Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
DICLOFENAC EPOLAMINE (UNII: X5F8EKL9ZG) (DICLOFENAC - UNII:144O8QL0L1)
Rebel Distributors Corp
DICLOFENAC EPOLAMINE
DICLOFENAC EPOLAMINE 180 mg
TOPICAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of Flector® Patch and other treatment options before deciding to use Flector® Patch. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (seeWARNINGS ). Flector® Patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. Flector® Patch is contraindicated in patients with known hypersensitivity to diclofenac. Flector® Patch should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (seeWARNINGS - Anaphylactoid Reactions , andPRECAUTIONS - Preexisting Asthma ). Flector® Patch is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (seeWARNINGS ). Flector® Patch should not be applied to non-intact or damaged skin resulting fr
The Flector® Patch is supplied in resealable envelopes, containing 1 patch (10 cm x 14 cm) (NDC 21695-707-01). It is also supplied in boxes of 30 patches (NDC 21695-707-30). Each individual patch is embossed with “Diclofenac Epolamine Patch 1.3%”. Manufacturer: Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695, Japan Distributor: Alpharma Pharmaceuticals LLC, One New England Avenue, Piscataway, NJ 08854 (Telephone: 1-877-452-3426) Repackaged by: Rebel Distributors Corp, Thousand Oaks, CA 91320 Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: Do not take an NSAID medicine: Tell your healthcare provider: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. NSAID medicines that need a prescription This Medication Guide has been approved by the U.S. Food and Drug Administration. Distributed by: Alpharma Pharmaceuticals LLC One New England Avenue, Piscataway, NJ 08854 USA (Telephone:1-888-840-8884) • www.FlectorPatch.com Manufactured for: IBSA Institut Biochimique SA, CH-6903 Lugano, Switzerland Manufactured by: Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695 Japan Repackaged by: Rebel Distributors Corp, Thousand Oaks, CA 91320
New Drug Application
Rebel Distributors Corp ---------- Revised: 9/2010 Document Id: 3c9f9507-8f72-4850-aa43-9ff5532f1396 Set id: e58641de-b6fd-484c-8902-b9262d7ce251 Version: 2 Effective Time: 20100927 Rebel Distributors Corp Izlasiet visu dokumentu
FLECTOR- DICLOFENAC EPOLAMINE PATCH REBEL DISTRIBUTORS CORP ---------- FLECTOR® PATCH (DICLOFENAC EPOLAMINE TOPICAL PATCH) 1.3% CARDIOVASCULAR RISK Gastrointestinal Risk Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti- inflammatory drug. DESCRIPTION Flector® Patch (10 cm x 14 cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin. Diclofenac epolamine is a non-opioid analgesic chemically designated as 2-[(2,6-dichlorophenyl) amino]benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C H C N O (molecular weight 411.3), an n-octanol/water partition coefficient of 8 at pH 8.5, and the following structure: Each adhesive patch contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: 1,3-butylene glycol, dihydroxyaluminum aminoacetate, disodium edetate, D-sorbitol, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, tartaric acid, titanium dioxide, and purified water. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Flector® Patch applied to intact skin provides local analgesia by releasing diclofenac epolamine from the patch into the skin. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). In pharmacologic studies, diclofenac has shown anti-inflammatory, analgesic, and antipyretic activity. As with other NSAIDs, its mode of action is not known; its ability to inhibit prostaglandin synthesis, however, may be 1 20 24 l2 2 3 involved in its anti-inflammatory activity, as well as contribute to its efficacy in relieving pain associated with inflammation. PHARMACOKINETICS _ABSORPTION_ Following a single application of the Flector Patch on the upper inner arm, pe Izlasiet visu dokumentu