Linagliptin & Metformin

Linagliptin/metformin is a prescription medication used to treat type 2 diabetes in adults. Linagliptin/metformin is a tablet containing two prescription drugs, linagliptin and metformin. Linagliptin belongs to a group of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, which help lower blood sugar levels. Metformin belongs to a group of drugs called biguanides, which decrease the amount of sugar made by the liver and help cells to respond to insulin.

This medication comes in tablet form and is taken twice a day, with meals.

This medication is also available as an extended-release tablet and is to be taken once a day with a meal. Do not split, crush, dissolve or chew tablets. Swallow tablets whole.

Common side effects of linagliptin/metformin include stuffy nose, sore throat, and diarrhea. 

Linagliptin/metformin is a prescription medicine that contains 2 diabetes medicines, linagliptin and metformin. It can be used along with diet and exercise to help control blood sugar in adults with type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Linagliptin & Metformin may be found in some form under the following brand names:

• Jentadueto

Linagliptin/metformin may cause serious side effects. See "Drug Precautions".

The most common side effects of linagliptin/metformin include:

• stuffy or runny nose and sore throat
• diarrhea

Linagliptin/metformin can also cause low blood sugar (hypoglycemia). If you take linagliptin/metformin with another medication that can cause low blood sugar, such as sulfonylureas or insulin, you have a higher risk of having low blood sugar. Tell your doctor if you take other diabetes medicines. If you have symptoms of low blood sugar, you should check your blood sugar and treat it if it is low; then call your doctor. Symptoms of low blood sugar include:

• shaking
• sweating
• rapid heartbeat
• change in vision
• hunger
• headache
• change in mood

These are not all the possible side effects of linagliptin/metformin. For more information, ask your doctor or pharmacist.

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:

• other medicines that can lower your blood sugar
• rifampin (Rifadin, Rimactane, Rifater, Rifamate), an antibiotic that is used to treat tuberculosis

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

Serious side effects can happen in people taking linagliptin/metformin, including:

1. Lactic Acidosis. Metformin, one of the medicines in linagliptin/metformin, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Stop taking linagliptin/metformin and call your doctor right away if you get any of the following symptoms of lactic acidosis:

• feel very weak or tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have unusual sleepiness or sleep longer than usual
• have sudden stomach or intestinal problems with nausea and vomiting or diarrhea
• feel cold, especially in your arms and legs
• feel dizzy or lightheaded
• have a slow or irregular heartbeat

You have a higher chance of getting lactic acidosis with linagliptin/metformin if you:

• have kidney problems. People whose kidneys are not working properly should not take linagliptin/metformin.
• have liver problems
• have congestive heart failure that requires treatment with medicines
• drink alcohol very often, or drink a lot of alcohol in short-term ("binge" drinking)
• get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
• have certain x-ray tests with dyes or contrast agents that are injected into your body
• have surgery
• have a heart attack, severe infection, or stroke
• are 80 years of age or older and have not had your kidneys tested

2. Low blood sugar (hypoglycemia). If you take linagliptin/metformin with another medication that can cause low blood sugar, such as sulfonylureas or insulin, you have a higher risk of having low blood sugar. Tell your doctor if you take other diabetes medicines. If you have symptoms of low blood sugar, you should check your blood sugar and treat it if it is low; then call your doctor. Symptoms of low blood sugar include:

• shaking
• sweating
• rapid heartbeat
• change in vision
• hunger
• headache
• change in mood

3. 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.

Do not take linagliptin/metformin if you:

• have kidney problems
• have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine).
• are allergic to linagliptin, metformin, or any of the ingredients in linagliptin/metformin.

Symptoms of a serious allergic reaction to linagliptin/metformin are:

• rash
• raised red patches on your skin (hives)
• swelling of your face, lips, and throat that may cause difficulty breathing or swallowing

Follow dietary (food) recommendations made by your doctor and dietitian which should include a healthy diet. Skipping meals should be avoided as this can cause problems maintaining blood sugar control. There are no specific foods to avoid while using linagliptin/metformin.

Before you take linagliptin/metformin, tell your doctor if you:

• have kidney problems
• are going to get an injection of dye or contrast agents for an x-ray procedure. Linagliptin/metformin will need to be stopped for a short time. Talk to your doctor about when you should stop linagliptin/metformin and when you should start linagliptin/metformin again. 
• have liver problems
• have heart problems, including congestive heart failure
• drink alcohol very often, or drink a lot of alcohol in short term "binge" drinking
• have any other medical conditions
• are pregnant or planning to become pregnant. It is not known if linagliptin/metformin will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
• are breastfeeding or plan to breastfeed. It is not known if linagliptin/metformin passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take linagliptin/metformin.

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.

Linagliptin/metformin falls into category B. In animal studies, pregnant animals were given linagliptin, and some babies had problems. There are no well-done studies that have been done in humans with linagliptin.

It is not known if linagliptin/metformin 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 linagliptin/metformin.

Take linagliptin/metformin exactly as your doctor tells you to take it.

This medication comes as a regular release tablet and as an extended-release tablet. 

• Take linagliptin/metformin regular release tablet (Jentadueto) 2 times each day with meals. Taking linagliptin/metformin with meals may lower your chance of having an upset stomach.
• Take linagliptin/metformin extended-release tablets (Jentadueto XR) once a day with a meal. Do not split, crush, dissolve or chew tablets. Swallow tablets whole.

Your doctor will tell you how much linagliptin/metformin to take and when to take it.

• If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take 2 doses of linagliptin/metformin at the same time.
• Your doctor may tell you to take linagliptin/metformin along with other diabetes medicines. Low blood sugar can happen more often when linagliptin/metformin is taken with certain other diabetes medicines.
• You may need to stop taking linagliptin/metformin for a short time. Call your doctor for instructions if you:
  • are dehydrated (have lost too much body fluid). Dehydration can occur if you are sick with severe vomiting, diarrhea, or fever, or if you drink a lot less fluid than normal.
  • plan to have surgery
• When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor’s instructions.
• Check your blood sugar as your doctor tells you to.
• Stay on your prescribed diet and exercise program while taking linagliptin/metformin.
• Talk to your doctor about how to prevent, recognize, and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and complications of diabetes.
• Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
• Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with linagliptin/metformin.

Take linagliptin/metformin exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

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

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your kidney function

The maximum recommended dose  is 5 mg linagliptin/2000 mg metformin hydrochloride. 

If you take too much linagliptin/metformin, call your doctor, or go to the nearest hospital emergency room right away.

• Store linagliptin/metformin at 59°F to 86°F (15°C to 30°C).
• Keep tablets dry.

Keep linagliptin/metformin and all medicines out of the reach of children.

WARNING: RISK OF LACTIC ACIDOSIS

Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk increases with conditions such as renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure.

The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress.

Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.

If acidosis is suspected, linagliptin/metformin should be discontinued and the patient hospitalized immediately.