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Meloxicam (Tablet)
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SPL Medguide: Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs.) 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: NSAID medicines should never be used right before or after a heart surgery called a���coronary artery bypass graft (CABG).��� The chance of a person getting an ulcer or bleeding increases with: NSAID medicines should only be used: 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: Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: Tell your healthcare provider: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines. Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days. NSAID medicines that need a prescription Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Osteoarthritis and Rheumatoid Arthritis:
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Mechanism of Action:<br/>Pharmacokinetics:<br/>Absorption:<br/>Food and Antacid Effects:<br/>Distribution:<br/>Metabolism:<br/>Excretion:<br/>Special Populations:<br/>Geriatric:<br/>Gender:<br/>Hepatic Insufficiency:<br/>Renal Insufficiency:<br/>Hemodialysis:<br/>CLINICAL TRIALS:<br/>Osteoarthritis and Rheumatoid Arthritis:
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BOXED WARNING:<br/>Cardiovascular Risk:<br/>Gastrointestinal Risk:
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General:<br/>Hepatic Effects:<br/>Renal Effects:<br/>Hematological Effects:<br/>Pre-existing Asthma:<br/>Information for Patients:<br/>Laboratory Tests:<br/>Drug Interactions:<br/>ACE-inhibitors:<br/>Aspirin:<br/>Cholestyramine:<br/>Cimetidine:<br/>Digoxin:<br/>Furosemide:<br/>Lithium:<br/>Methotrexate:<br/>Warfarin:<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:<br/>Pregnancy:<br/>Teratogenic effects:<br/>Nonteratogenic effects:<br/>Labor and Delivery:<br/>Nursing Mothers:<br/>Pediatric Use:<br/>Geriatric Use:
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Meloxicam
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Meloxicam (Tablet)
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Adults:<br/>Osteoarthritis and Rheumatoid Arthritis: The meloxicam Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with meloxicam 7.5 mg/day, 3,505 OA patients and 1351 RA patients treated with meloxicam 15 mg/day. Meloxicam at these doses was administered to 661 patients for at least 6 months and to 312 patients for at least one year. Approximately 10,500 of these patients were treated in ten placebo and/or active-controlled osteoarthritistrials and 2363 of these patients were treated in ten placebo and/or active-controlled rheumatoid arthritis trials. Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups across meloxicam trials. A 12-week multicenter, double-blind, randomized trial was conducted in patients with osteoarthritis of the knee or hip to compare the efficacy and safety of meloxicam with placebo and with an active control. Two 12-week multicenter, double-blind, randomized trials were conducted in patients with rheumatoid arthritis to compare the efficacy and safety of meloxicam with placebo. Table 2a depicts adverse events that occurred in���2% of the meloxicam treatment groups in a 12-week placebo and active-controlled osteoarthritis trial. Table 2b depicts adverse events that occurred in���2% of the meloxicam treatment groups in two 12-week placebo controlled rheumatoid arthritis trials.
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Cardiovascular Effects:<br/>Cardiovascular Thrombotic Events:<br/>Hypertension:<br/>Congestive Heart Failure and Edema:<br/>Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation:<br/>Renal Effects:<br/>Advanced Renal Disease:<br/>Anaphylactoid Reactions:<br/>Skin Reactions:<br/>Pregnancy:
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Meloxicam