Empagliflozin + Metformin Hcl Tablets 5mg/500mg, 5mg/1000mg, 12.5mg/500mg, 12.5mg/1000mg Tablet

What is Empagliflozin + Metformin HCl Tablets 5mg/500mg, 5mg/1000mg, 12.5mg/500mg, 12.5mg/1000mg Tablet?

Empagliflozin + Metformin HCl Tablets combine empagliflozin, an SGLT2 inhibitor, with metformin, a biguanide antidiabetic medicine. Available in four strengths, this oral combination is used in the management of type 2 diabetes mellitus as part of an appropriate treatment plan that may include diet and lifestyle measures.

Uses / Indications

Empagliflozin + Metformin HCl Tablets may be used in the management of:

• Type 2 diabetes mellitus
• Inadequately controlled blood glucose levels where combination therapy is appropriate
• Type 2 diabetes requiring complementary glucose-lowering mechanisms
• Glycemic control alongside appropriate diet and lifestyle measures

The product is not intended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Benefits

• Combines two glucose-lowering medicines with complementary mechanisms.
• Empagliflozin supports urinary glucose excretion through SGLT2 inhibition.
• Metformin helps reduce hepatic glucose production and improves insulin sensitivity.
• Available in four strength combinations for appropriate treatment plans.
• Provides an oral fixed-dose combination in a single tablet.

Side Effects

Common Side Effects

Possible side effects may include:

• Nausea
• Diarrhea
• Abdominal discomfort
• Increased urination
• Genital fungal infections
• Urinary tract infections
• Headache

Gastrointestinal effects are particularly associated with metformin, especially when treatment is initiated or the dose is increased.

Less Common or Serious Side Effects

Important but less common reactions may include dehydration, low blood pressure, serious genital or urinary infections, ketoacidosis, vitamin B12 deficiency with prolonged metformin use, and lactic acidosis associated with metformin in appropriate high-risk situations. Severe allergic reactions may also occur.

Prompt medical attention is appropriate for symptoms such as severe weakness, persistent vomiting, severe abdominal pain, unusual breathing difficulty, confusion, or symptoms of a serious allergic reaction.

How Does It Work?

Empagliflozin inhibits sodium-glucose cotransporter 2 (SGLT2) in the kidneys, reducing glucose reabsorption and increasing urinary glucose excretion. Metformin primarily decreases hepatic glucose production and improves insulin sensitivity, supporting greater peripheral glucose utilization. Together, the two medicines provide complementary approaches to blood glucose management in type 2 diabetes.

Dosage Guidelines

The appropriate regimen should be determined according to the approved product information and the individual patient’s clinical circumstances.

Available combinations include:

• Empagliflozin 5 mg + Metformin HCl 500 mg
• Empagliflozin 5 mg + Metformin HCl 1000 mg
• Empagliflozin 12.5 mg + Metformin HCl 500 mg
• Empagliflozin 12.5 mg + Metformin HCl 1000 mg

The appropriate strength and dosing schedule depend on factors such as current diabetes therapy, glycemic control, renal function, tolerability, and clinical requirements.

• Take the medicine exactly as prescribed.
• Follow the approved instructions regarding administration with meals.
• Do not change the strength or dose without professional guidance.
• Renal function should be considered when determining whether treatment is appropriate.

When Not to Use

This combination should generally not be used in circumstances such as:

• Type 1 diabetes mellitus
• Diabetic ketoacidosis
• Severe renal impairment or situations where metformin or empagliflozin is contraindicated
• Metabolic acidosis, including lactic acidosis
• Known serious hypersensitivity to empagliflozin, metformin, or any component of the product
• Certain acute conditions associated with significant dehydration or impaired oxygenation

The approved product information should be reviewed for the complete contraindications.

Drug / Product Interactions

Potential interactions may occur with:

• Insulin and insulin secretagogues, which may increase the risk of hypoglycemia
• Diuretics, which may increase the risk of volume depletion
• Certain medicines affecting renal function
• Alcohol, particularly excessive intake, which may increase the risk of metabolic complications associated with metformin
• Iodinated contrast media in situations where temporary interruption of metformin may be required
• Certain medicines that can affect glucose levels or renal function

A complete medication history should be reviewed before treatment.

Safety Advice

• Assess renal function before treatment and periodically during therapy as appropriate.
• Maintain adequate hydration unless fluid restriction has been advised.
• Monitor for symptoms of ketoacidosis, including nausea, vomiting, abdominal pain, unusual tiredness, or difficulty breathing.
• Report persistent or severe gastrointestinal symptoms.
• Be alert for symptoms of lactic acidosis, particularly in high-risk situations.
• Monitor for urinary and genital infections.
• Inform healthcare professionals before major surgery or procedures involving iodinated contrast media.
• Long-term metformin treatment may be associated with reduced vitamin B12 levels, and monitoring may be considered where clinically appropriate.
• Hypoglycemia risk may increase when used with insulin or insulin secretagogues.

General Instructions

• Take the tablet exactly as prescribed.
• Follow the approved product instructions regarding administration with food.
• Swallow the tablet as directed and do not alter the dosage form unless instructed.
• Maintain adequate fluid intake unless otherwise advised.
• Continue appropriate dietary and lifestyle measures.
• Do not discontinue treatment or change the strength without professional guidance.
• Product details should be confirmed against the approved product specification.

Special Dietary / Lifestyle Tips

• Follow a balanced diet appropriate for diabetes management.
• Maintain regular physical activity when medically appropriate.
• Maintain adequate hydration.
• Monitor blood glucose according to the recommended schedule.
• Avoid excessive alcohol consumption.
• Maintain regular medical follow-up and laboratory monitoring when advised.

Comparison with Other Treatments

Empagliflozin + Metformin combines an SGLT2 inhibitor with a biguanide and therefore provides two complementary glucose-lowering mechanisms. Other diabetes treatments, including DPP-4 inhibitors, sulfonylureas, GLP-1 receptor agonists, insulin, and other SGLT2 inhibitor combinations, work differently and have their own precautions and monitoring requirements. Selection depends on the patient’s clinical circumstances, treatment history, renal function, tolerability, and approved treatment guidance.

Precautions & Warnings

• Evaluate kidney function before and during treatment as appropriate.
• Use caution in patients at increased risk of dehydration or volume depletion.
• Be alert for ketoacidosis, which may occur even when blood glucose is not markedly elevated.
• Metformin-associated lactic acidosis is uncommon but serious and is more likely in certain high-risk clinical situations.
• Consider temporary interruption in situations such as major surgery, prolonged fasting, acute serious illness, or specific contrast-imaging procedures according to professional guidance.
• Monitor for genital and urinary tract infections.
• Long-term metformin therapy may require consideration of vitamin B12 monitoring.
• Patients taking insulin or insulin secretagogues may require closer monitoring for hypoglycemia.
• Use during pregnancy or breastfeeding should be discussed with an appropriate healthcare professional.

Can I Use It With Other Medicines?

Generally Compatible With

This combination may be used with other glucose-lowering medicines when specifically prescribed and monitored. It can form part of a broader type 2 diabetes treatment plan when clinically appropriate.

Use With Caution / Avoid

Particular caution may be required with:

• Insulin
• Sulfonylureas and other insulin secretagogues
• Diuretics
• Medicines affecting kidney function
• Iodinated contrast media
• Excessive alcohol consumption
• Medicines that may significantly alter blood glucose levels

All concurrent medicines should be reviewed by a healthcare professional.

Storage

Store according to the approved product label and packaging instructions. Keep the tablets protected from unsuitable environmental conditions and out of reach of children. Do not use after the stated expiry date.

Frequently Asked Questions

1. What is Empagliflozin + Metformin HCl used for?

It is an oral antidiabetic combination used in the management of type 2 diabetes mellitus.

2. What strengths are available?

The product is available as empagliflozin 5 mg + metformin HCl 500 mg, 5 mg + 1000 mg, 12.5 mg + 500 mg, and 12.5 mg + 1000 mg.

3. How does Empagliflozin work?

Empagliflozin inhibits SGLT2 in the kidneys, reducing glucose reabsorption and increasing urinary glucose excretion.

4. How does Metformin work?

Metformin primarily reduces glucose production by the liver and improves the body’s sensitivity to insulin.

5. Is this medicine used for type 1 diabetes?

No. This combination is intended for type 2 diabetes management and is not indicated for treating type 1 diabetes or diabetic ketoacidosis.

6. Can this medicine cause low blood sugar?

The combination itself has a relatively low intrinsic risk of hypoglycemia, but the risk can increase when it is used with insulin or insulin secretagogues.

7. Why is kidney function important with this medicine?

Both empagliflozin and metformin require consideration of renal function. Kidney function can affect treatment suitability, dosing, and safety.

8. What is the supplied packing?

The supplied packing is 6×10 Alu-Alu Blister / As per your requirement. Product details should be confirmed against the approved product specification.