البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
DICLOFENAC EPOLAMINE (UNII: X5F8EKL9ZG) (DICLOFENAC - UNII:144O8QL0L1)
STAT Rx USA LLC
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, each containing 5 patches (NDC 42549-606-05) (10 cm x 14 cm), with 6 envelopes per box (NDC 42549-606-30). Each individual patch is embossed with “Diclofenac Epolamine Patch 1.3%”. Each patch contains 180 mg of diclofenac epolamine in an aqueous base (13 mg of active per gram of adhesive or 1.3%). The product is intended for topical use only Keep out of reach of children and pets. The ENVELOPES SHOULD BE SEALED AT ALL TIMES WHEN NOT IN USE. Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature]. 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) Version June 2008 8283 Ed II/06.08 Relabeling and Repackaging by : STAT Rx USA LLC Gainesville, GA 30501
New Drug Application
STAT Rx USA LLC ---------- MEDICATION GUIDE FOR NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non- Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: ● with longer use of NSAID medicines ● in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).” NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:● can happen without warning symptoms ● may cause death The chance of a person getting an ulcer or bleeding increases with:● taking medicines called “corticosteroids” and “anticoagulants” ● longer use ● smoking ● drinking alcohol ● older age ● having poor health NSAID medicines should only be used:● exactly as prescribed ● at the lowest dose possible for your treatment ● for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: • different types of arthritis • menstrual cramps and other types of short-term pain Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine • for pain right before or after heart bypass surgery Tell your healthcare provider: • about all your medical conditions. • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. • if you are pregnant. NSAID medicines should not be اقرأ الوثيقة كاملة
FLECTOR - DICLOFENAC EPOLAMINE PATCH STAT RX USA LLC ---------- FLECTOR® PATCH (DICLOFENAC EPOLAMINE TOPICAL PATCH) 1.3% CARDIOVASCULAR RISK NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. (SeeWARNINGS andCLINICAL TRIALS). Flector® Patch is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (seeWARNINGS). GASTROINTESTINAL RISK NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. (SeeWARNINGS). 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, 1 1 20 24 l2 2 3 polysorbate 80, povidone, propylene glycol, propy اقرأ الوثيقة كاملة