GLIDAPAFLOZIN M 5/500 & Dapagliflozin (5mg) and Metformin (500mg) Tablet - Steris Healthcare PVT LTD………

May 21, 2024

Introduction

GLIDAPAFLOZIN M 5/500 is a fixed-dose combination tablet that combines two highly effective oral anti-diabetic agents: Dapagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor, and Metformin SR, a biguanide. It is used for managing Type 2 Diabetes Mellitus (T2DM) in adults, especially when blood sugar control is inadequate with Metformin alone or other therapies.

Key Features

  • Dual-action therapy for T2DM

  • Sustained glucose control throughout the day

  • Reduces risk of hypoglycemia

  • Weight-neutral or weight-reducing

  • Cardiorenal benefits with Dapagliflozin

  • Improved gastrointestinal tolerance with Metformin SR

Pharmacological Class

  • Dapagliflozin: SGLT2 Inhibitor

  • Metformin SR: Biguanide (Antihyperglycemic agent)

How It Works

Dapagliflozin (5 mg)

  • Inhibits SGLT2 in renal proximal tubules

  • Reduces reabsorption of glucose

  • Promotes urinary glucose excretion (glucosuria)

  • Leads to lower blood glucose, weight loss, and mild BP reduction

Metformin SR (500 mg)

  • Decreases hepatic glucose production

  • Enhances insulin sensitivity

  • Improves peripheral glucose uptake

  • SR formulation improves GI tolerance by releasing the drug slowly

Uses / Indications

  • Type 2 Diabetes Mellitus in adults

  • Inadequate glycemic control on Metformin alone

  • As part of initial therapy when dual treatment is appropriate

  • Beneficial in overweight or obese diabetic patients

  • Can be combined with insulin or other oral antidiabetic agents

Not indicated for Type 1 Diabetes or Diabetic Ketoacidosis

Dosage and Administration

Parameter Recommendation
Initial Dose 1 tablet once daily with food
Maximum Dose As per physician’s discretion, not exceeding safety limits
Route Oral
Frequency Once or twice daily (as prescribed)
Intake Advice Take with meals to reduce GI side effects (Metformin)

Tablets must be swallowed whole, not crushed or chewed.

Warnings & Precautions

  • Monitor renal function before and during therapy

  • Risk of genital mycotic infections (e.g., candidiasis)

  • Risk of lactic acidosis with Metformin

  • Avoid in patients undergoing radiologic studies with iodinated contrast

  • Use caution in:

    • Elderly

    • Volume-depleted individuals

    • Heart failure patients

    • Liver impairment cases

Contraindications

  • Hypersensitivity to any ingredient

  • eGFR < 45 mL/min/1.73m²

  • Acute or chronic metabolic acidosis, including DKA

  • Severe renal or hepatic impairment

  • Alcohol abuse (increases lactic acidosis risk)

Drug Interactions

Drug Category Effect
Loop Diuretics Increased risk of dehydration and hypotension
Alcohol Heightened risk of lactic acidosis with Metformin
Insulin/Sulfonylureas Increased risk of hypoglycemia
Contrast Media May lead to renal failure and lactic acidosis
Cationic drugs (e.g., amiloride) May delay Metformin excretion, increasing toxicity

Side Effects

Common:

  • Increased urination

  • Vaginal or penile yeast infections

  • Nausea, vomiting, diarrhea

  • Loss of appetite

  • Headache

Rare but Serious:

  • Lactic acidosis (rare but life-threatening)

  • Euglycemic ketoacidosis (Dapagliflozin-related)

  • Hypotension (especially in dehydrated patients)

  • Acute kidney injury (rare)

Use in Special Populations

  • Pregnancy: Use only if clearly needed and prescribed

  • Breastfeeding: Not recommended

  • Geriatrics: Dose adjustments may be required due to renal decline

  • Pediatrics (<18 years): Safety and efficacy not established

Storage Instructions

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

  • Protect from light and moisture

  • Keep out of reach of children

Benefits of GLIDAPAFLOZIN M 5/500

  • Dual action provides superior glycemic control

  • Low risk of hypoglycemia

  • Improves insulin sensitivity and urinary glucose clearance

  • Weight reduction and BP-lowering effects (Dapagliflozin)

  • Cardiovascular and renal protective properties

Frequently Asked Questions (FAQs)

1. What is GLIDAPAFLOZIN M 5/500 used for?

It is used to treat adults with type 2 diabetes mellitus, especially when Metformin alone is not enough to control blood sugar.

2. Can I take GLIDAPAFLOZIN M 5/500 with insulin?

Yes, it can be prescribed alongside insulin or other oral agents under medical supervision.

3. Does it cause low blood sugar?

It generally doesn’t, but when combined with insulin or sulfonylureas, the risk may increase.

4. Is weight loss expected with this medicine?

Yes, Dapagliflozin helps in mild to moderate weight reduction in many patients.

5. When should I not take this tablet?

Avoid it if you have kidney disease, liver failure, or are at risk of lactic acidosis.

Conclusion

GLIDAPAFLOZIN M 5/500 is a powerful and well-tolerated oral therapy for type 2 diabetes, combining the glucose-lowering efficacy of Metformin SR with the renal-glucose excreting action of Dapagliflozin. It offers an effective, safe, and convenient solution for patients requiring dual therapy to manage blood glucose, especially those with weight or cardiovascular concerns. Always use under the guidance of a qualified healthcare provider.

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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