Dapagliflozin 5mg Metformin 1000mg | GLIDAPAFLOZIN M 5/ 1000

Glidapaflozin M 5/1000 is a fixed-dose combination (FDC) tablet that pairs a lower strength of Dapagliflozin with the standard maximal maintenance dose of metformin, offering physicians a valuable dose-titration option within the broader dapagliflozin-metformin combination class. Rather than a one-size-fits-all approach, having access to a 5mg Dapagliflozin strength allows for more individualized therapy, particularly for patients who are initiating SGLT2 inhibitor treatment for the first time or who may be more prone to its characteristic side effects.

Manufactured by Steris Healthcare, this combination is prescribed by physicians, endocrinologists, and diabetologists across India for patients requiring metformin-based combination therapy with a more conservative Dapagliflozin starting dose.

Product Information

Why It's Important

While the 10mg strength of Dapagliflozin is commonly used and well established in combination with metformin, clinical practice increasingly recognizes the value of dose flexibility when introducing SGLT2 inhibitor therapy — particularly for patients who may be more susceptible to the characteristic volume-related and genitourinary side effects of this drug class, such as elderly patients, those with borderline renal function, or patients on concurrent diuretic therapy.

This is where Glidapaflozin M 5/1000 offers meaningful clinical value. By pairing a lower, more conservative Dapagliflozin dose with the maximal, well-tolerated 1000mg metformin dose, this combination allows physicians to introduce SGLT2 inhibitor therapy cautiously without sacrificing the substantial glucose-lowering contribution of metformin at its established, effective ceiling dose. This approach reflects sound clinical titration practice — starting at a lower dose of a newer medication class while maintaining an already well-tolerated component at its optimal dose, then reassessing for potential escalation based on individual response and tolerability.

Beyond initial dose caution, some patients — particularly older adults or those with modest baseline blood glucose elevation — may achieve adequate additional glycemic benefit at the lower Dapagliflozin strength without requiring the full 10mg dose, allowing for a more individually tailored treatment intensity rather than defaulting to the higher strength for every patient. This is particularly relevant in India's diverse diabetic population, where patient age, renal function, and concurrent medication use vary considerably and benefit from a flexible, dose-appropriate treatment approach.

Key Benefits 

What Are the Benefits of Glidapaflozin M 5/1000?

Dapagliflozin 5mg + Metformin Hydrochloride 1000mg, as formulated in Glidapaflozin M 5/1000, offers several clinically meaningful advantages:

• Cautious, individualized SGLT2 inhibitor initiation: The lower Dapagliflozin strength allows physicians to introduce this drug class more conservatively, particularly valuable for patients new to SGLT2 inhibitor therapy.
• Full metformin benefit maintained: Pairing the lower Dapagliflozin dose with the maximal 1000mg metformin dose ensures patients continue to receive the full, well-established glucose-lowering benefit of metformin therapy.
• Reduced initial side-effect burden: A lower Dapagliflozin dose may be associated with a somewhat gentler side-effect profile during treatment initiation, particularly regarding volume-related effects.
• Suitable for elderly or renally cautious patients: This lower strength offers a more conservative option for patients where a more gradual introduction to SGLT2 inhibitor therapy is clinically preferred.
• Dose-titration flexibility: Provides physicians with a clear stepping stone toward higher Dapagliflozin strengths if greater glycemic or weight benefit is needed and tolerated well at this dose.
• Low hypoglycemia risk: Both components work through largely insulin-independent or glucose-dependent mechanisms, maintaining a comparatively low hypoglycemia risk profile.
• Modest weight and blood pressure benefit: Even at the lower dose, Dapagliflozin's glucosuria-related weight reduction and mild diuretic effect on blood pressure remain clinically relevant.
• Trusted manufacturing standards: Glidapaflozin M 5/1000 is manufactured by Steris Healthcare, a WHO-GMP and ISO 9001:2018 certified pharmaceutical company, ensuring consistent potency and reliable quality across every batch.

Side Effects 

Common side effects associated with this combination include:

• Gastrointestinal disturbances such as nausea, diarrhea, or abdominal discomfort, particularly associated with the metformin component
• Urinary tract infections, related to the Dapagliflozin component's glucosuria effect
• Genital fungal infections, also related to increased urinary glucose
• Increased urination frequency, though often somewhat less pronounced than at higher Dapagliflozin doses
• Metallic taste, occasionally reported with metformin
• Mild headache
• Reduced appetite

Most gastrointestinal effects associated with metformin tend to improve with continued use, while genitourinary effects related to Dapagliflozin are generally manageable with adequate hydration and hygiene.

Precautions & Warnings

Before starting Glidapaflozin M 5/1000, patients and prescribers should consider the following precautions:

• Renal Impairment: Both components require careful renal function assessment before initiation and periodically during treatment.
• Lactic Acidosis Risk Factors: Caution is required in patients with conditions predisposing to lactic acidosis, including significant liver disease or heavy alcohol use.
• Volume Depletion: Even at the lower Dapagliflozin dose, patients who are elderly, on diuretics, or have low blood pressure should be monitored for signs of dehydration.
• Genital and Urinary Infections: Patients should be counseled on genital hygiene practices to reduce infection risk associated with increased urinary glucose.
• Diabetic Ketoacidosis Risk: Patients should be aware of ketoacidosis signs and should temporarily discontinue therapy during acute illness or significantly reduced food/fluid intake, as directed by the physician.
• Vitamin B12 Levels: Long-term metformin use has been associated with reduced vitamin B12 absorption; periodic monitoring may be advised.
• Contrast Dye Procedures: This medication is typically withheld before and after procedures involving iodinated contrast dye, as directed by the physician.
• Pregnancy and Lactation: Generally not recommended during pregnancy or breastfeeding; alternative diabetes management should be discussed with the treating physician.
• Drug Interactions: Caution is required when combining with diuretics and other antihyperglycemic agents, due to potential additive effects.

Mechanism of Action 

Glidapaflozin M 5/1000 works through two independent, complementary mechanisms, with the Dapagliflozin component delivered at a lower dose:

Dapagliflozin (SGLT2 Inhibitor, 5mg):

1. Inhibition of Renal Glucose Reabsorption: Dapagliflozin selectively inhibits SGLT2 in the proximal renal tubule, reducing glucose reabsorption even at the lower 5mg dose, though the overall magnitude of glucose excretion is somewhat more modest than at the 10mg strength.
2. Insulin-Independent Glucose Control: This mechanism remains fully insulin-independent at the lower dose, preserving the class's characteristic benefit for patients with declining pancreatic function.
3. Modest Metabolic Effects: Weight and blood pressure benefits remain present at this dose, though generally proportionally smaller than seen with the 10mg strength.

Metformin Hydrochloride (Biguanide, 1000mg):

1. Reduced Hepatic Glucose Production: At the full 1000mg dose, metformin provides maximal suppression of hepatic gluconeogenesis, forming the foundation of this combination's glycemic effect.
2. Improved Peripheral Insulin Sensitivity: Enhances glucose uptake and utilization in skeletal muscle tissue.
3. AMPK Activation: Underlies metformin's broader cellular metabolic effects at this well-established therapeutic dose.

Combined Effect: This lower-dose Dapagliflozin, high-dose metformin combination allows physicians to harness metformin's full, well-tolerated glucose-lowering potential while introducing SGLT2 inhibitor therapy in a more measured, individually appropriate manner — particularly valuable during treatment initiation or in patients where a gentler approach to this newer drug class is clinically preferred.

Frequently Asked Questions 

1. Where can I buy Dapagliflozin and Metformin Hydrochloride online?
You can purchase Dapagliflozin and Metformin Hydrochloride through licensed online pharmacies or authorized pharmaceutical suppliers. Check the strength, manufacturer, batch number, expiry date, and packaging before purchasing.

2. What is the price of Dapagliflozin and Metformin Hydrochloride?
The price may vary depending on the brand, strength, formulation, pack size, manufacturer, seller, and applicable pharmacy charges. Check the current listed price before placing an order.

3. Can I order Dapagliflozin and Metformin Hydrochloride online?
Yes, it can be ordered online where legally available. Since it is a prescription medicine, purchase it through a licensed pharmacy and provide a valid prescription when required.

4. Is Dapagliflozin and Metformin Hydrochloride available from Steris Healthcare?
Availability depends on Steris Healthcare's current product range and stock status. Contact Steris Healthcare or an authorized distributor to confirm availability, strength, pack size, and ordering details.

5. What is Dapagliflozin and Metformin Hydrochloride used for?
Dapagliflozin and Metformin Hydrochloride are used together to help control blood glucose levels in adults with type 2 diabetes mellitus, along with diet and exercise. Dapagliflozin helps the kidneys remove excess glucose through urine, while metformin reduces glucose production by the liver and improves insulin sensitivity.

6. What is the composition of Dapagliflozin and Metformin Hydrochloride?
The combination contains Dapagliflozin and Metformin Hydrochloride as active pharmaceutical ingredients. The exact strengths and formulation may vary depending on the specific product.

7. Is a prescription required?
Yes, Dapagliflozin and Metformin Hydrochloride are generally prescription medicines and should be used under the supervision of a qualified healthcare professional. Follow the prescribed strength and dosage.

8. How should Dapagliflozin and Metformin Hydrochloride be taken?
Take the medicine exactly as prescribed by your doctor. It is generally taken with food to reduce stomach-related side effects, but the exact schedule depends on the formulation and prescribed dose. Swallow extended-release tablets whole if applicable, and do not change or stop treatment without medical advice.

9. What should I know before buying Dapagliflozin and Metformin Hydrochloride?
Before purchasing, verify the exact strength, formulation, manufacturer, batch number, expiry date, packaging, and storage instructions. Inform your healthcare professional about kidney or liver problems, dehydration, heart conditions, pregnancy or breastfeeding, and other medicines you take. Kidney function may need to be assessed before and during treatment.

10. How can I order Dapagliflozin and Metformin Hydrochloride online?
Order through a licensed online pharmacy or authorized pharmaceutical supplier. Select the prescribed strength and pack size, provide a valid prescription if required, and verify the manufacturer, batch number, expiry date, and delivery details before completing your order.