Kombiglyze XR (Saxagliptin and Metformin)

What Is Kombiglyze XR (Metformin+Saxagliptin)? 

Kombiglyze XR is a medication that combines two active ingredients: metformin and saxagliptin. Metformin is a commonly used oral diabetes medicine that helps control blood sugar levels by reducing the amount of glucose produced by the liver and improving the body's response to insulin. On the other hand, saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which works by increasing the levels of incretin hormones in the body. These hormones help regulate blood sugar by stimulating insulin release and reducing the amount of glucose the liver produces.

The combination of metformin and saxagliptin in Kombiglyze XR provides a dual mechanism of action to manage diabetes better. It is typically prescribed for adults with type 2 diabetes to improve glycemic control. The extended-release formulation of Kombiglyze XR allows for once-daily dosing, offering convenience for patients. 

NDC Code is 0310-6125-60.

Ingredients 

Kombiglyze XR combines two active ingredients: metformin hydrochloride and saxagliptin. Metformin belongs to the biguanide class of medications and helps reduce blood sugar levels by decreasing the production of glucose by the liver and improving the body's sensitivity to insulin. Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which works by increasing incretin hormone levels. This, in turn, helps regulate blood sugar levels by enhancing insulin release and reducing glucose production.

Combining these two ingredients in Kombiglyze XR provides a comprehensive approach to managing type 2 diabetes. It's important to note that the specific formulation and inactive ingredients can vary, so it's crucial to consult the medication's package insert or your healthcare provider for the most accurate and up-to-date information on Kombiglyze XR's composition.

Uses of Kombiglyze XR (Metformin + Saxagliptin)

Kombiglyze XR is prescribed for the management of type 2 diabetes in adults. Metformin and saxagliptin offer a dual mechanism of action to help control blood sugar levels in individuals with this condition.

Kombiglyze XR aims to improve glycemic control in individuals with type 2 diabetes. It is typically prescribed as part of a comprehensive treatment plan, including diet, lifestyle modifications, and other diabetes medications. As with any medication, individuals must follow their healthcare provider's guidance and monitor their response to treatment.

Who Can Take Kombiglyze XR (Metformin + Saxagliptin)?

Kombiglyze XR is generally prescribed for adults with type 2 diabetes. It is not typically recommended for use in individuals with type 1 diabetes or diabetic ketoacidosis. Before starting Kombiglyze XR or any medication, individuals must consult their healthcare provider to determine if it's the appropriate treatment for their health situation.

Your healthcare provider will consider factors such as your overall health, medical history, and any existing medications you may be taking. They may also assess your kidney function since metformin, one of the components of Kombiglyze XR, is excreted through the kidneys. In some cases, individuals with impaired kidney function may need adjustments to their dosage or alternative treatments.

Individuals must communicate openly with their healthcare provider about pre-existing conditions, allergies, or concerns to ensure the safe and effective use of Kombiglyze XR. As with any medication, adherence to prescribed dosages and regular monitoring are crucial for optimal diabetes management.

Dosage of Kombiglyze XR (Metformin + Saxagliptin) 

The dosage of Kombiglyze XR (Metformin + Saxagliptin) can vary based on individual health factors, including the severity of diabetes, kidney function, and overall medical condition. 

Adults

The typical starting dose for adults is one Kombiglyze XR tablet once daily with meals. The dosage may be adjusted based on individual response to treatment and the healthcare provider's recommendations. The maximum recommended daily dose is generally 5 mg of saxagliptin and 2,000 mg of metformin.

Children

The safety and effectiveness of Kombiglyze XR in children have not been established, and it is usually not prescribed for individuals under 18. Pediatric patients with diabetes are often managed with other medications or treatment approaches.

Seniors

Dosing for seniors may be based on individual health and kidney function. As age can be associated with changes in renal function, healthcare providers may adjust the dosage to ensure the safe and effective use of Kombiglyze XR in older adults.

It's crucial for individuals to follow their healthcare provider's specific instructions regarding dosage and to report any concerns or side effects promptly. Dosage adjustments may be necessary based on changes in health status or other factors, so regular communication with the healthcare team is essential for optimal diabetes management.

Important Safety Information

While Kombiglyze XR can effectively manage type 2 diabetes, it's essential to be aware of specific safety considerations. Kombiglyze XR contains metformin, and there is a rare but serious risk of lactic acidosis, a condition that can be life-threatening. This risk is higher in individuals with kidney impairment, liver problems, or those with conditions that can lead to hypoxia (low oxygen levels). It's crucial to inform your healthcare provider of kidney or liver issues.

Cases of pancreatitis (inflammation of the pancreas) have been reported using saxagliptin, one of the components of Kombiglyze XR. If you experience persistent severe abdominal pain, it's essential to seek medical attention promptly.

Saxagliptin has been associated with an increased risk of heart failure, especially in individuals with a history of heart disease. Inform your healthcare provider if you have a history of heart problems or experience symptoms of heart failure, such as shortness of breath, swelling, or rapid weight gain.

Kombiglyze XR, like other diabetes medications, can cause hypoglycemia. This risk is increased when combined with other medications that lower blood sugar. Be aware of low blood sugar symptoms, such as sweating, shakiness, and confusion, and take appropriate steps to address them.

As metformin is excreted through the kidneys, it's important to monitor renal function regularly. Dosage adjustments may be necessary for individuals with impaired kidney function.

If you experience allergic reactions such as rash, itching, or swelling, seek medical attention promptly. Severe allergic reactions are rare but can occur.

Always follow your healthcare provider's instructions, attend regular check-ups, and promptly communicate any concerns or side effects. 

Contraindications

Kombiglyze XR (Metformin + Saxagliptin) has specific contraindications, meaning there are situations where the medication should not be used. Contraindications may include:

1. Hypersensitivity: Individuals with a known hypersensitivity or allergic reaction to any component of Kombiglyze XR, including metformin or saxagliptin, should not use this medication.
2. Severe Renal Impairment: Kombiglyze XR contains metformin, and its use is contraindicated in individuals with severe renal impairment (estimated glomerular filtration rate [eGFR] below 30 mL/min/1.73 m²) due to the risk of lactic acidosis.
3. Acute or Chronic Metabolic Acidosis: Kombiglyze XR is contraindicated in individuals with conditions that can cause metabolic acidosis, including diabetic ketoacidosis. It's essential to address any such conditions before starting treatment.
4. History of Pancreatitis: If an individual has a history of pancreatitis, using Kombiglyze XR may be contraindicated due to the risk of exacerbating this condition.
5. Type 1 Diabetes: Kombiglyze XR is not indicated for the treatment of type 1 diabetes and should not be used in individuals with this condition.

Before starting any new medication, always inform your healthcare provider about your complete medical history, including any existing conditions or allergies. 

Interactions

Kombiglyze XR (Metformin + Saxagliptin) may interact with other medications, substances, or medical conditions. Here are some potential interactions to be aware of:

• Other Medications for Diabetes: Concurrent use of Kombiglyze XR with other medications that lower blood sugar (e.g., insulin, sulfonylureas) may increase the risk of hypoglycemia. Your healthcare provider will monitor and adjust your medications accordingly.
• Iodinated Contrast Materials: Using iodinated contrast materials for procedures such as X-rays or CT scans may increase the risk of acute kidney injury, particularly in individuals with pre-existing renal impairment. You must inform your healthcare provider if you are scheduled for such procedures.
• Drugs Affecting Renal Function: Medications that can affect renal function or compete for elimination through the kidneys may interact with metformin. It's crucial to inform your healthcare provider about all medications, including over-the-counter and herbal supplements.
• Alcohol: Excessive alcohol intake can potentiate the risk of lactic acidosis, a rare but severe side effect associated with metformin. It's advisable to limit alcohol consumption and discuss it with your healthcare provider.
• Heart Medications: Saxagliptin has been associated with an increased risk of heart failure. Inform your healthcare provider if you are taking medications for heart conditions, and monitor for symptoms of heart failure.
• Certain Infections: Serious infections, particularly those affecting the respiratory system, may increase the risk of lactic acidosis. Inform your healthcare provider if you develop any signs of infection.

Always provide your healthcare provider with a comprehensive list of all medications, supplements, and medical conditions you have before starting Kombiglyze XR. This helps ensure safe and effective use while minimizing the risk of potential interactions. Regular communication with your healthcare team is essential for optimal diabetes management.

Side Effects

Like any medication, Kombiglyze XR (Metformin + Saxagliptin) may cause side effects. It's important to note that not everyone will experience these side effects, and some may be more common than others. Common side effects may include:

1. Hypoglycemia: Low blood sugar levels can occur, mainly when Kombiglyze XR is combined with other medications that lower blood sugar. Symptoms may include sweating, shakiness, dizziness, and confusion.
2. Upper Respiratory Tract Infection: Respiratory infections like the common cold may occur.
3. Headache: Some individuals may experience headaches as a side effect.
4. Nasopharyngitis: Inflammation of the nasal passages and throat may occur.
5. Diarrhea: Gastrointestinal symptoms, including diarrhea, have been reported.
6. Increased Blood Pressure: Saxagliptin, one of the components of Kombiglyze XR, may be associated with a slight increase in blood pressure.
7. Lactic Acidosis: While rare, lactic acidosis is a severe side effect associated with metformin. Symptoms may include muscle pain, difficulty breathing, stomach pain, and lethargy. Seek medical attention if you experience these symptoms.

It's essential to report any unusual or persistent side effects to your healthcare provider. Additionally, individual responses to medications can vary, so not everyone will experience the same side effects. Your healthcare provider can guide you in managing side effects and may adjust the treatment plan if necessary. Always take the medication as prescribed and communicate openly with your healthcare team for the best management of your diabetes.

Overdose

An overdose of Kombiglyze XR (Metformin + Saxagliptin) can have severe consequences and requires immediate medical attention. If you suspect an overdose or experience symptoms such as severe dizziness, lightheadedness, weakness, or difficulty breathing, seek emergency medical assistance or contact your local poison control center.

Overdose symptoms may include hypoglycemia (low blood sugar) or lactic acidosis. Treatment for an overdose may involve supportive measures to address symptoms and complications. In the case of lactic acidosis, hospitalization may be necessary.

It's crucial to take Kombiglyze XR exactly as prescribed by your healthcare provider to minimize the risk of an overdose. If you miss a dose, take it as soon as you remember unless it is close to the time for your next dose. In such cases, skip the missed dose and resume your regular dosing schedule.

Be sure to inform your healthcare provider about any medications or substances you may have taken in excess and follow their guidance for appropriate management. 

How to Store 

Store Kombiglyze XR at room temperature, typically between 68°F to 77°F (20°C to 25°C).

Keep the medication in its original packaging to protect it from light and moisture. Avoid storing it in the bathroom, where humidity levels can be higher. Ensure the container is tightly closed when not in use to prevent exposure to air and moisture.

Avoid storing Kombiglyze XR near heat sources, such as direct sunlight, radiators, or heaters.

Store Kombiglyze XR in a location that is out of reach of children and pets.

Drugs Similar to Kombiglyze XR (Metformin + Saxagliptin)

Kombiglyze XR combines metformin and saxagliptin for the management of type 2 diabetes. If you're looking for similar medications or generic alternatives, here are some options:

1. Metformin (Generic): Metformin is available as a generic medication and is commonly prescribed on its own for diabetes management. It belongs to the biguanide class and helps control blood sugar levels by reducing glucose production by the liver and improving insulin sensitivity.
2. Saxagliptin (Onglyza): Saxagliptin is available as a standalone medication under the brand name Onglyza. It is a dipeptidyl peptidase-4 (DPP-4) inhibitor, similar to the saxagliptin component in Kombiglyze XR.
3. Janumet (Sitagliptin + Metformin): Janumet combines sitagliptin (another DPP-4 inhibitor) and metformin. It works similarly to Kombiglyze XR but with a different DPP-4 inhibitor.
4. Jentadueto (Linagliptin + Metformin): Jentadueto combines linagliptin, another DPP-4 inhibitor, with metformin to treat type 2 diabetes.
5. Glimepiride + Metformin Combinations: Some medications combine metformin with sulfonylurea, like glimepiride, offering a different mechanism of action to lower blood sugar levels.

It's important to note that while these medications may share similarities, individual responses can vary. Your healthcare provider will consider your specific health profile and requirements to determine the most suitable medication for your diabetes management.