Dapagliflozin

Uses of 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.

Precautions and Warnings

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 problems

Talk 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

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 swallowing

If 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.

Dosage

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Recommended dose for type 2 diabetes:

• Adults and children 10 years of age and older—At first, 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
• Children younger than 10 years of age—Use and dose must be determined by your doctor.

To lower risk of hospitalization for heart failure in patients with type 2 diabetes and cardiovascular (heart or blood vessel) disease:

• Adults—10 milligrams (mg) once a day.
• Children—Use and dose must be determined by your doctor.

To lower risk of cardiovascular death and hospitalization in patients with heart failure:

• Adults—10 milligrams (mg) once a day.
• Children—Use and dose must be determined by your doctor.

To lower risk of worsening of kidney disease, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease:

• Adults—10 milligrams (mg) once a day.
• Children—Use and dose must be determined by your doctor.

Side Effects

Common side effects:

• nausea
• vomiting
• stomach area (abdominal) pain
• tiredness
• trouble breathing