine topical system greenstone llc page 3 revision date 15jan2020 version 2 inhalation remove to fresh air. Diclofenac patch on the skin national library of medicine. Each individual patch is embossed with flector patch 1. Flector patch may induce allergic reaction such as hives, difficulty breathing, and swelling of. Patch 10 x 14 cm containing 180 mg of diclofenac epolamine, embossed with flector patch diclofenac epolamine topical patch 1. Acute pain flector diclofenac epolamine topical system. Diclofenac epolamine patch is contraindicated for use on nonintact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds.
Apply 1 topical system to the most painful area qday. Flector patches are used to treat pain caused by minor sprains, strains, or bruising. Buy flector effigel 1% gel, diclofenac epolamine, sprains, bruises, 50g vial warning. It is taken by mouth, used by injection, or applied to the skin. Dec 24, 2014 superiority of test diclofenac epolamine patch over placebo and of reference flector patch over placebo in vas score changes from baseline time frame. It is also available in combination with misoprostol in an. Diclofenac sodium drug bnf content published by nice.
Diclofenac is a nonsteroidal antiinflammatory drug nsaid. Edetate disodium mixture no data available material name. Flector patch, a minimally systemic topical patch formulation of diclofenac, is indicated for acute pain due to minor sprains, strains, and contusions. Your guide to acute pain flector diclofenac epolamine. The patch has been approved in many other countries outside the us under different brand names. Diclofenac epolamine works by reducing substances in the body that cause pain and inflammation.
May 28, 2018 flector patch contains 180 mg of diclofenac epolamine flector patch generic in an aqueous base. Conditions that diclofenac epolamine transdermal treats. Flector patch should not be applied to broken or damaged skin due to any cause, such as cuts, burns, infected wounds, or rashes with oozing fluid ask your doctor if flector patch is right for you. Diclofenac epolamine patch fda prescribing information. Tape the edges of the patch to your skin if the patch begins to peel off. Flector patches contain diclofenac epolamine, a nonsteroidal antiinflammatory drug nsaid.
Do not apply to damaged skin such as wounds or burns. Steadystate plasma diclofenac concentrations are present before 3 days application two patchesday and are in the order of. Please ensure you carefully read all literature provided with your product prior to use. Diclofenac epolamine patch description diclofenac epolamine topical system 1. Remove the release liner before applying the patch to the skin. The present invention concerns a process for the preparation of the salt diclofenac epolamine comprising the following steps.
Steadystate plasma diclofenac concentrations are present before 3 days application two patches day and are in the order of. Flector diclofenac epolamine dose, indications, adverse. If patch begins to peel off edges may be secured with adhesive tape. Do not wear a diclofenac patch for longer than 12 hours.
Flector patches are for use in adults and children at least 6 years old. Diclofenac topical side effects, dosage, interactions. Each patch contains 180 mg of diclofenac epolamine in an aqueous base mg of active per gram of adhesive or 1. Bathe or shower immediately before you need to apply a new patch. Side effect rates for flector diclofenac epolamine 0 reports these are side effects of flector diclofenac epolamine reported to the fda by people taking it, and by doctors and pharmacists. Flector patch diclofenac epolamine patch is a nonsteroidal antiinflammatory drug, available for topical application. Newly available postmarketing surveillance data covering approximately 14 years strengthen available safety data. Diclofenac, sold under the brand name voltaren among others, is a nonsteroidal antiinflammatory drug nsaid used to treat pain and inflammatory diseases such as gout.
Flector patch contains 180 mg of diclofenac epolamine flector patch generic in an aqueous base. Flector patches are used to treat pain caused by minor sprains, strains, or bruising flector patches are for use in adults and children at least 6 years old. Do not use extra patches to make up the missed dose. Side effects of flector patch diclofenac epolamine topical. Side effects of flector patch diclofenac epolamine. Flector effigel 1% gel, diclofenac epolamine, sprains. Upon topical application of the diclofenac epolamine patch to a specific area, the patch releases diclofenac epolamine into the skin. Flector patch is a 10 cm x 14 cm patch comprised of an adhesive material containing 1. Diclofenac epolamine patch is contraindicated in the setting of coronary artery bypass graft cabg surgery see warnings and precautions.
A prescription nonsteroidal antiinflammatory nsaid patch that is proven to treat acute pain due to minor strains, sprains, and bruises. When applied topically in a patch, diclofenac epolamine produces consistent and sustained drug release for 12 hours, with systemic drug exposure being 1020 times lower over 48 hours than that. Diclofenac is a nonsteroidal antiinflammatory drug nsaid diclofenac topical system patch is used to treat pain caused by minor sprains, strains, or bruising diclofenac topical system is for use in adults and children at least 6 years old. Diclofenac epolamine patch greenstone llc molecular weight.
Diclofenac topical system may also be used for purposes not listed in this medication guide. It is used to treat pain from bruises, sprains, or strains. It is used for external local application at any part of body except eyes and genitals. Superiority of test diclofenac epolamine patch over placebo and of reference flector patch over placebo in vas score changes from baseline time frame.
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