Združene države Amerike - angleščina - NLM (National Library of Medicine)

cambridge therapeutics technologies, llc - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 75 mg - carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see warnings ]. diclofenac is indicated: - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis - for acute or long-term use in the relief of the signs and symptoms of ankylosing spondylitis. diclofenac sodium delayed-release tablets is contraindicated in patients with known hypersensitivity to diclofenac. diclofenac should not be given to patients who have experienced asthma, urticaria, or other 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, anaphylactic reactions , and precautions, preexisting asthma ]. - in the settin

Združene države Amerike - angleščina - NLM (National Library of Medicine)

blenheim pharmacal, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam is indicated for relief of the signs and symptoms of osteoarthritis [see clinical studies (14.1) ]. meloxicam 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 weeks gestatio

Združene države Amerike - angleščina - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - 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.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

repharm llc - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 50 mg - carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see warnings; gastrointestinal bleeding, ulceration, and perforation ). diclofenac is indicated: - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis - for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis diclofenac sodium delayed-release tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product ( see warnings; anaphylactic reactions, serious skin reacti

Združene države Amerike - angleščina - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - famotidine (unii: 5qzo15j2z8) (famotidine - unii:5qzo15j2z8) - famotidine is indicated in: hypersensitivity to any component of these products. cross sensitivity in this class of compounds has been observed. therefore, famotidine should not be administered to patients with a history of hypersensitivity to other h2 -receptor antagonists.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

carlsbad technology, inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 years of age and older. levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. the use of levocetirizine dihydrochloride tablets is contraindicated in: patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. observed reactions range from urticaria to anaphylaxis [see adverse reactions ( 6.2) ]. patients with end-stage renal disease (cl cr < 10 ml/min)

Združene države Amerike - angleščina - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - famotidine (unii: 5qzo15j2z8) (famotidine - unii:5qzo15j2z8) - famotidine is indicated in: - short term treatment of active duodenal ulcer. most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks. - maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. controlled studies in adults have not extended beyond one year. - short term treatment of active benign gastric ulcer. most adult patients heal within 6 weeks. studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks. - short term treatment of gastroesophageal reflux disease (gerd). famotidine is indicated for short term treatment of patients with symptoms of gerd (see clinical pharmacology in adults, clinical studies ). famotidine is also indicated for the short term treatment of esopha

Združene države Amerike - angleščina - NLM (National Library of Medicine)

carlsbad technology, inc. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol 350 mg - carisoprodol tablets, usp is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. carisoprodol tablets, usp should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see dosage and administration ( 2) ]. carisoprodol tablets, usp is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. risk summary data over many decades of carisoprodol use in pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. data on meprobamate, the primary metabolite of carisoprodol, also do not show a c

Združene države Amerike - angleščina - NLM (National Library of Medicine)

carlsbad technology, inc. - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin film coated tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. 1.1 sexually transmitted diseases non-gonococcal urethritis and cervicitis due to chlamydia trachomatis 1.2 mycobacterial infections prophylaxis of disseminated mycobacterium avium complex (mac) disease azithromycin film coated tablets, taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated mac disease in persons with advanced hiv infection [see dosage and administration (2)]. treatment of disseminated mac disease azithromycin film coated tablets, taken in combination with ethambutol, is indicated for the treatment of disseminated mac infections

Združene države Amerike - angleščina - NLM (National Library of Medicine)

liberty pharmaceuticals, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - 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