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

Dapagliflozin - metformin is a combination of two medications that reduce blood sugar. Both dapagliflozin and metformin belong to the class of medications called oral hypoglycemics.

This medication is used by adults with type 2 diabetes who are already taking dapagliflozin and metformin as separate tablets and have good glucose control. It may also be used along with insulin or other medications used to treat diabetes. Dapagliflozin - metformin is intended to be used as part of an overall diabetes management plan that includes diet and exercise.

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. Metformin works by reducing the amount of glucose made by the liver and by making it easier for glucose to enter into the tissues of the body.

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 taking this medication, speak to your doctor. Do not stop taking 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 take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

5 mg/850 mg
Each brown, oval, biconvex, film-coated tablet debossed “5/850” on one side and “1067” on the other side contains 5 mg of dapagliflozin and 850 mg of metformin hydrochloride. Nonmedicinal ingredients: cellulose microcrystalline, hydroxypropyl cellulose, magnesium stearate (extragranular), and sodium starch glycolate; film coating: polyvinyl alcohol, macrogol/polyethylene glycol 3350, talc, titanium dioxide, iron oxide yellow, and iron oxide red.

5 mg/1000 mg
Each yellow, oval, biconvex, film-coated tablet, debossed “5/1000” on one side and “1069” on the other side contains 5 mg of dapagliflozin and 1000 mg of metformin hydrochloride. Nonmedicinal ingredients: cellulose microcrystalline, hydroxypropyl cellulose, magnesium stearate (extragranular), and sodium starch glycolate; film coating: polyvinyl alcohol, macrogol/polyethylene glycol 3350, talc, titanium dioxide, and iron oxide yellow.

How should I use this medication?

The recommended dose for dapagliflozin - metformin is one tablet taken by mouth 2 times a day. You will start at the dose closest to the dose of dapagliflozin and metformin that you are currently taking. Your doctor may adjust the dose up or down, depending on how effective it is and how well it is tolerated. The maximum daily dose is 10 mg of dapagliflozin and 2000 mg of metformin.

Dapagliflozin - metformin should be taken with meals.

Many things can affect the dose of 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 taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a 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 it 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 take this medication if you:

  • are allergic to dapagliflozin, metformin, or any ingredients of the medication
  • are breast-feeding
  • are experiencing physiological stress (e.g., severe infection, trauma, surgery or recovery after surgery)
  • are in a state of physiological shock
  • are or may be pregnant
  • are severely dehydrated
  • are taking the medication pioglitazone 
  • are undergoing radiologic studies (such as an X-ray or CT scan) and have received iodinated contrast materials
  • drink large amounts of alcohol in the short term or on a regular basis
  • have acute or chronic metabolic acidosis
  • have a history of ketoacidosis or lactic acidosis
  • have an unusually low level of oxygen in the blood
  • have heart failure or other severe heart problems
  • have moderately to severely decreased kidney function
  • have severely decreased liver function
  • have type 1 diabetes mellitus
  • have uncontrolled type 2 diabetes mellitus

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 symptoms (sudden lack of energy, fever, cough, sore throat)
  • headache
  • metallic taste in mouth
  • more frequent urination
  • 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:

  • signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
  • signs of a serious infection (fever, severe chills, rapid breathing, rapid heartbeart)
  • signs of vaginal yeast infection (e.g., vaginal odour, curd-like discharge, itching)
  • signs of yeast infection of the penis (e.g., thick, lumpy discharge under the foreskin, unpleasant odour, pain urinating or during sexual activity)
  • low blood pressure (e.g., dizziness, fainting or lightheadedness when rising from a lying or sitting position)
  • 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:

  • severe dehydration (e.g., confusion, sweating stops, heart palpitations)
  • signs of diabetic ketoacidosis (DKA) (e.g., difficulty breathing, extreme thirst, vomiting, nausea, loss of appetite, confusion, unusual tiredness)
  • signs of a serious infection (fever, severe chills, rapid breathing, rapid heartbeat)
  • severe hypoglycemia (low blood sugar; disorientation, loss of consciousness, seizure)
  • signs of lactic acidosis (e.g., nausea, vomiting, increased breathing rate, abdominal pain, unusual tiredness, dizziness, slow or irregular heart rate)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

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

May 16, 2016

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

Alcohol consumption: Anyone taking metformin should avoid excessive alcohol intake. Alcohol may increase the risk of lactic acidosis.

Bladder cancer: In clinical trials, a small number of people who took dapagliflozin developed bladder cancer. There were not enough cases to determine if this was caused by the medication. 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.

Dehydration: Dapagliflozin - metformin may cause a decrease in the amount of fluid in your body. This dehydration has effects throughout the body. Dehydration can cause decreased kidney function, which in turn reduces the effectiveness of this medication. It can cause decreased blood pressure, which may cause dizziness or fainting. Severely decreased blood pressure also contributes to heart problems. Certain other medications, such as diuretics (water pills) can also cause dehydration. If you experience symptoms of dehydration, such as thirst, decreased urine or tear production, dizziness, or headaches, contact your doctor.

Diabetic ketoacidosis (DKA): Dapagliflozin has been associated with DKA. This is a potentially life-threatening condition which occurs when there isn't enough insulin in the blood to use the glucose in the bloodstream. When this happens, the body starts to burn ketones for fuel and can make the blood acidic. This condition is more likely to develop if you are following a very low carbohydrate diet, are dehydrated, or have consumed a large amount of alcohol. Symptoms of DKA include difficulty breathing, nausea, vomiting, abdominal pain, confusion, loss of appetite, excessive thirst, and unusual fatigue or sleepiness. If you experience these symptoms, get immediate medical help.

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.

Dizziness/reduced alertness: Dapagliflozin - metformin may cause low blood sugar, which may in turn affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.

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. If you are using insulin, your doctor may suggest decreasing the dose of the insulin when you first start taking dapagliflozin - metformin. If you take other medications for diabetes, 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.

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.

Decreased kidney function or kidney disease can cause metformin to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, 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.

Lactic acidosis: Lactic acidosis is a rare but serious problem that occurs due to metformin accumulation (i.e., the body doesn't get rid of it fast enough) during treatment. If you have severe kidney disease you are at higher risk of developing lactic acidosis. Since alcohol may increase the risk of lactic acidosis, do not drink a lot of alcohol over the short- or long-term while taking this medication. Though it is very rare, when it does occur it is fatal in 50% of cases. If you experience symptoms of lactic acidosis (e.g., weakness, tiredness, drowsiness, unusual muscle pain, trouble breathing, stomach pain with nausea, vomiting or diarrhea, feeling cold, dizziness, light-headedness, or slow or irregular heartbeat), stop taking this medication and get immediate medical attention.

Liver function: Decreased liver function has been linked to lactic acidosis. This medication is not recommended for people with severely reduced liver function. If you have moderately reduced liver function, 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.

Reduced response: Over a period of time, you may become progressively less responsive to a particular treatment for diabetes because your diabetes worsens. If dapagliflozin - metformin fails to lower your blood sugar to target levels, talk to your doctor. Your doctor may want to stop metformin or recommend another medication.

Surgery: This medication should be stopped temporarily for surgery (except for minor surgery where food and fluid intake is not restricted). You will be restarted on this medication once you are eating and drinking and your kidney function has been tested and is normal. Talk to your doctor for specific instructions.

Vitamin B12 levels: This medication may decrease vitamin B12 levels. Your doctor will monitor your B12 levels with blood tests while you are taking this medication.

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. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if dapagliflozin - metformin 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 - metformin and any of the following:

  • acetazolamide
  • acetylsalicylic acid
  • alcohol
  • androgens (e.g., methyltestosterone, nandrolone, testosterone)
  • angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril)
  • atypical antipsychotics (e.g., clozapine, olanzapine, quetiapine, risperidone)
  • bupropion
  • cephalexin
  • cimetidine
  • corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
  • dabrafenib
  • danazol
  • disopyramide
  • dofetilide
  • dolutegravir
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • everolimus
  • glucagon
  • glycopyrrolate
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • iodinated contrast material
  • lamotrigine
  • lanreotide
  • loop diuretics (e.g., bumetanide, furosemide)
  • mifepristone
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • nateglinide
  • niacin
  • octreotide
  • other diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, , nateglinide, rosiglitazone)
  • pasireotide
  • pegvisomant
  • progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • somatostatin acetate
  • sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
  • sunitinib
  • tacrolimus
  • testosterone
  • thiazide diuretics (water pills; e.g., hydrochlorothiazide, indapamide, metolazone)
  • topiramate
  • trimethoprim
  • trospium
  • vorinostat
  • verapamil

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 – 2018. 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/Xigduo