Janumet 50/500mg Tablets

Janumet combines two antihyperglycemic agents with complementary mechanisms of action: sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride, a biguanide. Sitagliptin enhances the levels of active incretin hormones (GLP-1 and GIP) by inhibiting DPP-4, leading to increased insulin synthesis and release from pancreatic beta cells and decreased glucagon secretion from pancreatic alpha cells in a glucose-dependent manner. Metformin reduces 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

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 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 may 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 stomach problems, contact your doctor right away.
Severe and potentially life-threatening pancreas problems (pancreatitis), which can occur at any time during treatment. Symptoms may 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. Contact your doctor right away if you experience any of these symptoms.
A skin reaction called bullous pemphigoid, which may require hospitalization. Seek medical help immediately if you notice blisters or skin breakdown.
Heart failure, which has occurred in people taking this type of 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

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following possible side effects:

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

If any of these side effects bother you or persist, contact your doctor or seek medical attention. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.

Reporting Side Effects

You can 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
If you have recently experienced a heart attack or stroke.
If you are experiencing difficulties with eating or drinking, or if you are preparing for a procedure or surgery that may affect your ability to eat or drink normally.

Additionally, if you are scheduled to undergo an exam or test that involves contrast agents, or if you have had such a test 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, as this information will help determine whether it is safe for you to take this medication.

Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.

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 performed as directed by your doctor.

Before consuming alcohol, discuss the potential risks with your doctor. 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.

During periods of stress, such as fever, infection, injury, or surgery, your blood sugar levels may be more challenging to control. Changes in physical activity, exercise, or diet can also impact your blood sugar levels. Therefore, it is crucial to follow the diet and exercise plan recommended by your doctor.

In hot weather or during physical activity, be cautious and 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 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 a decrease in vitamin B-12 levels. If you have a history of low vitamin B-12 levels, consult 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, inform your doctor. It is essential to discuss the potential benefits and risks of this medication to both you and your baby.

• Iodinated contrast media (for imaging procedures in patients with eGFR < 60 mL/min/1.73 m² or history of liver disease, alcoholism, or heart failure)
• Cimetidine (significant increase in metformin exposure)

• Alcohol (increases risk of lactic acidosis)
• Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide - increase risk of lactic acidosis)
• Drugs that reduce metformin clearance (e.g., ranolazine, vandetanib, dolutegravir, cimetidine, isavuconazole, trimethoprim)
• Other antidiabetic agents (sulfonylureas, insulin - increased risk of hypoglycemia)

• Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin - may compete for renal tubular transport with metformin)
• Corticosteroids, diuretics (thiazide and loop), phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid (may cause hyperglycemia, requiring dose adjustment of Janumet)

• Not available

• Symptoms of lactic acidosis (malaise, myalgia, respiratory distress, somnolence, abdominal distress)
• Symptoms of hypoglycemia (sweating, tremor, dizziness, confusion, hunger)
• Gastrointestinal side effects (nausea, vomiting, diarrhea, abdominal pain)
• Symptoms of acute pancreatitis (severe, persistent abdominal pain, radiating to the back, with or without vomiting)
• Symptoms of bullous pemphigoid (blisters or erosions on the skin)

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 data from published observational studies and meta-analyses do not establish an increased risk of major birth defects or miscarriage. Generally, insulin is preferred for glycemic control during pregnancy.

Both sitagliptin and metformin are excreted into human milk. The effects on the breastfed infant and on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Janumet and any potential adverse effects on the breastfed infant from Janumet or from the underlying maternal condition. Monitor breastfed infants for signs of hypoglycemia.

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

Use with caution in elderly patients due to the greater likelihood of decreased renal function. Renal function should be assessed more frequently in elderly patients. Metformin is associated with an increased risk of vitamin B12 deficiency, which may be more prevalent in the elderly.

• Always take Janumet with meals to minimize gastrointestinal side effects associated with metformin.
• Educate patients thoroughly on the symptoms of lactic acidosis and the importance of seeking immediate medical attention if they occur.
• Advise patients to temporarily discontinue Janumet before any radiological study involving iodinated contrast media and for any surgical procedures requiring restricted food and fluid intake.
• Monitor renal function closely, especially in elderly patients or those on concomitant nephrotoxic medications.
• Consider vitamin B12 supplementation in patients on long-term metformin therapy, especially if they develop symptoms of neuropathy or anemia.
• If a patient is already on sitagliptin and metformin separately, Janumet can simplify their regimen, but ensure the combined doses do not exceed maximum recommended daily doses.

• Other DPP-4 inhibitors (e.g., sitagliptin, saxagliptin, linagliptin, alogliptin)
• Other biguanides (e.g., metformin monotherapy)
• Sulfonylureas (e.g., glipizide, glyburide)
• Thiazolidinediones (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 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 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.