What Is JANUVIA® sitagliptin?

what is the drug januvia

Elderly subjects (65 to 80 years) had approximately 19% higher plasma concentrations of sitagliptin compared to younger subjects. Following a [14C]sitagliptin oral dose, approximately 16% of the radioactivity was excreted as metabolites of sitagliptin. Six metabolites were detected at trace levels and are not expected to contribute to the plasma DPP-4 inhibitory activity of sitagliptin. In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin was CYP3A4, with contribution from CYP2C8. Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preÂeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity.

Januvia is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Ask your doctor or pharmacist about the best way to increase your blood sugar to a safe level. Make sure you have sources of sugar available so you can quickly treat hypoglycemia if you have it.

Sitigliptin, the active ingredient in Januvia, is also available in combination with metformin (Janumet and Janumet XR) in a fixed-dose tablet for ease of administration. If you notice any of these heart failure symptoms yourself, tell your doctor right away. They’ll monitor your heartbeat and prescribe you with medications to help your heart to function properly. Januvia is meant to be taken long term, and the drug shouldn’t stop working. Januvia should help manage your blood sugar for as long as you take it.

Interactions

There aren’t known interactions between Januvia and alcohol. But drinking too much alcohol can decrease the level of glucose (sugar) in your blood. This can lead to a condition called hypoglycemia (low blood sugar). If you drink heavily on a regular basis and have low blood sugar, your blood sugar level may drop even more. In these clinical studies, the overall rate of diarrhea was low when people took Januvia by itself or with other diabetes drugs. This included people who took metformin, which is a common cause of diarrhea.

If you’re interested in taking cinnamon, chromium, or another natural alternative to help treat type 2 diabetes, talk with your doctor.
If you have pancreatitis, your doctor may have you stop taking Januvia.
Heart failure occurs when your heart can’t pump enough blood to the rest of your body.
If you and your doctor determine that Januvia is safe and effective for you, you’ll likely take the drug long term.
Your doctor may prescribe Januvia by itself or with other drugs that also treat diabetes.
If you have any of these symptoms, tell your doctor right away.

Januvia may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before you take Januvia. Taking a medication with certain vaccines, foods, and other things can affect how the medication works. Metformin is one of the most commonly prescribed drugs for type 2 diabetes.

Januvia and pregnancy

There was an increased incidence of combined liver adenoma/carcinoma in males and females and of liver carcinoma in females at 500 mg/kg. This dose results in exposures approximately 60 times the human exposure at the maximum recommended daily adult human dose (MRHD) of 100 mg/day based on AUC comparisons. Liver tumors were not observed at 150 mg/kg, approximately 20 times the human exposure at the MRHD. A two-year carcinogenicity study was conducted in male and female mice given oral doses of sitagliptin of 50, 125, 250, and 500 mg/kg/day. There was no increase in the incidence of tumors in any organ up to 500 mg/kg, approximately 70 times human exposure at the MRHD.

If you’ve had heart failure in the past, taking Januvia may increase your risk of developing the condition again. Heart failure occurs when your heart can’t pump enough blood to the rest of your body. The Food and Drug Administration (FDA) hasn’t approved Januvia to treat type 1 diabetes. With type 2 diabetes, your body develops insulin resistance. This means that your body can’t use insulin the right way. As the level of sugar in your blood increases, the level decreases in your cells and organs.

what is the drug januvia

Also, tell your doctor if you’re taking any medications. This is important because some medications can interfere with Januvia. Januvia contains the active drug sitagliptin, and Tradjenta contains the active drug linagliptin. Another study suggested that certain people may have a higher risk of thyroid cancer with Januvia.

Drug Summary

It is unclear how these findings relate to changes in glycemic control in patients with type 2 diabetes mellitus. JANUVIA (jah-NEW-vee-ah) is a once-daily prescription pill that, along with diet and exercise, helps lower blood sugar levels in adults with type 2 diabetes. Normally, incretin hormones are rapidly deactivated by an enzyme called dipeptidyl peptidase 4 (DPP-4). However, Januvia is in a class of drugs known as dipeptidyl peptidase 4 (DPP-4) inhibitors, which work by blocking the deactivation of incretin hormones. By increasing and prolonging active incretin levels, Januvia increases insulin release from the pancreas and decreases glucagon levels and glucose release from the liver. Januvia works in response to your differing blood sugar levels.

How is Januvia taken?

People in this study had high blood pressure and high cholesterol but did not have diabetes. After taking Januvia for 3 months, they reported reduced body weight. However, it’s possible that Januvia might help people with type 1 diabetes in other ways. Until more studies are done, there is not enough information to recommend Januvia to treat type 1 diabetes. They can recommend the best treatment to help you manage your condition. Other drugs are available that can treat your condition.

Januvia stops the activity of a protein called dipeptidyl peptidase 4 (DPP-4). DPP-4 reduces the amount of two substances that decrease the amount of insulin in your body. These chemicals are called glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Your body helps regulate the amount of sugar in your blood with a type of hormone called insulin. Hormones are substances that can affect how certain cells and organs work. Once you start taking Januvia, your doctor may adjust your dosage of insulin or insulin medications.

If you notice other effects not listed above, contact your doctor or pharmacist. Read the Medication Guide provided by your pharmacist before you start using sitagliptin and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all medicines you start or stop using.

Januvia blocks a certain protein in your body that inactivates incretin hormones. These hormones help control your blood sugar levels by affecting your pancreas and stimulating it to make and release insulin. By blocking the protein, more active incretin hormones are available to help control your blood sugar levels. In a randomized, placebo-controlled crossover study, 79 healthy subjects were administered a single oral dose of sitagliptin 100 mg, sitagliptin 800 mg (8 times the recommended dose), and placebo. At the recommended dose of 100 mg, there was no effect on the QTc interval obtained at the peak plasma concentration, or at any other time during the study.

Low blood sugar is more likely if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal. Like Januvia, glipizide is a diabetes drug that stimulates the pancreas to release insulin. (Insulin helps lower blood sugar levels.) It belongs to the same group of diabetes drugs as glyburide (Glynase) and glimepiride (Amaryl).