Saxagliptin 2.5mg Tablets

Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It slows the inactivation of incretin hormones, such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), by inhibiting the DPP-4 enzyme. This increases the concentrations of active incretin hormones, which enhances glucose-dependent insulin secretion from pancreatic beta cells and decreases glucagon secretion from pancreatic alpha cells. The net effect is improved glycemic control in patients with type 2 diabetes mellitus.

Serious Side Effects: Seek Medical Help 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 attention 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 may 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
+ Significant weight gain
+ Swelling in the arms or legs
Severe joint pain that can be debilitating. 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

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:

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 symptoms you experienced as a result of the allergy.
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) and health issues with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments and health conditions.

Remember, do not initiate, discontinue, or modify 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 can significantly increase your risk of being involved in an accident.

Regularly monitor your blood sugar levels as instructed by your doctor. Additionally, undergo blood tests as recommended by your doctor and discuss the results with them.

Be aware that stress, such as fever, infection, injury, or surgery, can make it more challenging to manage your blood sugar levels. Changes in physical activity, exercise, or diet can also impact your blood sugar control.

Before consuming alcohol, consult with your doctor to discuss any potential risks.

Adhere to the diet and exercise plan outlined by your doctor to maintain optimal blood sugar control.

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

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor, as they will need to weigh the benefits and risks of this medication for both you and your baby.

• 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): No dose adjustment typically needed, but monitor for adverse effects.

• Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger)
• Symptoms of pancreatitis (e.g., severe abdominal pain, radiating to the back, with or without nausea and vomiting)
• Symptoms of heart failure (e.g., shortness of breath, swelling of ankles/feet, rapid weight gain)
• Symptoms of hypersensitivity reactions (e.g., rash, urticaria, angioedema)
• Symptoms of severe arthralgia (severe joint pain)
• Symptoms of bullous pemphigoid (e.g., blisters or erosions on the skin)

Limited data on saxagliptin use in pregnant women are insufficient to determine a drug-associated risk for major birth defects or miscarriage. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.

Saxagliptin and its active metabolite are excreted in the milk of lactating rats. It is not known whether saxagliptin 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.

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

No dosage adjustment is recommended based on age alone. However, older patients are more likely to have decreased renal function, which may necessitate dose adjustment based on renal impairment. Monitor renal function in elderly patients.

• Saxagliptin is generally well-tolerated. The most common side effects are upper respiratory tract infection, urinary tract infection, and headache.
• Patients should be educated on the symptoms of pancreatitis and heart failure, and advised to seek immediate medical attention if these occur.
• The risk of hypoglycemia is low when saxagliptin is used as monotherapy but increases significantly when combined with insulin or sulfonylureas.
• Renal function must be assessed prior to initiation and periodically thereafter to ensure appropriate dosing.
• There have been postmarketing reports of severe and disabling arthralgia (joint pain) with DPP-4 inhibitors, including saxagliptin. Consider discontinuing the drug if severe joint pain develops.
• Cases of bullous pemphigoid requiring hospitalization have been reported with DPP-4 inhibitor use. If bullous pemphigoid is suspected, saxagliptin should be discontinued.

• 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)
• Thiazolidinediones (e.g., pioglitazone)
• Metformin
• 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 is a crucial patient fact sheet. Please read it carefully and review it again each time you receive a refill. 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 medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.