Janumet XR 50mg/500mg Tablets

Janumet XR combines two antihyperglycemic agents with complementary mechanisms of action to improve glycemic control in patients with type 2 diabetes mellitus: Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and Metformin HCl, a biguanide. Sitagliptin works by inhibiting the inactivation of incretin hormones (glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]), thereby increasing their active levels. This leads to increased insulin synthesis and release from pancreatic beta cells and decreased glucagon secretion from pancreatic alpha cells in a glucose-dependent manner. Metformin primarily decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Urgent Side Effects: Seek Medical Attention Immediately

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Low blood sugar (hypoglycemia), which may be more likely when taking this medication with other diabetes drugs. Symptoms include:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Stomach problems that occur later during treatment, which may be a sign of lactic acidosis (a buildup of acid in the blood)
Severe and potentially life-threatening pancreas problems (pancreatitis), which can occur at any time during treatment. Symptoms include:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
A severe skin reaction called Stevens-Johnson syndrome, which can cause serious health problems and even death. Symptoms include:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Severe joint pain that is disabling or persistent
A skin reaction called bullous pemphigoid, which can cause blisters or skin breakdown
Heart failure, which can occur in people taking this medication, especially those with a history of heart failure or kidney problems. Symptoms include:
+ Feeling very tired
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs

Other Possible Side Effects

Most people do not experience serious side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical help if they bother you or do not go away:

Stomach pain or heartburn
Diarrhea, upset stomach, or vomiting
Gas
Feeling tired or weak
Headache
Signs of a common cold
Nose or throat irritation

Reporting Side Effects

If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. You can also contact your doctor for medical advice about side effects.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have type 1 diabetes, as this medication is not intended to treat this condition.
Certain health conditions, including:
+ Acidic blood problems
+ Kidney disease
+ Liver disease
Recent heart attack or stroke
Any difficulties with eating or drinking normally, such as before undergoing a procedure or surgery

Additionally, if you are scheduled to undergo an exam or test that involves contrast media, or have had one within the past 48 hours, discuss this with your doctor.

To ensure safe treatment, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any health problems you have

This information will help your doctor determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and laboratory tests should be conducted as directed by your doctor.

Before consuming alcohol, consult with your doctor to discuss any potential risks. Additionally, monitor your blood sugar levels as instructed by your doctor. If you experience low blood sugar, avoid driving, as it may increase your risk of being involved in an accident.

Be aware that stress, such as fever, infection, injury, or surgery, can affect your blood sugar control. Changes in physical activity, exercise, or diet may also impact your blood sugar levels. Adhere to the diet and exercise plan recommended by your doctor to maintain optimal blood sugar control.

In hot weather or during physical activity, drink plenty of fluids to prevent dehydration. If you are unable to consume liquids orally or experience persistent upset stomach, vomiting, or diarrhea, contact your doctor for guidance on preventing dehydration. Dehydration can lead to low blood pressure or worsen existing kidney problems.

Kidney problems have been reported in some individuals taking this medication, and in severe cases, hospitalization or dialysis may be necessary. Long-term treatment with metformin may cause low vitamin B-12 levels. If you have a history of low vitamin B-12 levels, discuss this with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Women of childbearing age who have not been ovulating may experience a return of fertility while taking this medication. To avoid pregnancy, use birth control measures while taking this drug.

If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks to you and your baby.

• Iodinated contrast agents (temporarily discontinue Janumet XR at the time of or prior to the procedure in patients with an eGFR between 30 and 60 mL/min/1.73m2; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the procedure; restart Janumet XR if renal function is stable.)
• Alcohol (acute or chronic excess use due to increased risk of lactic acidosis)

• Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide): May increase risk of lactic acidosis due to increased metformin accumulation.
• Drugs that reduce metformin clearance (e.g., ranolazine, vandetanib, dolutegravir, cimetidine): May increase metformin accumulation and risk of lactic acidosis. Consider benefits and risks of concomitant use.

• Digoxin: Sitagliptin may slightly increase digoxin plasma concentrations. Monitor digoxin levels if co-administered.
• Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin) that are eliminated by renal tubular secretion: May compete with metformin for renal tubular transport, potentially increasing metformin concentrations.
• Diuretics (especially loop diuretics): May increase risk of lactic acidosis due to potential for renal impairment.

• Not available

• Symptoms of lactic acidosis (e.g., malaise, unusual muscle pain, somnolence, respiratory distress, abdominal distress, hypothermia, hypotension)
• Symptoms of hypoglycemia (if used with insulin or sulfonylurea: e.g., sweating, tremor, dizziness, confusion, hunger)
• Gastrointestinal side effects (e.g., diarrhea, nausea, vomiting, abdominal discomfort)
• Symptoms of acute pancreatitis (e.g., severe, persistent abdominal pain, radiating to the back, with or without vomiting)
• Symptoms of bullous pemphigoid (e.g., blistering or erosions of the skin)

Limited data on Janumet XR use in pregnant women. Metformin is often continued in pregnant women with type 2 diabetes or gestational diabetes when diet and exercise are insufficient. Sitagliptin data are more limited. Use only if the potential benefit justifies the potential risk to the fetus.

Metformin is excreted into human milk in small amounts and is generally considered compatible with breastfeeding. Sitagliptin is excreted into milk in rats; human data are limited. Weigh the developmental and health benefits of breastfeeding against the mother’s clinical need for Janumet XR and any potential adverse effects on the breastfed infant.

Safety and effectiveness in pediatric patients have not been established. Not recommended for use in patients younger than 18 years of age.

Use with caution in elderly patients due to the greater likelihood of decreased renal function. Renal function should be assessed more frequently in older patients. The risk of lactic acidosis increases with advancing age and renal impairment.

• Janumet XR should be taken once daily with the evening meal to reduce gastrointestinal side effects associated with metformin.
• Patients should be instructed not to crush, cut, or chew the extended-release tablets, as this can affect drug release and lead to higher peak concentrations.
• Educate patients on the symptoms of lactic acidosis and emphasize the importance of seeking immediate medical attention if these occur.
• Temporarily discontinue Janumet XR before or at the time of iodinated contrast imaging procedures and before surgical procedures requiring restricted food and fluid intake.
• Monitor Vitamin B12 levels periodically in patients on long-term metformin therapy, especially those with risk factors for deficiency.
• Be aware of the potential for acute pancreatitis with sitagliptin; instruct patients to report severe, persistent abdominal pain.

• Other DPP-4 inhibitors (e.g., saxagliptin, linagliptin, alogliptin)
• Other biguanides (Metformin IR)
• Sulfonylureas (e.g., glipizide, glyburide, glimepiride)
• Thiazolidinediones (TZDs) (e.g., pioglitazone, rosiglitazone)
• SGLT2 inhibitors (e.g., empagliflozin, dapagliflozin, canagliflozin)
• GLP-1 receptor agonists (e.g., liraglutide, semaglutide, dulaglutide)
• Insulin
• Alpha-glucosidase inhibitors (e.g., acarbose, miglitol)
• Meglitinides (e.g., repaglinide, nateglinide)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.