Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - meloxicam, quantity: 15 mg - capsule, hard - excipient ingredients: lactose monohydrate; maize starch; sodium citrate dihydrate; magnesium stearate; gelatin; titanium dioxide; sunset yellow fcf; brilliant blue fcf; quinoline yellow - meloxicam is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - meloxicam, quantity: 7.5 mg - capsule, hard - excipient ingredients: lactose monohydrate; maize starch; sodium citrate dihydrate; magnesium stearate; gelatin; titanium dioxide; sunset yellow fcf; brilliant blue fcf - meloxicam is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis.

United States - English - NLM (National Library of Medicine)

avpak - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 7.5 mg - meloxicam tablets, usp is indicated for relief of the signs and symptoms of osteoarthritis [ see clinical studies ( 14.1) ]. meloxicam tablets, usp is indicated for relief of the signs and symptoms of rheumatoid arthritis [ see clinical studies ( 14.1) ]. meloxicam tablets, usp is 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 is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam. meloxicam 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 is 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 placental barrier. prior to 30 weeks gestation, use meloxicam during pregnancy only if the potential benefit justifies the potential risk to the fetus. starting at 30 weeks gestation, avoid meloxicam and other nsaids, in pregnant women as premature closure of the ductus arteriosus in the fetus may occur. if this drug is used during this time period in pregnancy, inform the patient of the potential hazard to a fetus [ see warnings and precautions ( 5.9) and patient counseling information ( 17.8) ]. teratogenic effects meloxicam was not teratogenic when administered to pregnant rats during fetal organogenesis at oral doses up to 4 mg/kg/day (2.6-fold greater than the maximum recommended human daily dose [mrhd] based on body surface area [bsa] comparison). administration of meloxicam to pregnant rabbits throughout embryogenesis produced an increased incidence of septal defects of the heart at an oral dose of 60 mg/kg/day. the no effect level was 20 mg/kg/day (26-fold greater than the mrhd based on bsa conversion). nonteratogenic effects in rats and rabbits, embryolethality occurred at oral meloxicam doses of 1 mg/kg/day and 5 mg/kg/day, respectively (0.65-and 6.5-fold greater, respectively, than the mrhd based on bsa comparison) when administered throughout organogenesis. the effects of meloxicam on labor and delivery of pregnant women are unknown. oral administration of meloxicam to pregnant rats during late gestation through lactation increased the incidence of dystocia, delayed parturition, and decreased offspring survival at meloxicam doses of 0.125 mg/kg/day or greater (at least 12.5 times lower than the maximum recommended human daily dose based on body surface area comparison). it is not known whether this drug is excreted in human milk; however, meloxicam was excreted in the milk of lactating rats at concentrations higher than those in plasma. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from meloxicam, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. the safety and effectiveness of meloxicam in pediatric jra patients from 2 to 17 years of age has been evaluated in three clinical trials [ see dosage and administration ( 2.3), adverse reactions ( 6.1), and clinical studies ( 14.2) ] as with any nsaid, caution should be exercised in treating the elderly (65 years and older). of the total number of subjects in clinical studies, 5157 were age 65 and over (4044 in oa studies and 1113 in ra studies). no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dose adjustment is necessary in patients with mild to moderate hepatic impairment. patients with severe hepatic impairment have not been adequately studied. since meloxicam is significantly metabolized in the liver; the use of meloxicam in these patients should be done with caution [ see warnings and precautions ( 5.3) and clinical pharmacology ( 12.3) ]. no dose adjustment is necessary in patients with mild to moderate renal impairment. patients with severe renal impairment have not been studied. the use of meloxicam in subjects with severe renal impairment is not recommended. following a single dose of meloxicam, the free c max plasma concentrations were higher in patients with renal failure on chronic hemodialysis (1% free fraction) in comparison to healthy volunteers (0.3% free fraction). therefore, it is recommended that meloxicam dosage in this population not exceed 7.5 mg per day hemodialysis did not lower the total drug concentration in plasma; therefore, additional doses are not necessary after hemodialysis. meloxicam is not dialyzable [ see dosage and administration ( 2.1), warnings and precautions ( 5.6), and clinical pharmacology ( 12.3) ]. data from several small studies in humans and from studies in animals indicate that nsaids, including meloxicam , may be associated with a reversible delay in ovulation. therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, use of meloxicam is not recommended.

United States - English - NLM (National Library of Medicine)

ranbaxy pharmaceuticals inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - tablet - 7.5 mg - carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). meloxicam is indicated for relief of the signs and symptoms of osteoarthritis. meloxicam is contraindicated in patients with known hypersensitivity to meloxicam. meloxicam 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 , anaphylactoid reactions , and precautions , pre-existing asthma ). meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (cabg) surgery (see warnings ).

United States - English - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 7.5 mg - 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)]. there are no adequate and well-controlled studies in pregnant women. meloxicam crosses the placental barrier. prior to 30 weeks gestation, use meloxicam during

United States - English - NLM (National Library of Medicine)

dr. reddy's laboratories limited - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - tablet - 7.5 mg - carefully consider the potential benefits and risks of meloxicam tablets and other treatment options before deciding to use meloxicam tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis. meloxicam tablets are contraindicated in patients with known hypersensitivity to meloxicam. meloxicam tablet 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, anaphylactoid reactions, and precautions, pre-existing asthma ). meloxicam tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (cabg) surgery (see warnings ).

United States - English - NLM (National Library of Medicine)

watson laboratories inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - tablet - 7.5 mg - carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (seewarnings ). meloxicam is indicated for relief of the signs and symptoms of osteoarthritis. meloxicam is contraindicated in patients with known hypersensitivity to meloxicam. meloxicam 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 (seewarnings, anaphylactoid reactions , andprecautions, pre-existing asthma ). meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (cabg) surgery (seewarnings ).

United States - English - NLM (National Library of Medicine)

blenheim pharmacal, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 7.5 mg - meloxicam tablet is indicated for relief of the signs and symptoms of osteoarthritis [see clinical studies (14.1)]. meloxicam tablet is indicated for relief of the signs and symptoms of rheumatoid arthritis [see clinical studies (14.1)]. meloxicam is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam. meloxicam 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 is 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 placental barrier. prior to 30 week

United States - English - NLM (National Library of Medicine)

kaiser foundation hospitals - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 7.5 mg - 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 reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [ see warnings and precautions ( 5.7, 5.8) ] - in the setting of coronary artery bypass

United States - English - NLM (National Library of Medicine)

putney, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 5 mg in 1 ml - indications: dogs: meloxicam solution for injection is indicated in dogs for the control of pain and inflammation associated with osteoarthritis. contraindications: dogs with known hypersensitivity to meloxicam should not receive meloxicam solution for injection. indications: cats: for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery. contraindications: cats with known hypersensitivity to meloxicam should not receive meloxicam solution for injection. additional doses of meloxicam or other nsaids in cats are contraindicated, as no safe dosage for repeated nsaid administration has been established (see animal safety). do not use meloxicam in cats with pre-existing renal dysfunction.