Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
MELOXICAM (UNII: VG2QF83CGL) (MELOXICAM - UNII:VG2QF83CGL)
Preferred Pharmaceuticals, Inc.
MELOXICAM
MELOXICAM 7.5 mg
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 is contraindicated in the following patients: Risk Summary Use of NSAIDs, including meloxicam, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including meloxicam, in pregnant women starting at 30 weeks of gestation (third trimester) [see Warnings and Precautions (5.10) ]. There are no adequate and well-controlled studies of meloxicam in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women
Meloxicam Tablets USP, 7.5 mg are yellow, round-shaped, flat beveled edge, uncoated tablets debossed with 'ZC' and '25' on one side and plain on other side and are supplied as follows: Bottle of 15 – 68788-9898-1 Bottle of 20 - 68788-9898-2 Bottle of 28 - 68788-9898-8 Bottle of 30 - 68788-9898-3 Bottle of 60 - 68788-9898-6 Bottle of 90 - 68788-9898-9 Bottle of 100 - 68788-9898-0 Meloxicam Tablets USP, 15 mg are yellow, round-shaped, flat beveled edge, uncoated tablet debossed with 'ZC' and '26' on one side and plain on other side and are supplied as follows: Bottle of 15 – 68788-9897-1 Bottle of 20 - 68788-9897-2 Bottle of 28 - 68788-9897-8 Bottle of 30 - 68788-9897-3 Bottle of 60 - 68788-9897-6 Bottle of 90 - 68788-9897-9 Bottle of 100 - 68788-9897-0 Storage Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Keep meloxicam tablets 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 Preferred Pharmaceuticals, 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: o with increasing doses of NSAIDs o 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: o anytime during use o without warning symptoms o that may cause death The risk of getting an ulcer or bleeding increases with: o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs o taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" o increasing doses of NSAIDs o older age o longer use of NSAIDs o poor health o smoking o advanced liver disease o drinking alcohol o bleeding problems NSAIDs should only be used: o exactly as prescribed o at the lowest dose possible for your treatment o 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 i Lire le document complet
MELOXICAM- MELOXICAM TABLET PREFERRED PHARMACEUTICALS, INC. ---------- 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_. • • • 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 non-steroidal anti-inflammatory drug indicated for: • • • DOSAGE AND ADMINISTRATION Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (2.1). • ο Starting dose: 7.5 mg once daily ο Dose may be increased to 15 mg once daily • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • • • • • • • ADVERSE REACTIONS • • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ZYDUS PHARMACEUTICALS (USA) INC. AT 1-877-993-8779 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6) DRUG INTERACTIONS • • • • USE IN SPECIFIC POPULATIONS • • SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE. REVISED: 11/2018 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS 1 INDICATIONS AND USAGE 1.1 Osteoarthritis (OA) 1.2 Rheumatoid Arthritis (RA) 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course 2 DOSAGE AND ADMINISTRATION 2.1 Lire le document complet