Dapagliflozin Tablets 10mg

What is dapagliflozin?

Dapagliflozin is a prescription medication that is mainly used alongside diet and exercise to help treat type 2 diabetes, but it is also used in the treatment of heart failure. It was first approved by the US Food and Drug Administration (FDA) in 2014.

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. This class of drug uses the kidneys to help control your glucose (blood sugar) levels. It works by increasing the amount of glucose removed from the body when you urinate. It also reduces the amount of effort your heart has to put in to pumping blood around your body.

What is dapagliflozin used for?

• Dapagliflozin is a prescription medicine used:
  • along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes
  • to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes who also have known cardiovascular disease or multiple cardiovascular risk factors
  • to reduce the risk of cardiovascular death, hospitalization for heart failure in adult patients with heart failure, when the heart is weak and cannot pump enough blood to the rest of your body
  • to reduce the risk of further worsening of your kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization for heart failure in adults with chronic kidney disease.
• Dapagliflozin is not for people with type 1 diabetes. Dapagliflozin may increase the risk of diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes.
• Dapagliflozin is not for use to improve blood sugar (glucose) control in adults with type 2 diabetes who have moderate to severe kidney problems, because it may not work.
• Dapagliflozin is not for people with certain genetic forms of polycystic kidney disease, or who are taking or have recently received immunosuppressive therapy to treat kidney disease. Dapagliflozin is not expected to work if you have these conditions.
• It is not known if dapagliflozin is safe and effective in children younger than 18 years of age.

Important information

Dapagliflozin can cause serious side effects, including:

• Dehydration. Dapagliflozin can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden kidney injury in people with Type 2 diabetes who are taking dapagliflozin. You may be at a higher risk of dehydration if you:
  • take medicines to lower your blood pressure, including water pills (diuretics)
  • are 65 years of age or older
  • are on a low salt diet
  • have kidney problemsTalk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you cannot eat or you start to lose liquids from your body, for example from vomiting, diarrhea, or being in the sun too long.
• Vaginal yeast infection. Women who take dapagliflozin may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
  • vaginal odor
  • white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
  • vaginal itching
• Yeast infection of the penis (balanitis). Men who take dapagliflozin may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:
  • • redness, itching, or swelling of the penis
    • rash of the penis
    • foul smelling discharge from the penis
    • pain in the skin around the penis

  Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medication and your symptoms do not go away.

• Who should not take dapagliflozin?

  Do not take dapagliflozin if you:

  • are allergic to dapagliflozin or any of the ingredients in dapagliflozin. See below for a list of ingredients in dapagliflozin. Symptoms of a serious allergic reaction to dapagliflozin may include:
    • skin rash
    • raised red patches on your skin (hives)
    • swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowingIf you have any of these symptoms, stop taking dapagliflozin and contact your healthcare provider or go to the nearest hospital emergency room right away.
  • are on dialysis.

  What should I tell my doctor before taking dapagliflozin?

  Before you take dapagliflozin, tell your healthcare provider if you:

  • have type 1 diabetes or have had diabetic ketoacidosis.
  • have liver problems.
  • have a history of urinary tract infections or problems urinating.
  • are going to have surgery. Your doctor may stop your dapagliflozin before you have surgery. Talk to your doctor if you are having surgery about when to stop taking dapagliflozin and when to start it again.
  • are eating less or there is a change in your diet.
  • have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.
  • drink alcohol very often or drink a lot of alcohol in the short term (“binge” drinking).

  How should I take dapagliflozin?

  • Take dapagliflozin exactly as your healthcare provider tells you to take it.
  • Do not change your dose of dapagliflozin without talking to your healthcare provider.
  • Take dapagliflozin by mouth 1 time each day, with or without food.
  • Stay on your prescribed diet and exercise program while taking dapagliflozin.
  • Dapagliflozin will cause your urine to test positive for glucose.
  • Your healthcare provider may do certain blood tests before you start dapagliflozin and during your treatment.
  • If you have diabetes
    • When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your healthcare provider right away if you have any of these conditions and follow your healthcare provider’s instructions.
    • Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your HbA1c.
    • Follow your healthcare provider’s instructions for treating low blood sugar (hypoglycemia). Talk to your healthcare provider if low blood sugar is a problem for you.