United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - metoprolol tartrate 50 mg - metoprolol tartrate and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal 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 metoprolol. 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 1 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. metoprolol tartrate and hydrochlorothiazide tablets may be administered with other antihypertensive agents. limitation of use:  metoprolol tartrate and hydrochlorothiazide tablets are not indicated for initial therapy of hypertension. if the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components. metoprolol tartrate and hydrochlorothiazide tablets are contraindicated in patients with: untreated hypertension during pregnancy can lead to adverse outcomes for the mother and the fetus (see clinical considerations) . available data from published observational studies have not demonstrated a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes with metoprolol use during pregnancy. however, there are inconsistent reports of intrauterine growth restriction, preterm birth, and perinatal mortality with maternal use of beta blockers, including metoprolol, during pregnancy (see data) . there have been rare reports of jaundice, thrombocytopenia, and electrolyte imbalances in infants exposed to thiazide medications during pregnancy. in animal reproduction studies, metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at oral dosages up to 24 times, on a mg/m2 basis, the daily dose of 200 mg in a 60-kg patient. the combination of metoprolol tartrate/hydrochlorothiazide administered to rats from mid-late gestation through lactation also produced increased post-implantation loss and decreased neonatal survival (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 clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. 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. metoprolol metoprolol crosses the placenta. neonates born to mothers who are receiving metoprolol during pregnancy, may be at risk for hypotension, hypoglycemia, bradycardia, and respiratory depression. observe neonates for symptoms of hypotension, bradycardia, hypoglycemia and respiratory depression and manage accordingly. data from published observational studies did not demonstrate an association of major congenital malformations and use of either metoprolol or hydrochlorothiazide in pregnancy. the published literature has reported inconsistent findings of intrauterine growth retardation, preterm birth and perinatal mortality with maternal use of metoprolol during pregnancy; however, these studies have methodological limitations hindering interpretation. methodological limitations include retrospective design, concomitant use of other medications, and other unadjusted confounders that may account for the study findings including the underlying disease in the mother. these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. oral administration of metoprolol tartrate/hydrochlorothiazide combinations to pregnant rats during organogenesis at doses up to 200/50 mg/kg/day (10 and 20 times the mrhd on a mg/m2 basis for metoprolol and hydrochlorothiazide, respectively) or to pregnant rabbits at doses up to 25/6.25 mg/kg/day (about 2.5 and 5 times the mrhd on a mg/m2 basis for metoprolol and hydrochlorothiazide, respectively) produced no teratogenic effects. a 200/50 mg/kg/day metoprolol tartrate/hydrochlorothiazide combination administered to rats from mid-late gestation through lactation produced increased post-implantation loss and decreased neonatal survival. metoprolol metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at doses up to 24 times, on a mg/m2 basis, the daily dose of 200 mg in a 60-kg patient. distribution studies in mice confirm exposure of the fetus when metoprolol tartrate is administered to the pregnant animal. these studies have revealed no evidence of impaired fertility or teratogenicity. hydrochlorothiazide hydrochlorothiazide administered to pregnant mice and rats during organogenesis at doses up to 3000 and 1000 mg/kg/day (600 and 400 times the mrhd on a mg/m2 basis), respectively, produced no harm to the fetus. thiazides cross the placental barrier and appear in the cord blood. there are no data on the presence of metoprolol tartrate and hydrochlorothiazide in human milk, the effects on the breastfed infant, or the effects on milk production. however, data are available on the individual components of metoprolol tartrate and hydrochlorothiazide tablets. available data from published literature on metoprolol and hydrochlorothiazide report that each drug is present in human milk (see data) . there are no reports of adverse effects on breastfed infants exposed to metoprolol or hydrochlorothiazide during lactation. doses of hydrochlorothiazide associated with clinically significant diuresis have been associated with impaired milk production. there is no information regarding the effects of metoprolol on milk production. monitor infants exposed to metoprolol tartrate and hydrochlorothiazide tablets though breastmilk for drowsiness or poor feeding (see clinical considerations ) . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for metoprolol tartrate and hydrochlorothiazide tablets and any potential adverse effects on the breastfed child from metoprolol tartrate and hydrochlorothiazide tablets or from the underlying maternal condition. monitor the breastfed infant for bradycardia or somnolence. based on published case reports, the estimated daily infant dose of metoprolol received from breastmilk ranged from 0.05 mg to less than 1 mg. the estimated relative infant dosage was 0.5% to 2% of the mother’s weight-adjusted dosage. in two women who were taking unspecified amount of metoprolol, milk samples were taken after one dose of metoprolol. the estimated amount of metoprolol and alpha-hydroxymetoprolol in breast milk is reported to be less than 2% of the mother's weight-adjusted dosage. in a small study, breast milk was collected every 2 to 3 hours over one dosage interval, in three mothers (at least 3 months postpartum) who took metoprolol of unspecified amount. the average amount of metoprolol present in breast milk was 71.5 mcg/day (range 17.0 to 158.7). the average relative infant dosage was 0.5% of the mother's weight-adjusted dosage. a single study involving one woman and her infant showed a peak concentration of 275 mcg/l at 3 hours following 50 mg dose. no drug was detected (< 20 mcg/l) in the infant’s plasma at 2 and 11 hours following mother’s dose. based on the published literature, beta blockers (including metoprolol) may cause erectile dysfunction and inhibit sperm motility. no evidence of impaired fertility due to metoprolol or hydrochlorothiazide was observed in rats [see nonclinical toxicology (13)] . safety and effectiveness in pediatric patients have not been established. clinical studies of metoprolol tartrate and hydrochlorothiazide tablets 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. hydrochlorothiazide is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see warnings and precautions (5.8)] . 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 concomitant disease or other drug therapy.

United States - English - NLM (National Library of Medicine)

bluepoint laboratories - metoprolol succinate (unii: th25pd4ccb) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 25 mg - metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal 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 metoprolol. 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 1 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

United States - English - NLM (National Library of Medicine)

cambridge therapeutics technologies, llc - metoprolol succinate (unii: th25pd4ccb) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 25 mg - metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal 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 metoprolol. 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 1 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

United States - English - NLM (National Library of Medicine)

directrx - metoprolol succinate (unii: th25pd4ccb) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 50 mg - - 1.1 hypertension metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal 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 metoprolol. 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 1 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 var

United States - English - NLM (National Library of Medicine)

actavis pharma, inc. - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 50 mg - metoprolol tartrate tablets, usp are indicated for the treatment of hypertension. they may be used alone or in combination with other antihypertensive agents. metoprolol tartrate tablets, usp are indicated in the long-term treatment of angina pectoris. metoprolol tartrate tablets, usp are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. treatment with intravenous metoprolol tartrate can be initiated as soon as the patient’s clinical condition allows (see dosage and administration , contraindications , and warnings ). metoprolol tartrate is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see warnings ). hypersensitivity to metoprolol and related derivatives, or to any of the excipients; hypersensitivity to other beta blockers (cross sensitivity between beta blockers can occur). sick-sinus syndrome. severe peripheral arterial circulato

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - metoprolol tartrate 50 mg - metoprolol tartrate and hydrochlorothiazide tablets are indicated for the management of hypertension. this fixed-combination drug is not indicated for initial therapy of hypertension. if the fixed combination represents the dose titrated to the individual patient's needs, therapy with the fixed combination may be more convenient than with the separate components. metoprolol tartrate tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see warnings). hypersensitivity to metoprolol tartrate and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cross sensitivity between beta-blockers can occur). sick-sinus syndrome. severe peripheral arterial circulatory disorders. hydrochlorothiazide is contraindicated in patients with anuria or hypersensitivity to this or other sulfonamide-derived drugs (see warnings).

United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 100 mg - metoprolol tartrate tablets, usp are indicated for the treatment of hypertension. they may be used alone or in combination with other antihypertensive agents. metoprolol tartrate tablets, usp are indicated in the long-term treatment of angina pectoris. metoprolol tartrate tablets, usp are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. oral metoprolol tartrate tablets, usp therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see dosage and administration, contraindications , and warnings ). metoprolol tartrate tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see warnings ). hypersensitivity to metoprolol and related derivatives, or to any of the excipients; hyperse

United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 25 mg - metoprolol tartrate tablets, usp are indicated for the treatment of hypertension. they may be used alone or in combination with other antihypertensive agents. metoprolol tartrate tablets, usp are indicated in the long-term treatment of angina pectoris. metoprolol tartrate tablets, usp are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. oral metoprolol tartrate tablets, usp therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see dosage and administration ,  contraindications and warnings ). metoprolol tartrate tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see warnings ). hypersensitivity

United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - metoprolol tartrate 50 mg - metoprolol tartrate and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal 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 metoprolol. 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 1 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. metoprolol tartrate and hydrochlorothiazide tablets may be administered with other antihypertensive agents. limitation of use metoprolol tartrate and hydrochlorothiazide tablets are not indicated for initial therapy of hypertension. if the fixed combination represents the dose titrated to the individual patient’s needs, therapy with the fixed combination may be more convenient than with the separate components. metoprolol tartrate and hydrochlorothiazide tablets are contraindicated in patients with: - cardiogenic shock or decompensated heart failure. - sinus bradycardia, sick sinus syndrome, and greater than first-degree block unless a permanent pacemaker is in place. - anuria - hypersensitivity to metoprolol tartrate or hydrochlorothiazide or to other sulfonamide derived drugs. risk summary untreated hypertension during pregnancy can lead to adverse outcomes for the mother and the fetus (see clinical considerations) . available data from published observational studies have not demonstrated a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes with metoprolol use during pregnancy. however, there are inconsistent reports of intrauterine growth restriction, preterm birth, and perinatal mortality with maternal use of beta blockers, including metoprolol, during pregnancy (see data). there have been rare reports of jaundice, thrombocytopenia, and electrolyte imbalances in infants exposed to thiazide medications during pregnancy. in animal reproduction studies, metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at oral dosages up to 24 times, on a mg/m2 basis, the daily dose of 200 mg in a 60-kg patient. the combination of metoprolol tartrate/hydrochlorothiazide administered to rats from mid-late gestation through lactation also produced increased post-implantation loss and decreased neonatal survival (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 clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical consideration 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 metoprolol metoprolol crosses the placenta. neonates born to mothers who are receiving metoprolol during pregnancy, may be at risk for hypotension, hypoglycemia, bradycardia, and respiratory depression. observe neonates for symptoms of hypotension, bradycardia, hypoglycemia and respiratory depression and manage accordingly.     data   human data data from published observational studies did not demonstrate an association of major congenital malformations and use of either metoprolol or hydrochlorothiazide in pregnancy. the published literature has reported inconsistent findings of intrauterine growth retardation, preterm birth and perinatal mortality with maternal use of metoprolol during pregnancy; however, these studies have methodological limitations hindering interpretation. methodological limitations include retrospective design, concomitant use of other medications, and other unadjusted confounders that may account for the study findings including the underlying disease in the mother. these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. animal data oral administration of metoprolol tartrate/hydrochlorothiazide combinations to pregnant rats during organogenesis at doses up to 200/50 mg/kg/day (10 and 20 times the mrhd on a mg/m2 basis for metoprolol and hydrochlorothiazide, respectively) or to pregnant rabbits at doses up to 25/6.25 mg/kg/day (about 2.5 and 5 times the mrhd on a mg/m2 basis for metoprolol and hydrochlorothiazide, respectively) produced no teratogenic effects. a 200/50 mg/kg/day metoprolol tartrate/hydrochlorothiazide combination administered to rats from mid-late gestation through lactation produced increased post-implantation loss and decreased neonatal survival. metoprolol metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at doses up to 24 times, on a mg/m2 basis, the daily dose of 200 mg in a 60-kg patient. distribution studies in mice confirm exposure of the fetus when metoprolol tartrate is administered to the pregnant animal. these studies have revealed no evidence of impaired fertility or teratogenicity. hydrochlorothiazide hydrochlorothiazide administered to pregnant mice and rats during organogenesis at doses up to 3000 and 1000 mg/kg/day (600 and 400 times the mrhd on a mg/m2 basis), respectively, produced no harm to the fetus. thiazides cross the placental barrier and appear in the cord blood. risk summary there are no data on the presence of metoprolol tartrate and hydrochlorothiazide in human milk, the effects on the breastfed infant, or the effects on milk production. however, data are available on the individual components of metoprolol tartrate and hydrochlorothiazide. available data from published literature on metoprolol and hydrochlorothiazide report that each drug is present in human milk (see data) . there are no reports of adverse effects on breastfed infants exposed to metoprolol or hydrochlorothiazide during lactation. doses of hydrochlorothiazide associated with clinically significant diuresis have been associated with impaired milk production. there is no information regarding the effects of metoprolol on milk production. monitor infants exposed to metoprolol tartrate and hydrochlorothiazide though breastmilk for drowsiness or poor feeding (see clinical considerations).   the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for metoprolol tartrate and hydrochlorothiazide and any potential adverse effects on the breastfed child from metoprolol tartrate and hydrochlorothiazide or from the underlying maternal condition. clinical considerations monitor the breastfed infant for bradycardia or somnolence. data metoprolol based on published case reports, the estimated daily infant dose of metoprolol received from breastmilk ranged from 0.05 mg to less than 1 mg. the estimated relative infant dosage was 0.5% to 2% of the mother’s weight-adjusted dosage. in two women who were taking unspecified amount of metoprolol, milk samples were taken after one dose of metoprolol. the estimated amount of metoprolol and alpha-hydroxymetoprolol in breast milk is reported to be less than 2% of the mother's weight-adjusted dosage. in a small study, breast milk was collected every 2 to 3 hours over one dosage interval, in three mothers (at least 3 months postpartum) who took metoprolol of unspecified amount. the average amount of metoprolol present in breast milk was 71.5 mcg/day (range 17 to 158.7). the average relative infant dosage was 0.5% of the mother's weight-adjusted dosage. hydrochlorothiazide a single study involving one woman and her infant showed a peak concentration of 275 mcg/l at 3 hours following 50 mg dose. no drug was detected (< 20 mcg/l) in the infant’s plasma at 2-and 11-hours following mother’s dose. infertility   males based on the published literature, beta blockers (including metoprolol) may cause erectile dysfunction and inhibit sperm motility. no evidence of impaired fertility due to metoprolol or hydrochlorothiazide was observed in rats [see nonclinical toxicology (13.1)]. safety and effectiveness in pediatric patients have not been established. clinical studies of metoprolol tartrate 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. hydrochlorothiazide is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see warnings and precautions (5.8)]. 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 concomitant disease or other drug therapy.

United States - English - NLM (National Library of Medicine)

baxter healthcare corporation - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 5 mg in 5 ml - metoprolol tartrate injection is indicated in the treatment of definite or suspected acute myocardial infarction in hemodynamically stable patients to reduce cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy. hypersensitivity to metoprolol tartrate injection and related derivatives, or to any of the excipients; hypersensitivity to other beta blockers (cross sensitivity between beta blockers can occur). metoprolol tartrate injection is contraindicated in patients with a heart rate <45 beats/min; second- and third-degree heart block (unless a functioning pacemaker is present); significant first-degree heart block (p-r interval ≥0.24 sec); systolic blood pressure <100 mmhg; or decompensated cardiac failure. risk summary available data from published observational studies have not demonstrated an association of adverse developmental outcomes with maternal use of metoprolol during pregnancy (see data). untreated hypertension and heart failure during pregnancy can lead to a