Dapagliflozin

Generic name: Dapagliflozin
Brand names: Farxiga
Dosage form: oral tablet
Drug class: SGLT-2 inhibitors

Usage 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.

Dapagliflozin side effects

Dapagliflozin may cause serious side effects, including:

See “Important information” above.

Ketoacidosis in people with diabetes mellitus (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with dapagliflozin. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with dapagliflozin. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with dapagliflozin even if your blood sugar is less than 250 mg/dL. Stop taking dapagliflozin and call your healthcare provider right away if you get any of the following symptoms:

nausea

vomiting

stomach area (abdominal) pain

tiredness

trouble breathing If you get any of these symptoms during treatment with dapagliflozin, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.

Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking dapagliflozin. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.

Low blood sugar (hypoglycemia) in patients with diabetes mellitus. If you take dapagliflozin with another medicine that can cause low blood sugar, such as a sulfonylUrea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take dapagliflozin. Signs and symptoms of low blood sugar may include:

headache

shaking or feeling jittery

irritability

fast heartbeat

weakness

drowsiness

sweating

confusion

dizziness

hunger

A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men with diabetes mellitus who take dapagliflozin. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have fever or you are feeling very weak, tired, or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around the anus and genitals:

pain or tenderness

swelling

redness of skin (erythema)

The most common side effects of dapagliflozin include:

vaginal yeast infections and yeast infections of the penis

stuffy or runny nose and sore throat

changes in urination, including urgent need to urinate more often, in larger amounts, or at night

These are not all the possible side effects of dapagliflozin. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Dapagliflozin

Tell your doctor if you are pregnant or plan to become pregnant. Dapagliflozin may harm your unborn baby. If you become pregnant while taking dapagliflozin, your healthcare provider may switch you to a different medicine to control your blood sugar. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if dapagliflozin passes into your breast milk. You should not breastfeed if you take dapagliflozin.

Relate drugs

How to use Dapagliflozin

Estimated glomerular filtration rate (eGFR) 45 mL/min/1.73m2 or greater: To improve glycemic control, the recommended starting dose is 5mg orally once daily. Dose can be increased to 10mg orally once daily for additional glycemic control. For all other indications, the recommended starting dose is 10mg orally once daily.

eGFR 25 mL/min/1.73m2to less than 45: 10 mg orally once daily

eGFR less than 25 mL/min/1.73m2: Initiation is not recommended, however patients may continue 10mg orally once daily to reduce the risk of eGFR decline, ESKD, CV death and hHF.

On dialysis: Contraindicated

Warnings

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 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

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.

What other drugs will affect Dapagliflozin

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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