Steglujan 15-100mg Tablets

Steglujan combines two antihyperglycemic agents with complementary mechanisms of action: Ertugliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. Ertugliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose (RTG), thereby increasing urinary glucose excretion (UGE) and lowering blood glucose concentrations. Sitagliptin inhibits the enzyme DPP-4, which normally inactivates incretin hormones (glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]). By inhibiting DPP-4, sitagliptin increases the levels of active incretin hormones, leading to enhanced glucose-dependent insulin release from pancreatic beta cells and suppressed glucagon secretion from pancreatic alpha cells, thereby improving glycemic control.

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:

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.
Fluid and Electrolyte Problems: Mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or passing out, increased thirst, seizures, feeling very tired or weak, decreased appetite, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or severe upset stomach or throwing up.
Kidney Problems: Unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
Too Much Acid in the Blood (Acidosis): Confusion; fast breathing; fast heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
Urinary Tract Infection (UTI): Blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
Vaginal Yeast Infection: Itching, bad odor, or discharge. Report these symptoms to your doctor.
Yeast Infection of the Penis: Pain, swelling, rash, or discharge. Report these symptoms to your doctor.
Low Blood Sugar: Dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating. If you experience any of these symptoms, contact your doctor right away and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Pancreas Problems (Pancreatitis): Severe stomach pain, severe back pain, or severe upset stomach or throwing up. These can be signs of severe and potentially deadly pancreas problems.
Heart Failure: If you have a history of heart failure or kidney problems, inform your doctor. Call your doctor right away if you feel very tired or experience shortness of breath, a big weight gain, or swelling in the arms or legs.
Increased Risk of Lower Limb Amputations: Toe and foot amputations have occurred most often. Discuss foot care with your doctor, especially if you have a history of amputation, blood vessel disease, nerve disease, or a foot ulcer caused by diabetes. Report any new pain or tenderness, sores or ulcers, or infections in your legs or feet to your doctor immediately.
Severe Joint Pain: Very bad joint pain or any joint pain that does not go away. Contact your doctor right away if you experience this symptom.
Bullous Pemphigoid: A skin reaction that can cause blisters or skin breakdown. Sometimes, hospitalization is required. Call your doctor right away if you notice blisters or skin breakdown.
Rare but Serious Infection: If your genitals or the area between your genitals and rectum becomes tender, red, or swollen, and you have a fever or do not feel well, seek medical help immediately. This infection can be deadly.
Severe Skin Reaction (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis): Red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes. This reaction can cause severe health problems that may not go away and can be fatal. Seek medical help right away if you notice any of these symptoms.

Other Side Effects

Most people do not experience side effects or only have minor ones. However, if you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:

Signs of a common cold
Nose or throat irritation
Headache
Upset stomach
Diarrhea

These are not all the possible side effects. If you have questions about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or 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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have type 1 diabetes, as this medication is not intended to treat this condition.
If you have a condition that affects the acidity of your blood.
If you have kidney disease or are undergoing dialysis.
If you have liver disease.
If you are dehydrated, as this may require special consideration.
If you are pregnant or think you might be pregnant. Do not take this medication during the second or third trimester of pregnancy.
If you are breastfeeding, as you should not breastfeed while taking this medication.

Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes:

All prescription medications you are currently taking.
Over-the-counter medications, such as pain relievers or antihistamines.
Natural products, including herbal supplements or vitamins.
Any health problems you have, as they may interact with this medication.

Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety. This list is not exhaustive, and your doctor and pharmacist need to be aware of all your medications and health conditions to determine if it is safe for you to take this medication.

Important Warnings and Precautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.

Monitoring and Laboratory Tests

Your doctor will instruct you to have regular blood work and other laboratory tests to monitor your condition. Be aware that this medication may affect the results of certain lab tests, so it is crucial to inform all your healthcare providers and laboratory personnel that you are taking this drug.

Blood Sugar Control

During times of stress, such as fever, infection, injury, or surgery, it may be more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also impact your blood sugar levels. Follow your doctor's instructions for monitoring your blood sugar levels, and discuss the most suitable glucose tests to use.

Safety Precautions

Do not drive if your blood sugar levels are low, as this can increase the risk of accidents. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and exercise caution when climbing stairs.

Diet and Exercise

Adhere to the diet and exercise plan recommended by your doctor. If you are on a low-salt or salt-free diet, consult with your doctor before making any changes. Additionally, discuss the consumption of alcohol with your doctor before drinking.

Special Situations

If you are unable to eat or drink normally, such as during illness, fasting, or certain medical procedures, consult with your doctor for guidance. In hot weather or during physical activity, drink plenty of fluids to prevent dehydration. If you experience vomiting, diarrhea, or are unable to drink liquids, contact your doctor to avoid dehydration, which can lead to low blood pressure or worsen kidney problems.

Potential Side Effects

High cholesterol has been reported in patients taking this medication. If you have concerns, discuss them with your doctor. Additionally, this drug can increase the risk of ketoacidosis (too much acid in the blood or urine), which can be life-threatening and may require hospitalization. This risk is higher in patients with diabetes, pancreas problems, or those who are sick, dehydrated, or have skipped meals. If you use insulin, taking less than the prescribed dose or missing a dose can also increase the risk of ketoacidosis. Monitor your ketone levels as instructed by your doctor, and seek medical attention if you have questions or concerns.

Urinary Tract Infections and Kidney Problems

Severe urinary tract infections (UTIs) have been reported in patients taking this medication, and in some cases, hospitalization was necessary. Kidney problems have also occurred, which may require hospitalization or dialysis.

Special Populations

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately.

• Diuretics (e.g., loop diuretics, thiazide diuretics): Increased risk of volume depletion and orthostatic hypotension due to additive diuretic effect of ertugliflozin.
• Insulin and Insulin Secretagogues (e.g., sulfonylureas): Increased risk of hypoglycemia when used in combination with sitagliptin. A lower dose of insulin or sulfonylurea may be required.

• Digoxin: Sitagliptin can slightly increase digoxin concentrations. Monitor digoxin levels when initiating Steglujan or changing dose.
• Lithium: SGLT2 inhibitors may decrease lithium levels due to increased urinary excretion. Monitor lithium levels frequently.

• Excessive thirst
• Frequent urination
• Dizziness or lightheadedness (especially when standing)
• Fatigue
• Nausea, vomiting, abdominal pain (potential DKA)
• Unusual vaginal discharge or itching (genital mycotic infection)
• Painful or frequent urination, fever, back pain (UTI)
• Severe, persistent abdominal pain (pancreatitis)
• Signs of hypoglycemia (sweating, tremor, confusion, hunger)

Contraindicated during the second and third trimesters of pregnancy due to potential adverse effects on renal development in the fetus (based on animal data with ertugliflozin). Limited human data on use in pregnancy.

Not recommended during breastfeeding. It is unknown if ertugliflozin or sitagliptin are excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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 (≥65 years of age) due to increased risk of volume depletion, orthostatic hypotension, and urinary tract infections. Renal function should be monitored more frequently. No dose adjustment is generally needed based on age alone, but consider renal function.

• Steglujan is a fixed-dose combination and should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
• Prior to initiation, assess renal function (eGFR). Steglujan is contraindicated in patients with severe renal impairment (eGFR < 45 mL/min/1.73 m2), ESRD, or on dialysis.
• Counsel patients on the signs and symptoms of diabetic ketoacidosis (DKA) and instruct them to seek immediate medical attention if these occur. Risk factors for DKA include acute illness, reduced caloric intake, surgery, and reduced insulin dose.
• Advise patients to maintain adequate hydration to reduce the risk of volume depletion, especially during periods of illness or increased physical activity.
• Educate patients on proper genital hygiene to minimize the risk of genital mycotic infections.
• Discontinue Steglujan if pancreatitis is suspected.
• Patients on insulin or sulfonylureas may require a dose reduction of these agents to minimize the risk of hypoglycemia when starting Steglujan.

• Other SGLT2 inhibitors (e.g., canagliflozin, dapagliflozin, empagliflozin)
• Other DPP-4 inhibitors (e.g., saxagliptin, linagliptin, alogliptin)
• GLP-1 receptor agonists (e.g., liraglutide, semaglutide)
• Insulin
• Sulfonylureas
• Metformin
• Thiazolidinediones (TZDs)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 about its use. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, don't hesitate 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 reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.