Glyxambi 10mg/5mg Tablets

Glyxambi combines two antihyperglycemic agents with complementary mechanisms of action: empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. Empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, leading to increased urinary glucose excretion. Linagliptin inhibits the enzyme DPP-4, which is responsible for the inactivation of incretin hormones (glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]). By inhibiting DPP-4, linagliptin increases the concentrations of active incretin hormones, which enhances glucose-dependent insulin release from pancreatic beta cells and decreases glucagon secretion from pancreatic alpha cells.

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 immediate medical attention:

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 fluid and electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Unable to pass urine or changes in urine production
+ Dry mouth
+ Dry eyes
+ Severe stomach upset or vomiting
Signs of kidney problems, such as:
+ Unable to pass urine
+ Changes in urine production
+ Blood in the urine
+ Sudden weight gain
Signs of too much acid in the blood (acidosis), including:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Abnormal heartbeat
+ Severe stomach pain
+ Upset stomach or vomiting
+ Feeling very sleepy
+ Shortness of breath
+ Feeling very tired or weak
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain while passing urine
+ Frequent or urgent need to pass urine
+ Fever
+ Lower stomach pain
+ Pelvic pain
Vaginal yeast infection: Report itching, bad odor, or discharge
Yeast infection of the penis: Report pain, swelling, rash, or discharge
Severe headache
Joint pain that is severe, disabling, or persistent: Contact your doctor immediately
A skin reaction called bullous pemphigoid: Contact your doctor right away if you notice blisters or skin breakdown

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:

Nose or throat irritation
Signs of a common cold

Reporting Side Effects

This is not a comprehensive list of all 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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the 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.
If you have kidney disease or any kidney problems.
If you are dehydrated, as this may affect the medication's efficacy or increase the risk of side effects. Discuss your dehydration with your doctor before starting treatment.
If you are taking rifampin, as it may interact with this medication.
If you are pregnant or plan to become pregnant. Do not take this medication during the second or third trimester of pregnancy.
If you are breastfeeding, as you should not breastfeed while taking this medication.

Additionally, it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, to your doctor and pharmacist. This information will help them assess potential interactions and ensure safe treatment. Never start, stop, or change the dose of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.

Be aware that low blood sugar (hypoglycemia) can occur, especially when this medication is used in combination with other diabetes treatments. Symptoms of low blood sugar may include dizziness, headache, fatigue, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating. If you experience any of these symptoms, contact your doctor immediately and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or consuming certain fruit juices.

To minimize the risk of accidents, do not drive if you have recently experienced low blood sugar. Additionally, to reduce the risk of dizziness or fainting, rise slowly from a sitting or lying position and exercise caution when navigating stairs.

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

This medication has been associated with severe and potentially life-threatening pancreas problems (pancreatitis). Seek immediate medical attention if you experience severe stomach pain, back pain, or severe nausea and vomiting.

There is also a risk of developing too much acid in the blood or urine (ketoacidosis), which can be fatal. This condition can occur even if your blood sugar levels are below 250. Individuals with diabetes, pancreas problems, or those who are ill, dehydrated, or have a history of skipping meals are at a higher risk of developing ketoacidosis. The risk is also increased in people who use insulin and take less than their prescribed dose or miss a dose. As directed by your doctor, monitor your ketone levels and consult with them if you have any questions or concerns.

Severe urinary tract infections (UTIs) have been reported with this medication, and in some cases, hospitalization was required. Kidney problems have also occurred, which may necessitate hospitalization or dialysis. If you have a history of heart failure or kidney problems, inform your doctor, and seek immediate medical attention if you experience extreme fatigue, shortness of breath, significant weight gain, or swelling in your arms or legs.

This medication may increase the risk of lower limb amputations, particularly toe and foot amputations. Discuss with your doctor ways to properly care for your feet, and inform them if you have a history of amputations, blood vessel disease, nerve disease, or foot ulcers related to diabetes. If you experience new pain, tenderness, sores, ulcers, or infections in your legs or feet, contact your doctor promptly.

A rare but potentially life-threatening infection has been associated with this class of medications. Seek immediate medical attention if you experience tenderness, redness, or swelling in the genital area or the region between your genitals and rectum, accompanied by fever or a general feeling of illness.

If you are pregnant or become pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby.

• Insulin and Insulin Secretagogues (e.g., Sulfonylureas): Increased risk of hypoglycemia. Dose reduction of insulin or sulfonylurea may be required.
• Diuretics (especially loop diuretics): Increased risk of volume depletion and hypotension due to empagliflozin's osmotic diuretic effect.

• UGT Inducers (e.g., Rifampin, Phenytoin, Phenobarbital): May decrease empagliflozin exposure. Clinical significance generally not considered major.
• P-glycoprotein (P-gp) Inducers (e.g., Rifampin): May decrease linagliptin exposure. Clinical significance generally not considered major.

• Signs and symptoms of hypoglycemia (e.g., sweating, tremor, confusion, hunger)
• Signs and symptoms of diabetic ketoacidosis (DKA) (e.g., nausea, vomiting, abdominal pain, rapid breathing, unusual fatigue, fruity breath)
• Signs and symptoms of urinary tract infection (UTI) (e.g., painful urination, frequent urination, urgency, fever)
• Signs and symptoms of genital mycotic infections (e.g., itching, redness, discharge)
• Signs and symptoms of volume depletion/dehydration (e.g., dizziness, lightheadedness, orthostatic hypotension)
• Signs and symptoms of acute kidney injury (e.g., decreased urine output, swelling)
• Signs and symptoms of severe arthralgia (joint pain)
• Signs and symptoms of bullous pemphigoid (blisters or erosions on the skin)

Not recommended during the second and third trimesters of pregnancy due to potential adverse effects on renal development in the fetus (empagliflozin). Limited data on use in pregnant women. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Not recommended during breastfeeding. It is unknown if empagliflozin or linagliptin are 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 discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness of Glyxambi 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. However, older patients may be at increased risk for volume depletion and renal impairment due to empagliflozin. Renal function should be assessed more frequently in elderly patients.

• Educate patients on the signs and symptoms of diabetic ketoacidosis (DKA), even if blood glucose levels are not severely elevated (euglycemic DKA), and instruct them to seek immediate medical attention if these symptoms occur.
• Advise patients to maintain adequate hydration to minimize the risk of volume depletion and hypotension, especially during periods of illness, hot weather, or increased physical activity.
• Counsel patients on proper genital hygiene to reduce the risk of genital mycotic infections, a common side effect of SGLT2 inhibitors.
• Monitor renal function before initiating and periodically during treatment, as empagliflozin's efficacy is dependent on renal function and it is contraindicated in severe renal impairment.
• If co-administered with insulin or insulin secretagogues (e.g., sulfonylureas), consider a lower dose of insulin or the secretagogue to reduce the risk of hypoglycemia.
• Patients should be advised to temporarily discontinue Glyxambi prior to surgery or during prolonged fasting to reduce the risk of DKA.

• Other SGLT2 inhibitors (e.g., Jardiance, Farxiga, Invokana)
• Other DPP-4 inhibitors (e.g., Tradjenta, Januvia, Onglyza)
• Metformin
• Sulfonylureas
• Thiazolidinediones (TZDs)
• GLP-1 receptor agonists
• 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 provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.