Kombiglyze Xr 5 Mg/1000 Mg Tablet (7 Tab)

KOMBIGLYZE XR 5 MG/1000 MG TABLET is a medication manufactured by ASTRAZENECA PHARMA INDIA LIMITED for the management of Type 2 diabetes mellitus.

Name

• Brand Name: KOMBIGLYZE XR
• Common Name: Saxagliptin and Metformin Hydrochloride Extended-Release Tablet

Composition

KOMBIGLYZE XR 5 MG/1000 MG TABLET contains two active ingredients:

• Saxagliptin: 5 mg (as hydrochloride)
• Metformin Hydrochloride Extended-Release: 1000 mg Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin is a biguanide.

Uses

KOMBIGLYZE XR is used as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus. It helps lower blood sugar levels and can be used alone or in combination with other diabetes medications, including insulin or sulfonylureas.

Dosage and Administration

This medication is typically administered once daily with the evening meal. Tablets must be swallowed whole and should not be crushed, cut, or chewed. Gradual dose titration may be used to minimize gastrointestinal side effects associated with metformin. The maximum daily recommended dose is 5 mg for saxagliptin and 2000 mg for metformin extended-release.

Side Effects

Common Side Effects:

• Upper respiratory tract infections
• Stuffy or runny nose and sore throat
• Urinary tract infection
• Headache
• Diarrhea
• Nausea and vomiting

Serious Side Effects:

• Lactic Acidosis: A rare but serious complication due to metformin accumulation that can be fatal. Symptoms include unusual muscle pain, trouble breathing, unusual sleepiness, and stomach pain.
• Pancreatitis: Severe and persistent abdominal pain, with or without vomiting, may indicate pancreatitis.
• Severe Allergic Reactions: Symptoms such as swelling of the face, lips, throat, or difficulty breathing, skin rash, itching, flaking, or peeling.
• Heart Failure: Symptoms like increasing shortness of breath, rapid weight gain, and swelling of the feet.
• Severe and persistent joint pain.
• Bullous pemphigoid (blistering skin reaction).
• Hypoglycemia (low blood sugar), especially when used with insulin or sulfonylureas.

Precautions

• Lactic Acidosis Risk: Higher risk in patients with kidney problems, liver problems, excessive alcohol intake, dehydration, or those aged 65 years or older. Renal function should be assessed before and during treatment.
• Kidney Impairment: KOMBIGLYZE XR is contraindicated in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2).
• Liver Impairment: Not recommended in patients with hepatic impairment.
• Pancreatitis: Not studied in patients with a history of pancreatitis. Observe for symptoms of pancreatitis.
• Heart Failure: Consider risks and benefits in patients at higher risk for heart failure.
• Not for Type 1 diabetes or diabetic ketoacidosis.
• Use with caution with strong CYP3A4/5 inhibitors.
• Regular monitoring of blood sugar levels and kidney function is necessary.
• Long-term use of metformin may cause a decrease in vitamin B12 levels.

Storage

Store KOMBIGLYZE XR between 68°F and 77°F (20°C and 25°C) or below 30°C. Keep the tablets in the blister pack until it is time to take them and out of reach of children.

KOMBIGLYZE XR 5 MG/1000 MG TABLET is a prescription medication used to manage type 2 diabetes in adults. It combines two active ingredients, saxagliptin and metformin hydrochloride extended-release, to help lower blood sugar levels in conjunction with diet and exercise.

What is KOMBIGLYZE XR used for?

KOMBIGLYZE XR is used to improve glycemic control (blood sugar levels) in adults with type 2 diabetes mellitus. It's prescribed when diet and exercise alone are not enough to control blood sugar. This medication can be used alone or in combination with other diabetes treatments, including insulin.

How does KOMBIGLYZE XR work?

KOMBIGLYZE XR contains two active ingredients: saxagliptin and metformin.

• Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It works by increasing the levels of incretin hormones in the body, which helps to increase insulin secretion and decrease glucagon levels in response to meals, thus controlling blood sugar.
• Metformin is a biguanide that lowers blood sugar by reducing the amount of glucose produced by the liver, decreasing glucose absorption from the intestines, and improving the body's sensitivity to insulin. Together, these mechanisms provide a comprehensive approach to managing type 2 diabetes.

What is the usual dosage?

KOMBIGLYZE XR is typically taken once daily with the evening meal. The dosage is individualized based on the patient's current treatment regimen, effectiveness, and tolerability, with a maximum recommended dose of saxagliptin 5 mg and metformin extended-release 2000 mg per day. Tablets should be swallowed whole and not crushed, cut, or chewed.

What are the possible side effects?

Serious side effects can occur, including lactic acidosis (a rare but serious buildup of lactic acid in the blood) due to metformin, which can be fatal. Symptoms of lactic acidosis require immediate medical attention. Common side effects of KOMBIGLYZE XR include:

• Upper respiratory tract infection
• Stuffy or runny nose and sore throat
• Urinary tract infection
• Headache
• Diarrhea
• Nausea and vomiting Other potential serious side effects include pancreatitis, severe allergic reactions, and severe joint pain. Low blood sugar (hypoglycemia) can also occur, especially if taken with other diabetes medications.

Is it safe during pregnancy or breastfeeding?

KOMBIGLYZE XR is generally not recommended during pregnancy or breastfeeding. The safety of KOMBIGLYZE XR in pregnant women has not been established, and insulin is often considered more suitable for blood glucose control during pregnancy. It is not known if KOMBIGLYZE XR passes into breast milk. Always consult your healthcare provider for the best way to manage diabetes during pregnancy or while breastfeeding.

Can it be taken with other medications?

KOMBIGLYZE XR can interact with other medications. Tell your healthcare provider about all medicines you take, including prescription and nonprescription drugs, vitamins, and herbal supplements. For instance, the dose of KOMBIGLYZE XR may need to be limited when coadministered with strong CYP3A4/5 inhibitors (e.g., ketoconazole, clarithromycin). Other medications, such as some cationic drugs (e.g., amiloride, digoxin) and certain antibiotics, can also interact with metformin. If taken with insulin or sulfonylureas, a lower dose of those medications may be required to minimize the risk of hypoglycemia.

What precautions should be taken?

Several precautions should be considered:

• Kidney and Liver Problems: KOMBIGLYZE XR is contraindicated in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²) and should be avoided in patients with hepatic impairment due to the increased risk of lactic acidosis. Kidney function should be assessed before and during treatment.
• Alcohol Intake: Avoid excessive alcohol intake, as it can increase the risk of lactic acidosis.
• Surgery and Medical Tests: KOMBIGLYZE XR may need to be temporarily stopped before certain surgical procedures or imaging tests involving iodinated contrast agents.
• Pancreatitis and Heart Failure: There have been post-marketing reports of acute pancreatitis and heart failure. Patients should be monitored for symptoms.
• Vitamin B12 Levels: Metformin may reduce Vitamin B12 levels, and periodic monitoring may be necessary.

What happens if a dose is missed?

If you miss a dose of KOMBIGLYZE XR, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or an extra dose the next day.

How should it be stored?

Store KOMBIGLYZE XR tablets in their original packaging in a cool, dry place at room temperature, typically between 68°F and 77°F (20°C and 25°C), and below 30°C. Keep the medicine away from heat, moisture, direct light, and out of the reach of children. Do not store it in the bathroom or near a sink.