Jentadueto

(Linagliptin/Metformin Hydrochloride)

The active ingredients in the diabetes medicine Jentadueto are linagliptin and metformin hydrochloride. Linagliptin is a DPP-4 inhibitor. It acts by inhibiting DPP-4 (dipeptidyl peptidase-4), a protein that degrades some hormones in the body. When DPP-4 reduces these hormone levels, you get excessive blood sugar levels. Linagliptin increases insulin production while decreasing sugar production by inhibiting the function of DPP-4.

Metformin HCl is a biguanide that reduces blood sugar in a variety of ways. It reduces the quantity of sugar that your liver produces. It also increases your body's sensitivity to insulin. When your body is able to better use insulin, it can transport more blood sugar into your cells and use it as energy. Metformin also reduces the quantity of sugar absorbed through the intestines.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Jentadueto. However, the following is a synopsis of the general guidelines for the use of Jentadueto:

• Jentadueto is typically taken with food.
• Swallow the tablet whole; do not chew, crush, or break it.
• You should be able to recognize the symptoms of low blood sugar (hypoglycemia). This includes feeling extremely hungry, dizzy, angry, confused, worried, or shaky. To correct hypoglycemia quickly, eat or drink something with a high sugar content.
• If you suffer from severe hypoglycemia, your doctor may prescribe a glucagon injection kit. Make sure your family or close friends know how to administer this injection in an emergency.

The most common side effects of Jentadueto include:

• Upper respiratory tract infection symptoms such as cough, runny nose, and sore throat.
• Diarrhea.
• Nausea.

Some individuals may experience serious side effects while using Jentadueto. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Increased risk of lactic acidosis with symptoms such as confusion, weakness, fast or slow heartbeat, unusual muscle pain, trouble breathing, loss of appetite, nausea, and vomiting.
• Pancreatic inflammation causes upper stomach pain, fever, nausea, and vomiting.
• Severe skin reactions (such as bullous pemphigoid) or allergic reactions include skin rash, blisters, hives, sores, difficulty breathing, and swelling.
• Heart failure symptoms such as shortness of breath, swelling of the ankles, feet, or hands, unusual weight gain, weakness, or fatigue.
• Low vitamin B12 levels can cause pain and tingling sensations.
• Severe joint pain.

These are not all of the possible side effects of Jentadueto. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Jentadueto, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Kidney problems.
• Liver problems.
• Heart failure
• A recent heart attack.
• History of pancreatitis.
• Gallstones.
• High triglycerides.
• Irregular heartbeat or fast heartbeat.
• Drink alcohol.
• Vitamin B12 deficiency.
• Severe infection.
• Have an MRI, X-ray, or CT scan that requires a contrast agent.

Boxed Warning

Metformin-associated lactic acidosis is an uncommon but significant illness that can be fatal, with reported symptoms including coldness, hypotension, and arrhythmias. It is mainly caused by metformin buildup and is more common in individuals with kidney or liver impairment, sepsis, dehydration, heavy alcohol consumption, acute heart failure, surgery, or certain medicines such as carbonic anhydrase inhibitors. Symptoms of lactic acidosis include malaise, muscle discomfort, breathing problems, sleepiness, and stomach pain. If lactic acidosis is suspected, the patient should be admitted to the hospital for supportive treatment, and hemodialysis should be initiated as soon as possible.

• Severe kidney issues.
• Metabolic acidosis, including diabetic ketoacidosis.
• History of adverse reaction to metformin or Tradjenta (linagliptin).

A 6-month clinical research found that persons who took Jentadueto saw their A1C drop by 1.2% to 1.6% (depending on the dose of Jentadueto), compared to a 0.1% decline in those who took a placebo. A1C is a measure of the average amount of sugar in your blood over three months. Furthermore, participants who took Jentadueto observed their fasting blood sugar levels (before their first meal of the day) decline by an average of 33 mg/dL to 49 mg/dL, whereas those who took a placebo saw their fasting blood sugar levels rise by roughly 10 mg/dL.

When Jentadueto is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Rifampin.
• Cimetidine.
• Sulfonylurea.

Jentadueto (linagliptin/metformin): The typical starting dose is 2.5 mg/500 mg (linagliptin/metformin) taken orally twice daily with food; this is usually a lower dose. The highest dose is 2.5 mg/1000 mg (linagliptin/metformin) twice a day.

Jentadueto XR (linagliptin and metformin hydrochloride extended-release): The typical starting dose is 5 mg/1000 mg (linagliptin/metformin) taken orally once daily with food. The maximum dose is 5 mg/2000 mg (linagliptin/metformin) once daily.]

If you miss a dose, take the drug (with food) as soon as possible, but skip the missed dose if it is nearly time for the next dose. Do not take two doses at the same time.

Store at room temperature and keep out of reach of children.

Boehringer Ingelheim is the company that manufactures Jentadueto.

There are no generic name versions available of Jentadueto.

Do not discontinue Jentadueto without first talking to your doctor. Stopping this medication quickly can worsen your blood sugar levels and cause other health issues.

If you are or become pregnant, follow your doctor's instructions for using Jentadueto. Controlling diabetes is critical during pregnancy because high blood sugar levels (hyperglycemia) can create difficulties in both the mother and the baby.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you during lactation.