How does this medication work? What will it do for me?

Dapagliflozin belongs to the class of medications known as oral antihyperglycemic agents. It is used alone and in combination with other medications for the control of blood glucose in people with type 2 diabetes. This medication should be used as part of an overall diabetes management plan that includes a diet and exercise program. Dapagliflozin works by increasing the amount of glucose being removed from the body by the kidneys, which decreases the amount of sugar in the blood.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

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What form(s) does this medication come in?

5 mg
Each yellow, biconvex, round, film-coated tablet, with “5” engraved on one side and “1427” engraved on the other side, contains 5 mg of dapagliflozin as dapagliflozin propanediol monohydrate. Nonmedicinal ingredients: anhydrous lactose, crospovidone, magnesium stearate, microcrystalline cellulose, and silicon dioxide; film coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and yellow iron oxide.

10 mg
Each yellow, biconvex, diamond, film-coated tablet with “10” engraved on one side and “1428” engraved on the other side, contains 10 mg of dapagliflozin as dapagliflozin propanediol monohydrate. Nonmedicinal ingredients: anhydrous lactose, crospovidone, magnesium stearate, microcrystalline cellulose, and silicon dioxide; film coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and yellow iron oxide.

How should I use this medication?

The recommended starting dose for dapagliflozin is 5 mg taken by mouth once a day. Your doctor may adjust the dose up to a maximum 10 mg daily, depending on how effective it is and how well it is tolerated.

Dapagliflozin should be taken at the same time every day. The tablets should be swallowed whole with some fluid and may be taken with food or on an empty stomach.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are administering the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. Do not stop using the medication because you feel better. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you:

  • are allergic to dapagliflozin or any ingredients of this medication
  • are taking the medication pioglitazone
  • have moderate-to-severely reduced kidney function or end stage kidney disease
  • have type 1 diabetes

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • back pain
  • constipation
  • diarrhea
  • flu-like illness
  • headache
  • nausea
  • pain in the arms, legs, hands, or feet
  • sore throat

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • dizziness or lightheadedness when rising from a sitting or lying position
  • redness or rash of the penis or foreskin (yeast infection)
  • signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
  • signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, change of urine colour)
  • signs of vaginal yeast infection (e.g., vaginal odour, curd-like discharge, itching)
  • symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness, blurred vision)
  • symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain, strong odour)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • fainting or lightheadedness when standing
  • severe dehydration (e.g., confusion, sweating stops, heart palpitations)
  • severe hypoglycemia (low blood sugar; disorientation, loss of consciousness, seizure)
  • signs of ketoacidosis (e.g., confusion, extreme thirst, loss of appetite, stomach pain, trouble breathing, nausea, vomiting, or unusual tiredness)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • symptoms of a serious infection (e.g., fever, chills, rapid breathing or heartbeat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

[June 22, 2015]

Health Canada has issued new restrictions concerning the use of dapagliflozin (Forxiga). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Bladder cancer: In clinical trials, a small number of people who took dapagliflozin developed bladder cancer. However, there is insufficient data to suggest that this medication increases the risk of bladder cancer. If you have a history of bladder cancer, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you have concerns about the risk of bladder cancer, talk to your doctor.

Cholesterol: Dapagliflozin may cause increases in the levels of low-density lipoprotein (LDL) cholesterol in your blood. If you have elevated cholesterol, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dizziness: Some people taking dapagliflozin may experience decreases in blood pressure. This occurs because the medication causes an increased amount of fluid, along with the glucose, to be removed from the body through the kidneys. These blood pressure drops could lead to dizziness, lightheadedness, and falls. This may occur when you shift your body position, such as rising from a sitting or lying position. If you experience this problem, try getting up more slowly. If it persists or if you faint, contact your doctor. Seniors and other individuals who are at risk of experiencing low blood pressure (e.g., dehydration, taking medications for high blood pressure) should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Glucose control: When dapagliflozin is taken along with other medications for diabetes, glucose levels may drop too far, causing confusion, cold sweats, cool and pale skin, headache, fast heartbeat, or weakness. Your doctor may suggest decreasing the dose of your other medications when you first start taking dapagliflozin. If you take other medications for diabetes or medications that can decrease blood glucose levels, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Ketoacidosis: There have been reports that diabetic ketoacidosis has been experienced by people taking dapagliflozin and other similar medications. Ketoacidosis is a serious condition that occurs when the body does not have enough insulin to use the glucose in the blood. As a result, the body starts to break down fat for energy. This can cause ketones to build up in the blood, making it more acidic. This is a warning sign that your diabetes is out of control.

If you experience high blood glucose levels, thirst, very dry mouth or frequent urination, you may be experiencing early signs of ketoacidosis. Contact your doctor as soon as possible for advice on how to manage this condition.

Kidney function: The effectiveness of dapagliflozin depends on kidney function because it increases the amount of glucose eliminated through the kidneys. Over time, this medication may cause kidney problems. If you experience signs of kidney problems, such as puffy hands, face or feet, high blood pressure, unusual muscle cramping, or darkened urine, this medication may be affecting how well your kidneys are working. If you notice any of these symptoms, contact your doctor as soon as possible.

Yeast infections: There is an increased risk of developing genital or vaginal yeast infections when taking dapagliflozin as a result of increased glucose in the urine. This is more likely to occur for uncircumcised males and for people who have a history of yeast infections.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if dapagliflozin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Breast-feeding is not recommended when you are taking this medication.

Children: The safety and effectiveness of this medication have not been established for children less than 18 years of age.

Seniors: Seniors are more likely to experience side effects with this medication and may require lower doses.

What other drugs could interact with this medication?

There may be an interaction between dapagliflozin and any of the following:

  • aliskiren
  • alpha agonists (e.g., clonidine, methyldopa)
  • alpha lipoic acid
  • androgens (e.g., methyltestosterone, nandrolone, testosterone)
  • angiotensin-converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
  • angiotensin receptor blockers (ARBs; e.g., candasartan, irbesartan, losartan)
  • aspirin (ASA)
  • atypical antipsychotics (e.g., clozapine, olanzapine, quetiapine, risperidone)
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
  • beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
  • buserelin
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • danazol
  • diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
  • disopyramide
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • glucagon
  • goserelin
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
  • lanreotide
  • leuprolide
  • mifepristone
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • niacin
  • octreotide
  • oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
  • pasireotide
  • pegvisomant
  • pentamidine
  • phenytoin
  • progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, levofloxacin)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • somatostatin acetate
  • somatotropin
  • sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
  • sunitinib
  • tacrolimus
  • triptorelin
  • vorinostat

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2019. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Forxiga