ארצות הברית - אנגלית - NLM (National Library of Medicine)

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

ארצות הברית - אנגלית - NLM (National Library of Medicine)

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

ארצות הברית - אנגלית - NLM (National Library of Medicine)

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) ]. -

ארצות הברית - אנגלית - NLM (National Library of Medicine)

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

ארצות הברית - אנגלית - NLM (National Library of Medicine)

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

ארצות הברית - אנגלית - NLM (National Library of Medicine)

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

ארצות הברית - אנגלית - NLM (National Library of Medicine)

zydus lifesciences limited - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 20 mg - duloxetine delayed-release capsules are indicated for the treatment of: -   major depressive disorder [see clinical studies (14.1)] -   generalized anxiety disorder [see clinical studies (14.2)] -   diabetic peripheral neuropathy [see clinical studies (14.3)] -   chronic musculoskeletal pain [see clinical studies (14.5)] monoamine oxidase inhibitors (maois) the use of maois intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)] . starting duloxetine in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration (2.9) and  warnings and precautions (5.4)] . pregn

ארצות הברית - אנגלית - NLM (National Library of Medicine)

rising pharmaceuticals, inc. - alendronate sodium (unii: 2uy4m2u3ra) (alendronic acid - unii:x1j18r4w8p) - alendronic acid 10 mg - alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women, alendronate sodium tablets increase bone mass and reduce the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [see clinical studies (14.1).] alendronate sodium tablets are indicated for the prevention of postmenopausal osteoporosis [see clinical studies (14.2)] . alendronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis [see clinical studies (14.3)] . alendronate sodium tablets are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see clinical studies (14.4)] . alendronate sodium tablets are indicated for the treatment of paget’s disease of bone in men and women. treatment is indicated in patients with paget's disease of bone who have al

ארצות הברית - אנגלית - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), olmesartan medoxomil (unii: 6m97xtv3hd) (olmesartan - unii:8w1iqp3u10) - amlodipine 5 mg - amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (cv) events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. the decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. individual blood pressure goals may vary based upon the patient’s risk. data from an 8-week, placebo-controlled, parallel-group factorial study [see clinical studies (14.1) ] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. the figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. the curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. the right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. figure 1: probability of achieving systolic blood pressure (sbp) < 140 mmhg at week 8 with locf figure 2: probability of achieving diastolic blood pressure (dbp) < 90 mmhg at week 8 with locf figure 3: probability of achieving systolic blood pressure (sbp) < 130 mmhg at week 8 with locf figure 4: probability of achieving diastolic blood pressure (dbp) < 80 mmhg at week 8 with locf the figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., week 8 sbp <140 mmhg or <130 mmhg or a dbp <90 mmhg or <80 mmhg) for the high-dose treatment groups evaluated in the study. amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. for example, a patient with a baseline blood pressure of 160/100 mmhg has about a 48% likelihood of achieving a goal of <140 mmhg (systolic) and a 51% likelihood of achieving a goal of <90 mmhg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmhg (systolic) and a 60% likelihood of achieving a goal of <90 mmhg (diastolic) on monotherapy with amlodipine 10 mg. the likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg. do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes [see drug interactions (7.2)] . risk summary amlodipine and olmesartan medoxomil tablets can cause fetal harm when administered to a pregnant woman. use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death [see clinical considerations] . most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. when pregnancy is detected, discontinue amlodipine and olmesartan medoxomil tablets as soon as possible. consider alternative antihypertensive therapy during pregnancy. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background 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 embryo/fetal risk hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. pregnant women with hypertension should be carefully monitored and managed accordingly. fetal/neonatal adverse reactions olmesartan medoxomil oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. perform serial ultrasound examinations to assess the intra-amniotic environment. fetal testing may be appropriate, based on the week of gestation. patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. closely observe infants with histories of in utero exposure to olmesartan for hypotension, oliguria, and hyperkalemia. in neonates with a history of in utero exposure to olmesartan, if oliguria or hypotension occur, utilize measures to maintain adequate blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and supporting renal function [see use in specific populations (8.4)]. data animal data no reproductive studies have been conducted with the combination of olmesartan medoxomil, and amlodipine. however, these studies have been conducted for olmesartan medoxomil and amlodipine alone. olmesartan medoxomil no teratogenic effects were observed when olmesartan medoxomil was administered to pregnant rats at oral doses up to 1000 mg/kg/day (240 times the maximum recommended human dose [mrhd] on a mg/m2 basis) or pregnant rabbits at oral doses up to 1 mg/kg/day (half the mrhd on a mg/m2 basis; higher doses could not be evaluated for effects on fetal development as they were lethal to the dose). in rats, significant decreases in pup birth weight and weight gain were observed at doses ≥1.6 mg/kg/day, and delays in developmental milestones (delayed separation of ear auricular, eruption of lower incisors, appearance of abdominal hair, descent of testes, and separation of eyelids) and dose-dependent increases in the incidence of dilation of the renal pelvis were observed at doses ≥ 8 mg/kg/day. the no observed effect dose for developmental toxicity in rats is 0.3 mg/kg/day, about one-tenth the mrhd of 40 mg/day. amlodipine no evidence of teratogenicity or other embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses of up to 10 mg amlodipine/kg/day (respectively about 10 and 20 times the maximum recommended human dose of 10 mg amlodipine on a mg/m2 basis) during their respective periods of major organogenesis (calculations based on a patient weight of 60 kg). however, litter size was significantly decreased (by about 50%), and the number of intrauterine deaths was significantly increased (about 5-fold) in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation. amlodipine maleate has been shown to prolong both the gestational period and the duration of labor in rats at this dose. risk summary there is limited information regarding the presence of amlodipine and olmesartan medoxomil tablets in human milk, the effects on the breastfed infant, or the effects on milk production. amlodipine is present in human milk. olmesartan is present in rat milk [see data]. because of the potential for adverse effects on the nursing infant, advise a nursing woman that breastfeeding is not recommended during treatment with amlodipine and olmesartan medoxomil tablets. data presence of olmesartan in milk was observed after a single oral administration of 5 mg/kg [14c] olmesartan medoxomil to lactating rats. the safety and effectiveness of amlodipine and olmesartan medoxomil tablets in pediatric patients have not been established. of the total number of subjects in the double-blind clinical study of amlodipine and olmesartan medoxomil tablets, 20% (384/1940) were 65 years of age or older and 3% (62/1940) were 75 years or older. no overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects. elderly patients have decreased clearance of amlodipine. starting amlodipine or adding amlodipine at 2.5 mg in patients ≥75 years old is recommended. the lowest dose of amlodipine and olmesartan medoxomil tablets is 5/20 mg; therefore, initial therapy with amlodipine and olmesartan medoxomil tablets is not recommended in patients ≥75 years old. amlodipine. reported clinical experience has not identified differences in responses between the elderly and younger patients. 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. elderly patients have decreased clearance of amlodipine with a resulting increase of auc of approximately 40% to 60%, and a lower initial dose may be required. olmesartan medoxomil. of the total number of hypertensive patients receiving olmesartan medoxomil in clinical studies, more than 20% were 65 years of age and over, while more than 5% were 75 years of age and older. no overall differences in effectiveness or safety were observed between elderly patients and younger patients. 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. there are no studies of amlodipine and olmesartan medoxomil tablets in patients with hepatic insufficiency, but both amlodipine and olmesartan medoxomil show moderate increases in exposure in patients with hepatic impairment. the recommended initial dose of amlodipine in patients with severe hepatic impairment is 2.5 mg, a dose not available with amlodipine and olmesartan medoxomil tablets. amlodipine. amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t½) is 56 hours in patients with severely impaired hepatic function [see warnings and precautions (5.5)] . olmesartan medoxomil . increases in auc0-∞ and peak plasma concentration (cmax ) for olmesartan were observed with moderate hepatic impairment compared to those in matched controls with an increase in auc of about 60%. there are no studies of amlodipine and olmesartan medoxomil tablets in patients with renal impairment. amlodipine. the pharmacokinetics of amlodipine are not significantly influenced by renal impairment. patients with renal failure may therefore receive the usual initial dose. olmesartan medoxomil. patients with renal insufficiency have elevated serum concentrations of olmesartan compared with patients with normal renal function. after repeated dosing, auc was approximately tripled in patients with severe renal impairment (creatinine clearance <20 ml/min). no initial dosage adjustment is recommended for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min). of the total number of subjects in the double-blind clinical study of amlodipine and olmesartan medoxomil tablets, 25% (481/1940) were black patients. amlodipine and olmesartan medoxomil tablets was effective in treating black patients (usually a low-renin population), and the magnitude of blood pressure reduction in black patients approached that observed for non-black patients.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - desvenlafaxine succinate (unii: zb22enf0xr) (desvenlafaxine - unii:ng99554anw) - desvenlafaxine 50 mg - pristiq is indicated for the treatment of adults with major depressive disorder (mdd) [see clinical studies (14)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185. risk summary based on data from published observational studies, exposure to snris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions (5.4) and clinical considerations] . there are no published studies on pristiq in pregnant women; however published epidemiologic studies of pregnant women exposed to venlafaxine, the parent compound, have not reported a clear association with adverse developmental outcomes (see data) . there are risks associated with untreated depression in pregnancy and with expos