Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
MELOXICAM (UNII: VG2QF83CGL) (MELOXICAM - UNII:VG2QF83CGL)
RedPharm Drug, Inc.
MELOXICAM
MELOXICAM 7.5 mg
ORAL
PRESCRIPTION DRUG
1.1 Osteoarthritis (OA) Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see CLINICAL STUDIES (14.1)]. 1.2 Rheumatoid Arthritis (RA) Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see CLINICAL STUDIES (14.1)]. 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥60 kg [see DOSAGE AND ADMINISTRATION (2.4) and CLINICAL STUDIES (14.2)]. Meloxicam tablets are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam 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 bee
Meloxicam Tablets USP, 7.5 mg are pastel yellow, round, biconvex, uncoated tablet debossed with ‘C’ on one side and ‘79’ on the other side, and is supplied as follows: Bottles of 100 NDC 65862-097-01 Bottles of 500 NDC 65862-097-05 Bottles of 1,000 NDC 65862-097-99 Meloxicam Tablets USP, 15 mg are pastel yellow, oblong, biconvex, uncoated tablet debossed with ‘C’ on one side and ‘80’ on the other side, and is supplied as follows: Bottles of 100 NDC 65862-098-01 Bottles of 500 NDC 65862-098-05 Bottles of 1,000 NDC 65862-098-99 Storage Store at 20 to 25oC (68 to 77oF) [See USP Controlled Room Temperature]. Protect from moisture. Keep in a dry place. Dispense tablets in a tight container. Keep this and all medications out of the reach of children.
Abbreviated New Drug Application
MELOXICAM- meloxicam tablet RedPharm Drug, 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 your medical conditions, including if you: have liver or kidney problems hav Prečítajte si celý dokument
MELOXICAM- MELOXICAM TABLET REDPHARM DRUG, INC. ---------- BOXED WARNING WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events 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 [see WARNINGS AND PRECAUTIONS (5.1)]. Meloxicam is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.1)]. Gastrointestinal Bleeding, Ulceration, and Perforation 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 [see WARNINGS AND PRECAUTIONS (5.2)]. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MELOXICAM TABLETS safely and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral use Initial U.S. Approval: 2000 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) Meloxicam 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 Prečítajte si celý dokument