Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
MELOXICAM (UNII: VG2QF83CGL) (MELOXICAM - UNII:VG2QF83CGL)
MedVantx, Inc.
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 contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam. Meloxicam tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.13) ]. Meloxicam tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ]. There are no adequate and well-controlled studies in pregnant women. Meloxicam crosses the placental barrier. Prior to 30 weeks gestation, use meloxicam
Meloxicam tablets USP are available as follows: 7.5 mg - mottled yellow, capsule-shaped tablets, debossed with “93” on one side and “7234” on the other in bottles of 100 and 1000. 15 mg - mottled yellow, pillow-shaped tablets, debossed with “93” on one side and “7299” on the other in bottles of 100 and 1000. Store at 20 ° to 25 °C (68 ° to 77 °F) [See USP Controlled Room Temperature]. Keep meloxicam tablets USP in a dry place. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children.
Abbreviated New Drug Application
MELOXICAM- MELOXICAM TABLET MedVantx, Inc. ---------- Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Rx only (See the end of this Medication Guide for a list of prescription NSAID medicines.) 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: • with longer use of NSAID medicines • in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).” NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: • can happen without warning symptoms • may cause death The chance of a person getting an ulcer or bleeding increases with: • taking medicines called “corticosteroids” and “anticoagulants” • longer use • smoking • drinking alcohol • older age • having poor health NSAID medicines should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed 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: • different types of arthritis • menstrual cramps and other types of short-term pain Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine • for pain right before or after heart bypass surgery Tell your healthcare provider: • about all of your medical conditions. • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. • if you ar Aqra d-dokument sħiħ
MELOXICAM- MELOXICAM TABLET MEDVANTX, INC. ---------- 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: CARDIOVASCULAR AND GASTROINTESTINAL RISKS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_. CARDIOVASCULAR RISK • • GASTROINTESTINAL RISK • INDICATIONS AND USAGE Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: • • DOSAGE AND ADMINISTRATION Use the lowest effective dose for the shortest duration consistent with individual treatment goals for the individual patient. • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • NSAIDS MAY CAUSE AN INCREASED RISK OF SERIOUS CARDIOVASCULAR THROMBOTIC EVENTS, MYOCARDIAL INFARCTION, AND STROKE, WHICH CAN BE FATAL. THIS RISK MAY INCREASE WITH DURATION OF USE. PATIENTS WITH CARDIOVASCULAR DISEASE OR RISK FACTORS FOR CARDIOVASCULAR DISEASE MAY BE AT GREATER RISK. (5.1 ) MELOXICAM TABLETS ARE CONTRAINDICATED FOR THE TREATMENT OF PERI-OPERATIVE PAIN IN THE SETTING OF CORONARY ARTERY BYPASSS GRAFT (CABG) SURGERY. (4.2 , 5.1 ) NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL 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 ARE AT GREATER RISK FOR SERIOUS GASTROINTESTINAL EVENTS. (5.2 ) Osteoarthritis (OA) (1.1) Rheumatoid Arthritis (RA) (1.2) OA (2.2) and RA (2.3): Starting dose: 7.5 mg once daily Dose may be increased to 15 mg once daily Tablets: 7.5 mg, 15 mg (3) Known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam (4.1) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4.1) Use during the peri-operat Aqra d-dokument sħiħ