Janumet 50/1000mg Tablets

Janumet combines two antihyperglycemic agents with complementary mechanisms of action to improve glycemic control in patients with type 2 diabetes: 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), 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 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 immediately or seek emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Low blood sugar (hypoglycemia): dizziness, headache, feeling sleepy or weak, shaking, rapid 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 that occur later during treatment, such as upset stomach, vomiting, or diarrhea, which could be a sign of lactic acidosis (a condition characterized by excess acid in the blood).
Severe and potentially life-threatening pancreas problems (pancreatitis): severe stomach pain, severe back pain, or severe nausea and vomiting. Seek medical help immediately if you experience any of these symptoms.
A severe skin reaction (Stevens-Johnson syndrome): red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes. Get medical help right away if you notice any of these symptoms.
Severe joint pain that is disabling or persistent. Contact your doctor immediately if you experience any unusual or severe joint pain.
A skin reaction called bullous pemphigoid: blisters or skin breakdown. Seek medical help right away if you notice any of these symptoms.
Heart failure: 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, significant weight gain, or swelling in your 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 potential 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 for guidance. Remember, this is not an exhaustive list of possible side effects. If you have concerns or questions, don't hesitate to reach out to your doctor.

Reporting Side Effects

You can report any side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice and guidance on managing 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 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 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 existing health problems

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, 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 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 may also impact 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 stomach upset, vomiting, or diarrhea, consult your doctor to avoid dehydration, which can lead to low blood pressure or worsen kidney problems.

Kidney problems, including those requiring hospitalization or dialysis, have been associated with this medication. 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 renewed risk of pregnancy. To avoid pregnancy, use birth control while taking this medication.

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

• Iodinated contrast agents (temporarily discontinue Janumet at time of or prior to procedure in patients with 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 if renal function is stable.)
• Alcohol (acute or chronic alcohol ingestion, due to increased risk of lactic acidosis with metformin)

• Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide) - may increase risk of lactic acidosis with metformin.
• Drugs that reduce metformin clearance (e.g., ranolazine, vandetanib, dolutegravir, cimetidine) - may increase metformin accumulation and risk of lactic acidosis.

• Digoxin (sitagliptin may slightly increase digoxin concentrations, monitor digoxin levels)
• Sulfonylureas or insulin (increased risk of hypoglycemia when co-administered with sitagliptin; dose reduction of sulfonylurea or insulin may be required)
• 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.

• Not many specific minor interactions listed for the combination that are clinically significant beyond the above.

• Symptoms of lactic acidosis (malaise, myalgia, respiratory distress, somnolence, abdominal distress, hypothermia, hypotension, resistant bradyarrhythmias)
• Symptoms of hypoglycemia (sweating, tremor, dizziness, confusion, hunger, irritability)
• Symptoms of pancreatitis (severe, persistent abdominal pain, radiating to the back, with or without vomiting)
• Symptoms of hypersensitivity reactions (rash, urticaria, angioedema, anaphylaxis, exfoliative skin conditions)
• Symptoms of bullous pemphigoid (blisters or erosions on the skin)

Category C. Limited data on sitagliptin use in pregnant women. Metformin has been widely used in pregnancy with no clear evidence of adverse outcomes. Janumet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Sitagliptin is excreted in the milk of lactating rats; it is unknown if it is excreted in human milk. Metformin is excreted into human milk in small amounts. The American Academy of Pediatrics considers metformin compatible with breastfeeding. Weigh the benefits of breastfeeding against the potential risks to the infant.

Safety and effectiveness in pediatric patients under 18 years of age have not been established. 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. Elderly patients are at increased risk for lactic acidosis with metformin.

• Always assess renal function (eGFR) before initiating Janumet and periodically thereafter, as metformin is contraindicated in severe renal impairment and sitagliptin dose needs adjustment.
• Educate patients 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 procedure involving iodinated contrast agents or any surgical procedure requiring restricted food/fluid intake.
• Monitor for symptoms of pancreatitis, a rare but serious adverse effect associated with DPP-4 inhibitors.
• If co-prescribing with a sulfonylurea or insulin, consider a dose reduction of the sulfonylurea or insulin to minimize the risk of hypoglycemia.
• Janumet should be taken with meals to reduce gastrointestinal side effects associated with metformin.

• Other oral antidiabetic agents (e.g., SGLT2 inhibitors, GLP-1 receptor agonists, sulfonylureas, thiazolidinediones)
• Insulin therapy
• Lifestyle modifications alone (diet and exercise) for early or mild type 2 diabetes

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 amount, and the time it occurred.