Dapagliflozin and metformin hydrochloride extended-release

What Is Xigduo XR? Xigduo XR (dapagliflozin and metformin HCl) is a combination of two oral antihyperglycemic medications used as an adjunct to diet and exercise to improve glycemic control in adults with What Are Side Effects of Xigduo XR? Xigduo XRmay cause serious side effects including: • hives, • difficulty breathing, • swelling of your face, lips, tongue, or throat, • bladder pain, • bloody urine, • cloudy urine, • change in color, amount, or odor of vaginal discharge, • burning or painful urination, • frequent urge to urinate, • lower back or side pain, • decreased appetite, • diarrhea, • fast or shallow breathing, • general ill feeling, • muscle pain or cramping, • nausea, • sleepiness, • stomach pain, • unusual tiredness or weakness, • anxiety, • blurred vision, • chills, • clay-colored stools, • cold sweats, • pale skin, • depression, • lightheadedness, • fast heartbeat, • fever, • headache, • itches, • dizziness, • hoarseness, • increased appetite, • irritation, • joint pain, stiffness, or swelling, • loss of appetite, • loss of consciousness, • nightmares, • pain, tenderness, redness, or swelling of the area between the anus and genitals, • redness of the skin, • seizures, • tremors, • shakiness, • slurred speech, • sweating, • tightness in the chest, • difficulty swallowing, • unpleasant breath odor, • vomiting blood, and • yellowing of the skin or eyes (jaundice) Get medical help right away, if you have any of the symptoms listed above. Common side effects of...

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...

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...

• • Dapagliflozin-Metformin Tablet, Immediate Release And Extended Release, Biphasic 24Hr (Tablet,Immed & Ext Release,Biphasic 24Hr) Dapagliflozin-Metformin Tablet, Immediate Release And Extended Release, Biphasic 24Hr (Tablet,Immed & Ext Release,Biphasic 24Hr) - Uses, Side Effects, and More Common Brand(S): Xigduo XR Generic Name(S): dapagliflozin-metformin View Free Coupon Read the Take this medication by The dosage is based on your medical condition, response to treatment, and other Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Tell your doctor if your condition does not improve or if it worsens (your See also Warning section. An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: signs of a This medication may cause a new This medication does not usually cause Symptoms of high blood sugar ( This medication may cause you to become dehydrated. This can lead to serious kidney damage. Drink plenty of fluids to prevent A very serious This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or ...

Description and Brand Names Drug information provided by: US Brand Name • Xigduo XR Descriptions Dapagliflozin and metformin combination is used together with proper diet and exercise to treat type 2 diabetes. It is also used to lower the risk of hospitalization for heart failure in patients with type 2 diabetes and cardiovascular (heart or blood vessel) disease or multiple cardiovascular risk factors. This medicine is also used to lower the risk of cardiovascular death and hospitalization in patients with heart failure with reduced ejection fraction (the heart is weak and cannot pump enough blood to the rest of the body. Dapagliflozin and metformin combination is also used to lower the risk of worsening of kidney disease, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease. Dapagliflozin works in the kidneys to prevent absorption of glucose (blood sugar). This helps lower the blood sugar level. Metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and helps your body use sugar better. It does not help patients who have insulin-dependent or type 1 diabetes. Type 1 diabetic patients must use insulin injections. This medicine is available only with your doctor's prescription. This product is available in the following dosage forms: • Tablet, Extended Release Before Using In deciding to use a medicine, the risks of taking the medicine must be wei...