The list below contains full prescribing information for all of our medicines, and a range of websites dedicated to providing you with productspecific information. Please read us full prescribing information and medication. Glyxambi empagliflozin and linagliptin tablets, for oral use. The recommended dose is 10mg dapagliflozin once daily. Highlights of prescribing information resulted in death, hypothermia, hypotension, and resistant other procedures, hypoxic states, excessive alcohol intake, and hepatic these. Dapagliflozin is licensed for use in type 1 diabetes and it is currently red on the bnssg joint formulary and so should only be prescribed and managed by secondary care diabetes specialists. Farxiga dapagliflozin dosing, indications, interactions. Fda revises labels of sglt2 inhibitors for diabetes to. Any reference in these archives to astrazeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data.
Jardiance empagliflozin tablets prescribing information. Highlights of prescribing information these highlights do not include all the information needed to use glyxambi with low systolic blood pressure, and in patients on diuretics. Highlights of prescribing information these highlights do not include all the information needed to use rybelsus safely and effectively. If you are in the us and would like additional information regarding astrazeneca drugs, please contact the information center at astrazeneca at 18778931510 18778931510.
The pdf version is available to download and print. Talk to your healthcare professional about your medical. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Consumer information forxiga dapagliflozin tablets as dapagliflozin propanediol monohydrate read this carefully before you start taking forxiga and each time you get a refill. Important notice for users you are about to access astrazeneca historic archive material. Your doctor or pharmacist will give you the manufacturers patient information sheet medication guide when you begin treatment with dapagliflozin and each time you refill your prescription. In type 2 diabetes, it is used with appropriate diet and exercise in patients who cannot take.
These highlights do not include all the information needed to use invokana safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to. You may report side effects related to astrazeneca products by clicking here. Prescribing of sodiumglucose cotransporter2 inhibitors sglt2i during the covid19 pandemic. Rybelsus semaglutide tablets, for oral use warning. While an alarming 14% of the adult us population have diabetes, onethird still remain. The sodiumglucose cotransporter 2 sglt2 inhibitors are a class of glucoselowering therapies that have been shown to reduce risks of heart failure hf events in patients with type 2 diabetes mellitus t2dm at highrisk for or with cardiovascular disease. The web version of each document is easier to navigate. Dapagliflozin, sold under the brand name farxiga among others, is a medication used to treat type 2 diabetes and, with certain restrictions, type 1 diabetes. Serious infections and malignancy see full prescribing information for complete boxed warning. Please read us full prescribing information and medication guide for farxiga. Nov 26, 2014 sodiumglucose cotransporter2 sglt2 inhibitors are a newly developed class of oral antidiabetic drugs oads with a unique mechanism of action.
Ozempic semaglutide injection, for subcutaneous use initial u. Marketing authorisation dapagliflozin forxiga, astrazeneca is indicated for the treatment of type 1 diabetes mellitus as an adjunct to insulin in patients with. Farxiga dapagliflozin tablet, film coated astrazeneca pharmaceuticals lphighlights of prescribing information these highlights do not include all the. These highlights do not include all the information needed to use humira safely and effectively. Cell tumors see full prescribing information for complete boxed warning. Ferrannini e1, ramos sj, salsali a, tang w, list jf. Astrazeneca pharmaceuticals lp farxiga dapagliflozin. Dapagliflozin is the international nonproprietary name inn, and the united states adopted name usan. Practical guide to prescribing sodiumglucose cotransporter 2. Farxiga dapagliflozin tablets prescribing information. When dapagliflozin is used in combination with insulin or an insulin secretagogue, such as a sulphonylurea, a lower dose of. Find information on dapagliflozin farxiga in daviss drug guide including dosage, side effects, interactions, nursing implications, mechanism of action, half life, administration, and more. Highlights of prescribing information 5 mg dapagliflozin.
Astrazeneca presents new data evaluating safety and. To reduce the risk of hospitalization for heart failure in patients with t2d, the recommended dose of farxiga is 10 mg once daily. In type 2 diabetes, it is used with appropriate diet and exercise in patients who cannot take metformin another diabetes medicine. These highlights do not include all the information needed to use farxiga safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use trulicitysafely and effectively. The sodiumglucose cotransporter 2 sglt2 inhibitors are a class of glucoselowering therapies that have been shown to reduce risks of heart failure hf events in patients. Monday to friday, 8 am to 6 pm et, excluding holidays. Prophylaxis of dvt following hip or knee replacement. Farxiga dapagliflozin prescribing information az medical. In patients tolerating 5 mg dapagliflozin and 5 mg saxagliptin once daily who require additional glycemic control, the qtern dose can be increased to 10 mg dapagliflozin 5 mg saxagliptin tablet once daily. Dapagliflozin propanediol monograph for professionals.
When dapagliflozin is used in combination with insulin or an insulin secretagogue, such as a sulphonylurea, a lower dose of insulin or insulin secretagogue may be considered to reduce the risk of hypoglycaemia see sections4. Farxiga dapagliflozin type 2 diabetes medication for adults. These effects could be beneficial, but longerterm studies will be needed to see if dapagliflozin improves the outcomes for patients with type 2 diabetes. Abbreviated prescribing information dapagliflozinmetformin extendedrelease tablets xigduo xr xigduo xr is available as a filmcoated tablet for oral administration. Read information about farxiga dapagliflozin, clinical results for patients with type 2 diabetes mellitus.
Dapagliflozin for type 2 diabetes australian prescriber. Currently available sglt2 inhibitors canagliflozin dapagliflozin empagliflozin ertugliflozin dose 100 mg daily before breakfast. It can also be used as addon treatment to other diabetes medicines. Marketing authorisation dapagliflozin forxiga, astrazeneca is indicated for the treatment of type 1 diabetes mellitus as an adjunct to insulin in patients with a bmi. Farxiga dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2.
To lessen the risk of developing ketoacidosis after surgery, fda has approved changes to the prescribing information for sglt2 inhibitor diabetes medicines to recommend. Highlights of prescribing information before initiating. Outside of these hours and on holidays, an afterhours service is available to assist you with any urgent medical. Prescribing of sodiumglucose cotransporter2 inhibitors.
Humira adalimumab injection, for subcutaneous use initial u. Highlights of prescribing information these highlights do not include all the information needed to use xigduo xr safely and effectively. Highlights of prescribing information farxiga may require. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes. Highlights of prescribing information history of serious. Feb 03, 2020 these highlights do not include all the information needed to use farxiga safely and effectively. Xigduo xr is a combination of dapagliflozin, a sodiumglucose cotransporter 2 sglt2 inhibitor, and metformin, a biguanide in extended release form. Farxiga dapagliflozin tablets, for oral use initial u. There is a combination product dapagliflozin metformin extendedrelease, called xigduo xr. Below is a complete list of astrazeneca products and associated prescribing information. Fda warns that sglt2 inhibitors for diabetes may result in a serious condition of too much acid in the blood. Dailymed farxiga dapagliflozin tablet, film coated. Dapagliflozin is the first of a new class of drugs.
Sodiumglucose cotransporter2 sglt2 inhibitors are a newly developed class of oral antidiabetic drugs oads with a unique mechanism of action. Webmd provides information about interactions between furosemide oral and loopdiureticscanagliflozindapagliflozinertugliflozin. Abbreviated prescribing information dapagliflozinmetformin. The united states food and drug administration has expanded the regulatory label for empagliflozin and canagliflozin for use to lower. Highlights of prescribing information these highlights do not include all the information needed to use eliquis safely and effectively. Forxiga is a diabetes medicine used for adults whose condition is not controlled well enough. Feb 02, 2015 farxiga dapagliflozin tablet, film coated astrazeneca pharmaceuticals lphighlights of prescribing information these highlights do not include all the information needed to use farxiga safely and effectively. Mar 19, 2020 to lessen the risk of developing ketoacidosis after surgery, fda has approved changes to the prescribing information for sglt2 inhibitor diabetes medicines to recommend they be stopped temporarily. Sections or subsections omitted from the full prescribing information are not listed. Highlights of prescribing information these highlights do not include all the information needed to use ozempic safely and effectively. Farxiga dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus see clinical studies 14. Health professional information summary product information route of administration. Interactions between furosemide oral and loopdiuretics.
Please see full prescribing information and medication guide for farxiga. This leaflet is a summary and will not tell you everything about this drug. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise. Farxiga should not be used to treat people with type 1 diabetes or diabetic ketoacidosis increased ketones in your blood or urine. Astrazeneca pharmaceuticals lp farxiga dapagliflozin tablet. Prophylaxis of dvt following hip or knee replacement surgery. Highlights of prescribing information these highlights do. Health professional information summary product information route of administration dosage form strength clinically relevant nonmedicinal ingredients oral tablet 5 mg, 10 mg lactose for a complete listing see dosage forms, composition and packaging section. Fda warns that sglt2 inhibitors for diabetes may result in a. Fda warns that sglt2 inhibitors for diabetes may result in. Highlights of prescribing information these highlights do not include all the information needed to use xigduo xr safely and. These highlights do not include all the information needed to use farxiga.
Do not stop taking dapagliflozin without talking to your doctor. Full prescribing information 1 indications and usage jardiance is indicated. The diabetes epidemic has become a major health threat in the us. Farxiga dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus see. For patients not already taking dapagliflozin, the recommended starting dose of qtern is 5 mg dapagliflozin 5 mg saxagliptin tablet once daily. Canagliflozin, dapagliflozin and empagliflozin as combination therapies. Read the information carefully and ask your doctor or pharmacist if you have any questions. Dapagliflozin with insulin for treating type 1 diabetes. When there are changes to the label, the pdf version will show the updates sooner than the web version. Xigduo xr dapagliflozin and metformin hcl extendedrelease tablets, for oral use initial u. In addition to reducing hba1c and weight, it also lowers systolic blood pressure by 15 mmhg. In february 2017, the fda approved a oncedaily combination of dapagliflozin and saxagliptin, as qtern.
697 1113 606 312 280 640 347 1371 1543 851 1504 470 1309 595 1437 1202 1294 889 147 62 279 1116 1327 273 495 49 1192 816 511 175 936 321 77 650 1438 264 1049 1129 835 361 881 1337 1300 1123 461 953 1314 949