empagliflozin and linagliptin (Oral route)
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Pharmacologic Class: Sodium Glucose Co-Transporter 2 Inhibitor
Uses For empagliflozin and linagliptin
Empagliflozin and linagliptin combination is used together with proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes. It is also used to lower risk of death in patients with type 2 diabetes and heart disease. Empagliflozin works in the kidneys to prevent absorption of glucose (blood sugar). Linagliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar (glucose) when there is too much sugar in the blood. empagliflozin and linagliptin does not help patients who have insulin-dependent or type 1 diabetes.
empagliflozin and linagliptin is available only with your doctor's prescription.
Before Using empagliflozin and linagliptin
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For empagliflozin and linagliptin, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to empagliflozin and linagliptin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of empagliflozin and linagliptin combination in the pediatric population.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of empagliflozin and linagliptin combination in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking empagliflozin and linagliptin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using empagliflozin and linagliptin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- St John's Wort
- Thioctic Acid
Using empagliflozin and linagliptin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of empagliflozin and linagliptin. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, history of or
- Pancreatic insulin deficiency, history of—May increase risk for more serious side effects.
- Dehydration or
- Dyslipidemia (high fats or cholesterol in the blood) or
- Genital yeast (fungus) infections (eg, balanitis, balanoposthitis, vulvovaginitis), history of or
- Hypotension (low blood pressure) or
- Kidney disease or
- Urinary tract infection, history of—Use with caution. May make these conditions worse.
- Diabetic ketoacidosis (high ketones and acid in the blood) or
- Kidney disease, severe or
- Patients receiving dialysis or
- Type I diabetes—Should not be used in patients with these conditions.
- Hypercholesterolemia (high cholesterol in the blood) or
- Hypertriglyceridemia (high triglycerides and fats in the blood) or
- Obesity or
- Pancreas problems, history of—Use with caution. May increase risk for pancreatitis (swelling of the pancreas).
Proper Use of empagliflozin and linagliptin
Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and will help the medicine work properly. Exercise regularly and test for sugar in your blood or urine as directed.
empagliflozin and linagliptin comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take empagliflozin and linagliptin with or without food.
The dose of empagliflozin and linagliptin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of empagliflozin and linagliptin. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For type 2 diabetes:
- Adults—1 tablet once a day, taken in the morning. Each tablet contains 10 milligrams (mg) of empagliflozin and 5 mg of linagliptin. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 25 mg of empagliflozin and 5 mg of linagliptin.
- Children—Use and dose must be determined by your doctor.
- For type 2 diabetes:
If you miss a dose of empagliflozin and linagliptin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using empagliflozin and linagliptin
It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take empagliflozin and linagliptin. Blood and urine tests may be needed to check for unwanted effects.
Pancreatitis may occur while you are using empagliflozin and linagliptin. Check with your doctor right away if you have a sudden and severe stomach pain, chills, constipation, nausea, vomiting, loss of appetite, fever, or lightheadedness.
Dizziness, lightheadedness, or fainting may occur with empagliflozin and linagliptin. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Taking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Check with your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water.
Ketoacidosis (high ketones and acid in the blood) may occur while you are using empagliflozin and linagliptin. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination.
empagliflozin and linagliptin may cause hypoglycemia (low blood sugar). This is more common when empagliflozin and linagliptin is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. . It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.
empagliflozin and linagliptin may cause vaginal yeast infections in women and yeast infections of the penis in men. This is more common in patients who have a history of genital yeast infections or in men who are not circumcised. Women may have a vaginal discharge, itching, or odor. Men may have redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis. Check with your doctor right away if you have any of these symptoms.
empagliflozin and linagliptin may increase risk of having urinary tract infections, including pyelonephritis or urosepsis. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.
empagliflozin and linagliptin may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using empagliflozin and linagliptin.
empagliflozin and linagliptin may cause severe and disabling joint pain. Call your doctor right away if you have severe joint pain while using empagliflozin and linagliptin.
empagliflozin and linagliptin may cause bullous pemphigoid. Tell your doctor if you have large, hard skin blisters while using empagliflozin and linagliptin.
Make sure any doctor or dentist who treats you knows that you are using empagliflozin and linagliptin. empagliflozin and linagliptin may affect the results of certain medical tests (eg, urine glucose tests may not be accurate).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
empagliflozin and linagliptin Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- frequent urge to urinate
- lower back or side pain
- blurred vision
- cold sweats
- cool, pale skin
- darkened urine
- dry mouth
- fast heartbeat
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- large, hard skin blisters
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- loss of consciousness
- pains in the stomach, side, or abdomen, radiating to the back
- severe joint pain
- slurred speech
- stomach pain
- troubled breathing
- unexplained weight loss
- unusual tiredness or weakness
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Body aches or pain
- difficulty with breathing
- ear congestion
- loss of voice
- runny or stuffy nose
- sore throat
- Discharge with a strong odor from the penis
- redness, itching, swelling, or pain around the penis
- vaginal discharge, itching, or odor
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
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More about empagliflozin/linagliptin
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- Support Group
- En Español
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- Drug class: antidiabetic combinations
Other brands: Glyxambi