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

falcon pharmaceuticals, ltd. - metipranolol (unii: x39al81keb) (metipranolol - unii:x39al81keb) - metipranolol 3 mg in 1 ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bausch & lomb uk ltd - metipranolol - eye drops - 1mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bausch & lomb uk ltd - metipranolol - eye drops - 3mg/1ml

Malta - English - Medicines Authority

chauvin phamaceuticals limited - metipranolol 0.1 % (w/v) - eye drops, solution

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

inova pharmaceuticals (pty) ltd - drops - each 1 ml contains metipranolol 6 mg

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

contract pharmacy services-pa - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 50 mg - metoprolol tartrate tablets are indicated for the treatment of hypertension. they may be used alone or in combination with other antihypertensive agents. metoprolol tartrate is indicated in the long-term treatment of angina pectoris. metoprolol tartrate tablets 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 tartrate. oral metoprolol tartrate therapy can be initiated after intravenous metoprolol tartrate 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 is 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

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

aurobindo pharma limited - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 25 mg - metoprolol tartrate tablets are indicated for the treatment of hypertension in adult patients, 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 tablets may be administered with other antihypertensive agents. metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance. metoprolol tartrate tablets 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. metoprolol tartrate tablets are contraindicated in severe bradycardia, second- or third-degree heart block, cardiogenic shock, systolic blood pressure <100, decompensated heart failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product. 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 myocardial infarction during pregnancy can lead to adverse outcomes for the mother and the fetus (see clinical considerations). in animal reproduction studies, metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at oral dosages of 500 mg/kg/day, approximately 11 times the daily dose of 450 mg in a 60-kg patient on a mg/m2 basis. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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 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 and manage accordingly. data human data data from published observational studies did not demonstrate an association of major congenital malformations and use of metoprolol 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 metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at oral dosages of 500 mg/kg/day, i.e., 11 times, on a mg/m2 basis, the daily dose of 450 mg in a 60-kg patient. no fetal abnormalities were observed when pregnant rats received metoprolol orally up to a dose of 200 mg/kg/day, i.e., 4 times, the daily dose of 400 mg in a 60-kg patient. risk summary limited available data from published literature report that metoprolol is present in human milk. the estimated daily infant dose of metoprolol received from breastmilk ranges 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 (see data). no adverse reactions of metoprolol on the breastfed infant have been identified. there is no information regarding the effects of metoprolol on milk production. clinical consideration monitoring for adverse reactions for a lactating woman who is a slow metabolizer of metoprolol, monitor the breastfed infant for bradycardia and other symptoms of beta-blockade such as dry mouth, skin or eyes, diarrhea or constipation. in a report of 6 mothers taking metoprolol, none reported adverse effects in her breastfed infant. data limited published cases estimate the infant daily dose of metoprolol received from breast milk range from 0.05 mg to less than 1 mg. in 2 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. risk summary based on the published literature, beta-blockers (including metoprolol) may cause erectile dysfunction and inhibit sperm motility. in animal fertility studies, metoprolol has been associated with reversible adverse effects on spermatogenesis starting at oral dose level of 3.5 mg/kg in rats, which would correspond to a dose of 34 mg/day in humans in mg/m2 equivalent, although other studies have shown no effect of metoprolol on reproductive performance in male rats. no evidence of impaired fertility due to metoprolol was observed in rats [see nonclinical toxicology (13.1)]. safety and effectiveness of metoprolol have not been established in pediatric patients. clinical studies of metoprolol in hypertension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience in hypertensive patients has not identified differences in responses between elderly and younger patients. in worldwide clinical trials of metoprolol in myocardial infarction, where approximately 478 patients were over 65 years of age (0 over 75 years of age), no age-related differences in safety and effectiveness were found. other reported clinical experience in myocardial infarction has not identified differences in response between the elderly and younger patients. in general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. no studies have been performed with metoprolol in patients with hepatic impairment. because metoprolol is metabolized by the liver, metoprolol blood levels are likely to increase substantially with poor hepatic function. therefore, initiate therapy at doses lower than those recommended for a given indication; and increase doses gradually in patients with impaired hepatic function. the systemic availability and half-life of metoprolol in patients with renal failure do not differ to a clinically significant degree from those in normal subjects. no reduction in dosage is needed in patients with chronic renal failure [see clinical pharmacology (12.3)].

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

trigen laboratories, llc - 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 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 hydrochlorothiazide is contraindicated in patients with anuria or hypersensitivity to this or other sulfonamide-derived drugs (see warnings).