Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

alembic pharmaceuticals limited - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - aripiprazole is indicated for the treatment of: •schizophrenia [see clinical studies (14.1)] additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)]. teratogenic effects pregnancy category c: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs (includi

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

dr.reddy's laboratories limited - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 10 mg - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions ( 5.1)], reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium is not indicated for the treatment of an acute asthma attack. montelukast sodium is contraindicated in patients with hypersensitivity to any of its components. risk summary available data from published prospective and retrospective cohort studies over decades with

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

golden state medical supply, inc. - citalopram hydrobromide (unii: i1e9d14f36) (citalopram - unii:0dhu5b8d6v) - citalopram 10 mg - citalopram tablets are indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies (14)]. citalopram tablets are contraindicated in patients: - taking, or within 14 days of stopping, maois (including maois such as linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.3), drug interactions (7)]. - taking pimozide because of risk of qt prolongation [see drug interactions (7)]. - with known hypersensitivity to citalopram or any of the inactive ingredients in citalopram tablets. reactions have included angioedema and anaphylaxis [see adverse reactions (6.2)]. 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 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants. available data from published epidemiologic studies and postmarketing reports with citalopram use in pregnancy have not established an increased risk of major birth defects or miscarriage. published studies demonstrated that citalopram levels in both cord blood and amniotic fluid are similar to those observed in maternal serum. there are risks of persistent pulmonary hypertension of the newborn (pphn) (see data) and/or poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (ssris), including citalopram, during pregnancy. there also are risks associated with untreated depression in pregnancy (see clinical considerations). in animal reproduction studies, citalopram caused adverse embryo/fetal effects at doses that caused maternal toxicity (see data). 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 the clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. disease-associated maternal and/or embryo/fetal risk women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. this finding is from a prospective longitudinal study of 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. fetal/neonatal adverse reactions neonates exposed to citalopram and other ssris late in third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. these findings are consistent with either a direct toxic effect of ssris or possibly, a drug discontinuation syndrome. it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see warnings and precautions (5.3)]. human data exposure during late pregnancy to ssris may have an increased risk for persistent pulmonary hypertension of the newborn (pphn). pphn occurs in 1-2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. animal data citalopram was administered orally to pregnant rats during the period of organogenesis at doses of 32, 56, and 112 mg/kg/day, which are approximately 8, 14, and 27 times the maximum recommended human dose (mrhd) of 40 mg, based on mg/m 2 body surface area. citalopram caused maternal toxicity of cns clinical signs and decreased weight gain at 112 mg/kg/day, which is 27 times the mrhd. at this maternally toxic dose, citalopram decreased embryo/fetal growth and survival and increased fetal abnormalities (including cardiovascular and skeletal defects). the no observed adverse effect level (noael) for maternal and embryo fetal toxicity is 56 mg/kg/day, which is approximately 14 times the mrhd. citalopram was administered orally to pregnant rabbits during the period of organogenesis at doses up to 16 mg/kg/day, which is approximately 8 times the mrhd of 40 mg, based on mg/m 2 body surface area. no maternal or embryo fetal toxicity was observed. the noael for maternal and embryo fetal toxicity is 16 mg/kg/day, which is approximately 8 times the mrhd. citalopram was administered orally to pregnant rats during late gestation and lactation periods at doses of 4.8, 12.8, and 32 mg/kg/day, which are approximately 1, 3, and 8 times the mrhd of 40 mg, based on mg/m 2 body surface area. citalopram increased offspring mortality during the first 4 days of birth and decreased offspring growth at 32 mg/kg/day, which is approximately 8 times the mrhd. the noael for developmental toxicity is 12.8 mg/kg/day, which is approximately 3 times the mrhd. in a separate study, similar effects on offspring mortality and growth were seen when dams were treated throughout gestation and early lactation at doses ≥ 24 mg/kg/day, which is approximately 6 times the mrhd. a noael was not determined in that study. data from the published literature report the presence of citalopram in human milk at relative infant doses ranging between 0.7 to 9.4% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.78 to 4.3. there are reports of breastfed infants exposed to citalopram experiencing irritability, restlessness, excessive somnolence, decreased feeding, and weight loss (see clinical considerations). there is no information about effects of citalopram on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for citalopram tablets and any potential adverse effects on the breastfed child from citalopram tablets or from the underlying maternal condition. monitor breastfeeding infants for adverse reactions, such as irritability, restlessness, excessive somnolence, decreased feeding, and weight loss. the safety and effectiveness of citalopram tablets have not been established in pediatric patients. two placebo-controlled trials in 407 pediatric patients with mdd have been conducted with citalopram tablets, and the data were not sufficient to support use in pediatric patients. antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see boxed warning, warnings and precautions (5.1)]. decreased appetite and weight loss have been observed in association with the use of ssris in pediatric patients. of 4422 patients in clinical studies of citalopram tablets, 1357 were 60 and over, 1034 were 65 and over, and 457 were 75 and over. in two pharmacokinetic studies, citalopram auc was increased by 23% and 30%, respectively, in subjects ≥ 60 years of age as compared to younger subjects, and its half-life was increased by 30% and 50%, respectively [see clinical pharmacology (12.3)]. therefore, the maximum recommended dosage in patients 60 years of age and older is lower than younger patients [see dosage and administration (2.3), warnings and precautions (5.2)]. ssris, including citalopram, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see warnings and precautions (5.9)]. increased citalopram exposure occurs in patients with hepatic impairment. the maximum recommended dosage of citalopram tablets is lower in patients with hepatic impairment [see dosage and administration (2.3), clinical pharmacology (12.3)]. citalopram hydrobromide is not a controlled substance. animal studies suggest that the abuse liability of citalopram tablets is low. citalopram tablets have not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. the premarketing clinical experience with citalopram tablets did not reveal any drug-seeking behavior. however, these observations were not systematic and it is not possible to predict, on the basis of this limited experience, the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, health care providers should carefully evaluate citalopram tablets patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

roerig - doxazosin mesylate (unii: 86p6pqk0mu) (doxazosin - unii:nw1291f1w8) - doxazosin 4 mg - cardura® xl is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph). cardura xl is not indicated for the treatment of hypertension. cardura xl is contraindicated in patients with a known hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of the inert ingredients. allergic reactions to doxazosin and other quinazolines have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see adverse reactions (6.2) ]. risk summary cardura xl is not indicated for use in females and is not indicated for the treatment of hypertension. the limited available data with cardura xl in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. no adverse developmental outcomes were observed in animal reproduction studies with oral administration of doxazosin to pregnant rats and rabbits at doses of up to 10 and 4 times, respectively, the 12 mg/day recommended dose. postnatal development was delayed in rats at a dose of 8 times the 12 mg/day recommended dose [see data]. data animal data radioactivity was found to cross the placenta following oral administration of labeled doxazosin to pregnant rats. studies in pregnant rabbits and rats at daily oral doses of up to 41 and 20 mg/kg, respectively (plasma drug concentrations of 10 and 4 times, respectively, the human auc exposures with a 12 mg/day therapeutic dose), during organogenesis have revealed no evidence of adverse developmental effects. a dosage regimen of 82 mg/kg/day in the rabbit was associated with reduced fetal survival. in peri- and postnatal studies in rats, postnatal development at maternal doses of 40 or 50 mg/kg/day of doxazosin (about 8 times human auc exposure with a 12 mg/day therapeutic dose) was delayed, as evidenced by slower body weight gain and slightly later appearance of anatomical features and reflexes. risk summary cardura xl is not indicated for use in females and is not indicated for the treatment of hypertension. doxazosin is present in human milk. there is no information on the effects of cardura xl on the breastfeed infant or the effects on milk production. the safety and effectiveness of cardura xl in pediatric patients have not been established. the incidence of hypotension with cardura xl use appears to be age related and more prevalent in patients 70 years or older. at steady state, increases of 27% in maximum plasma concentrations (cmax ) and 34% in the area under the concentration-time curve (auc) were seen in the elderly (>65 years old) compared to the young [see clinical pharmacology (12.3) ]. of the 666 patients with bph who received cardura xl in the two controlled clinical efficacy and safety studies, 325 patients (49%) were 65 years of age or older. one hundred thirty-six patients treated with cardura xl (20%) were >70 years of age. in these two studies, the cumulative incidence of hypotension appeared to be age related. the reason for an increased incidence of hypotension in patients older than 70 years of age may be related to a modest increase in systemic exposure to doxazosin [see clinical pharmacology (12.3) ], to an increased propensity to orthostasis in the elderly, or to an enhanced sensitivity to vasodilatory agents in the elderly. the incidence of hypotension reported as an adverse reaction was higher in patients 70 years of age and older (4/136; 2.9%) as compared to patients < 70 years of age (7/530; 1.3%). since there is no clinical experience in patients with severe hepatic impairment, use in these patients is not recommended. cardura xl should be administered with caution to patients with mild or moderate hepatic impairment [see warnings and precautions (5.6), clinical pharmacology (12.3) ].

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

aurobindo pharma limited - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 25 mg - venlafaxine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets, usp in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the ef

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

ncs healthcare of ky, llc dba vangard labs - clonidine hydrochloride (unii: w76i6xxf06) (clonidine - unii:mn3l5rmn02) - clonidine hydrochloride 0.2 mg - clonidine hydrochloride tablets are indicated in the treatment of hypertension. clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents. clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine (see precautions ).

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

jubilant draximage (usa) inc. - technetium tc-99m sestamibi (unii: 971z4w1s09) (technetium tc-99m sestamibi - unii:971z4w1s09) - tetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborate 1 mg in 1 ml - myocardial imaging: kit for the preparation of technetium tc 99m sestamibi injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. technetium tc 99m sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agents labeling). it is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. breast imaging: kit for the preparation of technetium tc 99m sestamibi injection is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. kit f

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

aurobindo pharma limited - olmesartan medoxomil (unii: 6m97xtv3hd) (olmesartan - unii:8w1iqp3u10), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - olmesartan medoxomil 20 mg - olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see dosage and administration (2) ]. 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 including the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide 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. olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs. olmesartan medoxomil and hydrochlorothiazide tablets are contraindicated: - in patients with hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide tablets [see adverse reactions (6.1, 6.2)] - in patients with anuria [see warnings and precautions (5.3) and adverse reactions (6.1)] - for coadministration with aliskiren in patients with diabetes [see drug interactions (7.4)]. pregnancy category d 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. resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. when pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide as soon as possible. these adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. 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. appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. in the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. perform serial ultrasound examinations to assess the intraamniotic environment. if oligohydramnios is observed, discontinue olmesartan medoxomil and hydrochlorothiazide, unless it is considered lifesaving for the mother. fetal testing may be appropriate, based on the week of pregnancy. 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 medoxomil and hydrochlorothiazide for hypotension, oliguria, and hyperkalemia [see use in specific populations (8.4)]. it is not known whether olmesartan is excreted in human milk, but olmesartan is secreted at low concentration in the milk of lactating rats. thiazides appear in human milk. because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue olmesartan medoxomil and hydrochlorothiazide, taking into account the importance of the drug to the mother. neonates with a history of in utero exposure to olmesartan medoxomil and hydrochlorothiazide: if oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and substituting for disordered renal function. safety and effectiveness of olmesartan medoxomil and hydrochlorothiazide in pediatric patients have not been established. clinical studies of olmesartan medoxomil and hydrochlorothiazide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other 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 diseases or other drug therapy. olmesartan and hydrochlorothiazide are substantially excreted by the kidney, and the risk of toxic reactions to olmesartan medoxomil and hydrochlorothiazide may be greater in patients with impaired renal function. safety and effectiveness of olmesartan medoxomil and hydrochlorothiazide in patients with severe renal impairment (crcl ≤ 30 ml/min) have not been established. no dose adjustment is required in patients with mild (crcl 60 to 90 ml/min) or moderate (crcl 30 to 60) renal impairment. olmesartan medoxomil no dose adjustment is necessary for patients with mild-to-severe liver disease. hydrochlorothiazide minor alterations of fluid and electrolyte balance may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

aurobindo pharma limited - valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i) - valsartan 40 mg - valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year of age and older. 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, including the class to which valsartan principally belongs. there are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan 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 (e.g., 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. valsartan tablets may be used alone or in combination with other antihypertensive agents. valsartan tablets are indicated to reduce the risk of hospitalization for heart failure in adult patients with heart failure (nyha class ii to iv). there is no evidence that valsartan tablets provides added benefits when they are used with an adequate dose of an angiotensin converting enzyme (ace) inhibitor [see clinical studies (14.2)]. in clinically stable adult patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, valsartan tablets are indicated to reduce the risk of cardiovascular mortality [see clinical studies (14.3)]. do not use in patients with known hypersensitivity to any component. do not coadminister aliskiren with valsartan tablets in patients with diabetes [see drug interactions (7.3)]. risk summary valsartan 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. 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. published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan (see clinical considerations ). when pregnancy is detected, consider alternative drug treatment and discontinue valsartan as soon as possible. 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 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. in the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. in patients taking valsartan during pregnancy, 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. if oligohydramnios is observed, consider alternative drug treatment. closely observe neonates with histories of in utero exposure to valsartan for hypotension, oliguria, and hyperkalemia. in neonates with a history of in utero exposure to valsartan, if oliguria or hypotension occurs, support blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. data animal data no teratogenic effects were observed when valsartan was administered to pregnant mice and rats at oral doses of up to 600 mg/kg/day (9 and 18 times the maximum recommended human dose (mrhd) on a mg/m2 basis) and to pregnant rabbits at oral doses of up to 10 mg/kg/day.  in rats, oral valsartan administered at maternally toxic doses (600 mg/kg/day) during organogenesis or late gestation and lactation, resulted in decreased fetal and pup weight, pup survival and delayed developmental milestones. in rabbits administered maternally toxic doses of 5 and 10 mg/kg/day, fetotoxicity was observed. risk summary there is no information regarding the presence of valsartan in human milk, the effects on the breastfed infant, or the effects on milk production. valsartan is present in rat milk. because of the potential for serious adverse reactions in breastfed infants from exposure to valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with valsartan. data valsartan was detected in the milk of lactating rats 15 minutes after oral administration of a 3 mg/kg dose. the antihypertensive effects of valsartan have been evaluated in 5 clinical studies in pediatric patients from 1 to 16 years of age [see clinical studies (14.1)]. the pharmacokinetics of valsartan have been evaluated in pediatric patients 1 to 16 years of age [see clinical pharmacology (12.3)]. the adverse experience profile of valsartan was similar to that described for adults [see adverse reactions (6.1)].   in children and adolescents with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated. use of valsartan is not recommended in children less than 1 year of age. [see nonclinical toxicology (13.2)] . it is not known whether post-natal use of valsartan, before maturation of renal function is complete, has a long- term deleterious effect on the kidney.    no data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate less than 30 ml/min/1.73 m2 . in the controlled clinical trials of valsartan, 1,214 (36.2%) hypertensive patients treated with valsartan were ≥ 65 years and 265 (7.9%) were ≥ 75 years. no overall difference in the efficacy or safety of valsartan was observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out. exposure [measured by area under the curve (auc)] to valsartan is higher by 70% in the elderly than in the young, however no dosage adjustment is necessary [see clinical pharmacology (12.3)] . of the 2,511 patients with heart failure randomized to valsartan in the valsartan heart failure trial, 45% (1,141) were 65 years of age or older. in the valsartan in acute myocardial infarction trial (valiant), 53% (2,596) of the 4,909 patients treated with valsartan and 51% (2,515) of the 4,885 patients treated with valsartan + captopril were 65 years of age or older. there were no notable differences in efficacy or safety between older and younger patients in either trial. safety and effectiveness of valsartan in patients with severe renal impairment (glomerular filtration rate less than 30 ml/min/1.73 m2 ) have not been established. no dose adjustment is required in patients with mild (glomerular filtration rate 60 to 90 ml/min/1.73 m2 ) or moderate (glomerular filtration rate 30 to 60 ml/min/1.73 m2 ) renal impairment. no dose adjustment is necessary for patients with mild-to-moderate liver disease. no dosing recommendations can be provided for patients with severe liver disease.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

aurobindo pharma limited - didanosine (unii: k3gdh6oh08) (didanosine - unii:k3gdh6oh08) - didanosine 125 mg - didanosine delayed-release capsules, also known as ddi, in combination with other antiretroviral agents are indicated for the treatment of human immunodeficiency virus (hiv)-1 infection [see clinical studies (14) ] . didanosine delayed-release capsules are contraindicated when coadministered with the following medications: - stavudine- potential for serious and/or life-threatening events, notably pancreatitis, lactic acidosis, hepatotoxicity, and peripheral neuropathy [see warnings and precautions (5.1, 5.2, 5.3, 5.5)] . - allopurinol- systemic exposures of didanosine are increased, which may increase didanosine-associated toxicity [see clinical pharmacology (12.3) ]. - ribavirin- exposures of the active metabolite of didanosine (dideoxyadenosine 5′-triphosphate) are increased. fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in patients receiving both didanosine and ribavirin. pregnancy exposure registry there is a preg