Onglyza 5mg Tablets

Saxagliptin is a highly selective, reversible, competitive 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 DPP-4. By increasing and prolonging active incretin levels, saxagliptin enhances glucose-dependent insulin release from pancreatic beta cells and decreases glucagon secretion from pancreatic alpha cells, leading to improved 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:

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 while urinating
+ Frequent or urgent need to urinate
+ 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
+ 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.
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 and disabling joint pain. 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

Reporting Side Effects

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 with your other medications and health conditions.

Remember, do not start, stop, or change the dose 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.

Monitor your blood sugar levels as directed by your doctor to ensure they remain within a healthy range. Additionally, undergo blood tests as scheduled 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 understand the potential effects on your condition.

Adhere to the diet and exercise plan recommended by your doctor to maintain optimal blood sugar management.

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. 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, verapamil, fluconazole): No dose adjustment specified, but monitor for increased saxagliptin exposure.

• Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger)
• Symptoms of pancreatitis (e.g., severe, persistent abdominal pain, radiating to the back, with or without vomiting)
• Symptoms of heart failure (e.g., shortness of breath, swelling of ankles or feet, rapid weight gain)
• 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 hypersensitivity reactions (e.g., rash, urticaria, angioedema)

Limited data on saxagliptin use in pregnant women. Studies in animals have shown no direct or indirect harmful effects with respect to reproductive toxicity. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is unknown whether saxagliptin is excreted in human milk. Saxagliptin and its active metabolite are excreted in the milk of lactating rats. 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 Onglyza have not been established in pediatric patients. Not recommended for use in patients younger than 18 years of age.

No dose adjustment is recommended based on age alone. However, older patients are more likely to have decreased renal function, so renal function should be assessed and dose adjusted accordingly.

• Saxagliptin is generally weight-neutral and has a low risk of hypoglycemia when used as monotherapy or with metformin.
• A dose reduction is required for patients with moderate to severe renal impairment or end-stage renal disease (ESRD) requiring dialysis.
• There is an increased risk of heart failure hospitalization with saxagliptin, particularly in patients with a history of heart failure or renal impairment. Use with caution in these populations.
• Cases of acute pancreatitis have been reported with DPP-4 inhibitors, including saxagliptin. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain.
• Severe and disabling arthralgia has been reported with DPP-4 inhibitors. Consider saxagliptin as a possible cause if a patient develops severe joint pain and discontinue if appropriate.
• Bullous pemphigoid, a serious blistering skin condition, has been reported with DPP-4 inhibitor use. If suspected, discontinue saxagliptin.

• Metformin
• Sulfonylureas (e.g., glipizide, glyburide, glimepiride)
• Thiazolidinediones (TZDs) (e.g., pioglitazone, rosiglitazone)
• GLP-1 receptor agonists (e.g., liraglutide, semaglutide, dulaglutide)
• SGLT2 inhibitors (e.g., empagliflozin, canagliflozin, dapagliflozin)
• Insulin
• Alpha-glucosidase inhibitors (e.g., acarbose, miglitol)
• Meglitinides (e.g., repaglinide, nateglinide)

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. If you have any questions or concerns about this medication, don't hesitate to consult 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 quantity, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.