Empagliflozin, Linagliptin, And Metformin (Oral Route) Description and Brand Names

Description and Brand Names

Drug information provided by: Merative, Micromedex®

Descriptions

Empagliflozin, linagliptin, and metformin combination is used with proper diet and exercise to lower high blood sugar levels caused by type 2 diabetes. It is also used to lower the risk of death in patients with type 2 diabetes and heart disease.

Empagliflozin works in the kidneys to prevent absorption of glucose (blood sugar). This helps lower the blood sugar level. Linagliptin helps to control blood sugar levels by making the pancreas gland release more insulin. It also signals the liver to stop producing sugar when there is too much sugar in the blood. Metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and helps your body use sugar better. This medicine does not help patients who have insulin-dependent or type 1 diabetes. Type 1 diabetic patients must use insulin injections.

This medicine is available only with your doctor's prescription.

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of empagliflozin, linagliptin, and metformin combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of empagliflozin, linagliptin, and metformin combination in the elderly. However, elderly patients are more likely to have kidney problems, low blood pressure, and lactic acidosis, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breastfeeding

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.

Drug Interactions

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 this medicine, 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 this medicine 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.

Abiraterone Acetate
Acetazolamide
Alogliptin
Apalutamide
Aspirin
Berotralstat
Bexagliflozin
Bictegravir
Brinzolamide
Bupropion
Capmatinib
Carbamazepine
Chloroquine
Chlorothiazide
Chlorpropamide
Chlorthalidone
Cimetidine
Ciprofloxacin
Clarithromycin
Dasabuvir
Delafloxacin
Diatrizoate
Dichlorphenamide
Dofetilide
Dolutegravir
Dorzolamide
Efavirenz
Enoxacin
Enzalutamide
Ethiodized Oil
Fedratinib
Fexinidazole
Fosphenytoin
Furosemide
Gatifloxacin
Gemifloxacin
Glimepiride
Glipizide
Glyburide
Grepafloxacin
Hydrochlorothiazide
Hydroflumethiazide
Hydroxychloroquine
Indapamide
Insulin
Insulin Aspart, Recombinant
Insulin Bovine
Insulin Degludec
Insulin Detemir
Insulin Glargine, Recombinant
Insulin Glulisine
Insulin Lispro, Recombinant
Iodipamide
Iodixanol
Iohexol
Iopamidol
Iopanoic Acid
Iopromide
Iothalamate
Iotrolan
Ioversol
Ioxaglate
Ipodate
Isavuconazole
Itraconazole
Lanreotide Acetate
Levofloxacin
Levoketoconazole
Liraglutide
Lithium
Lomefloxacin
Lumacaftor
Methazolamide
Metolazone
Metrizamide
Mitotane
Moxifloxacin
Nateglinide
Norfloxacin
Octreotide Acetate
Ofloxacin
Ombitasvir
Oxcarbazepine
Paritaprevir
Pasireotide Diaspartate
Phenytoin
Pioglitazone
Polythiazide
Pramlintide
Primidone
Ranolazine
Repaglinide
Rifabutin
Rifampin
Rifapentine
Semaglutide
Sitagliptin
Somatrogon-ghla
Sotagliflozin
Sparfloxacin
St John's Wort
Tafenoquine
Thioctic Acid
Tipranavir
Tolazamide
Tolbutamide
Topiramate
Triamterene
Trovafloxacin
Vandetanib
Zonisamide

Using this medicine 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.

Acebutolol
Atenolol
Betaxolol
Bisoprolol
Bitter Melon
Carteolol
Carvedilol
Celiprolol
Colesevelam
Esmolol
Fenugreek
Glecaprevir
Glucomannan
Goldenseal
Guar Gum
Hydrastis
Isocarboxazid
Labetalol
Levobunolol
Linezolid
Methylene Blue
Metipranolol
Metoprolol
Nadolol
Nebivolol
Oxprenolol
Ozanimod
Patiromer
Penbutolol
Phenelzine
Pibrentasvir
Pindolol
Practolol
Procarbazine
Propranolol
Psyllium
Rasagiline
Rifampin
Safinamide
Selegiline
Sotalol
Timolol
Tirzepatide
Tranylcypromine
Verapamil

Other Interactions

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Do not stop or change your dose unless directed by your doctor.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Tell your doctor if you are on a low-salt or sodium diet.

Swallow the tablet whole. Do not cut, break, or chew it. Take this medicine in the morning with food.

Part of the extended-release tablet may pass into your stool (bowel movement). This is normal and nothing to worry about.

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.

Dosing

The dose of this medicine 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 this medicine. 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 (extended-release tablets):
- For type 2 diabetes:
  - Adults—1 tablet of 10 milligrams (mg) empagliflozin, 5 mg linagliptin, and 1000 mg metformin, or 25 mg empagliflozin, 5 mg linagliptin, and 1000 mg metformin once a day. Some patients may take 2 tablets of 5 milligrams (mg) empagliflozin, 2.5 mg linagliptin, and 1000 mg metformin, or 12.5 mg empagliflozin, 2.5 mg linagliptin, and 1000 mg metformin once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 25 mg empagliflozin, 5 mg linagliptin, and 2000 mg metformin.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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.

Storage

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

It is very important that your doctor check your progress at regular visits especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. It is not safe to take this medicine during the second and third trimester of pregnancy. It could harm an unborn baby. This medicine may cause some women who do not have regular monthly periods to ovulate. This can increase the chance of pregnancy if you are sexually active. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.

Under certain conditions, too much metformin can cause a serious condition called lactic acidosis. The symptoms of lactic acidosis are severe and appear quickly. Lactic acidosis usually occurs when other serious health problems are present, such as a heart attack or kidney failure. The symptoms of lactic acidosis include: stomach discomfort, decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, muscle pain or cramping, and unusual sleepiness, tiredness, or weakness. If you have more than one of these symptoms together, you should get immediate emergency medical help.

Limit how much alcohol you drink while using this medicine. Heavy alcohol use can increase your risk for lactic acidosis.

Pancreatitis (swelling and inflammation of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

If you are rapidly gaining weight, having chest pain, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of a heart problem.

Dizziness, lightheadedness, or fainting may occur with this medicine. 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 this medicine. 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, or stomach pain.

Tell your doctor if you have bloody urine, decrease in how much or how often you urinate, painful or difficult urination, lower back or side pain, fever, chills, rapid weight gain, or swelling of the face, finger, or lower legs. These may be symptoms of a serious kidney problem.

This medicine 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.

This medicine 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.

This medicine may cause a rare but serious bacterial infection, called necrotizing fasciitis of the perineum or Fournier's gangrene, which can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). Fournier's gangrene may lead to hospitalization, multiple surgeries, or death. Check with your doctor right away if you have fever, unusual tiredness or weakness, or pain, tenderness, redness, or swelling of the area between and around your anus and genitals.

This medicine may increase your risk of having lower leg, foot, or toe amputation. Check with your doctor right away if you have pain, tenderness, sores or ulcers, or infections on your leg or foot.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine 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.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a chest tightness, cough, difficulty swallowing, dizziness, rash, itching, blistering, peeling, or loosening of the skin, fast heartbeat, fever or chills, trouble breathing or swallowing, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue while you are using this medicine.

This medicine may cause severe joint pain. Call your doctor right away if you have difficulty in moving, severe joint pain, muscle pain or stiffness with this medicine.

This medicine may cause bullous pemphigoid. Tell your doctor if you have large, hard skin blisters while using this medicine.

There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes with a list of all your medicines.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine at least 3 days before having a major surgery, other procedures that require fasting, or diagnostic tests, especially tests that use a contrast dye. This medicine may also 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.

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:

Incidence not known

Agitation
bloating
blurred vision
change in the color, amount, or odor of vaginal discharge
chest pain or tightness
chills
cold sweats
coma
confusion
constipation
cool, pale skin
cough
cracks in the skin
darkened urine
decreased urine output
difficulty with moving
difficulty with swallowing
dilated neck veins
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
dry mouth
extreme fatigue
fast heartbeat
fever
flushed, dry skin
frequent or painful urination
fruit-like breath odor
headache
hives, itching, skin rash
hostility
increased hunger
increased thirst
increased urination
indigestion
irregular breathing
irregular heartbeat
irritability
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
lethargy
loss of appetite
loss of consciousness
loss of heat from the body
muscle pain or stiffness
muscle twitching
nausea
pain, tenderness, redness, or swelling of the area between and around your anus and genitals
pains in the stomach, side, or abdomen, possibly radiating to the back
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid weight gain
red, swollen skin
redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis
scaly skin
seizures
severe joint pain
shakiness
slurred speech
stupor
sweating
swelling of the face, fingers, ankles, hands, feet, or lower legs
trouble breathing
unexplained weight loss
unusual tiredness or weakness
vomiting
weight gain
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
ear congestion
loss of voice
runny or stuffy nose
sneezing
sore throat

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.

Portions of this document last updated: May 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/empagliflozin-linagliptin-and-metformin-oral-route/description/drg-20481614

Empagliflozin, Linagliptin, And Metformin (Oral Route)