Empagliflozin and linagliptin

Empagliflozin/linagliptin is a prescription medication used to treat Type 2 Diabetes.

It is a single product containing 2 medications: empagliflozin and linagliptin.

Empagliflozin belongs to a group of drugs called sodium-glucose co-transporter-2 (SGLT2) inhibitor. It works by stopping the reabsorption of glucose by the kidney, increasing glucose excretion from the body, and lowering blood sugar levels.

Linagliptin belongs to a group of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors. These work by increasing the amount of insulin made by the body after meals, and by decreasing the amount of glucose produced by the liver.

This medication comes in tablet form and is taken typically once a day in the morning, with or without food.

Common side effects of empagliflozin/linagliptin include urinary tract infections, stuffy or runny nose and sore throat, and upper respiratory tract infections.

Empagliflozin/linagliptin is a prescription medication used to treat Type 2 Diabetes.

Empagliflozin and linagliptin may be found in some form under the following brand names:

• Glyxambi

Serious side effects have been reported with empagliflozin/linagliptin. See the “Drug Precautions” section.

Common side effects of empagliflozin/linagliptin include the following:

• Urinary tract infections (UTIs)
• Increased frequency of urination 
• Low blood sugars
• Headaches
• Back and joint pain
• Upper respiratory infections
• Genital fungal infections (yeast infections)
• Increases in LDL cholesterol (bad cholesterol)

This is not a complete list of side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Diuretics such as
  • acetazolamide (Diamox)
  • amiloride (Midamor)
  • bumetanide (Bumex)
  • chlorothiazide (Diuril)
  • chlorthalidone (Thalitone)
  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • hydrochlorothiazide (Microzide, HCTZ)
  • metolazone (Zaroxolyn)
  • torsemide (Demadex)
  • triamterene (Dyrenium, Dyazide, Maxzide)
• Insulin
• Certain sugar lowering medication, such as
  • Glyburide (Micronase, Diabeta, Glynase)
  • Glimepiride (Amaryl)
  • Glipizide (Glucotrol)
  • Repaglinide (Prandin)
  • Nateglinide (Starlix)
• Medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)
• Medications that block the p-glycoprotein transporter such as amiodarone (Cordarone, Pacerone), azithromycin (Zithromax, Zmax), captopril (Capoten), carvedilol (Coreg), clarithromycin (Biaxin), conivaptan (Vaprisol), cyclosporine (Neoral, Sandimmune, Gengraf), diltiazem (Cardizem), dronedarone (Multaq), erythromycin (EES, Ery-Tab), felodipine (Plendil),  itraconazole (Sporanox, Onmel), ketoconazole (Nizoral), lopinavir and ritonavir (Kaletra), quinidine (Cardioquine, Quinact, Duraquin), ranolazine (Ranexa), verapamil (Calan, Isoptin, Covera, Verelan)

This is not a complete list of drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with empagliflozin/linagliptin including the following:

• Pancreatitis (inflammation or swelling of the pancreas). Tell your healthcare provider right away if you have some or all of the following symptoms of pancreatitis:
  • Stomach or abdominal pains
  • Swollen or tender stomach/abdomen
  • Nausea
  • Vomiting
  • Fever
• Low Blood Pressure (hypotension). Tell your healthcare provider right away if you have some or all of the following symptoms of low blood pressure:
  • Dizziness
  • Feeling lightheaded, especially when standing up
  • Fainting
  • Feeling tired or fatigue
  • Having blurry vision
• Low Blood Sugars (hypoglycemia). Tell your healthcare provider right away if you have some or all of the following symptoms of low blood sugars:
  • Feeling shaky or trembling
  • Feeling nervous or anxious
  • Sweating
  • Confusion
  • Having a fast or irregular heartbeat
  • Having blurry vision
• Genital fungal infections (yeast infections). Tell your healthcare provider right away if you have some or all of the following symptoms of a yeast infection:
  • Having an abnormal vaginal discharge. Discharge can range from water to think/chunky and white. 
  • Itching or burning of the vaginal area
  • Pain during intercourse or sex
  • Pain when urinating or peeing
  • Redness in the vaginal area
• Severe and persistent joint pain. If you experience severe and persistent joint pain, contact your doctor right away. Do not stop taking your medication. Your doctor will decide if your medication is the possible cause of severe  joint pain and will discontinue the drug if appropriate.
• Urinary Tract Infections (UTIs). Tell your healthcare provider right away if you have some or all of the following symptoms of
  • Having pain or burning when urinating (peeing)
  • Having a fever
  • Feeling tired
  • Having an urge to urinate or pee often
  • Having urine or pee that smells bad
  • Urine that looks red or cloudy
  • Pain in the lower back

Do not take empagliflozin/linagliptin if you:

• are allergic to empagliflozin, linagliptin or to any of its ingredients
• have severe kidney damage or are on dialysis

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of empagliflozin/linagliptin, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking empagliflozin/linagliptin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to empagliflozin, linagliptin, or to any of its ingredients
• have kidney problems
• are taking insulin or any other medications that lower blood sugars
• have, or have a history of, low blood pressure
• have problems with high cholesterol levels

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Empagliflozin/linagliptin falls into category ­C. There are no well-controlled studies that have been done in pregnant women. Empagliflozin/linagliptin should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if empagliflozin/linagliptin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using empagliflozin/linagliptin.

Take empagliflozin/linagliptin exactly as prescribed.

Empagliflozin/linagliptin comes in a tablet form, and is taken once daily.

Empagliflozin/linagliptin can be taken with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of empagliflozin/linagliptin at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of empagliflozin/linagliptin is is 10 mg empagliflozin/5 mg linagliptin once daily. The maximum dose is 25 mg empagliflozin/5 mg linagliptin once daily.

If you take too much empagliflozin/linagliptin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If empagliflozin/linagliptin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store empagliflozin/linagliptin at room temperature.
• Keep this and all medicines out of the reach of children.