Janumet XR 50mg/1000mg 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 hydrochloride, a biguanide. Sitagliptin works by inhibiting the inactivation of incretin hormones (GLP-1 and GIP) by DPP-4. This increases the levels of active incretin hormones, which enhances glucose-dependent insulin secretion from pancreatic beta cells and decreases glucagon secretion from pancreatic alpha cells. 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 Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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). If you experience:
+ Upset stomach
+ Vomiting
+ Diarrhea
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 (Stevens-Johnson syndrome), which can cause serious health problems and even death. Seek medical help immediately if you notice:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
Joint pain that is severe, disabling, or persistent
A skin reaction called bullous pemphigoid, which can cause blisters or skin breakdown. Seek medical help if you notice:
+ Blisters
+ Skin breakdown
Heart failure, which can occur in people taking this medication. If you have a history of heart failure or kidney problems, inform your doctor. Seek medical help immediately if you experience:
+ Extreme fatigue
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs

Other Possible Side Effects

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

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 symptoms 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, such as before undergoing a procedure or surgery

Additionally, if you are scheduled for 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 medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
* 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. Regularly monitor your blood work and other lab tests as instructed by your doctor.

Before consuming alcohol, discuss the potential risks with your doctor. Additionally, check your blood sugar levels as directed by your doctor to ensure they are within a safe range. If your blood sugar levels are low, avoid driving, as this can increase the risk of accidents.

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

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 stomach upset, 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, which may require hospitalization or dialysis, have been associated with this medication. Long-term treatment with metformin may also lead to low vitamin B-12 levels. If you have a history of low vitamin B-12 levels, consult your doctor.

If you are 65 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, inform your doctor to discuss the potential benefits and risks to you and your baby.

• Iodinated contrast agents (for metformin, temporarily discontinue Janumet XR at the time of or prior to the procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; 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.)
• Severe renal impairment (eGFR < 30 mL/min/1.73m2)
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
• Hypersensitivity to sitagliptin, metformin, or any component of Janumet XR

• Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide): May increase risk of lactic acidosis with metformin.
• Alcohol: Potentiates the effect of metformin on lactate metabolism, increasing the risk of lactic acidosis, especially with excessive intake or in patients with hepatic impairment.
• Drugs that reduce metformin clearance (e.g., ranolazine, vandetanib, dolutegravir, cimetidine, isavuconazonium, verapamil, daclatasvir): May increase metformin accumulation and risk of lactic acidosis. Consider benefits and risks of co-administration.

• 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 plasma concentrations.
• Thiazide diuretics and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid: May produce hyperglycemia, potentially leading to loss of glycemic control. Monitor blood glucose closely.

• Not specifically listed for minor interactions with significant clinical impact for this combination.

• Symptoms of lactic acidosis (e.g., malaise, myalgia, respiratory distress, somnolence, abdominal distress, hypothermia, hypotension, bradyarrhythmias)
• Symptoms of pancreatitis (e.g., severe, persistent abdominal pain, radiating to the back, with or without vomiting)
• Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger, irritability) - especially if used with insulin or sulfonylureas
• Symptoms of bullous pemphigoid (e.g., blistering or erosion of the skin)
• Symptoms of hypersensitivity reactions (e.g., rash, urticaria, angioedema)

Category B. Limited data on sitagliptin use in pregnant women are insufficient to determine a drug-associated risk for major birth defects or miscarriage. Metformin has not been shown to be teratogenic in animal studies. Clinical experience with metformin in pregnancy is limited, but available data do not suggest an increased risk of major birth defects. Generally, insulin is preferred for glycemic control in pregnancy.

Sitagliptin is present in the milk of lactating rats. It is not known whether sitagliptin is excreted in human milk. Metformin is excreted into human milk in small amounts. The clinical significance of metformin exposure in breastfed infants is not known. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Janumet XR and any potential adverse effects on the breastfed infant from Janumet XR or from the underlying maternal condition. Lactation risk is L3 (Metformin is L2, Sitagliptin is L3).

Safety and effectiveness of Janumet XR have not been established in pediatric patients under 18 years of age. Not recommended for use in this population.

Use with caution in elderly patients due to the increased likelihood of decreased renal function. Renal function should be assessed more frequently in elderly patients. The risk of metformin-associated lactic acidosis increases with advancing age. Initiate therapy at the lower end of the dosing range and titrate carefully.

• Janumet XR should be taken once daily with the evening meal to enhance metformin absorption and minimize gastrointestinal side effects.
• Swallow tablets whole; do not crush, chew, or split, as this will affect the extended-release properties of metformin.
• Patients should be educated on the symptoms of lactic acidosis (a rare but serious side effect of metformin) and instructed to seek immediate medical attention if they occur.
• Renal function must be assessed before initiating therapy and monitored regularly, especially in elderly patients or those with risk factors for renal impairment.
• Temporarily discontinue Janumet XR before or at the time of iodinated contrast imaging procedures in patients with certain risk factors for acute kidney injury.
• Monitor for symptoms of pancreatitis, a rare but serious side effect associated with DPP-4 inhibitors like sitagliptin.
• Vitamin B12 levels should be monitored periodically in patients on long-term metformin therapy, as it can cause a decrease in B12 absorption.

• Other oral antidiabetic agents (e.g., sulfonylureas, thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists, alpha-glucosidase inhibitors)
• Insulin therapy

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, 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, consult 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 reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.