How does this medication work? What will it do for me?
This combination product contains two medications: ertugliflozin and metformin. These medications belong to the class of medications called oral hypoglycemics.
Ertugliflozin 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 is used by adults with type 2 diabetes to control blood glucose (blood sugar), who are already taking ertugliflozin and metformin as separate tablets and have good glucose control. It may also be used along with metformin or metformin and sitagliptin, if blood glucose hasn't been well controlled on metformin plus the other medication. Ertugliflozin - metformin is intended to be used 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?
2.5 mg/500 mg
Each pink, oval, film-coated tablet, debossed with "2.5/500" on one side and plain on the other side, contains 2.5 mg of ertugliflozin and 500 mg of metformin. Nonmedicinal ingredients: carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and titanium dioxide.
2.5 mg/1000 mg
Each pink, oval, film-coated tablet, debossed with "2.5/1000" on one side and plain on the other side, contains 2.5 mg of ertugliflozin and 1000 mg of metformin. Nonmedicinal ingredients: carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and titanium dioxide.
7.5 mg/500 mg
Each red, oval, film-coated tablet, debossed with "7.5/500" on one side and plain on the other side, contains 7.5 of mg ertugliflozin and 500 mg of metformin. Nonmedicinal ingredients: carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and titanium dioxide.
7.5 mg/1000 mg
Each red, oval, film-coated tablet, debossed with "7.5/1000" on one side and plain on the other side, contains 7.5 mg of ertugliflozin and 1000 mg of metformin. Nonmedicinal ingredients: carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and titanium dioxide.
How should I use this medication?
The recommended dose for ertugliflozin - metformin is one tablet taken by mouth twice a day, with meals. Your doctor may adjust the dose up or down, depending on how effective it is and how well it is tolerated. The maximum total daily dose is 15 mg of ertugliflozin and 2000 mg of metformin.
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 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 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 ertugliflozin, metformin, or any ingredients of the medication
- have type 1 diabetes mellitus
- have a history of ketoacidosis
- have a history of lactic acidosis
- have acute or chronic metabolic acidosis
- have moderately-to-severely decreased kidney function
- consume excessive amounts of alcohol
- have severely decreased liver function
- have an unusually low level of oxygen in the blood
- have severe heart problems or heart failure
- are in a state of physiologic shock
- are experiencing physiological stress (e.g., severe infection, trauma, surgery or recovery after surgery)
- are severely dehydrated
- are or may be pregnant
- are breast-feeding
- have recently been treated with iodinated contrast materials for X-ray or CT scan
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.
- loss of appetite
- metallic taste in the mouth
- more frequent urination
- rash or hives
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 fainting when rising from a sitting or lying position
- feeling of numbness, tingling, or prickling in the fingers, feet, and hands
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
- signs of kidney problems (e.g., any change in amount, frequency, or colour of urine)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- skin ulcers or sores
- symptoms of low blood pressure (e.g., fainting, dizziness, lightheadedness, blurred vision, increased thirst, nausea)
- symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness)
- 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., odour, white or yellowish vaginal discharge, itching)
- 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)
- vitamin B12 deficiency (e.g., fatigue, shortness of breath, tingling or numbness of the fingers/toes, difficulty walking, irritability, confusion, lower leg pain)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- signs of diabetic ketoacidosis (DKA) (e.g., difficulty breathing, extreme thirst, vomiting, nausea, loss of appetite, confusion, unusual tiredness)
- signs of encephalopathy (e.g., difficulty speaking, swallowing, making decisions, or concentrating; unusual muscle weakness)
- signs of lactic acidosis (e.g., nausea, vomiting, increased breathing rate, abdominal pain, unusual tiredness, dizziness, rapid heart rate)
- signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
- severely low blood sugar (e.g., disorientation, loss of consciousness, seizure)
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.
Alcohol consumption: If you are taking metformin, you should limit your consumption of alcohol.
Amputation: There may be an increased risk for lower leg or toe amputations in people taking this medication, especially if you are at high risk for heart disease. Good foot care is very important for people with diabetes. Contact your doctor as soon as possible if you notice symptoms of leg pain; poor circulation; bluish, cold skin; and poor hair or toenail growth.
Blood pressure: Some people taking ertugliflozin may experience decreases in blood pressure. This occurs because the medication causes an increased amount of fluid to be removed from the body through the kidneys along with the glucose. 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.
Cholesterol: Your levels of certain forms of cholesterol may increase when taking ertugliflozin-metformin. Your doctor will monitor you for these changes while you are taking this medication.
Dehydration: Ertugliflozin - metformin may cause a decrease in the amount of fluid in your 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 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): Ertugliflozin 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, even if your blood glucose level is normal.
Glucose control: When ertugliflozin 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. Ertugliflozin - metformin should not be used with insulin. 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 ertugliflozin depends on kidney function. 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. When lactic acidosis does occur (very rarely), 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.
Pancreatitis: Ertugliflozin - metformin 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.
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.
Thyroid function: Metformin can cause a decrease in thyroid stimulating hormone, the messenger that causes thyroid hormone to be produced by the body, if the thyroid gland is not working properly. If you have decreased thyroid 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.
If you develop symptoms of decreased thyroid function, such as unexpectedly feeling cold, depression, constipation, or fatigue, let your doctor know.
Urinary tract infections: Ertugliflozin has been associated with serious urinary tract infections, including kidney infections and blood infections caused by bacteria spreading from the urinary tract. If you experience symptoms of a urinary tract infection, such as a burning feeling when you urinate; pain or pressure in your back or lower abdomen; cloudy, dark, bloody, or strange-smelling urine; or fever or chills; contact your doctor as soon as possible.
Vitamin B12 levels: Metformin 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 ertugliflozin 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 ertugliflozin passes into breast milk. 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: People over the age of 65 are more likely to experience side effects of taking ertugliflozin - metformin
What other drugs could interact with this medication?
There may be an interaction between ertugliflozin -metformin and any of the following:
- acetylsalicylic acid (ASA)
- androgens (e.g., testosterone)
- angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril)
- atypical antipsychotics (e.g., clozapine, olanzapine, quetiapine, risperidone)
- carbonic anhydrase inhibitors (e.g., acetazolamide, brinzolamide, dorzolamide, topiramate)
- corticosteroids (e.g., budesonide, dexamethasone, hydrocortisone, prednisone)
- other diabetes medications (e.g., chlorpropamide, glyburide, insulin, rosiglitazone)
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
- hepatitis C antivirals (e.g., asunaprevir, daclatasvir, elbasvir, ledipasvir, sofosbuvir)
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- iodinated contrast agents
- monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, rasagiline, selegiline, tranylcypromine)
- progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
- 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)
- thyroid medications (e.g., levothyroxine)
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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