Dapagliflozin (10mg), Metformin (1000mg)

May 23, 2023

Introduction

GLIDAPAFLOZIN M 10/1000 is a fixed-dose combination antidiabetic tablet formulated for the management of Type 2 Diabetes Mellitus (T2DM) in adults. It combines two complementary agents—Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and Metformin SR, a biguanide.This dual-therapy targets both renal glucose reabsorption and hepatic glucose production, offering enhanced glycemic control, weight benefits, and cardiovascular protection.

Composition and Strength

Each film-coated tablet contains:

Also known as:

  • Tab Dapagliflozin 10 mg

  • Tab Metformin SR 1000 mg

Indications / Uses

  • Type 2 Diabetes Mellitus (T2DM) in adults

  • Inadequate glycemic control on Metformin monotherapy or other agents

  • Can be part of dual or triple therapy

  • Suitable for patients with overweight, insulin resistance, or cardiovascular risk factors

Not indicated for Type 1 Diabetes Mellitus or Diabetic Ketoacidosis (DKA).

How It Works

Dapagliflozin (10 mg) – SGLT2 Inhibitor

  • Inhibits SGLT2 transporters in the proximal renal tubules

  • Prevents glucose reabsorption → increases urinary glucose excretion

  • Reduces fasting and postprandial blood glucose

  • Helps in weight loss, BP control, and has cardiorenal benefits

Metformin SR (1000 mg) – Biguanide

  • Decreases hepatic glucose production

  • Improves insulin sensitivity in peripheral tissues

  • Reduces intestinal glucose absorption

  • SR formulation ensures sustained action and improved GI tolerance

Clinical Benefits

  • Improves HbA1c, fasting and postprandial glucose

  • Promotes weight loss or weight neutrality

  • Reduces systolic blood pressure

  • Lowers cardiovascular risk in high-risk patients

  • Supports kidney function in early nephropathy

Dosage and Administration

Parameter Details
Usual Adult Dose 1 tablet once or twice daily with meals
Route Oral
Titration May be adjusted based on glycemic response and tolerance
Renal Monitoring Required before initiation and regularly thereafter

Tablets must be swallowed whole—do not crush or chew.

Side Effects of Dapagliflozin 10 mg

Common Side Effects:

  • Increased urination (polyuria)

  • Genital infections (e.g., candidiasis, balanitis)

  • Urinary tract infections (UTIs)

  • Thirst or dehydration

  • Mild weight loss

  • Headache

Serious But Rare Side Effects:

  • Euglycemic Diabetic Ketoacidosis (EDKA)

  • Hypotension, especially in volume-depleted patients

  • Acute kidney injury (rare)

  • Necrotizing fasciitis of the perineum (Fournier’s gangrene)

Report any signs of infection, abdominal pain, or unusual fatigue immediately.

Side Effects of Metformin 1000 mg (SR)

  • Nausea

  • Diarrhea

  • Metallic taste

  • Abdominal bloating or discomfort

  • Lactic acidosis (rare but life-threatening, especially in renal or liver dysfunction)

Contraindications

  • Hypersensitivity to Dapagliflozin or Metformin

  • Severe renal impairment (eGFR < 45 mL/min/1.73 m²)

  • Metabolic acidosis or diabetic ketoacidosis (DKA)

  • Acute or chronic liver disease

  • History of lactic acidosis

  • Excessive alcohol intake

Drug Interactions

Interacting Drug Class Clinical Concern
Diuretics Increased risk of volume depletion and hypotension
Insulin or Sulfonylureas Higher risk of hypoglycemia
Contrast Media Risk of lactic acidosis (Metformin)
Alcohol Increases risk of lactic acidosis
Ranitidine or Cimetidine May reduce clearance of Metformin

Special Population Usage

  • Pregnancy: Use only if clearly needed under medical advice

  • Breastfeeding: Not recommended due to potential drug excretion in breast milk

  • Elderly: Monitor renal function closely

  • Pediatrics: Not recommended under 18 years

Storage Information

  • Store below 30°C in a dry and cool place

  • Protect from light and moisture

  • Keep out of reach of children

Key Benefits of GLIDAPAFLOZIN M 10/1000

  • Potent glycemic control via dual mechanism

  • Aids in weight reduction

  • Lowers systolic blood pressure

  • Minimal risk of hypoglycemia

  • Cardiovascular and renal protection

  • Convenient once or twice-daily dosing

Frequently Asked Questions (FAQs)

Q1: Can GLIDAPAFLOZIN M 10/1000 be taken long-term?

Yes. It is safe for long-term use under medical supervision with regular monitoring.

Q2: Does Dapagliflozin 10 mg cause frequent urination?

Yes, due to its glucose-excreting action, mild increase in urination is expected.

Q3: What is the best time to take GLIDAPAFLOZIN M 10/1000?

Take it with morning and/or evening meals to minimize GI discomfort.

Q4: Can it cause weight loss?

Yes. Dapagliflozin promotes calorie loss through glucosuria, which helps in modest weight loss.

Q5: Is it safe for kidney patients?

It should be avoided in patients with eGFR < 45. Always monitor renal function.

Conclusion

GLIDAPAFLOZIN M 10/1000 is an advanced and effective dual therapy combining Dapagliflozin 10 mg and Metformin 1000 mg (SR) for managing Type 2 Diabetes Mellitus. It not only controls blood sugar effectively but also supports weight loss, improves cardiovascular markers, and reduces insulin resistance. Regular monitoring and adherence to medical advice are essential for safe and optimal outcomes.

About The Author

STERIS HEALTHCARE PVT LTD

Steris Healthcare Pvt Ltd, known as Sterispharma, was founded in February 2018 by a team of experienced professionals in the pharmaceutical industry. Headquartered in Navi Mumbai, the company holds certifications from WHO, GMP, and ISO, reflecting its dedication to maintaining high standards of quality and safety. Sterispharma’s mission is to provide affordable, high-quality medications across India, strictly adhering to WHO guidelines. With the convenience of an online pharmacy, customers can easily order medicines with home delivery options.

For further information 

Email: info@sterispharma.com / contact@sterispharma.com

Call/WhatsApp: 8209542042 , 8824175417

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