国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
MELOXICAM (UNII: VG2QF83CGL) (MELOXICAM - UNII:VG2QF83CGL)
St. Mary's Medical Park Pharmacy
ORAL
PRESCRIPTION DRUG
Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [ see Clinical Studies ( 14.1) ]. Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [ see Clinical Studies ( 14.1) ]. 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 reac
Meloxicam tablets USP are available as a light yellow, round, flat, uncoated tablet containing meloxicam 7.5 mg. The 7.5 mg tablet is impressed with letter U and L on one side and tablet code 7.5 on the other side. Meloxicam Tablets USP 7.5 mg are available as follows: NDC 60760-404-10 BOTTLES OF 10 60760-404-30 BOTTLES OF 30 60760-404-60 BOTTLES OF 60 60760-404-90 BOTTLES OF 90 60760-404-07 BOTTLES OF 7 60760-404-14 BOTTLES OF 14 Storage Store at 20 0 to 25 0 C (68 0 to 77 0 F) [See USP Controlled Room Temperature]. Keep Meloxicam Tablets USP 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
St. Mary's Medical Park Pharmacy ---------- Unichem Pharmaceuticals (USA), Inc. meloxicam meloxicam MELOXICAM MELOXICAM CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE K30 SILICON DIOXIDE TRISODIUM CITRATE DIHYDRATE U;L;7;5 meloxicam meloxicam MELOXICAM MELOXICAM CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE K30 SILICON DIOXIDE TRISODIUM CITRATE DIHYDRATE U;L;15 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 tablets are 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) 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 tablets are 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 includin 完全なドキュメントを読む
MELOXICAM- MELOXICAM TABLET ST. MARY'S MEDICAL PARK PHARMACY ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MELOXICAM TABLETS USP. SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MELOXICAM TABLETS USP. MELOXICAM TABLETS USP, 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 TABLETS ARE 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 Boxed Warning 5/2016 Indications and Usage, Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course ( 1.3) 6/2016 Dosage and Administration, General Dosing Instructions ( 2.1) 6/2016 Dosage and Administration, Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course ( 2.4) 6/2016 Warnings and Precautions, Cardiovascular Thrombotic Events ( 5.1) 5/2016 Warnings and Precautions, Heart Failure and Edema ( 5.5) 5/2016 INDICATIONS AND USAGE Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1) Rheumatoid Arthritis (RA) ( 1.2) Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3) DOSAGE AND ADMINISTRATION Use the lowest effective dosage for the shortest duration consist 完全なドキュメントを読む