Glyxambi 10mg/5mg Tablet

GLYXAMBI 10MG/5MG TABLET by BOEHRINGER INGELHEIM

Name

Brand Name: GLYXAMBI Common Name: Empagliflozin and Linagliptin

Composition

Each GLYXAMBI 10 mg/5 mg tablet contains 10 mg of empagliflozin and 5 mg of linagliptin. Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor.

Uses

GLYXAMBI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Additionally, empagliflozin, one of its components, is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. It is not for the treatment of type 1 diabetes or diabetic ketoacidosis.

Dosage and Administration

The recommended starting dose of GLYXAMBI is one 10 mg empagliflozin/5 mg linagliptin tablet once daily, taken in the morning, with or without food. For patients requiring additional glycemic control and tolerating the initial dose, it may be increased to a 25 mg empagliflozin/5 mg linagliptin tablet once daily. If a dose is missed, it should be taken as soon as the patient remembers, but a double dose should not be taken on the same day.

Side Effects

Common Side Effects: These may include urinary tract infections, common cold symptoms (runny or stuffy nose, sore throat), upper respiratory infections, and mild joint pain. Serious Side Effects: Serious side effects, though rare, can include diabetic ketoacidosis, pancreatitis, Fournier's gangrene (a serious genital infection), bullous pemphigoid (a severe skin reaction), dehydration, and severe allergic reactions. Low blood sugar (hypoglycemia) can occur, especially when used with other anti-diabetic medications like insulin or sulfonylureas.

Precautions

Assess renal function and volume status before initiating GLYXAMBI. GLYXAMBI is not recommended for patients with severe kidney disease (eGFR less than 30 mL/min/1.73 m2) or those on dialysis. Caution is advised in patients with a history of pancreatitis, as it's unknown if they are at increased risk. Alcohol consumption can increase the risk of low blood sugar and diabetic ketoacidosis. If GLYXAMBI is used with insulin or sulfonylureas, a lower dose of these medications may be necessary to reduce the risk of hypoglycemia. Temporary interruption of GLYXAMBI is recommended for at least 3 days prior to major surgery or prolonged fasting. It is not recommended during the second and third trimesters of pregnancy or while breastfeeding.

Storage

Store GLYXAMBI at room temperature, between 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°-30°C (59°-86°F). Protect from heat and dampness. Keep out of reach of children.

What is Glyxambi 10mg/5mg Tablet used for?

Glyxambi 10mg/5mg Tablet is a combination medication used with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. It is also prescribed to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have established heart disease. Glyxambi is not intended for treating type 1 diabetes.

How does Glyxambi 10mg/5mg Tablet work?

Glyxambi contains two active ingredients: empagliflozin (10mg) and linagliptin (5mg). Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that helps the kidneys remove excess glucose from the bloodstream by increasing its excretion in the urine. Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by regulating the levels of insulin the body produces after eating and lowering glucose production in the liver. This dual action helps to improve overall blood sugar control.

What is the usual dosage of Glyxambi 10mg/5mg Tablet?

The recommended starting dose of Glyxambi is one 10mg empagliflozin/5mg linagliptin tablet taken once daily in the morning, with or without food. Your doctor may increase the dose to 25mg empagliflozin/5mg linagliptin once daily if additional blood sugar control is needed and the initial dose is tolerated. Always take Glyxambi exactly as prescribed by your doctor.

What are the possible side effects of Glyxambi 10mg/5mg Tablet?

Common side effects can include urinary tract infections (UTIs), nasopharyngitis (common cold), upper respiratory tract infections, cough, itching, frequent urination, and mild joint pain. More serious, though less common, side effects include dehydration, low blood sugar (especially when used with other diabetes medications like insulin or sulfonylureas), pancreatitis (inflammation of the pancreas), severe genital infections (Fournier's gangrene), and diabetic ketoacidosis.

Is Glyxambi 10mg/5mg Tablet safe during pregnancy or breastfeeding?

Glyxambi is generally not recommended during pregnancy, particularly in the second and third trimesters, as animal studies have shown potential adverse effects on postnatal development. It is also not recommended while breastfeeding because it is unknown if the active ingredients pass into human breast milk and could potentially affect the baby. Always consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Can Glyxambi 10mg/5mg Tablet be taken with other medications?

Glyxambi can interact with other medications. If taken with insulin or insulin secretagogues (e.g., sulfonylureas), a lower dose of these medications may be necessary to reduce the risk of hypoglycemia (low blood sugar). Diuretics can also interact with Glyxambi, potentially leading to increased urine volume and frequency, which might enhance the risk of volume depletion. It's crucial to inform your doctor about all medications you are currently taking, including over-the-counter drugs and herbal supplements, before starting Glyxambi.

What precautions should be taken with Glyxambi 10mg/5mg Tablet?

Before taking Glyxambi, inform your doctor if you have kidney or liver problems, a history of pancreatitis, urinary tract infections, or are taking diuretics. Glyxambi is not recommended for patients with severe kidney disease (or if on dialysis) or type 1 diabetes. Stay well-hydrated, especially during illness, vomiting, or diarrhea. Alcohol consumption should be avoided or limited, as it can increase the risk of low blood sugar or dehydration. Glyxambi can affect the results of certain urine glucose tests and 1,5-AG assays, so tell any doctor treating you that you are using this medicine.

What happens if a dose of Glyxambi 10mg/5mg Tablet is missed?

If you miss a dose of Glyxambi, take it as soon as you remember. However, if it is almost time for your next dose (generally less than 12 hours away), skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed one, as this may increase the risk of side effects.

How should Glyxambi 10mg/5mg Tablet be stored?

Store Glyxambi tablets at room temperature, below 30°C (86°F), away from moisture and heat. Keep the tablets in their original pack until it's time to take them, and store them out of reach of children. Do not store in the bathroom, near a sink, or in the car.