국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
DICLOFENAC EPOLAMINE (UNII: X5F8EKL9ZG) (DICLOFENAC - UNII:144O8QL0L1)
IBSA Pharma Inc.
TOPICAL
PRESCRIPTION DRUG
FLECTOR ® is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. FLECTOR is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [ see Warnings and Precautions (5.7, 5.9) ] - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions (5.7, 5.8) ] - In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions (5.1) ] - FLECTOR is contraindicated for use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczem
Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].
New Drug Application
FLECTOR- DICLOFENAC EPOLAMINE SYSTEM IBSA Pharma Inc. ---------- MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) What is the most important information I should know about medicines called Nonsteroidal Anti- inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: • with increasing doses of NSAIDs • with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: • anytime during use • without warning symptoms • that may cause death The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" • increasing doses of NSAIDs • longer use of NSAIDs • smoking • drinking alcohol • older age • poor health • advanced liver disease • bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are NSAIDs? NSAIDs 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 NSAIDs? Do not take NSAIDs: • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • right before or after heart bypass surgery. Before taking NSAIDS, tell your healthcare provider about all of yo 전체 문서 읽기
FLECTOR- DICLOFENAC EPOLAMINE SYSTEM IBSA PHARMA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLECTOR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLECTOR. FLECTOR (DICLOFENAC EPOLAMINE) TOPICAL SYSTEM INITIAL U.S. APPROVAL: 1988 WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE AN INCREASED RISK OF SERIOUS CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING MYOCARDIAL INFARCTION AND STROKE, WHICH CAN BE FATAL. THIS RISK MAY OCCUR EARLY IN TREATMENT AND MAY INCREASE WITH DURATION OF USE ( 5.1) FLECTOR IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY ( 4, 5.1) NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI) 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 AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC ULCER DISEASE AND/OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS ( 5.2) RECENT MAJOR CHANGES Warning and Precautions, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) ( 5.10) 04/2021 Warning and Precautions, Fetal Toxicity ( 5.11) 04/2021 INDICATIONS AND USAGE FLECTOR is a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. ( 1) DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consist with the individual patient treatment goals. ( 2.1) The recommended dose of FLECTOR for adults and pediatric patients 6 years and older is one (1) topical system to the most painful area twice a day. ( 2) FLECTOR should not be applied to damaged or non-intact skin. ( 2) DOSAGE FORMS AND STRENGTHS FLECTOR (diclofenac epolamine) to 전체 문서 읽기