Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
MELOXICAM (UNII: VG2QF83CGL) (MELOXICAM - UNII:VG2QF83CGL)
Belcher Pharmaceuticals,LLC
MELOXICAM
MELOXICAM 15 mg
ORAL
PRESCRIPTION DRUG
Meloxicam Tablets USP are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)] . Meloxicam Tablets USP are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)] . Meloxicam tablets,USP are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients 2 years of age and older [see Clinical Studies (14.2)] . Meloxicam Tablets USP are contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam. Meloxicam Tablets USP 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 USP are contraindicated for the treatment of peri-operative pain in the setting of cor
Meloxicam Tablets USP are available as 7.5 mg pastel yellow, round, uncoated, debossed tablets with ‘B404’ on one side and plain on the other side, and as 15 mg pastel yellow, capsule-shaped, uncoated, debossed tablets with‘B419’ on one side and plain on the other side. Meloxicam Tablets USP 7.5 mg: NDC 62250-675-30; Bottles of 30 NDC 62250-675-10; Bottles of 100 NDC 62250-675-03; Bottles of 1000 Meloxicam Tablets USP 15 mg: NDC 62250-676-30; Bottles of 30 NDC 62250-676-10; Bottles of 100 NDC 62250-676-03; Bottles of 1000 Storage Store at 25°C (77°F); excursions permitted to 15°C -30°C (59°F -86°F). 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 BELCHER PHARMACEUTICALS,LLC ---------- 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 7.5 MG AND 15 MG 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 USP 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, USP is a non-steroidal anti-inflammatory drug indicated for: •Osteoarthritis (OA) (1.1) •Rheumatoid Arthritis (RA) (1.2) •Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older (1.3) 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 •JRA (2.4): •0.125 mg/kg once daily up to a maximum of 7.5 mg. DOSAGE FORMS AND STRENGTHS TABLETS: 7.5 mg, 15 mg (3) CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS •Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial Leggi il documento completo