How does this medication work? What will it do for me?
Ertugliflozin – sitagliptin is a combination of two medications that work in different ways to reduce blood sugar. Both ertugliflozin and sitagliptin 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 sitagliptin and require additional medication to control blood glucose, or are already taking metformin, ertugliflozin and sitagliptin as individual components and have controlled blood glucose.
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. Sitagliptin 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.
This medication should be used as part of an overall diabetes management plan that includes a diet and exercise program.
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/100 mg
Each beige, almond-shaped, film-coated tablet, debossed with "554" on one side and plain on the other side, contains 5 mg of ertugliflozin and 100 mg of sitagliptin. Nonmedicinal ingredients: carnauba wax, croscarmellose sodium, dibasic calcium phosphate anhydrous, ferrosoferric oxide/black iron oxide, hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, sodium stearyl fumarate, and titanium dioxide.
15 mg/100 mg
Each brown, almond-shaped, film-coated tablet, debossed with "555" on one side and plain on the other side, contains 15 mg of ertugliflozin and 100 mg of sitagliptin. Nonmedicinal ingredients: carnauba wax, croscarmellose sodium, dibasic calcium phosphate anhydrous, ferrosoferric oxide/black iron oxide, hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, sodium stearyl fumarate, and titanium dioxide.
How should I use this medication?
The recommended starting dose of ertugliflozin - sitagliptin is 5 mg of ertugliflozin and 100 mg of sitagliptin, taken by mouth, once daily, in the morning. It may be taken with or without food. If your blood glucose level doesn't decrease enough, and additional glucose control is needed, your doctor may gradually increase the dose to a maximum of 15 mg of ertugliflozin and 100 mg of sitagliptin, taken once daily.
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 or any ingredients of this medication
- have severely reduced kidney function, end stage kidney disease, or are receiving dialysis
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.
- arm, leg or back pain
- increased need to urinate at night
- increased frequency of urination
- joint pain
- muscle aches
- sore throat
- stuffy or runny nose
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:
- low blood pressure (dizziness, fainting or lightheadedness when rising from a lying or sitting position)
- 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, painful or difficult urination)
- skin ulcers or sores
- symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness, blurred vision)
- symptoms of a kidney infection (e.g., painful, frequent or urgent need to urinate, fever or chills, cloudy or foul smelling urine, blood in the urine)
- symptoms of vaginal yeast infection (women; e.g., vaginal odour, curd-like discharge, itching)
- symptoms of yeast infection of the penis (men; e.g., lumpy, odorous discharge under foreskin; red, swollen, itchy head of the penis; pain when urinating or during sexual activity)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of diabetic ketoacidosis (e.g., difficulty breathing, nausea, vomiting, stomach pain, loss of appetite, confusion, extreme thirst, and unusual tiredness)
- signs of kidney failure (e.g., nausea, loss of appetite, weakness, passing little or no urine, breathlessness)
- signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- signs of a severe infection that has spread throughout the body (sepsis; fever, rapid breathing, fast heartbeat, pain or difficult urination)
- signs of a severe skin reaction (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)
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.
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.
Dehydration: Ertugliflozin 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): Ertugliflozin has been associated with DKA. This is a potentially life-threatening condition that 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: Some people taking ertugliflozin - sitagliptin 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.
Glucose control: When ertugliflozin - sitagliptin 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 ertugliflozin - sitagliptin. 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: Ertugliflozin - sitagliptin may cause a decrease in kidney function. 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.
Liver function: If you have reduced liver function or liver 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. This medication is not recommended for people with severely reduced liver function.
Pancreatitis: Ertugliflozin – sitagliptin 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: The ertugliflozin component of this medication 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.
Yeast infections: There is an increased risk of developing genital or vaginal yeast infections when taking ertugliflozin – sitagliptin. This occurs as a result of the increased glucose in the urine caused by ertugliflozin. 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 ertugliflozin or sitagliptin pass into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. It is recommended that women do not breast-feed if they are taking this medication.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: People over the age of 65 are more likely to experience side effects of taking ertugliflozin -sitagliptin. Doses for seniors should generally be lower and increase more slowly than for other adults.
What other drugs could interact with this medication?
There may be an interaction between ertugliflozin - sitagliptin and any of the following:
- acetylsalicylic acid (ASA)
- angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril)
- atypical antipsychotics (e.g., clozapine, olanzapine, quetiapine, risperidone)
- "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- blood pressure medications
- corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
- diabetes medications (e.g., chlorpropamide, gliclazide, glyburide, insulin, metformin, rosiglitazone)
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
- progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
- quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
- St. John's wort
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
- somatostatin acetate
- sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
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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