Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
MELOXICAM (UNII: VG2QF83CGL) (MELOXICAM - UNII:VG2QF83CGL)
New Horizon Rx Group, LLC
MELOXICAM
MELOXICAM 15 mg
ORAL
PRESCRIPTION DRUG
Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)]. Meloxicam tablet 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)]. Pregnancy Category C; Category D starting 30 weeks gestation There are no adequate and well-controlled studies in pregnant women. Meloxicam crosses the placent
Meloxicam Tablets USP are available as light yellow, oblong, biconvex, uncoated tablets containing meloxicam 15 mg. The 15 mg tablet is impressed with letter U and L on one side and tablet code 15 on the other side. Meloxicam Tablets USP 15 mg are available as follows: NDC 58517-260-30 Bottles of 30 STORAGE Store at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP]. 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
MELOXICAM - MELOXICAM TABLET NEW HORIZON RX GROUP, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MELOXICAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MELOXICAM. MELOXICAM (MELOXICAM) TABLET FOR ORAL USE. INITIAL U.S. APPROVAL: 2000 WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. CARDIOVASCULAR RISK 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 BYPASS GRAFT (CABG) SURGERY (4.2, 5.1) GASTROINTESTINAL RISK 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) INDICATIONS AND USAGE Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) (1.1) Rheumatoid Arthritis (RA) (1.2) DOSAGE AND ADMINISTRATION Use the lowest effective dose for the shortest duration consistent with individual treatment goals for the individual patient. OA (2.2) and RA (2.3): Starting dose: 7.5 mg once daily Dose may be increased to 15 mg once daily DOSAGE FORMS AND STRENGTHS Tablets: 15 mg (3) CONTRAINDICATIONS Known hypersensitivity (e.g., analphylactoid 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-operative period in the setting of coronary artery bypass graft (CABG) surgery (4.2) WARNINGS AND PREC Leggi il documento completo