Dapagliflozin

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Generic Name: Dapagliflozin Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Dapagliflozin used for?

Dapagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Dapagliflozin works by increasing the removal of sugar by your kidneys.

How should I take Dapagliflozin?

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. The dosage is based on your medical condition and response to treatment.

Use 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 (such as if your blood sugar remains high or increases).

How do I store Dapagliflozin?

Dapagliflozin is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Dapagliflozin in the bathroom or the freezer. There may be different brands of Dapagliflozin that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Dapagliflozin down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Dapagliflozin?

Before taking dapagliflozin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease/failure (dialysis), bladder cancer, loss of too much body water (dehydration), low blood pressure, heart failure, history of yeast infections in the vagina or penis.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar and a high ketone level.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Also, if you are eating less or not able to eat due to these conditions or any illness, this can lead to a high ketone level while you are taking this medication. Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar or ketone testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dizziness/fainting (usually when standing), dehydration, and kidney disease.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Dapagliflozin during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Dapagliflozin. Dapagliflozin is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Dapagliflozin?

Frequent urination, dizziness, or lightheadedness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she 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 urinary tract infection (such as burning/painful/frequent/urgent urination, pink/bloody urine), signs of kidney problems (such as change in the amount of urine, swelling legs/feet).

Get medical help right away if you have any very serious side effects, including: unusual tiredness, nausea/vomiting, stomach/abdominal pain, trouble breathing.

Dapagliflozin can sometimes cause painful urination or pink/bloody urine that are usually signs of a urinary tract infection, but they may also be signs of a rare condition (bladder cancer). Bladder cancer may or may not be caused by dapagliflozin. Tell your doctor right away if you develop these symptoms.

Use of this medication may result in a new yeast infection in the vagina or penis. You are more likely to get a yeast infection from dapagliflozin if you had yeast infections in the genital area before. Uncircumcised men are also at an increased risk for infections. Tell your doctor right away if you have signs of yeast infection in the vagina (such as unusual vaginal discharge/burning/itching/odor) or in the penis (such as redness/itching/swelling of the penis, unusual discharge from the penis). Your doctor may direct you to use nonprescription antifungal products to treat these infections. Tell your doctor if your condition persists or worsens after treatment.

Dapagliflozin does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other diabetes medications, or if you do not consume enough calories from food, or if you do unusually heavy exercise. Talk with your doctor or pharmacist about whether the dose of your other diabetes medication needs to be lowered. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don’t have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medications.

This medication may cause you to lose too much body water (dehydration). This can lead to serious kidney damage. Drink plenty of fluids to prevent dehydration. Tell your doctor or pharmacist right away if you are not able to drink fluids as usual, or losing fluid (such as due to vomiting, diarrhea, or heavy sweating). Also, tell your doctor right away if you have any signs of dehydration, such as urinating less than usual, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness/fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Dapagliflozin?

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.

Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Your urine will test positive for glucose. Make sure laboratory personnel and all your doctors know you use this drug.

Dapagliflozin may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Dapagliflozin?

Dapagliflozin may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Dapagliflozin?

Dapagliflozin may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Dapagliflozin.

What is the dose of Dapagliflozin for an adult?

Usual Adult Dose for Diabetes Type 2

Initial dose: 5 mg orally once a day

-May increase to 10 mg orally once a day in patients tolerating therapy with lower dose and requiring additional glycemic control

Maximum dose: 10 mg/day

Comments:

-Correct volume depletion prior to initiating therapy.

-If used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue should be considered to reduce the risk of hypoglycemia.

Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Renal Dose Adjustments

Mild renal impairment (eGFR 60 mL/min/1.73 m2 or greater): No adjustment recommended

Moderate renal impairment (eGFR 30 to less than 60 mL/min/1.73 m2:): Initiation of therapy is not recommended

Severe renal impairment (eGFR is less than 30 mL/min/1.73 m2): Use is contraindicated

If during therapy, patients eGFR is persistently between 30 and less than 60 mL/min/1.73 m2; therapy should be discontinued

Liver Dose Adjustments

No adjustment recommended; however, for patients with severe hepatic impairment, use caution as the safety and efficacy has not been specifically studied

Dialysis

Contraindicated

Other Comments

Administration advice:

-Take orally in the morning, with or without food

Missed Dose: If a dose is missed, take it as soon as it is remembered, unless it is almost time for the next dose. If this is the case, skip the missed dose and take at the next regularly scheduled time; do not take 2 doses at the same time.

General:

-Correct volume depletion prior to initiating treatment

-Not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis

Monitoring:

-Assess fluid status prior to initiation and monitor for signs and symptoms of volume depletion during therapy.

-Verify renal function at baseline, and monitor periodically during therapy.

-Monitor for signs and symptoms of acute kidney injury

-Monitor for LDL-C per standard of care.

-Evaluate for the presence of acidosis, including ketoacidosis in symptomatic patients, even if blood sugar is below 250 mg/dL.

Patient advice:

-This drug will cause the urine to test positive for glucose.

-Ensure adequate fluid intake to avoid adverse reactions related to volume depletion such as orthostatic hypotension.

-Seek medical advice during periods of stress as medical management of diabetes may change.

-Inform patients that genital mycotic infections, urinary tract infections, and hypersensitivity reactions may occur; patients should be instructed to contact their health care professional.

-Patients experiencing symptoms of ketoacidosis such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue, or sleepiness should be instructed to seek immediate medical attention.

-Patients should promptly report signs of macroscopic hematuria or other symptoms potentially related to bladder cancer.

-Patients should be instructed to seek medical attention promptly for signs and symptoms of acute kidney injury such as decreased urine, swelling in the legs or feet.

-Patients should be instructed on routine preventative foot care.

What is the dose of Dapagliflozin for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Dapagliflozin available?

Dapagliflozin is available in the following dosage forms and strengths:

  • Oral tablet.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Dapagliflozin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: August 16, 2018 | Last Modified: August 16, 2018

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