Janumet

The active ingredients in Janumet are sitagliptin phosphate and metformin hydrochloride. Sitagliptin is considered to be a dipeptidyl peptidase-4 (DPP-4) inhibitor, while metformin HCL is known as a biguanide.

As a DPP-4 inhibitor, sitagliptin works to keep blood sugar levels low by blocking the action of DPP-4. This helps prevent the breakdown of insulin while also stopping your body from making glucagon, a hormone that increases your blood sugar.

Metformin works to decrease the amount of sugar your body absorbs from food, reduces the amount of sugar that your liver makes, and helps your body’s own insulin work better.

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 Janumet. However, the following is a synopsis of the general guidelines for the use of Janumet:

• Take this medication orally exactly as directed by your physician.
• The starting dose of Janumet should be individualized for the patient.
• Typically, you take Janumet orally twice daily with meals (with gradual dose escalation to reduce the gastrointestinal (GI) side effects, such as upset stomach, due to metformin).
• Your doctor may adjust the dose based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin.

The most common side effects of Janumet seen in clinical studies include:

• Diarrhea.
• Stuffy or runny nose or sore throat.
• Upper respiratory tract infection.
• Headache.

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

• Severe allergic reaction - hives, itching, swelling of the face, rash, trouble breathing.
• Severe skin reaction - bullous pemphigoid.
• Kidney problems.
• Inflammation of the pancreas (pancreatitis).
• Heart failure - shortness of breath, irregular heartbeat, chest pain, unusual weight gain.
• Low blood sugar (hypoglycemia).
• Symptoms of lactic acidosis - muscle pain, stomach pain, fast heartbeat.
• Vitamin B12 deficiency.
• Severe joint pain.

These are not all of the possible side effects of Janumet. 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 Janumet, 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 if you have:

• Liver problems.
• Heart problems (congestive heart failure, heart attack).
• Drink alcohol in excess amounts.
• Dehydration.
• Severe infection.
• Stroke.
• Inflammation of the pancreas (pancreatitis).
• Gallbladder problems.
• High triglyceride levels.
• Low vitamin B12 levels.
• Upcoming surgery.

Boxed Warning

• Increased risk of lactic acidosis can occur due to metformin accumulation.

• Severe kidney disease or diabetic ketoacidosis.
• Temporarily discontinue Janumet in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials.
• Previous hypersensitivity/allergic reaction to metformin or sitagliptin (Januvia).

Janumet works quickly to lower blood sugar within the first one to two weeks of use.

When Janumet 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:

• Anti-seizure medications.
• Anti-viral medications for HIV or AIDS.
• Antipsychotic medications.
• Dichlorphenamide.
• Cimetidine.
• Ranolazine.
• Vandetanib.
• Corticosteroid medications (prednisone).
• Estrogen-containing medications (birth control pills).
• Heart or blood pressure medications.
• Other diabetes medications (insulin, sulfonylureas).

Janumet comes in a variety of dosage forms, including:

• Oral tablets - 50 mg/500 mg, 50 mg/1000 mg.
• Extended-release tablets (Janumet XR) - 50 mg/500 mg, 50 mg/1000 mg, 100 mg/1000 mg.

Store this medication at room temperature and keep it out of the reach of children.

Merck & Co. Inc. is the pharmaceutical company that manufactures Janumet.

There are lower-cost generics available for the brand-name Janumet.

Do not stop or adjust your use of this medication without first consulting your doctor.

It is unknown if or how Janumet could affect pregnancy or harm an unborn baby. It is known that poorly controlled diabetes in pregnancy can increase the risk of harm to you and your unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown if Janumet passes into breast milk. 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.