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

a-s medication solutions - dulaglutide (unii: wtt295hsy5) (dulaglutide - unii:wtt295hsy5) - trulicity® is indicated: - as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. - to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. limitations of use trulicity: - has not been studied in patients with a history of pancreatitis [see warnings and precautions (5.2)] . consider other antidiabetic therapies in patients with a history of pancreatitis. - should not be used in patients with type 1 diabetes mellitus. - has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients [see warnings and precautions (5.6)] . trulicity is contraindicated in patients with: - personal or family history of medullary thyroid carcinoma (mtc) or in patients with multiple endocrine neoplasia syndrome type 2 (men 2) [see warnings and precautions (5.1)] . - serious hypersensitivity reaction to dulaglutide or to any of the product components. serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with trulicity [see warnings and precautions (5.4)] . risk summary limited data with trulicity in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. there are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy [see clinical considerations]. based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy. trulicity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in pregnant rats administered dulaglutide during organogenesis, early embryonic deaths, fetal growth reductions, and fetal abnormalities occurred at systemic exposures at least 6-times human exposure at the maximum recommended human dose (mrhd) of 4.5 mg/week. in pregnant rabbits administered dulaglutide during organogenesis, major fetal abnormalities occurred at 5-times human exposure at the mrhd. adverse embryo/fetal effects in animals occurred in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide [see data] . the estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes with an hba1c >7% and has been reported to be as high as 20–25% in women with an hba1c >10%. the estimated background risk of 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 2–4% and 15–20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. data animal data pregnant rats given subcutaneous doses of 0.49, 1.63, or 4.89 mg/kg dulaglutide every 3 days during organogenesis had systemic exposures 2-, 6-, and 18-times human exposure at the maximum recommended human dose (mrhd) of 4.5 mg/week, respectively, based on plasma area under the time-concentration curve (auc) comparison. reduced fetal weights associated with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide were observed at ≥1.63 mg/kg. irregular skeletal ossifications and increases in post-implantation loss also were observed at 4.89 mg/kg. in pregnant rabbits given subcutaneous doses of 0.04, 0.12, or 0.41 mg/kg dulaglutide every 3 days during organogenesis, systemic exposures in pregnant rabbits were 0.5-, 2-, and 5-times human exposure at the mrhd, based on plasma auc comparison. fetal visceral malformation of lung lobular agenesis and skeletal malformations of the vertebrae and/or ribs were observed in conjunction with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide at 0.41 mg/kg. in a prenatal-postnatal study in f0 maternal rats given subcutaneous doses of 0.2, 0.49, or 1.63 mg/kg every third day from implantation through lactation, systemic exposures in pregnant rats were 1-, 2-, and 7-times human exposure at the mrhd, based on plasma auc comparison. f1 pups from f0 maternal rats given 1.63 mg/kg dulaglutide had statistically significantly lower mean body weight from birth through postnatal day 63 for males and postnatal day 84 for females. f1 offspring from f0 maternal rats receiving 1.63 mg/kg dulaglutide had decreased forelimb and hindlimb grip strength and males had delayed balano-preputial separation. females had decreased startle response. these physical findings may relate to the decreased size of the offspring relative to controls as they appeared at early postnatal assessments but were not observed at a later assessment. f1 female offspring of the f0 maternal rats given 1.63 mg/kg of dulaglutide had a longer mean escape time and a higher mean number of errors relative to concurrent control during 1 of 2 trials in the memory evaluation portion of the biel water maze. these findings occurred in conjunction with decreased f0 maternal food intake and decreased weight gain attributed to the pharmacologic activity at 1.63 mg/kg. the human relevance of these memory deficits in the f1 female rats is not known. risk summary there are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. the presence of dulaglutide in milk of treated lactating animals was not determined. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for trulicity and any potential adverse effects on the breastfed infant from trulicity or from the underlying maternal condition. the safety and effectiveness of trulicity as an adjunct to diet and exercise to improve glycemic control in pediatric patients 10 years of age and older with type 2 diabetes mellitus have been established. use of trulicity for this indication is supported by a 26-week, multicenter, randomized, double-blind, parallel arm, placebo-controlled trial in 154 pediatric patients 10 years of age and older with type 2 diabetes mellitus [see clinical studies (14.6)] . trulicity-treated pediatric patients reported a higher incidence of injection site-related reactions compared to trulicity-treated adults [see adverse reactions (6.1)] . the safety and effectiveness of trulicity have not been established in pediatric patients less than 10 years of age. in the adult glycemic control trials [see clinical studies (14.2, 14.3)] , 620 (19%) of trulicity-treated patients were 65 years of age or older and 65 (2%) of trulicity-treated patients were 75 years of age or older at baseline. in the trulicity 1.5 mg treatment arm of the rewind trial (cardiovascular outcomes trial in adults with type 2 diabetes mellitus and cardiovascular disease or multiple cardiovascular risk factors) [see clinical studies (14.5)] , 2,619 (53%) patients were 65 years of age or older, and 484 (10%) patients were 75 years of age or older at baseline. no overall differences in safety or effectiveness for trulicity have been observed between patients 65 years of age and older and younger adult patients. trulicity has been studied in patients with varying degrees of renal function, including a dedicated clinical trial in patients with moderate to severe chronic kidney disease. no overall differences in safety or effectiveness were observed in these studies according to renal function [see clinical studies (14.2, 14.3, 14.4)] . in a clinical pharmacology study in patients with renal impairment, including end-stage renal disease (esrd), no clinically relevant change in dulaglutide pharmacokinetics (pk) was observed. in the 52-week trial in patients with type 2 diabetes and moderate to severe renal impairment, the pk behavior of trulicity 0.75 mg and 1.5 mg once weekly was similar to that demonstrated in previous clinical studies [see clinical pharmacology (12.3)] . no dose adjustment is recommended in patients with renal impairment including end-stage renal disease (esrd). monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. use trulicity with caution in patients with esrd [see warning and precautions (5.5), clinical pharmacology (12.3)] . in a clinical pharmacology study in patients with varying degrees of hepatic impairment, no clinically relevant change in dulaglutide pk was observed [see clinical pharmacology (12.3)] . however, there is limited clinical experience in patients with mild, moderate, or severe hepatic impairment; therefore, use trulicity with caution in these patient populations. dulaglutide slows gastric emptying. trulicity has not been studied in patients with preexisting gastroparesis. use trulicity with caution in patients with gastroparesis. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (0.75 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site. unlock by turning the lock ring. unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for up to a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (1.5 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site. unlock by turning the lock ring. unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for up to a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. information about trulicity single-dose pen please read this instructions for use and the medication guide carefully and completely before using your trulicity single-dose pen. talk to your healthcare provider about how to inject trulicity the right way. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (3 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. you may want to mark your calendar to remind you when to take your next dose. before you get started choose your injection site your healthcare provider can help you choose the injection site that is best for you. step 1 uncap the pen make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site. unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. important information disposal of pen storage and handling commonly asked questions other information where to learn more - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. storage and handling - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. commonly asked questions what if i see air bubbles in my pen? air bubbles are normal. what if i unlock the pen and press the green injection button before pulling off the base cap? do not remove the base cap. throw away the pen and get a new pen. what if there is a drop of liquid on the tip of the needle when i remove the base cap? a drop of liquid on the tip of the needle is normal. do i need to hold the injection button down until the injection is complete? this is not necessary, but it may help you keep the pen steady and firm against your skin. i heard more than 2 clicks during my injection—2 louder clicks and 1 soft one. did i get my complete injection? some people may hear a soft click right before the second loud click. that is the normal operation of the pen. do not remove the pen from your skin until you hear the second louder click. what if there is a drop of liquid or blood on my skin after my injection? this is normal. i am not sure if my pen worked the right way. check to see if you have received your dose. your dose was delivered the right way if the gray plunger is visible (see step 3) . also contact lilly at 1-800-lilly-rx (1-800-545-5979) for further instructions. until then, store your pen safely to avoid an accidental needle stick. other information - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. where to learn more - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. this instructions for use has been approved by the u.s. food and drug administration. eli lilly and company indianapolis, in 46285, usa us license number 1891 trulicity is a registered trademark of eli lilly and company. copyright © 2020, 2023, eli lilly and company. all rights reserved. the trulicity pen meets the current dose accuracy and functional requirements of iso 11608-1:2012 and 11608-5:2012. implemented: 04/2023 tru3mg-0002-ifu-20230407 information about trulicity single-dose pen please read this instructions for use and the medication guide carefully and completely before using your trulicity single-dose pen. talk to your healthcare provider about how to inject trulicity the right way. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (4.5 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. you may want to mark your calendar to remind you when to take your next dose. before you get started choose your injection site your healthcare provider can help you choose the injection site that is best for you. step 1 uncap the pen make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site . place the clear base flat and firmly against your skin at the injection site . unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. important information disposal of pen storage and handling commonly asked questions other information where to learn more - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. storage and handling - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. commonly asked questions what if i see air bubbles in my pen? air bubbles are normal. what if i unlock the pen and press the green injection button before pulling off the base cap? do not remove the base cap. throw away the pen and get a new pen. what if there is a drop of liquid on the tip of the needle when i remove the base cap? a drop of liquid on the tip of the needle is normal. do i need to hold the injection button down until the injection is complete? this is not necessary, but it may help you keep the pen steady and firm against your skin. i heard more than 2 clicks during my injection—2 louder clicks and 1 soft one. did i get my complete injection? some people may hear a soft click right before the second loud click. that is the normal operation of the pen. do not remove the pen from your skin until you hear the second louder click. what if there is a drop of liquid or blood on my skin after my injection? this is normal. i am not sure if my pen worked the right way. check to see if you have received your dose. your dose was delivered the right way if the gray plunger is visible (see step 3) . also contact lilly at 1-800-lilly-rx (1-800-545-5979) for further instructions. until then, store your pen safely to avoid an accidental needle stick. other information - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. where to learn more - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. this instructions for use has been approved by the u.s. food and drug administration. eli lilly and company indianapolis, in 46285, usa us license number 1891 trulicity is a registered trademark of eli lilly and company. copyright © 2020, 2023, eli lilly and company. all rights reserved. the trulicity pen meets the current dose accuracy and functional requirements of iso 11608-1:2012 and 11608-5:2012. implemented: 04/2023 tru4.5mg-0002-ifu-20230407

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

a-s medication solutions - dulaglutide (unii: wtt295hsy5) (dulaglutide - unii:wtt295hsy5) - trulicity® is indicated: - as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. - to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. limitations of use trulicity: - has not been studied in patients with a history of pancreatitis [see warnings and precautions (5.2)] . consider other antidiabetic therapies in patients with a history of pancreatitis. - should not be used in patients with type 1 diabetes mellitus. - has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients [see warnings and precautions (5.6)] . trulicity is contraindicated in patients with: - personal or family history of medullary thyroid carcinoma (mtc) or in patients with multiple endocrine neoplasia syndrome type 2 (men 2) [see warnings and precautions (5.1)] . - serious hypersensitivity reaction to dulaglutide or to any of the product components. serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with trulicity [see warnings and precautions (5.4)] . risk summary limited data with trulicity in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. there are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy [see clinical considerations]. based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy. trulicity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in pregnant rats administered dulaglutide during organogenesis, early embryonic deaths, fetal growth reductions, and fetal abnormalities occurred at systemic exposures at least 6-times human exposure at the maximum recommended human dose (mrhd) of 4.5 mg/week. in pregnant rabbits administered dulaglutide during organogenesis, major fetal abnormalities occurred at 5-times human exposure at the mrhd. adverse embryo/fetal effects in animals occurred in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide [see data] . the estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes with an hba1c >7% and has been reported to be as high as 20–25% in women with an hba1c >10%. the estimated background risk of 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 2–4% and 15–20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. data animal data pregnant rats given subcutaneous doses of 0.49, 1.63, or 4.89 mg/kg dulaglutide every 3 days during organogenesis had systemic exposures 2-, 6-, and 18-times human exposure at the maximum recommended human dose (mrhd) of 4.5 mg/week, respectively, based on plasma area under the time-concentration curve (auc) comparison. reduced fetal weights associated with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide were observed at ≥1.63 mg/kg. irregular skeletal ossifications and increases in post-implantation loss also were observed at 4.89 mg/kg. in pregnant rabbits given subcutaneous doses of 0.04, 0.12, or 0.41 mg/kg dulaglutide every 3 days during organogenesis, systemic exposures in pregnant rabbits were 0.5-, 2-, and 5-times human exposure at the mrhd, based on plasma auc comparison. fetal visceral malformation of lung lobular agenesis and skeletal malformations of the vertebrae and/or ribs were observed in conjunction with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide at 0.41 mg/kg. in a prenatal-postnatal study in f0 maternal rats given subcutaneous doses of 0.2, 0.49, or 1.63 mg/kg every third day from implantation through lactation, systemic exposures in pregnant rats were 1-, 2-, and 7-times human exposure at the mrhd, based on plasma auc comparison. f1 pups from f0 maternal rats given 1.63 mg/kg dulaglutide had statistically significantly lower mean body weight from birth through postnatal day 63 for males and postnatal day 84 for females. f1 offspring from f0 maternal rats receiving 1.63 mg/kg dulaglutide had decreased forelimb and hindlimb grip strength and males had delayed balano-preputial separation. females had decreased startle response. these physical findings may relate to the decreased size of the offspring relative to controls as they appeared at early postnatal assessments but were not observed at a later assessment. f1 female offspring of the f0 maternal rats given 1.63 mg/kg of dulaglutide had a longer mean escape time and a higher mean number of errors relative to concurrent control during 1 of 2 trials in the memory evaluation portion of the biel water maze. these findings occurred in conjunction with decreased f0 maternal food intake and decreased weight gain attributed to the pharmacologic activity at 1.63 mg/kg. the human relevance of these memory deficits in the f1 female rats is not known. risk summary there are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. the presence of dulaglutide in milk of treated lactating animals was not determined. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for trulicity and any potential adverse effects on the breastfed infant from trulicity or from the underlying maternal condition. the safety and effectiveness of trulicity as an adjunct to diet and exercise to improve glycemic control in pediatric patients 10 years of age and older with type 2 diabetes mellitus have been established. use of trulicity for this indication is supported by a 26-week, multicenter, randomized, double-blind, parallel arm, placebo-controlled trial in 154 pediatric patients 10 years of age and older with type 2 diabetes mellitus [see clinical studies (14.6)] . trulicity-treated pediatric patients reported a higher incidence of injection site-related reactions compared to trulicity-treated adults [see adverse reactions (6.1)] . the safety and effectiveness of trulicity have not been established in pediatric patients less than 10 years of age. in the adult glycemic control trials [see clinical studies (14.2, 14.3)] , 620 (19%) of trulicity-treated patients were 65 years of age or older and 65 (2%) of trulicity-treated patients were 75 years of age or older at baseline. in the trulicity 1.5 mg treatment arm of the rewind trial (cardiovascular outcomes trial in adults with type 2 diabetes mellitus and cardiovascular disease or multiple cardiovascular risk factors) [see clinical studies (14.5)] , 2,619 (53%) patients were 65 years of age or older, and 484 (10%) patients were 75 years of age or older at baseline. no overall differences in safety or effectiveness for trulicity have been observed between patients 65 years of age and older and younger adult patients. trulicity has been studied in patients with varying degrees of renal function, including a dedicated clinical trial in patients with moderate to severe chronic kidney disease. no overall differences in safety or effectiveness were observed in these studies according to renal function [see clinical studies (14.2, 14.3, 14.4)] . in a clinical pharmacology study in patients with renal impairment, including end-stage renal disease (esrd), no clinically relevant change in dulaglutide pharmacokinetics (pk) was observed. in the 52-week trial in patients with type 2 diabetes and moderate to severe renal impairment, the pk behavior of trulicity 0.75 mg and 1.5 mg once weekly was similar to that demonstrated in previous clinical studies [see clinical pharmacology (12.3)] . no dose adjustment is recommended in patients with renal impairment including end-stage renal disease (esrd). monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. use trulicity with caution in patients with esrd [see warning and precautions (5.5), clinical pharmacology (12.3)] . in a clinical pharmacology study in patients with varying degrees of hepatic impairment, no clinically relevant change in dulaglutide pk was observed [see clinical pharmacology (12.3)] . however, there is limited clinical experience in patients with mild, moderate, or severe hepatic impairment; therefore, use trulicity with caution in these patient populations. dulaglutide slows gastric emptying. trulicity has not been studied in patients with preexisting gastroparesis. use trulicity with caution in patients with gastroparesis. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (0.75 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site. unlock by turning the lock ring. unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for up to a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (1.5 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site. unlock by turning the lock ring. unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for up to a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. information about trulicity single-dose pen please read this instructions for use and the medication guide carefully and completely before using your trulicity single-dose pen. talk to your healthcare provider about how to inject trulicity the right way. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (3 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. you may want to mark your calendar to remind you when to take your next dose. before you get started choose your injection site your healthcare provider can help you choose the injection site that is best for you. step 1 uncap the pen make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site. unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. important information disposal of pen storage and handling commonly asked questions other information where to learn more - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. storage and handling - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. commonly asked questions what if i see air bubbles in my pen? air bubbles are normal. what if i unlock the pen and press the green injection button before pulling off the base cap? do not remove the base cap. throw away the pen and get a new pen. what if there is a drop of liquid on the tip of the needle when i remove the base cap? a drop of liquid on the tip of the needle is normal. do i need to hold the injection button down until the injection is complete? this is not necessary, but it may help you keep the pen steady and firm against your skin. i heard more than 2 clicks during my injection—2 louder clicks and 1 soft one. did i get my complete injection? some people may hear a soft click right before the second loud click. that is the normal operation of the pen. do not remove the pen from your skin until you hear the second louder click. what if there is a drop of liquid or blood on my skin after my injection? this is normal. i am not sure if my pen worked the right way. check to see if you have received your dose. your dose was delivered the right way if the gray plunger is visible (see step 3) . also contact lilly at 1-800-lilly-rx (1-800-545-5979) for further instructions. until then, store your pen safely to avoid an accidental needle stick. other information - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. where to learn more - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. this instructions for use has been approved by the u.s. food and drug administration. eli lilly and company indianapolis, in 46285, usa us license number 1891 trulicity is a registered trademark of eli lilly and company. copyright © 2020, 2023, eli lilly and company. all rights reserved. the trulicity pen meets the current dose accuracy and functional requirements of iso 11608-1:2012 and 11608-5:2012. implemented: 04/2023 tru3mg-0002-ifu-20230407 information about trulicity single-dose pen please read this instructions for use and the medication guide carefully and completely before using your trulicity single-dose pen. talk to your healthcare provider about how to inject trulicity the right way. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (4.5 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. you may want to mark your calendar to remind you when to take your next dose. before you get started choose your injection site your healthcare provider can help you choose the injection site that is best for you. step 1 uncap the pen make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site . place the clear base flat and firmly against your skin at the injection site . unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. important information disposal of pen storage and handling commonly asked questions other information where to learn more - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. storage and handling - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. commonly asked questions what if i see air bubbles in my pen? air bubbles are normal. what if i unlock the pen and press the green injection button before pulling off the base cap? do not remove the base cap. throw away the pen and get a new pen. what if there is a drop of liquid on the tip of the needle when i remove the base cap? a drop of liquid on the tip of the needle is normal. do i need to hold the injection button down until the injection is complete? this is not necessary, but it may help you keep the pen steady and firm against your skin. i heard more than 2 clicks during my injection—2 louder clicks and 1 soft one. did i get my complete injection? some people may hear a soft click right before the second loud click. that is the normal operation of the pen. do not remove the pen from your skin until you hear the second louder click. what if there is a drop of liquid or blood on my skin after my injection? this is normal. i am not sure if my pen worked the right way. check to see if you have received your dose. your dose was delivered the right way if the gray plunger is visible (see step 3) . also contact lilly at 1-800-lilly-rx (1-800-545-5979) for further instructions. until then, store your pen safely to avoid an accidental needle stick. other information - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. where to learn more - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. this instructions for use has been approved by the u.s. food and drug administration. eli lilly and company indianapolis, in 46285, usa us license number 1891 trulicity is a registered trademark of eli lilly and company. copyright © 2020, 2023, eli lilly and company. all rights reserved. the trulicity pen meets the current dose accuracy and functional requirements of iso 11608-1:2012 and 11608-5:2012. implemented: 04/2023 tru4.5mg-0002-ifu-20230407

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

a-s medication solutions - benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - acne medication for the treatment of acne

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

a-s medication solutions - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam 2 mg - diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. the effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug for the individual patient. diazepam tablets are contraindicated in patients with a known hypersensitivity to diazepam and, because of lack of sufficient clinical experience, in pediatric patients under 6 months of age. diazepam tablets are also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, and sleep apnea syndrome. they may be used in patients with open-angle glaucoma who are receiving appropriate therapy, but are contraindicated in acute narrow-angle glaucoma. diazepam tablets contain diazepam, a schedule iv controlled substance. diazepam is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse of benzodiazepines may lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see warnings: abuse, misuse, and addiction ). the following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. death is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol). diazepam may produce physical dependence from continued therapy. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses), those who have had longer durations of use (see warnings: dependence and withdrawal reactions ). to reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam tablets or reduce the dosage (see dosage and administration: discontinuation or dosage reduction of diazepam tablets  and warnings: dependence and withdrawal reactions ). acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. tolerance to diazepam may develop from continued therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). tolerance to the therapeutic effect of diazepam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

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

a-s medication solutions - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 100 mg - dilantin is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. dilantin is contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] . - a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.8)]. - coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as dilantin, during pregnancy. physicians are advised to recommend that pregnant patients taking dilantin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be d

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

a-s medication solutions - salmeterol xinafoate (unii: 6ew8q962a5) (salmeterol - unii:2i4bc502bt), fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - salmeterol 50 ug - advair diskus is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. advair diskus should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an ics and long-acting beta2 -adrenergic agonist (laba). important limitation of use advair diskus is not indicated for the relief of acute bronchospasm. advair diskus 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. advair diskus 250/50 is also indicated to reduce exacerbations of copd in patients with a history of exacerbations. advair diskus 250/50 twice daily is the only approved dosage for the treatment of copd because an efficacy advantage of the higher strength advair diskus 500/50 over advair diskus 250/50 has not been demonstrated. important limitatio

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

a-s medication solutions - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - varenicline 0.5 mg - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix. risk summary available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see data]. smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see clinical considerations) . in animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (mrhd). additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the mrhd [see data] . the estimated background risk of oral clefts is increased by

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

a-s medication solutions - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - varenicline 1 mg - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix. risk summary available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see data]. smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see clinical considerations) . in animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (mrhd). additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the mrhd [see data] . the estimated background risk of oral clefts is increased by

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

a-s medication solutions - citalopram hydrobromide (unii: i1e9d14f36) (citalopram - unii:0dhu5b8d6v) - citalopram 20 mg - citalopram tablets are indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies (14)] . citalopram tablets are contraindicated in patients: • taking, or within 14 days of stopping, maois (including maois such as linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.3), drug interactions (7)] . • taking pimozide because of risk of qt prolongation [see drug interactions (7)] . • with known hypersensitivity to citalopram or any of the inactive ingredients in citalopram tablets. reactions have included angioedema and anaphylaxis [see adverse reactions (6.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants . risk summary based on data from published observational studies, exposure to ssris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions (5.4) and clinical considerations] . available data from published epidemiologic studies and postmarketing reports with citalopram use in pregnancy have not established an increased risk of major birth defects or miscarriage. published studies demonstrated that citalopram levels in both cord blood and amniotic fluid are similar to those observed in maternal serum. there are risks of persistent pulmonary hypertension of the newborn (pphn) (see data) and/or poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (ssris), including citalopram, during pregnancy . there also are risks associated with untreated depression in pregnancy (see clinical considerations) . in animal reproduction studies, citalopram caused adverse embryo/fetal effects at doses that caused maternal toxicity (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. this finding is from a prospective longitudinal study of 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. maternal adverse reactions use of citalopram tablet in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions (5.4)] . fetal/neonatal adverse reactions neonates exposed to citalopram and other ssris late in third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. these findings are consistent with either a direct toxic effect of ssris or possibly, a drug discontinuation syndrome. it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see warnings and precautions ( 5.3)] . data human data exposure during late pregnancy to ssris may have an increased risk for persistent pulmonary hypertension of the newborn (pphn). pphn occurs in 1- 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. animal data citalopram was administered orally to pregnant rats during the period of organogenesis at doses of 32, 56, and 112 mg/kg/day, which are approximately 8, 14, and 27 times the maximum recommended human dose (mrhd) of 40 mg, based on mg/m 2 body surface area. citalopram caused maternal toxicity of cns clinical signs and decreased weight gain at 112 mg/kg/day, which is 27 times the mrhd. at this maternally toxic dose, citalopram decreased embryo/fetal growth and survival and increased fetal abnormalities (including cardiovascular and skeletal defects). the no observed adverse effect level (noael) for maternal and embryofetal toxicity is 56 mg/kg/day, which is approximately 14 times the mrhd. citalopram was administered orally to pregnant rabbits during the period of organogenesis at doses up to 16 mg/kg/day, which is approximately 8 times the mrhd of 40 mg, based on mg/m 2 body surface area. no maternal or embryofetal toxicity was observed. the noael for maternal and embryofetal toxicity is 16 mg/kg/day, which is approximately 8 times the mrhd. citalopram was administered orally to pregnant rats during late gestation and lactation periods at doses of 4.8, 12.8, and 32 mg/kg/day, which are approximately 1, 3, and 8 times the mrhd of 40 mg, based on mg/m 2 body surface area. citalopram increased offspring mortality during the first 4 days of birth and decreased offspring growth at 32 mg/kg/day, which is approximately 8 times the mrhd. the noael for developmental toxicity is 12.8 mg/kg/day, which is approximately 3 times the mrhd. in a separate study, similar effects on offspring mortality and growth were seen when dams were treated throughout gestation and early lactation at doses ≥ 24 mg/kg/day, which is approximately 6 times the mrhd. a noael was not determined in that study. risk summary data from the published literature report the presence of citalopram in human milk at relative infant doses ranging between 0.7 to 9.4% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.78 to 4.3. there are reports of breastfed infants exposed to citalopram experiencing irritability, restlessness, excessive somnolence, decreased feeding, and weight loss (see clinical considerations). there is no information about effects of citalopram on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for citalopram and any potential adverse effects on the breastfed child from citalopram or from the underlying maternal condition. clinical considerations monitor breastfeeding infants for adverse reactions, such as irritability, restlessness, excessive somnolence, decreased feeding, and weight loss. the safety and effectiveness of citalopram have not been established in pediatric patients. two placebo-controlled trials in 407 pediatric patients with mdd have been conducted with citalopram, and the data were not sufficient to support use in pediatric patients. antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see boxed warning, warnings  and precautions ( 5.1)] . decreased appetite and weight loss have been observed in association with the use of ssris in pediatric patients. of 4,422 patients in clinical studies of citalopram, 1,357 were 60 and over, 1,034 were 65 and over, and 457 were 75 and over. in two pharmacokinetic studies, citalopram auc was increased by 23% and 30%, respectively, in subjects ≥ 60 years of age as compared to younger subjects, and its half-life was increased by 30% and 50%, respectively [see clinical pharmacology ( 12.3)] . therefore, the maximum recommended dosage in patients 60 years of age and older is lower than younger patients [see dosage and administration ( 2.3), warnings and precautions ( 5.2)] . ssris, including citalopram, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see warnings and precautions ( 5.9)] . increased citalopram exposure occurs in patients with hepatic impairment. the maximum recommended dosage of citalopram is lower in patients with hepatic impairment [see dosage and administration ( 2.3), clinical pharmacology ( 12.3)]. citalopram (citalopram hbr) is not a controlled substance. animal studies suggest that the abuse liability of citalopram is low. citalopram has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. the premarketing clinical experience with citalopram did not reveal any drug-seeking behavior. however, these observations were not systematic and it is not possible to predict, on the basis of this limited experience, the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, health care providers should carefully evaluate citalopram patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

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

a-s medication solutions - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - truvada is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies (14)] . truvada is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating truvada for hiv-1 prep [see dosage and administration (2.2), warnings and precautions (5.2)] . truvada for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to truvada during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary data on the use of truvada during pregnancy from observational s