Saxagliptin 5mg Tablets

Saxagliptin is a highly selective, reversible, competitive dipeptidyl peptidase-4 (DPP-4) inhibitor. It slows the inactivation of incretin hormones (glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]), thereby increasing their concentrations and enhancing their effects. This leads to increased glucose-dependent insulin secretion from pancreatic beta cells and decreased glucagon secretion from pancreatic alpha cells, resulting in improved glycemic control.

Serious Side Effects: Seek Medical Attention Immediately

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 help right away:

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 pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to pass urine
+ Fever
+ Lower stomach pain
+ Pelvic pain
Low blood sugar, which may be more likely when taking this medication with other diabetes drugs. Signs of low blood sugar include:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Contact your doctor right away 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 some fruit juices.
Heart failure, which has occurred in people taking this medication. If you have a history of heart failure or kidney problems, inform your doctor. Seek medical attention immediately if you experience:
+ Extreme fatigue
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs
Severe joint pain that is disabling or persistent. Contact your doctor right away if you experience:
+ Very bad joint pain
+ Joint pain that does not go away
Bullous pemphigoid, a skin reaction that may require hospitalization. Seek medical attention immediately if you notice:
+ Blisters
+ Skin breakdown

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:

Headache
* Signs of a common cold

This is not an exhaustive list of possible 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, including any 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.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.

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 to ensure timely interventions.

Regular blood tests, as scheduled by your doctor, are crucial to assess your health. Discuss any concerns or questions you may have with your doctor.

Be aware that stress, such as fever, infection, injury, or surgery, can affect blood sugar control. Additionally, changes in physical activity, exercise, or diet may also impact your blood sugar levels.

Before consuming alcohol, consult with your doctor to understand the potential effects on your condition. Adhere to the diet and exercise plan recommended by your doctor to maintain optimal health.

Note that this medication has been associated with a severe pancreas problem, known as pancreatitis, which can be life-threatening. If you have any questions or concerns, discuss them with your doctor.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of this medication to both you and your baby to make an informed decision.

• Strong CYP3A4/5 inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin) - reduce saxagliptin dose to 2.5 mg once daily.

• Moderate CYP3A4/5 inhibitors (e.g., diltiazem, erythromycin, fluconazole, verapamil) - reduce saxagliptin dose to 2.5 mg once daily.

• Symptoms of hypoglycemia (if used with sulfonylurea or insulin): sweating, tremor, dizziness, confusion, hunger
• Symptoms of pancreatitis: severe, persistent abdominal pain, radiating to the back, with or without vomiting
• Symptoms of heart failure: unusual shortness of breath, rapid weight gain, swelling of ankles/feet
• Symptoms of severe and disabling arthralgia: severe joint pain
• Symptoms of bullous pemphigoid: new or worsening blisters or erosions on the skin
• Symptoms of hypersensitivity reactions: rash, urticaria, angioedema

Use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus. Limited human data. Animal studies show potential for fetal harm at high doses.

Not recommended during breastfeeding. Saxagliptin and its active metabolite are excreted in the milk of lactating rats. It is unknown if it is excreted in human milk. Due to potential for serious adverse reactions in breastfed infants, 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. Not recommended for use in patients younger than 18 years of age.

No dose adjustment is required based on age alone. However, older patients are more likely to have decreased renal function, so renal function should be assessed prior to initiation and periodically thereafter.

• Saxagliptin has been associated with an increased risk of heart failure hospitalization in patients with established cardiovascular disease or multiple risk factors for heart failure (as observed in the SAVOR-TIMI 53 trial). Assess patients for heart failure risk factors before initiating.
• Cases of acute pancreatitis, sometimes fatal, have been reported. Patients should be advised to discontinue saxagliptin and seek medical attention if they develop symptoms of pancreatitis.
• Severe and disabling arthralgia (joint pain) has been reported. Consider discontinuing the drug if this occurs.
• Bullous pemphigoid, a serious blistering skin condition, has been reported. Discontinue if bullous pemphigoid is suspected.
• Risk of hypoglycemia is increased when co-administered with a sulfonylurea or insulin; a lower dose of sulfonylurea or insulin may be required.

• Other DPP-4 inhibitors (e.g., sitagliptin, linagliptin, alogliptin)
• GLP-1 receptor agonists (e.g., liraglutide, semaglutide)
• SGLT2 inhibitors (e.g., empagliflozin, canagliflozin)
• Sulfonylureas (e.g., glipizide, glyburide)
• Meglitinides (e.g., repaglinide)
• Thiazolidinediones (e.g., pioglitazone)
• Insulin
• Metformin

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. 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, we encourage you 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, and the time it occurred.