Izrael - angličtina - Ministry of Health

teva israel ltd - spironolactone - tablets - spironolactone 100 mg - spironolactone - spironolactone - edematous conditions: congestive heart failure; cirrosis of the liver accompanied by edema and/or ascites nephrotic syndrome. essential hypertention. primary hyperaldostronism. hypokalemia.

Malajzia - angličtina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

baxter healthcare (malaysia) sdn. bhd. - iron (iii)- hydroxide sucrose complex -

Malajzia - angličtina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

medispec (m) sdn.bhd - iron (iii)- hydroxide sucrose complex -

Spojené štáty - angličtina - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - iron sucrose (unii: fz7nyf5n8l) (ferric cation - unii:91o4lml611) - venofer is indicated for the treatment of iron deficiency anemia (ida) in patients with chronic kidney disease (ckd). known hypersensitivity to venofer. 8.1 pregnancy risk summary published studies on intravenous iron sucrose treatment after the first trimester of pregnancy have not shown adverse maternal or fetal outcomes (see data). available reports of intravenous iron sucrose use in pregnant women during the first trimester are insufficient to assess the risk of major birth defects and miscarriage. there are risks to the mother and fetus associated with untreated ida in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see clinical considerations). animal reproduction studies of iron sucrose administered to rats and rabbits during the period of organogenesis at elemental iron doses equivalent to the maximum recommended human dose based on body surface area revealed no evidence of harm to the fetus (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. in the u.s. 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 iron deficiency anemia during pregnancy should be treated. untreated ida in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. adverse pregnancy outcomes associated with ida include increased risk for preterm delivery and low birth weight. fetal/neonatal adverse reactions severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as venofer) which may cause fetal bradycardia, especially during the second and third trimester. data human data published data from randomized controlled studies and prospective observational studies on the use of venofer in pregnant women have not reported an association of venofer and adverse developmental outcomes. however, these studies did not include women exposed during the first trimester of pregnancy and were not designed to assess the risk of major birth defects. maternal adverse events reported in these studies are similar to those reported during clinical trials in adult males and non-pregnant females [seeadverse reactions ( 6.1)]. animal data iron sucrose was administered intravenously to rats and rabbits during the period of organogenesis at elemental iron doses up to 13 mg/kg/day (0.25 times or equivalent to the maximum recommended human dose based on body surface area, respectively) and revealed no evidence of harm to the fetus. 8.2 lactation risk summary iron sucrose is present in human milk, and available published reports following exposure to 100-300 mg intravenous iron sucrose have not reported adverse reactions in breastfed infants (see data). there are no data on the effects on milk production. the developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for venofer and any potential adverse effects on the breastfed child from venofer or from the underlying maternal condition. data a published study showed no difference in iron concentration in the colostrum of 10 iron deficient breastfeeding women who were 2 to 3 days postpartum and received a single dose of 100 mg of intravenous iron sucrose compared to 5 breastfeeding women who received no iron. these results may underestimate the amount of iron in breastmilk following the standard dose of venofer. a published report of 78 breastfeeding women who received 300 mg of intravenous iron sucrose over 3 days (infant age not reported) did not report on the safety of iron sucrose in breastfed infants; however adverse reactions in breastfed infants were not reported. clinical considerations monitor breastfed infants for gastrointestinal toxicity (constipation, diarrhea). 8.4 pediatric use safety and effectiveness of venofer for iron replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent ckd have not been established. safety and effectiveness of venofer for iron maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent ckd receiving erythropoietin therapy were studied. venofer at doses of 0.5 mg/kg, 1 mg/kg, and 2 mg/kg was administered. all three doses maintained hemoglobin between 10.5 g/dl and 14.0 g/dl in about 50% of subjects over the 12-week treatment period with stable epo dosing [see clinical studies ( 14.7)]. venofer has not been studied in patients younger than 2 years of age. in a country where venofer is available for use in children, at a single site, five premature infants (weight less than 1,250 g) developed necrotizing enterocolitis and two of the five died during or following a period when they received venofer, several other medications and erythropoietin. necrotizing enterocolitis may be a complication of prematurity in very low birth weight infants. no causal relationship to venofer or any other drugs could be established. 8.5 geriatric use of the 1,051 patients in two post-marketing safety studies of venofer, 40% were 65 years and older. 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. in general, dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Írsko - angličtina - HPRA (Health Products Regulatory Authority)

vifor france - iron carboxymaltose - dispersion for injection/infusion - 50 iron milligram(s)/millilitre - iron, parenteral preparations

Spojené štáty - angličtina - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride 5 mg - buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association's diagnostic and statistical manual, iii1 as follows: generalized, persistent anxiety (of at least 1 month continual du

Spojené štáty - angličtina - NLM (National Library of Medicine)

remedyrepack inc. - spironolactone (unii: 27o7w4t232) (spironolactone - unii:27o7w4t232) - spironolactone 25 mg - spironolactone tablets are indicated for treatment of nyha class iii–iv heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. spironolactone tablets are usually administered in conjunction with other heart failure therapies. spironolactone tablets are indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 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 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 dru

Spojené štáty - angličtina - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - spironolactone (unii: 27o7w4t232) (spironolactone - unii:27o7w4t232) - spironolactone 25 mg - spironolactone tablets are indicated in the management of: primary hyperaldosteronism for: establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. short-term preoperative treatment of patients with primary hyperaldosteronism. long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). edematous conditions for patients with: congestive heart failure: for the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures. spironolactone tablets are also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate. cirrhosis of the liver accompanied by edema and/or ascites: aldosterone levels may be exceptionally high in t

Spojené štáty - angličtina - NLM (National Library of Medicine)

accord healthcare, inc. - spironolactone (unii: 27o7w4t232) (spironolactone - unii:27o7w4t232) - spironolactone 25 mg - spironolactone tablets are indicated for treatment of nyha class iii–iv heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. spironolactone tablets are usually administered in conjunction with other heart failure therapies. spironolactone tablets are indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 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 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. spironolactone tablets are indicated for the management of edema in the following settings: - cirrhosis of the liver when edema is not responsive to fluid and sodium restriction. - nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response. because it increases serum potassium, spironolactone tablets may be useful for treating edema when administration of other diuretics has caused hypokalemia. spironolactone tablets are indicated in the following settings: - short-term preoperative treatment of patients with primary hyperaldosteronism. - long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery. - long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). spironolactone tablets are contraindicated in the patients with: - hyperkalemia - addison's disease - concomitant use of eplerenone risk summary based on mechanism of action and findings in animal studies, spironolactone may affect sex differentiation of the male during embryogenesis (see data) . rat embryofetal studies report feminization of male fetuses and endocrine dysfunction in females exposed to spironolactone in utero. limited available data from published case reports and case series did not demonstrate an association of major malformations or other adverse pregnancy outcomes with spironolactone . there are risks to the mother and fetus associated with heart failure, cirrhosis and poorly controlled hypertension during pregnancy (see clinical considerations) . because of the potential risk to the male fetus due to anti-androgenic properties of spironolactone and animal data, avoid spironolactone in pregnant women or advise a pregnant woman of the potential risk to a male fetus. 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 pregnant women with congestive 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. pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, preterm delivery, fetal growth restriction and maternal death. outcomes are worse with coexisting esophageal varices. pregnant women with cirrhosis of the liver should be carefully monitored and managed accordingly. 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. data animal data teratology studies with spironolactone have been carried out in mice and rabbits at doses of up to 20 mg/kg/day. on a body surface area basis, this dose in the mouse is substantially below the maximum recommended human dose and, in the rabbit, approximates the maximum recommended human dose. no teratogenic or other embryotoxic effects were observed in mice, but the 20 mg/kg dose caused an increased rate of resorption and a lower number of live fetuses in rabbits. because of its antiandrogenic activity and the requirement of testosterone for male morphogenesis, spironolactone may have the potential for adversely affecting sex differentiation of the male during embryogenesis. when administered to rats at 200 mg/kg/day between gestation days 13 and 21 (late embryogenesis and fetal development), feminization of male fetuses was observed. offspring exposed during late pregnancy to 50 and 100 mg/kg/day doses of spironolactone exhibited changes in the reproductive tract including dose-dependent decreases in weights of the ventral prostate and seminal vesicle in males, ovaries and uteri that were enlarged in females, and other indications of endocrine dysfunction, that persisted into adulthood. spironolactone has known endocrine effects in animals including progestational and antiandrogenic effects. risk summary spironolactone is not present in breastmilk; however, limited data from a lactating woman at 17 days postpartum reports the presence of the active metabolite, canrenone, in human breast milk in low amounts that are expected to be clinically inconsequential. in this case, there were no adverse effects reported for the breastfed infant after short term exposure to spironolactone; however, long term effects on a breastfed infant are unknown. there are no data on spironolactone effects on milk production. consider the developmental and health benefits of breastfeeding along with the mother's clinical need for spironolactone and any potential adverse effects on the breastfed child from spironolactone or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. spironolactone is substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, monitor renal function. spironolactone is substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. patients with renal impairment are at increased risk of hyperkalemia. monitor potassium closely. spironolactone can cause sudden alterations of fluid and electrolyte balance which may precipitate impaired neurological function, worsening hepatic encephalopathy and coma in patients with hepatic disease with cirrhosis and ascites. in these patients, initiate spironolactone in the hospital [see dosage and administration (2.4)and clinical pharmacology (12.3)] . clearance of spironolactone and its metabolites is reduced in patients with cirrhosis. in patients with cirrhosis, start with lowest initial dose and titrate slowly [see dosage and administration (2.4)and clinical pharmacology (12.3)] .

Spojené štáty - angličtina - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - spironolactone (unii: 27o7w4t232) (spironolactone - unii:27o7w4t232) - spironolactone 100 mg - spironolactone tablets are indicated for treatment of nyha class iii–iv heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. spironolactone tablets are usually administered in conjunction with other heart failure therapies. spironolactone tablets are indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 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 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 dru