Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

bryant ranch prepack - hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. use in pregnancy: routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. thiazides are indicated in pregnan

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

bryant ranch prepack - econazole nitrate (unii: h438wyn10e) (econazole - unii:6z1y2v4a7m) - econazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by trichophyton rubrum, trichophyton mentagrophytes, trichophyton tonsurans, microsporum canis, microsporum audouini, microsporum gypseum, and epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor. econazole nitrate cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - naftifine hydrochloride (unii: 25ur9n9041) (naftifine - unii:4fb1ton47a) - naftifine hydrochloride gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms trichophyton rubrum, trichophyton mentagrophytes, trichophyton tonsurans1 , epidermophyton floccosum1 . 1 efficacy for this organism in this organ system was studied in fewer than 10 infections. naftifine hydrochloride gel, 1% is contraindicated in individuals who have shown hypersensitivity to any of their components.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a., inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone 0.5 mg in 1 g - betamethasone dipropionate cream (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. betamethasone dipropionate cream (augmented), is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. risk summary there are no available data on betamethasone dipropionate cream (augmented) use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that betamethasone dipropionate cream (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate cream (augmented) on the smallest area

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

laboratoires clarins - titanium dioxide (unii: 15fix9v2jp) (titanium dioxide - unii:15fix9v2jp) - - helps prevent sunburn. - if used as directed with other sun protection measures (see directions) , decreases the risk of skin cancer and early skin aging caused by the sun.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z) - pyridoxine hydrochloride injection is effective for the treatment of pyridoxine deficiency as seen in the following: inadequate dietary intake. drug-induced deficiency, as from isoniazid (inh) or oral contraceptives. inborn errors of metabolism, e.g., vitamin b6 dependent convulsions or vitamin b6 responsive anemia. the parenteral route is indicated when oral administration is not feasible as in anorexia, nausea and vomiting, and preoperative and postoperative conditions. it is also indicated when gastrointestinal absorption is impaired. a history of sensitivity to pyridoxine or to any of the ingredients in pyridoxine hydrochloride injection, usp is a contraindication. symptoms of dependence have been noted in adults given only 200 mg daily, followed by withdrawal.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

mallinckrodt, inc. - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride 1 g in 1 g - 1.  for detoxification treatment of opioid addiction (heroin or other morphine-like drugs). 2.  for maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. conditions for distribution and use of methadone products for the treatment of opioid addiction code of federal regulations, title 42, sec 8. methadone products when used for the treatment of opioid addiction in detoxification or maintenance programs, shall be dispensed only by opioid treatment programs (and agencies, practitioners or institutions by formal agreement with the program sponsor) certified by the substance abuse and mental health services administration and approved by the designated state authority. certified treatment programs shall dispense and use methadone in oral form only and according to the treatment requirements stipulated in the federal opioid treatment standards (42 cfr 8.12). see below for important regulatory exceptions to the general requiremen

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

zydus lifesciences limited - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults. limitations of use: safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established. mesalamine delayed-release tablets are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release tablets [see warnings and precautions (5.3), adverse reactions (6.2), and description (11)] . risk summary limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. no fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 0.97 times (rat) and 1.95 times (rabbit) the recommended human dose [see data ]. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated back

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

greenstone llc - eplerenone (unii: 6995v82d0b) (eplerenone - unii:6995v82d0b) - eplerenone 25 mg - eplerenone is indicated to improve survival of stable patients with symptomatic heart failure with reduced ejection fraction (≤40%) (hfref) after an acute myocardial infarction (mi). eplerenone is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (cv) events, primarily strokes and mi. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. control of high blood pressure should be part of comprehensive cv 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 trea

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - eplerenone (unii: 6995v82d0b) (eplerenone - unii:6995v82d0b) - eplerenone 25 mg - inspra is indicated to improve survival of stable patients with symptomatic heart failure with reduced ejection fraction (≤40%) (hfref) after an acute myocardial infarction (mi). inspra is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (cv) events, primarily strokes and mi. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. control of high blood pressure should be part of comprehensive cv 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 cv 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 cv outcome benefit has been a reduction in the risk of stroke, but reductions in mi and cv mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cv 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. inspra may be used alone or in combination with other antihypertensive agents. for all patients inspra is contraindicated in all patients with: for patients treated for hypertension inspra is contraindicated for the treatment of hypertension in patients with: risk summary the available data from published case reports on eplerenone use during pregnancy are insufficient to establish a drug-associated risk of major birth defects, miscarriage, adverse maternal or fetal outcomes (see clinical considerations). in animal studies, no adverse developmental effects were observed when eplerenone was administered to pregnant rats and rabbits during organogenesis at exposures 32 and 31 times, respectively the human exposure at the 100 mg/day therapeutic dose. the estimated background risk of major birth defects and miscarriage for the indicated population are unknown. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, 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. pregnant women with heart failure are at increased risk for preterm birth. stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. clinical classification of heart disease may worsen with pregnancy and lead to maternal death. closely monitor pregnant patients for destabilization of their heart failure. data animal data embryo-fetal development studies were conducted with doses up to 1000 mg/kg/day in rats and 300 mg/kg/day in rabbits (exposures up to 32 and 31 times the human auc for the 100 mg/day therapeutic dose, respectively) administered during organogenesis. no teratogenic effects were seen in rats or rabbits, although decreased rat fetal weights were observed, and decreased body weight in maternal rabbits and increased rabbit fetal resorptions and post-implantation loss were observed at the highest administered dosages. in a pre- and postnatal development study pregnant rats were administered eplerenone at doses up to 1000 mg/kg/day from gestation day 6 through lactation day 20. decreased pup weights were observed beginning at birth at 1000 mg/kg/day. risk summary there are no human data available on whether eplerenone is present in human milk, or has effects on breastfed infants or on milk production. eplerenone was present in the milk of lactating rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk. infertility based on animal data, use of inspra may compromise male fertility. in mature rats, male fertility was decreased with eplerenone exposure at 17 times the 100 mg/day human therapeutic dose. reversibility of effects was not evaluated [see nonclinical toxicology (13.1)]. in a 10-week study of 304 hypertensive pediatric patients age 4 to 16 years treated with inspra up to 100 mg per day, doses that produced exposure similar to that in adults, inspra did not lower blood pressure effectively. in this study and in a 1-year pediatric safety study in 149 patients (age range 5 to 17 years), the incidence of reported adverse events was similar to that of adults. inspra has not been studied in hypertensive patients less than 4 years old because the study in older pediatric patients did not demonstrate effectiveness. inspra has not been studied in pediatric patients with heart failure. heart failure post-myocardial infarction of the total number of patients in ephesus, 3340 (50%) were 65 and over, while 1326 (20%) were 75 and over. patients greater than 75 years did not appear to benefit from the use of inspra [see clinical studies (14.1)]. no differences in overall incidence of adverse events were observed between elderly and younger patients. however, due to age-related decreases in creatinine clearance, the incidence of laboratory-documented hyperkalemia was increased in patients 65 and older [see warnings and precautions (5.1)]. hypertension of the total number of subjects in clinical hypertension studies of inspra, 1123 (23%) were 65 and over, while 212 (4%) were 75 and over. no overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, however due to age-related decreases in creatine clearance, the risk of hyperkalemia may be increased [see warnings and precautions (5.1)] .