Egyesült Államok - angol - NLM (National Library of Medicine)

alcon laboratories, inc. - dextran 70 (unii: 7sa290yk68) (dextran 70 - unii:7sa290yk68) - dextran 70 1 mg in 1 ml

Egyesült Államok - angol - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid 100 mg in 1 ml - cyklokapron® is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. cyklokapron injection is contraindicated: risk summary available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. there are 2 (0.02%) infant cases with structural abnormalities that resulted in death when tranexamic acid was used during conception or the first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear. tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration (see data) . reproduction studies performed in mice, rats, and rabbits have not revealed any adverse effects on the fetus due to tranexamic acid administered during organogenesis. doses examined were multiples of up to 3 times (mouse), 6 times (rat), and 3 times (rabbit) the maximum human dose based on body surface area in the mouse, rat, and rabbit, respectively (see data) . the estimated background risk for 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 2–4% and 15–20%, respectively. it is not known whether tranexamic acid use in pregnant women may cause a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. for decisions regarding the use of cyklokapron during pregnancy, the potential risk of cyklokapron administration on the fetus should always be considered along with the mother's clinical need for cyklokapron; an accurate risk-benefit evaluation should drive the treating physician's decision. data human data tranexamic acid passes through the placenta. the concentration in cord blood after an intravenous injection of 10 mg/kg to pregnant women is about 30 mg/l, as high as in the maternal blood. there were 13 clinical studies that described fetal and/or neonatal functional issues such as low apgar score, neonatal sepsis, cephalohematoma and 9 clinical studies that discussed alterations to growth including low birth weight and preterm birth at 22–36 weeks of gestation in fetuses and infants exposed to tranexamic acid in-utero. animal data in embryo-fetal development studies, tranexamic acid was administered to pregnant mice from gestation day (gd) 6 through gd 12 and rats from gd 9 through gd 14 at daily doses of 0.3 or 1.5 g/kg. there was no evidence of adverse developmental outcomes in mice and rats at multiple of 3 and 6 times the maximum recommended human dose based on body surface area in the mouse and rat, respectively. in rabbits, tranexamic acid was administered intravenously at doses of 50, 100, or 200 mg/kg/day or orally at doses of 100, 200, or 400 mg/kg/day from gd 6 through gd 18. there was no evidence of adverse developmental outcomes at dose multiples of 2 or 3 times, respectively, the maximum recommended human dose based on body surface area. intravenous doses of 200 mg/kg/day showed slightly retarded weight gain in pregnant rabbits. risk summary published literature reports the presence of tranexamic acid in human milk. there are no data on the effects of tranexamic acid on the breastfed child or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for cyklokapron and any potential adverse effects on the breastfed child from cyklokapron or from the underlying maternal condition. contraception concomitant use of cyklokapron, which is an antifibrinolytic, with hormonal contraceptives may increase the risk for thromboembolic adverse reactions. advise patients to use an effective alternative (nonhormonal) contraceptive method [see warnings and precautions (5.1), drug interactions (7.1)] . there are limited data concerning the use of cyklokapron in pediatric patients with hemophilia who are undergoing tooth extraction. the limited data suggest that there are no significant pharmacokinetic differences between adults and pediatric patients. clinical studies of cyklokapron 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. this drug 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 dosage and administration (2.2), clinical pharmacology (12.3)] . reduce the dosage of cyklokapron in patients with renal impairment, based on the patient's serum creatinine [see dosage and administration (2.2), clinical pharmacology (12.3)] .

Egyesült Államok - angol - NLM (National Library of Medicine)

accord healthcare inc. - lisinopril (unii: e7199s1ywr) (lisinopril anhydrous - unii:7q3p4bs2fd) - lisinopril 2.5 mg - lisinopril tablets, usp are indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older 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. 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. lisinopril tablets, usp may be administered alone or with other antihypertensive agents [see clinical studies (14.1) ]. lisinopril tablets, usp are indicated to reduce signs and symptoms of systolic heart failure [see clinical studies (14.2) ]. lisinopril tablets, usp are indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see clinical studies (14.3) ]. lisinopril is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer lisinopril within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see warnings and precautions (5.2)]. lisinopril is contraindicated in patients with: - a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme inhibitor - hereditary or idiopathic angioedema do not co-administer aliskiren with lisinopril in patients with diabetes [see drug interactions (7.4) ] lisinopril 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. when pregnancy is detected, discontinue lisinopril as soon as possible. the estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. in the general u.s. 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 and skeletal deformations, including skull hypoplasia, hypotension, and death. in the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin­angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. perform serial ultrasound examinations to assess the intra-amniotic environment. 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 lisinopril for hypotension, oliguria, and hyperkalemia. if oliguria or hypotension occur in neonates with a history of in utero exposure to lisinopril, support blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and substituting for disordered renal function. risk summary no data are available regarding the presence of lisinopril in human milk or the effects of lisinopril on the breast fed infant or on milk production. lisinopril is present in rat milk. because of the potential for severe adverse reactions in the breastfed infant, advise women not to breastfeed during treatment with lisinopril. antihypertensive effects and safety of lisinopril have been established in pediatric patients aged 6 to 16 years [see dosage and administration (2.1) and clinical studies (14.1) ] no relevant differences between the adverse reaction profile for pediatric patients and adult patients were identified. safety and effectiveness of lisinopril have not been established in pediatric patients under the age 6 or in pediatric patients with glomerular filtration rate < 30 ml/min/1.73 m 2 [see dosage and administration (2.1) , clinical pharmacology (12.3) , and clinical studies (14.1) ] neonates with a history of in utero exposure to lisinopril 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/or substituting for disordered renal function. no dosage adjustment with lisinopril is necessary in elderly patients. in a clinical study of lisinopril in patients with myocardial infarctions (gissi-3 trial) 4,413 (47%) were 65 and over, while 1,656 (18%) were 75 and over. in this study, 4.8 % of patients aged 75 years and older discontinued lisinopril treatment because of renal dysfunction vs. 1.3% of patients younger than 75 years. no other differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. ace inhibitors, including lisinopril, have an effect on blood pressure that is less in black patients than in non blacks. dose adjustment of lisinopril is required in patients undergoing hemodialysis or whose creatinine clearance is ≤ 30 ml/min. no dose adjustment of lisinopril is required in patients with creatinine clearance > 30 ml/min [see dosage and administration (2.4) and clinical pharmacology (12.3) ]

Egyesült Államok - angol - NLM (National Library of Medicine)

anazaohealth corporation - dextran 75 (unii: jy83shx053) (dextran 75 - unii:jy83shx053) - dextran 75 10 mg - technetium tc99m dextran by intravenous administration is indicated as a cardiac blood pool imaging agent and as an adjunct in the diagnosis of pericardial effusion, ventricular aneurysm, or gi bleed

Egyesült Államok - angol - NLM (National Library of Medicine)

virtus pharmaceuticals, llc - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 30 mg in 1 ml - carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). acute pain in adult patients ketorolac is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration, and adverse reactions ). patients should b

Egyesült Államok - angol - NLM (National Library of Medicine)

allergan, inc. - iron dextran (unii: 95hr524n2m) (ferric cation - unii:91o4lml611) - ferric cation 50 mg in 1 ml - infed is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response to oral iron. infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see warnings and precautions ( 5.1 ) ] . risk summary   parenteral iron administration may be associated with hypersensitivity reactions [see warnings and precautions ( 5.1 )] , which may have serious consequences, such as fetal bradycardia (see clinical considerations). advise pregnant persons of the potential risk to the fetus. available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. there are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see clinical considerations). iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbits, dogs, and monkeys when given in doses of about 3 times the maximum human dose. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, 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 2-4% and 15-20%, respectively. clinical considerations   disease-associated maternal and/or embryo/fetal risk    untreated iron deficiency anemia (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 persons with intravenous iron administration (such as infed) which may have serious consequences on the fetus such as fetal bradycardia, especially during the second and third trimester. data animal data no consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. the animals used in these tests were not iron deficient. risk summary trace amounts of unmetabolized iron dextran are present in human milk. there are no data on the effects of iron dextran in breastfed infants or effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for infed in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. infed is not recommended for use in infants under 4 months of age [s ee dosage and administration ( 2.2 ) ]. reports in the literature from countries outside the united states (in particular, new zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to e. coli.

Egyesült Államok - angol - NLM (National Library of Medicine)

alcon laboratories, inc. - dextran 70 (unii: 7sa290yk68) (dextran 70 - unii:7sa290yk68), glycerin (unii: pdc6a3c0ox) (glycerin - unii:pdc6a3c0ox), hypromelloses (unii: 3nxw29v3wo) (hypromelloses - unii:3nxw29v3wo) - dextran 70 1 mg in 1 ml - - for the temporary relief of burning and irritation due to dryness of the eye - for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun - if this solution changes color or becomes cloudy if this solution changes color or becomes cloudy - if you are sensitive to any ingredient in this product if you experience any of the following: - eye pain - changes in vision - continued redness of irritation of the eye - condition worsens or persists for more than 72 hours

Egyesült Államok - angol - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - lisinopril (unii: e7199s1ywr) (lisinopril anhydrous - unii:7q3p4bs2fd) - lisinopril tablets, usp, are indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older 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. 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 va

Egyesült Államok - angol - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine tablets, usp and other treatment options before deciding to use ketorolac tromethamine tablets, usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. ketorolac tromethamine tablets, usp are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine and ketorolac tromethamine tablets, usp are to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine tablets, usp and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings , precautions , dosage and adminis

Egyesült Államok - angol - NLM (National Library of Medicine)

asclemed usa, inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine tablets usp and other treatment options before deciding to use ketorolac tromethamine tablets usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. ketorolac tromethamine tablets usp are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine and ketorolac tromethamine tablets usp are to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine tablets usp and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings , precautions , dosage and administration , and adverse reactions ).