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

Empagliflozin - linagliptin is a combination of two medications that work in different ways to reduce blood sugar. Both empagliflozin and linagliptin belong to the class of medications called oral hypoglycemics.

This medication is used by adults with type 2 diabetes who are already taking metformin and empagliflozin or metformin and linagliptin and need additional medication to control blood glucose. It is also used by adults who are taking metformin, empagliflozin, and linagliptin as separate tablets.

Empagliflozin works by increasing the amount of glucose being removed from the body by the kidneys, which decreases the amount of sugar in the blood. Linagliptin works by increasing the amount of incretin released by the intestine. Incretin is a hormone that raises insulin levels when blood sugar is high (especially after a meal) and decreases the amount of sugar made by the body.

Empagliflozin - linagliptin is intended to be used along with metformin as part of an overall diabetes management plan that includes diet and exercise.

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?

Glyxambi is no longer being manufactured for sale in Canada and is no longer available under any brand names. This article is being kept available for reference purposes only. If you are using this medication, speak with your doctor or pharmacist for information about your treatment options.

How should I use this medication?

The recommended dose of this medication is determined by your current dose of empagliflozin or linagliptin.

Empagliflozin - linagliptin may be taken with or without food. It may be taken at any time during the day, however it is important to take the medication at the same time each day. Swallow the tablet whole with some fluid. Do not crush or chew the tablets.

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, take it as soon as possible and continue with your regular schedule. If it is less than 12 hours until 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. Do not take 2 doses within the same day. 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 empagliflozin, linagliptin, or any ingredients of the medication
  • are allergic to medications in the same class as empagliflozin (e.g., canagliflozin, dapagliflozin)
  • are allergic to medications in the same class as linagliptin (e.g., saxagliptin, sitagliptin)
  • have severely reduced kidney function
  • are receiving dialysis
  • are experiencing diabetic ketoacidosis (DKA)
  • have type 1 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.

  • abdominal pain
  • constipation
  • diarrhea
  • dizziness
  • headache
  • joint or back pain
  • muscle pain
  • nausea
  • vomiting
  • weight loss

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:

  • cold- or flu-like symptoms (e.g., cough, stuffy or runny nose, sore throat)
  • itchiness
  • low blood pressure (e.g., dizziness, fainting, lightheadedness when rising from sitting or lying position)
  • mouth ulcers
  • severe joint pain
  • 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)
  • skin rash
  • symptoms of low blood sugar (e.g., fainting, dizziness, lightheadedness, blurred vision, increased thirst, nausea)
  • symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
  • symptoms of vaginal yeast infection (e.g., vaginal itching, burning, soreness, cottage-cheese-like discharge)
  • symptoms of yeast infection of the penis (e.g., lumpy, odorous discharge under foreskin; red, swollen, itchy head of the penis; pain when urinating or during sexual activity)
  • tremor
  • weakness

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

  • pain, redness, or swelling in and around the anus or genitals, especially if accompanied by fever, tiredness, or weakness
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
  • signs of sepsis (infection that has spread throughout the body; e.g., fever, low body temperature, chills, rapid breathing, rapid heartbeat, pain urinating, difficulty urinating)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
  • symptoms of diabetic ketoacidosis (DKA; e.g., difficulty breathing, severe thirst, vomiting, stomach pain, nausea, loss of appetite, sweet smell to the breath, sweet or metallic taste in the mouth)

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.

Blood pressure: Empagliflozin can cause an increased amount of fluid to be removed from the body through urine. As a result, it can cause decreases in blood pressure that can cause dizziness, especially when rising from a sitting or lying position. To reduce the possibility of dizziness or fainting, rise slowly from sitting or lying down.

Cholesterol: Empagliflozin - linagliptin may cause increases in the levels of low-density lipoprotein (LDL) cholesterol in your blood. If you have high 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.

Congestive heart failure: The safety and effectiveness of empagliflozin - linagliptin have not been studied for people with congestive heart failure. If you have congestive heart failure you should not take this medication.

Dehydration: Empagliflozin - linagliptin may cause an increased amount of fluid to be removed from the body, resulting in dehydration. Dehydration can cause decreased blood pressure and also contribute to heart problems. Certain other medications, such as diuretics (water pills) can 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): Empagliflozin has been associated with DKAThis is a potentially life-threatening condition which occurs when the body does not have enough insulin to use the glucose in the bloodstream. When this happens, the body starts to burn ketones for fuel instead, which 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: This medication may cause dizziness or lightheadedness, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how this medication affects you.

Hypoglycemia (low blood sugar): Hypoglycemia may occur with empagliflozin-linagliptin. Hypoglycemia may also occur when you don't eat enough, exercise strenuously without eating enough, or drink alcohol. If you experience low blood sugar (e.g., headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery) contact your doctor.

Immunocompromised patients: Other medications in the same class as linagliptin have been linked to a decrease in certain white blood cells: those that protect the body from infection. People who have a compromised immune system, such as those with human immunodeficiency virus (HIV) or who have had a transplant, are at an increased risk of developing severe infections. If you have a compromised immune system, 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 empagliflozin 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 high blood pressure; puffy hands, face, or feet; 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.

Liver function: Empagliflozin is broken down by the liver. Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, 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. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Pancreatitis: Empagliflozin - linagliptin can cause the pancreas to become inflamed. If you have a history of pancreatitis, 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.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Urinary tract infections: Empagliflozin – linagliptin has been associated with increased severity and frequency of urinary tract infections. If you experience symptoms of a urinary tract infection, such as pain or burning when urinating, difficulty urinating, dark or cloudy urine, foul-smelling urine, nausea, vomiting, or fever, contact your doctor.

Yeast infections: There is an increased risk of developing genital or vaginal yeast infections when taking empagliflozin as a result of increased glucose in the urine. This is more likely to occur for uncircumcised men 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 empagliflozin or linagliptin pass into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: Seniors are more likely to experience side effects of this medication. People over the age of 75 should not take empagliflozin - linagliptin, as the safety and effectiveness of this medication have not been determined for this age group.

What other drugs could interact with this medication?

There may be an interaction between empagliflozin - linagliptin and any of the following:

  • acetylsalicylic acid (ASA)
  • amiodarone
  • angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril)
  • antipsychotics (e.g., clozapine, olanzapine, quetiapine, risperidone)
  • apalutamide
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • bosentan
  • carbamazepine
  • carvedilol
  • chloroquine
  • corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
  • cyclosporine
  • deferasirox
  • other diabetes medications (e.g., chlorpropamide, glyburide, insulin, metformin, rosiglitazone)
  • hepatitis C antivirals (e.g., daclatasvir, glecaprevir and pibrentasvir, ledipasvir, velpatasvir)
  • disopyramide
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide)
  • dronedarone
  • efavirenz
  • eliglustat
  • enzalutamide
  • epinephrine
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • etravirine
  • everolimus
  • glucagon
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • hydroxychloroquine
  • lanreotide
  • lumacaftor and ivacaftor
  • macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
  • mifepristone
  • mitotane
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • niacin
  • octreotide
  • pasireotide
  • pegvisomant
  • phenobarbital
  • phenytoin
  • primidone
  • progestins (e.g., progesterone, dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
  • propafenone
  • protein kinase inhibitors (e.g., crizotinib, dabrafenib, lapatinib, nilotinib, sunitinib)
  • quinidine
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
  • rifabutin
  • rifampin
  • sarilumab
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • siltuximab
  • sirolimus
  • St. John's wort
  • sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
  • tacrolimus
  • teriflunomide
  • testosterone
  • tocilizumab
  • tolvaptan
  • tramadol
  • verapamil
  • 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.

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