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almaject, inc. - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid injection 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. tranexamic acid injection is contraindicated: • in patients with subarachnoid hemorrhage. anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. • in patients with active intravascular clotting [see warnings and precautions (5.1)]. • in patients with hypersensitivity to tranexamic acid or any of the ingredients [see warnings and precautions (5.4)]. 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

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armas pharmaceuticals inc. - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid injection 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. tranexamic acid injection is contraindicated: - in patients with subarachnoid hemorrhage. anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. - in patients with active intravascular clotting[see warnings and precautions(5.1 )] . - in patients with hypersensitivity to tranexamic acid or any of the ingredients[see warnings and precautions(5.4 )] . 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 result

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bryant ranch prepack - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential [see clinical studies (14)] tranexamic acid tablets are contraindicated in females of reproductive potential who are [see warnings and precautions (5.1)] : - using combined hormonal contraception - known to have any of the following conditions: - active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis) - a history of thrombosis or thromboembolism, including retinal vein or artery occlusion - an intrinsic risk of thrombosis or thromboembolism (e.g., thrombogenic valvular disease, thrombogenic cardiac rhythm disease, or hypercoagulopathy) tranexamic acid tablets are contraindicated in females with reproductive potential with known hypersensitivity to tranexamic acid [see warnings and precautions (5.2) and adverse reactions (6.1)]. risk summary tranexamic acid tablets are not indicated for use in pregnant women. there are no available data

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sagent pharmaceuticals - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid injection 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. tranexamic acid injection is contraindicated: - in patients with subarachnoid hemorrhage. anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. - in patients with active intravascular clotting [see warnings and precautions (5.1)] . - in patients with hypersensitivity to tranexamic acid or any of the ingredients [see warnings and precautions (5.4)] . 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

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

akorn, inc. - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. tranexamic acid injection is contraindicated:

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american health packaging - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential [see clinical studies (14)]. tranexamic acid tablets are contraindicated in females of reproductive potential who are [see warnings and precautions (5.1)]: - using combined hormonal contraception - known to have any of the following conditions: active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis) a history of thrombosis or thromboembolism, including retinal vein or artery occlusion an intrinsic risk of thrombosis or thromboembolism (e.g., thrombogenic valvular disease, thrombogenic cardiac rhythm disease, or hypercoagulopathy) - active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis) - a history of thrombosis or thromboembolism, including retinal vein or artery occlusion - an intrinsic risk of thrombosis or thromboembolism (e.g., thrombogenic valvular disease, thrombog

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golden state medical supply, inc. - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid 650

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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)] .

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

heritage pharmaceuticals labs inc. d/b/a avet pharmaceuticals labs inc. - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid injection, usp 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. tranexamic acid injection, usp is contraindicated: -   in patients with subarachnoid hemorrhage. anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. -   in patients with active intravascular clotting [see warnings and precautions ( 5.1)] . -   in patients with hypersensitivity to tranexamic acid or any of the ingredients [see warnings and precautions ( 5.4 )]. 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 to 4% and 15 to 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 tranexamic acid injection during pregnancy, the potential risk of tranexamic acid injection administration on the fetus should always be considered along with the mother's clinical need for tranexamic acid injection; 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 to 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 tranexamic acid injection and any potential adverse effects on the breastfed child from tranexamic acid injection or from the underlying maternal condition. contraception concomitant use of tranexamic acid injection, 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 tranexamic acid injection 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 tranexamic acid injection 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 tranexamic acid injection in patients with renal impairment, based on the patient's serum creatinine [see dosage and administration (2.2), clinical pharmacology (12.3)] .

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

provepharm inc. - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid injection 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. tranexamic acid injection is contraindicated: - in patients with subarachnoid hemorrhage. anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. - in patients with active intravascular clotting [see warnings and precautions (5.1)] . - in patients with hypersensitivity to tranexamic acid or any of the ingredients [ see warnings and precautions (5.4)] . 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 tranexamic acid during pregnancy, the potential risk of tranexamic acid  administration on the fetus should always be considered along with the mother's clinical need for tranexamic acid ; 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 tranexamic acid injection and any potential adverse effects on the breastfed child from tranexamic acid injection or from the underlying maternal condition. contraception concomitant use of tranexamic acid , 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 tranexamic acid injection 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 tranexamic acid injection 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 tranexamic acid injection in patients with renal impairment, based on the patient's serum creatinine [see dosage and administration (2.2), clinical pharmacology (12.3)] .