Dapagliflozin and metformin hydrochloride extended-release uses

Dapagliflozin/metformin is a prescription medication used to improve blood sugar control in patients with type 2 It is a single product containing 2 medications: This medication comes in extended-release tablet form and is taken once a day, in the morning with food. Do not chew, divide, or break dapagliflozin/metformin tablets. Swallow tablets whole. Common side effects of dapagliflozin/metformin include yeast infection in females, a cold, urinary tract infection, diarrhea, and headache. Dapagliflozin/metformin can also cause dizziness. Do not drive or operate heavy machinery until you know how dapagliflozin/metformin affects you. Serious side effects have been reported with dapagliflozin/metformin. See the “Dapagliflozin/metformin Precautions” section. Common side effects of dapagliflozin/metformin include the following: • yeast infection in females • runny nose and sore throat • urinary tract infection • diarrhea • nausea • vomiting • headache This is not a complete list of Dapagliflozin/metformin side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take: • amiloride (Midamor) • calcium c...

The drug, however, is not recommended for patients with type 1 diabetes or diabetic ketoacidosis. Its label also contains a boxed warning for lactic acidosis, which can occur due to metformin accumulation during treatment. Further, the novel combination is contraindicated in those with moderate to severe renal impairment; a history of serious hypersensitivity to dapagliflozin or metformin; or with metabolic acidosis, including diabetic ketoacidosis. The agency based its decision for approval on four phase 3 clinical trials that demonstrated the safety and efficacy of dapagliflozin and metformin IR or XR tablets in treatment-naïve patients and in patients inadequately controlled with metformin. Researchers also compared the combination’s performance with No clinical studies have been conducted with Xigduo XR combination tablets, but bioequivalence was demonstrated in healthy adults between Xigduo XR and dapagliflozin plus metformin XR as separate tablets, according to the release. Currently, Xigduo XR is approved with multiple dosage strengths of dapagliflozin and metformin extended-release, including 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg and 10 mg/1,000 mg. The starting dose should be based on each individual patient’s current treatment regimen. The release also states that Xigduo XR should be taken once daily in the morning with food with gradual dose escalation to reduce the risk for gastrointestinal side effects related to metformin. The maximum daily recommended dos...

Boxed Warning Lactic acidosis Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (greater than 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally greater than 5 mcg/mL. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors such as topiramate), 65 years and older, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high-risk groups are provided in the full prescribing information. If metformin-associated lactic acidosis is suspected, immediately discontinue therapy and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. Dosage Forms Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Tablet Extended Release...

Dosage Forms & Strengths dapagliflozin/metformin extended-release tablet, extended-release • 2.5mg/1000mg • 5mg/500mg • 5mg/1000mg • 10mg/500mg • 10mg/1000mg Type 2 Diabetes Mellitus Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) when treatment with both dapagliflozin and metformin is appropriate Individualize starting dose based on current regimen Not already taking dapagliflozin: Initiate dapagliflozin at 5 mg PO qDay Adjust dose based on effectiveness and tolerability; not to exceed 10 mg dapagliflozin and 2,000 mg metformin Heart Failure and/or Chronic Kidney Disease Dapagliflozin indicated to reduce risk of • Hospitalization risk for heart failure (HF) in adults with T2DM and established cardiovascular disease (CVD) or multiple CV risk factors • CV death and hospitalization for HF in adults with T2DM who have HF (NYHA class II-IV) with reduced ejection fraction • Sustained eGFR rate decline, end-stage renal disease (ESRD), CV death, and hospitalization for HF in adults with chronic kidney disease at risk of progression Dose • Individualize starting dose based on current regimen • For indications related to heart failure and/or chronic kidney disease, recommended dapagliflozin is 10 mg PO qDay • Adjust dose based on effectiveness and tolerability; not to exceed 10 mg dapagliflozin and 2,000 mg metformin Dosage Modifications Renal impairment • Obtain eGFR before starting metformin • eGFR ≥45 mL/min...

Warning • Rarely, metformin may cause an acid health problem (lactic acidosis). The risk is higher in people who have kidney problems, liver problems, heart failure, use alcohol, or take other drugs like topiramate. The risk is also higher in older people (65 or older) and in people who are having surgery, an exam or test with contrast, or other procedures. If lactic acidosis happens, it can lead to other health problems and can be deadly. Kidney tests may be done while taking this medicine (dapagliflozin and metformin extended-release tablets). • Do not take this medicine (dapagliflozin and metformin extended-release tablets) if you have a very bad infection, low oxygen, or a lot of fluid loss (dehydration). • Call your doctor right away if you have signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast or slow heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness, feeling cold, or muscle pain or cramps. Uses of Dapagliflozin and Metformin Extended-Release Tablets: • It is used to lower blood sugar in patients with high blood sugar (diabetes). • It is used in certain people to lower the risk of having to go to the hospital for Related/similar drugs What do I need to tell my doctor BEFORE I take Dapagliflozin and Metformin Extended-Release Tablets? • If you are allergic to this medicine ( • If you have any of these heal...

These highlights do not include all the information needed to use XIGDUO XR safely and effectively. See full prescribing information for XIGDUO XR.XIGDUO® XR (dapagliflozin and metformin hydrochloride extended-release) tablets, for oral useInitial U.S. Approval: 2014 XIGDUOXRdapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN PROPANEDIOLdapagliflozinMETFORMIN HYDROCHLORIDEmetforminanhydrous lactoseCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDCROSPOVIDONE, UNSPECIFIEDHYPROMELLOSE 2208 (100000 MPA.S)magnesium stearateMICROCRYSTALLINE CELLULOSEsilicon dioxidecapsule-shaped1072;10;500XIGDUOXRdapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN PROPANEDIOLdapagliflozinMETFORMIN HYDROCHLORIDEmetforminanhydrous lactoseCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDCROSPOVIDONE, UNSPECIFIEDHYPROMELLOSE 2208 (100000 MPA.S)magnesium stearateMICROCRYSTALLINE CELLULOSEsilicon dioxideyellow to dark yellow1073;10;1000XIGDUOXRdapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN PROPANEDIOLdapagliflozinMETFORMIN HYDROCHLORIDEmetforminanhydrous lactoseCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDCROSPOVIDONE, UNSPECIFIEDHYPROMELLOSE 2208 (100000 MPA.S)HYPROMELLOSE 2910 (5 MPA.S)magnesium stearateMICROCRYSTALLINE CELLULOSEsilicon dioxidecapsule-shaped1070;5;500XIGDUOXRdapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN PROPANEDIOLdapagliflozinMETFORMIN HYDROCHLORIDEmetforminanhydrous lactoseCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDCROSPOVIDONE, UNSPECIFIEDHYPROMELLOSE 2208 (100000 MPA.S)HYP...

What Is Qternmet XR? Qternmet XR (dapagliflozin, saxagliptin, and metformin hydrochloride) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and a biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • Qternmet XR is available as a generic drug. What Are Side Effects ofQternmet XR? Common side effects of Qternmet XR include: • upper respiratory tract infection, • urinary tract infection (UTI), • high levels of fats in the blood (dyslipidemia), • headache, • diarrhea, • back pain, • genital infections, and • joint pain Seek medical care or call 911 at once if you have the following serious side effects: • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out; • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors. Dosage for Qternmet XR For patients not currently taking dapagliflozin, the recommended starting total daily dose of Qternmet XR is a 5 mg dapagliflozin/5 mg saxagliptin/1000 mg or 2000 mg metformin hydrochloride (HCl) once daily. • The maximum reco...

These highlights do not include all the information needed to use XIGDUO XR safely and effectively. See full prescribing information for XIGDUO XR.XIGDUO® XR (dapagliflozin and metformin hydrochloride extended-release) tablets, for oral useInitial U.S. Approval: 2014 XIGDUOXRdapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN PROPANEDIOLdapagliflozinMETFORMIN HYDROCHLORIDEmetforminanhydrous lactoseCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDCROSPOVIDONE, UNSPECIFIEDHYPROMELLOSE 2208 (100000 MPA.S)magnesium stearateMICROCRYSTALLINE CELLULOSEsilicon dioxidecapsule-shaped1072;10;500XIGDUOXRdapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN PROPANEDIOLdapagliflozinMETFORMIN HYDROCHLORIDEmetforminanhydrous lactoseCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDCROSPOVIDONE, UNSPECIFIEDHYPROMELLOSE 2208 (100000 MPA.S)magnesium stearateMICROCRYSTALLINE CELLULOSEsilicon dioxideyellow to dark yellow1073;10;1000XIGDUOXRdapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN PROPANEDIOLdapagliflozinMETFORMIN HYDROCHLORIDEmetforminanhydrous lactoseCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDCROSPOVIDONE, UNSPECIFIEDHYPROMELLOSE 2208 (100000 MPA.S)HYPROMELLOSE 2910 (5 MPA.S)magnesium stearateMICROCRYSTALLINE CELLULOSEsilicon dioxidecapsule-shaped1070;5;500XIGDUOXRdapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN PROPANEDIOLdapagliflozinMETFORMIN HYDROCHLORIDEmetforminanhydrous lactoseCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDCROSPOVIDONE, UNSPECIFIEDHYPROMELLOSE 2208 (100000 MPA.S)HYP...

Dosage Forms & Strengths dapagliflozin/metformin extended-release tablet, extended-release • 2.5mg/1000mg • 5mg/500mg • 5mg/1000mg • 10mg/500mg • 10mg/1000mg Type 2 Diabetes Mellitus Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) when treatment with both dapagliflozin and metformin is appropriate Individualize starting dose based on current regimen Not already taking dapagliflozin: Initiate dapagliflozin at 5 mg PO qDay Adjust dose based on effectiveness and tolerability; not to exceed 10 mg dapagliflozin and 2,000 mg metformin Heart Failure and/or Chronic Kidney Disease Dapagliflozin indicated to reduce risk of • Hospitalization risk for heart failure (HF) in adults with T2DM and established cardiovascular disease (CVD) or multiple CV risk factors • CV death and hospitalization for HF in adults with T2DM who have HF (NYHA class II-IV) with reduced ejection fraction • Sustained eGFR rate decline, end-stage renal disease (ESRD), CV death, and hospitalization for HF in adults with chronic kidney disease at risk of progression Dose • Individualize starting dose based on current regimen • For indications related to heart failure and/or chronic kidney disease, recommended dapagliflozin is 10 mg PO qDay • Adjust dose based on effectiveness and tolerability; not to exceed 10 mg dapagliflozin and 2,000 mg metformin Dosage Modifications Renal impairment • Obtain eGFR before starting metformin • eGFR ≥45 mL/min...

The drug, however, is not recommended for patients with type 1 diabetes or diabetic ketoacidosis. Its label also contains a boxed warning for lactic acidosis, which can occur due to metformin accumulation during treatment. Further, the novel combination is contraindicated in those with moderate to severe renal impairment; a history of serious hypersensitivity to dapagliflozin or metformin; or with metabolic acidosis, including diabetic ketoacidosis. The agency based its decision for approval on four phase 3 clinical trials that demonstrated the safety and efficacy of dapagliflozin and metformin IR or XR tablets in treatment-naïve patients and in patients inadequately controlled with metformin. Researchers also compared the combination’s performance with No clinical studies have been conducted with Xigduo XR combination tablets, but bioequivalence was demonstrated in healthy adults between Xigduo XR and dapagliflozin plus metformin XR as separate tablets, according to the release. Currently, Xigduo XR is approved with multiple dosage strengths of dapagliflozin and metformin extended-release, including 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg and 10 mg/1,000 mg. The starting dose should be based on each individual patient’s current treatment regimen. The release also states that Xigduo XR should be taken once daily in the morning with food with gradual dose escalation to reduce the risk for gastrointestinal side effects related to metformin. The maximum daily recommended dos...