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pd-rx pharmaceuticals, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 7.5 mg - mobic is indicated for relief of the signs and symptoms of osteoarthritis [ see clinical studies ( 14.1) ]. mobic is indicated for relief of the signs and symptoms of rheumatoid arthritis [ see clinical studies ( 14.1) ]. mobic is 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) ]. mobic is 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

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lake erie medical & surgical supply dba quality care products llc - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 500 mg

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ncs healthcare of ky, llc dba vangard labs - tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - tamsulosin hydrochloride 0.4 mg - tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14)] . tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see adverse reactions (6.2)].   risk summar y tamsulosin hydrochloride is not indicated for use in women. there are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride in pregnant women. no adverse developmental effects were observed in animal studies in which tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (gd 7 to 17 in the rat and gd 6 to 18 in the rabbit) [see data].  in the u.s. general population, the estim

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alembic pharmaceuticals inc. - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib 50 mg - celecoxib is indicated for the management of the signs and symptoms of oa [see clinical studies (14.1) ]. for the management of the signs and symptoms of ra [see clinical studies (14.2) ]. for the management of the signs and symptoms of jra in patients 2 years and older [see clinical studies (14.3) ]. for the management of the signs and symptoms of as [see clinical studies (14.4) ]. for the management of acute pain in adults [see clinical studies (14.5) ]. for the management of primary dysmenorrhea [see clinical studies (14.5) ]. celecoxib is contraindicated in the following patients: ·               known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions)to celecoxib, 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 pr

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cambridge therapeutics technologies, llc - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib 200 mg - celecoxib capsules are indicated for the management of the signs and symptoms of oa [see clinical studies (14.1) ] for the management of the signs and symptoms of ra [see clinical studies (14.2) ] for the management of the signs and symptoms of jra in patients 2 years and older [see clinical studies (14.3) ] for the management of the signs and symptoms of as [see clinical studies (14.4) ] for the management of acute pain in adults [see clinical studies (14.5) ] for the management of primary dysmenorrhea [see clinical studies (14.5) ] celecoxib capsules are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, 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

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contract pharmacy services-pa - tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - tamsulosin hydrochloride 0.4 mg - tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14)] . tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see adverse reactions (6.2)]. teratogenic effects, pregnancy category b. administration of tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic auc exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. tamsulosin hydroch

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denton pharma, inc. dba northwind pharmaceuticals - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib 200 mg - celecoxib capsules are indicated for the management of the signs and symptoms of oa [ see clinical studies (14.1) ]. for the management of the signs and symptoms of ra [ see clinical studies (14.2) ]. for the management of the signs and symptoms of jra in patients 2 years and older [ see clinical studies (14.3) ]. for the management of the signs and symptoms of as [ see clinical studies (14.4) ]. for the management of acute pain in adults [ see clinical studies (14.5) ]. for the management of primary dysmenorrhea [ see clinical studies (14.5) ]. celecoxib capsules are contraindicated in the following patients : - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [see warnings and precautions (5.7, 5.9) ]. -

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alembic pharmaceuticals limited - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib 50 mg - carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see warnings and precautions (5) ] celecoxib is indicated for relief of the signs and symptoms of oa [see clinical studies (14.1) ] celecoxib is indicated for relief of the signs and symptoms of ra [see clinical studies (14.2) ] celecoxib is indicated for relief of the signs and symptoms of jra in patients 2 years and older [see clinical studies (14.3) ] celecoxib is indicated for the relief of signs and symptoms of as [see clinical studies (14.4) ]  celecoxib is indicated for the management of ap in adults [see clinical studies (14.5) ] celecoxib is indicated for the treatment of pd [see clinical studies (14.5) ] celecoxib is contraindicated: - in patients with known hypersensitivity to celecoxib, aspirin, or other nsaids. - in patients who have demonstrated allergic-type rea

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rebel distributors corp. - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib 100 mg - carefully consider the potential benefits and risks of celebrex and other treatment options before deciding to use celebrex. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see warnings and precautions (5) ] celebrex is indicated for relief of the signs and symptoms of oa [see clinical studies (14.1) ] celebrex is indicated for relief of the signs and symptoms of ra [see clinical studies (14.2) ] celebrex is indicated for relief of the signs and symptoms of jra in patients 2 years and older [see clinical studies (14.3) ] celebrex is indicated for the relief of signs and symptoms of as [see clinical studies (14.4) ] celebrex is indicated for the management of ap in adults [see clinical studies (14.5) ] celebrex is indicated for the treatment of pd [see clinical studies (14.5) ] celebrex is indicated to reduce the number of adenomatous colorectal polyps in fap, as an adjunct to usual care (e.g., endoscopic surveillance, surgery). it is not known whethe

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glaxosmithkline llc - fluticasone furoate (unii: js86977wnv) (fluticasone - unii:cut2w21n7u) - fluticasone furoate 100 ug - arnuity ellipta is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. limitations of use arnuity ellipta is not indicated for the relief of acute bronchospasm. arnuity ellipta is contraindicated in the following conditions: risk summary there are insufficient data on the use of arnuity ellipta in pregnant women to inform a drug-associated risk (see clinical considerations) . in animal reproduction studies, fluticasone furoate administered by inhalation to rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. the highest fluticasone furoate doses in the rat and rabbit studies were 4 times and 1 time, respectively, the maximum recommended human daily inhalation dose (mrhdid) (see data.) . the estimated risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryofetal risk: in women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma. data animal data: fluticasone furoate : in 2 separate embryofetal developmental studies, pregnant rats and rabbits received fluticasone furoate during the period of organogenesis at doses up to approximately 4 and 1 times, respectively, the mrhdid (on a mcg/m2 basis at maternal inhalation doses up to 91 and 8 mcg/kg/day, respectively). no evidence of structural abnormalities in fetuses was observed in either species. in a perinatal and postnatal developmental study in rats, dams received fluticasone furoate during late gestation and lactation periods at doses up to approximately 1 time the mrhdid (on a mcg/m2 basis at maternal inhalation doses up to 27 mcg/kg/day). no evidence of effects on offspring development was observed. risk summary there is no information available on the presence of fluticasone furoate in human milk, the effects on the breastfed child, or the effects on milk production. low concentrations of other ics have been detected in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for arnuity ellipta and any potential adverse effects on the breastfed child from fluticasone furoate or from the underlying maternal condition. the safety and effectiveness of arnuity ellipta for maintenance treatment of asthma have been established in pediatric patients aged 5 years and older. use of arnuity ellipta for this indication in patients 12 years of age and older is supported by evidence from 4 adequate and well-controlled trials in adult and pediatric patients 12 years of age and older. use of arnuity ellipta for this indication in patients 5 to 11 years of age is supported by evidence from an adequate and well-controlled trial in patients 5 to 11 years of age [see dosage and administration (2.2), adverse reactions (6.1), and clinical studies (14.2)] . the safety and effectiveness of arnuity ellipta have not been established in pediatric patients less than 5 years of age. effects on growth orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. a reduction of growth velocity in these patients may occur as a result of poorly controlled asthma or from use of corticosteroids, including ics. the effects of long-term treatment of pediatric patients with ics, including fluticasone furoate, on final adult height are not known. controlled clinical trials have shown that ics may cause a reduction in growth in children. in these trials, the mean reduction in growth velocity was approximately 1 cm/year (range: 0.3 to 1.8 cm/year) and appears to be related to dose and duration of exposure. this effect has been observed in the absence of laboratory evidence of hpa axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in children than some commonly used tests of hpa axis function. the long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. the potential for “catch-up” growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied. the growth of pediatric patients receiving orally inhaled corticosteroids, including arnuity ellipta, should be monitored routinely (e.g., via stadiometry). the potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks associated with alternative therapies. to minimize the systemic effects of orally inhaled corticosteroids, including arnuity ellipta, each patient should be titrated to the lowest dose that effectively controls his/her symptoms. a randomized, double-blind, parallel-group, multicenter, 1-year, placebo-controlled trial evaluated the effect of once-daily treatment with arnuity ellipta 50 mcg on growth velocity assessed by stadiometry. the subjects were 457 prepubertal children (girls aged 5 to younger than 8 years and boys aged 5 to younger than 9 years). mean growth velocity over the 52-week treatment period was lower in the subjects receiving arnuity ellipta (5.90 cm/year) compared with placebo (6.06 cm/year). the mean difference in growth velocity was -0.16 cm/year (95% ci: -0.46, 0.14) [see warnings and precautions (5.10)] . for the 4 confirmatory trials, 71 subjects were aged 65 years and older (56 of which were treated with arnuity ellipta) and 5 were aged 75 years and older (1 of which was treated with arnuity ellipta) [see clinical studies (14.2)] . based on available data, no adjustment of the dosage of arnuity ellipta in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out. clinical trials of arnuity ellipta did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger subjects. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. fluticasone furoate systemic exposure increased by up to 3-fold in adult subjects with hepatic impairment compared with healthy subjects. use arnuity ellipta with caution in patients with moderate or severe hepatic impairment. monitor patients for corticosteroid-related side effects. the effect of hepatic impairment on fluticasone furoate systemic exposure in subjects aged younger than 18 years has not been evaluated [see clinical pharmacology (12.3)] . there were no significant increases in fluticasone furoate exposure in subjects with severe renal impairment (crcl <30 ml/min) compared with healthy subjects. no dosage adjustment is required in patients with renal impairment [see clinical pharmacology (12.3)] . instructions for use arnuity ellipta (ar-new-i-te e-lip-ta) (fluticasone furoate inhalation powder) for oral inhalation use read this before you start: your arnuity ellipta inhaler how to use your inhaler figure a figure b important notes: check the counter. see figure c. figure c prepare your dose: wait to open the cover until you are ready to take your dose. figure d figure e figure f figure g figure h figure i figure j figure k important note: when should you get a refill? figure l for more information about arnuity ellipta or how to use your inhaler, call 1-888-825-5249. trademarks are owned by or licensed to the gsk group of companies. glaxosmithkline, durham, nc 27701 ©2023 gsk group of companies or its licensor. arn:2ifu this instructions for use has been approved by the u.s. food and drug administration          revised: march 2023