Sitagliptin 50mg Tablets

Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It works by inhibiting the inactivation of incretin hormones, such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). By increasing the levels of active incretin hormones, sitagliptin enhances glucose-dependent insulin release from pancreatic beta cells and decreases glucagon secretion from pancreatic alpha cells, leading to improved glycemic control in patients with type 2 diabetes.

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.
Severe Skin Reaction (Stevens-Johnson Syndrome): Red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes.
Kidney Problems: Inability to pass urine, changes in urine output, blood in the urine, or sudden weight gain.
Heart Failure: If you have a history of heart failure or kidney problems, inform your doctor. Seek medical help right away if you experience extreme fatigue, shortness of breath, sudden weight gain, or swelling in the arms or legs.
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 immediately and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or consuming certain fruit juices.
Pancreas Problems (Pancreatitis): Severe stomach pain, severe back pain, or severe nausea and vomiting. Seek medical help right away if you experience any of these symptoms.
Skin Reaction (Bullous Pemphigoid): Blisters or skin breakdown. Contact your doctor immediately if you notice any of these symptoms.
Joint Pain: Severe and disabling joint pain. Seek medical help right away if you experience persistent or severe joint pain.

Other Possible Side Effects

While many people may not experience side effects or may only have mild side effects, it's essential to be aware of the following:

Headache
Common cold symptoms
* Nose or throat irritation

If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor for guidance. 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, including any symptoms that occurred.
If you have type 1 diabetes, as this medication is not intended to treat this condition.

This medication may interact with other medications or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or diseases

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication with all your other medications and health conditions.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

If you experience low blood sugar, do not operate a vehicle, as this increases your risk of being involved in an accident.

Monitor your blood sugar levels as directed by your doctor. Additionally, have your blood work checked as instructed by your doctor and discuss the results with them.

Before consuming alcohol, consult with your doctor to ensure safe consumption.

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

Kidney problems, which may require hospitalization or dialysis, have been associated with this medication.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.

• Digoxin (Sitagliptin may cause a slight increase in digoxin concentrations; monitor digoxin levels if co-administered)

• Cyclosporine (Cyclosporine may slightly increase sitagliptin exposure, but no dose adjustment is needed)

• Symptoms of pancreatitis (e.g., severe, persistent abdominal pain, radiating to the back, with or without vomiting)
• Symptoms of severe arthralgia (e.g., severe and disabling joint pain)
• Symptoms of bullous pemphigoid (e.g., blisters or erosions on the skin)
• Symptoms of heart failure (e.g., increasing shortness of breath, rapid weight gain, swelling in the legs/feet)
• Symptoms of hypoglycemia (especially when used with sulfonylurea or insulin)
• Symptoms of hypersensitivity reactions (e.g., rash, urticaria, angioedema)

Sitagliptin is Pregnancy Category B. Animal studies have shown no evidence of harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus.

Sitagliptin is excreted in the milk of lactating rats. It is not known whether sitagliptin is 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 to discontinue the drug, taking into account the importance of the drug to the mother. Lactation Risk Category L3 (Limited data – possible risk).

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

No dose adjustment is necessary based on age alone. However, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Renal function should be assessed prior to initiation and periodically thereafter.

• Sitagliptin is generally well-tolerated and has a low risk of hypoglycemia when used as monotherapy or in combination with metformin or thiazolidinediones.
• Increased risk of hypoglycemia when combined with sulfonylureas or insulin; a dose reduction of the sulfonylurea or insulin may be required.
• Postmarketing reports of acute pancreatitis, sometimes fatal, have been observed. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain.
• Cases of severe and disabling arthralgia (joint pain) have been reported. Consider discontinuing the drug if severe joint pain develops.
• Postmarketing reports of bullous pemphigoid have been observed. If bullous pemphigoid is suspected, sitagliptin should be discontinued.
• Heart failure has been reported with some DPP-4 inhibitors; monitor patients for signs and symptoms of heart failure.
• Not indicated for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

• Other DPP-4 inhibitors (e.g., Saxagliptin, Linagliptin, Alogliptin)
• GLP-1 Receptor Agonists (e.g., Liraglutide, Semaglutide)
• SGLT2 Inhibitors (e.g., Canagliflozin, Dapagliflozin, Empagliflozin)
• Sulfonylureas (e.g., Glipizide, Glyburide, Glimepiride)
• Metformin
• Thiazolidinediones (e.g., Pioglitazone, Rosiglitazone)
• Insulin

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 for guidance. 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.