Janumet XR 100mg/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, a biguanide. Sitagliptin works by inhibiting the inactivation of incretin hormones (GLP-1 and GIP) by DPP-4, thereby increasing their active levels. This leads to glucose-dependent increases in insulin synthesis and release from pancreatic beta cells and decreases in glucagon secretion from pancreatic alpha cells. Metformin acts by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity by increasing peripheral glucose uptake and utilization.

Urgent Side Effects: Seek Medical Help Right Away

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

Allergic Reaction: 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, or swelling of the mouth, face, lips, tongue, or throat.
Kidney Problems: Inability to pass urine, changes in urine output, blood in the urine, or significant weight gain.
Low Blood Sugar: Dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating. If you experience any of these symptoms, follow your doctor's instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or consuming certain fruit juices.
Stomach Problems: If you experience stomach issues later in treatment, such as upset stomach, vomiting, or diarrhea, contact your doctor right away, as this could be a sign of lactic acidosis (a blood acid health problem).
Pancreatitis: Severe and potentially life-threatening pancreas problems can occur at any time during treatment. Warning signs include severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Severe Skin Reaction (Stevens-Johnson Syndrome): This rare but potentially life-threatening condition can cause severe health problems and death. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
Joint Pain: If you experience severe or persistent joint pain, contact your doctor right away.
Bullous Pemphigoid: A skin reaction that can cause blisters or skin breakdown. Seek medical help immediately if you notice any of these symptoms.
Heart Failure: If you have a history of heart failure or kidney problems, inform your doctor. Contact your doctor right away if you experience extreme fatigue, shortness of breath, significant weight gain, or swelling in the arms or legs.

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

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 have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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 have an exam or test that involves contrast media, or have had one within the past 48 hours, discuss this with your doctor.

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

All medications you are currently 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 for you 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 directed by your doctor.

Before consuming alcohol, discuss the potential risks with your doctor. Additionally, check your blood sugar levels as instructed by your doctor to ensure they are within a safe range. If your blood sugar levels are low, avoid driving, as this can 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 can also impact your 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 are a potential side effect of this medication, and in some 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, 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 while taking this drug.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to you and your baby.

• Iodinated contrast agents (temporarily discontinue Janumet XR at the time of or prior to the procedure and for 48 hours after)
• Patients with metabolic acidosis, including diabetic ketoacidosis, acute or chronic, with or without coma
• Severe renal impairment (eGFR < 30 mL/min/1.73 m2)
• Acute or chronic conditions which may cause tissue hypoxia (e.g., cardiac or respiratory failure, recent myocardial infarction, shock)
• Hepatic impairment (severe)

• Alcohol (potentiates metformin's effect on lactate metabolism, increasing risk of lactic acidosis)
• Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide) - may increase risk of lactic acidosis
• Drugs that reduce metformin clearance (e.g., cimetidine, ranolazine, dolutegravir, isavuconazole, trimethoprim, vandetanib) - may increase metformin levels and risk of lactic acidosis
• Other antidiabetic agents (e.g., sulfonylureas, insulin) - increased risk of hypoglycemia

• Corticosteroids, diuretics (thiazide and loop), phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid - may produce hyperglycemia, requiring dose adjustment of Janumet XR
• Nifedipine - may increase metformin absorption
• Furosemide - may increase metformin plasma and blood concentrations

• Not available

• Symptoms of lactic acidosis (e.g., malaise, myalgia, respiratory distress, somnolence, abdominal distress)
• 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 sulfonylurea or insulin
• Symptoms of hypersensitivity reactions (e.g., rash, urticaria, angioedema, anaphylaxis)
• Symptoms of bullous pemphigoid (e.g., large, fluid-filled blisters on the skin)
• Symptoms of joint pain (severe and disabling arthralgia)

Generally not recommended during pregnancy. Poorly controlled diabetes during pregnancy increases the risk of birth defects, pregnancy loss, and other complications. Insulin is generally preferred for glycemic control during pregnancy.

Both sitagliptin and metformin are excreted into human milk. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother and the potential risks to the infant. Metformin is generally considered compatible with breastfeeding by some experts, but sitagliptin data is more limited.

Safety and effectiveness 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 higher likelihood of decreased renal function. Renal function should be assessed more frequently in elderly patients. Increased risk of lactic acidosis with metformin in this population.

• Always take Janumet XR with the evening meal to minimize gastrointestinal side effects and optimize metformin XR absorption.
• Swallow tablets whole; do not crush, chew, or break them, as this will disrupt the extended-release mechanism.
• Patients may notice a tablet ghost (empty matrix) in their stool, which is normal and does not mean the medication was not absorbed.
• Educate patients thoroughly on the symptoms of lactic acidosis and the importance of seeking immediate medical attention if they occur.
• Temporarily discontinue Janumet XR before any radiological procedure involving iodinated contrast agents or any surgical procedure requiring restricted food and fluid intake.
• Monitor renal function (eGFR) regularly, especially in elderly patients or those with risk factors for kidney impairment.
• Be aware of the increased risk of hypoglycemia when Janumet XR is used in combination with insulin or sulfonylureas, and consider dose adjustments of those agents.

• Other oral antidiabetic agents (e.g., sulfonylureas, TZDs, SGLT2 inhibitors, GLP-1 receptor agonists, alpha-glucosidase inhibitors)
• Insulin therapy
• Lifestyle modifications (diet and exercise)

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 each time 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 seeking help, be prepared to provide details about the overdose, including the amount taken and the time it occurred.