Dapagliflozin 5mg Metformin 500mg | GLIDAPAFLOZIN M 5/500
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Manufactured By Steris Healthcare Pvt Ltd
Composition dapagliflozin 5mg metformin 500mg
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Description:
Introduction
GLIDAPAFLOZIN M 5/500 is a fixed-dose combination tablet containing Dapagliflozin 5mg (an SGLT2 inhibitor) and Metformin Hydrochloride 500mg (a biguanide), manufactured by Steris Healthcare Pvt. Ltd. It is prescribed for adults with Type 2 Diabetes Mellitus who need better blood sugar control than metformin alone can provide. Dapagliflozin works by helping the kidneys remove excess glucose through urine, while metformin reduces glucose production in the liver and improves insulin sensitivity. Together, they offer a dual-mechanism approach that can also support modest weight loss and blood pressure benefits alongside glycemic control. This is a Schedule H prescription medicine — it must only be used under medical supervision. Common side effects include urinary tract infections, genital yeast infections, and mild gastrointestinal upset.
Product Information
| Attribute | Detail |
|---|---|
| Brand Name | GLIDAPAFLOZIN M 5/500 |
| Composition | Dapagliflozin 5mg + Metformin Hydrochloride 500mg |
| Drug Class | SGLT2 Inhibitor + Biguanide (Fixed-Dose Combination) |
| Product Form | Tablet |
| Pack Size | 10 Tablets |
| Manufacturer/Marketer | Steris Healthcare Pvt. Ltd. |
| Schedule | Schedule H – Prescription Required |
| Storage | Store below 30°C, in a dry place, protected from light and moisture |
| Country of Origin/Sale | India |
| Therapeutic Use | Type 2 Diabetes Mellitus |
What Is GLIDAPAFLOZIN M 5/500 Used For?
GLIDAPAFLOZIN M 5/500 is indicated for the management of Type 2 Diabetes Mellitus (T2DM) in adults, typically when:
- Blood sugar remains uncontrolled on Metformin alone
- A doctor wants to combine two complementary mechanisms in a single tablet to improve adherence
- There is a clinical need to also address modest weight and blood pressure concerns alongside glucose control
- A patient is transitioning from separate Dapagliflozin and Metformin tablets to a simplified, fixed-dose regimen
Clinical Indications Table
| Indication | Applicable? | Notes |
|---|---|---|
| Type 2 Diabetes Mellitus (adjunct to diet/exercise) | Yes | Core approved use |
| Inadequate control on Metformin monotherapy | Yes | Common reason for prescribing this FDC |
| Type 1 Diabetes | No | Contraindicated |
| Diabetic Ketoacidosis | No | Contraindicated |
| Severe renal impairment (eGFR <45 mL/min/1.73m², varies by product label) | No / Caution | Dose adjustment or avoidance needed |
| Pregnancy | Caution | Only if clearly advised by treating physician |
How Does GLIDAPAFLOZIN M 5/500 Work?
This tablet combines two distinct, complementary mechanisms:
1. Dapagliflozin (SGLT2 Inhibitor): Dapagliflozin blocks the sodium-glucose co-transporter-2 (SGLT2) protein in the kidney's proximal tubules. Normally, this protein reabsorbs filtered glucose back into the bloodstream. By inhibiting it, dapagliflozin allows excess glucose to be excreted directly through urine (a process called glucosuria), independent of insulin. This mechanism also has secondary benefits — mild diuresis (fluid loss) and a modest reduction in body weight and blood pressure.
2. Metformin Hydrochloride (Biguanide): Metformin primarily works by reducing hepatic glucose production (gluconeogenesis) in the liver. It also improves peripheral insulin sensitivity, helping muscle and fat cells use glucose more effectively, and modestly reduces glucose absorption from the intestine.
Because these two drugs act on different pathways — one insulin-independent (kidney) and one insulin-sensitizing (liver/muscle) — the combination often achieves better glycemic control than either drug alone, without necessarily increasing the risk of hypoglycemia when used without insulin or sulfonylureas.
Key Benefits
- Dual-action glucose control — targets both hepatic glucose overproduction and renal glucose reabsorption
- Weight-friendly profile — dapagliflozin's glucosuria effect is often associated with modest weight reduction, a welcome feature for many Type 2 diabetics
- Cardiovascular and renal considerations — SGLT2 inhibitors as a class have been studied for heart and kidney protective effects in diabetic patients (always per treating physician's assessment)
- Simplified regimen — combines two medicines into one tablet, which can improve day-to-day adherence
- Low intrinsic hypoglycemia risk — when not combined with insulin or sulfonylureas, the risk of dangerously low blood sugar is comparatively low
Dosage & How to Take It
- Typically taken once or twice daily, exactly as prescribed by your physician, based on your current metformin dose and glycemic targets
- Usually taken with meals to reduce gastrointestinal side effects associated with metformin
- Swallow the tablet whole with water — do not crush or chew unless your doctor specifically advises otherwise
- Maintain consistent timing each day to support stable blood sugar levels
- Do not double the dose if a dose is missed; skip it and resume the normal schedule
- Regular monitoring of blood glucose, HbA1c, and kidney function (eGFR) is typically advised by the prescribing doctor
Side Effects
Common Side Effects
- Urinary tract infections (UTIs)
- Genital yeast infections (balanitis in men, vulvovaginal candidiasis in women)
- Increased urination
- Mild gastrointestinal upset — nausea, diarrhea, bloating (usually from the metformin component)
- Mild dizziness, especially on standing
Less Common / Serious Side Effects (reviewer placeholder — incidence rates pending medical sign-off)
- Dehydration or symptomatic hypotension, particularly in elderly patients or those on diuretics
- Diabetic ketoacidosis (rare, can occur even with near-normal blood sugar — "euglycemic DKA")
- Lactic acidosis (rare but serious, associated with metformin, especially in kidney impairment)
- Vitamin B12 deficiency with long-term metformin use
- Fournier's gangrene (rare, serious genital infection — reported class-wide with SGLT2 inhibitors)
Substitutes / Comparable Combinations
| Combination | Mechanism | Typical Use Case |
|---|---|---|
| Dapagliflozin 5mg + Metformin 500mg (this product) | SGLT2 inhibitor + Biguanide | Add-on therapy for inadequate control on metformin alone |
| Empagliflozin + Metformin | SGLT2 inhibitor + Biguanide | Similar dual-mechanism alternative |
| Sitagliptin + Metformin | DPP-4 inhibitor + Biguanide | Alternative for patients who cannot tolerate SGLT2 inhibitors |
| Glimepiride + Metformin | Sulfonylurea + Biguanide | Higher hypoglycemia risk; different mechanism |
| Metformin (standalone) | Biguanide only | First-line therapy before combination is needed |
Precautions & Who Should Avoid It
- Kidney function: Requires periodic eGFR monitoring; not recommended in significant renal impairment
- Elderly patients: Higher risk of dehydration and urinary infections — extra fluid intake and hygiene are usually advised
- Before surgery or contrast imaging: Metformin is often paused temporarily — always inform your doctor and radiologist that you're on this medicine
- Alcohol: Should be avoided or limited, as it increases the risk of lactic acidosis and low blood sugar
- Genital hygiene: Good hygiene practices are recommended to reduce the risk of yeast infections associated with SGLT2 inhibitors
- Pregnancy/breastfeeding: Use only under specific medical advice
- Sick-day rules: During illness with vomiting, diarrhea, or reduced fluid intake, contact your doctor — temporary discontinuation may be advised
Buyer Intent & Transactional Information
Looking to buy GLIDAPAFLOZIN M 5/500 in India? Here's what you need to know before you order:
- Prescription required: This is a Schedule H medicine. A valid prescription from a registered physician is mandatory for purchase.
- Manufactured by: Steris Healthcare Pvt. Ltd. — a WHO-GMP and ISO-certified pharmaceutical manufacturer.
- Pack size: 10 tablets per strip (confirm with your supplier — pack configurations may vary by order quantity).
- Where to buy: Available through Steris Healthcare's authorized distributor and B2B/PCD franchise network across India. Retail pharmacies and hospital pharmacies may also stock it based on regional distribution.
- How to order: Reach out to Steris Healthcare directly via the contact details below for bulk/institutional inquiries, or ask your local pharmacy to source it through their regular distributor channel.
- Before you order: Have your doctor's prescription ready, confirm your current metformin/dapagliflozin dosage with your physician, and check with your pharmacist about storage (store below 30°C, in a dry place, away from direct sunlight).
Frequently Asked Questions
1. What is Dapagliflozin 5mg used for?
Dapagliflozin 5mg is used, either alone or in combination with other antidiabetic medicines like metformin, to lower blood sugar levels in adults with Type 2 Diabetes Mellitus by helping the kidneys remove excess glucose through urine.
2. What is GLIDAPAFLOZIN M 5/500 used for?
It is used to manage Type 2 Diabetes when blood sugar isn't adequately controlled on metformin alone, combining Dapagliflozin's kidney-based glucose removal with Metformin's liver-based glucose control.
3. How does Dapagliflozin lower blood sugar?
It blocks the SGLT2 protein in the kidneys that normally reabsorbs glucose back into the blood, causing excess sugar to be excreted through urine instead — a mechanism that doesn't depend on insulin.
4. What are the common side effects of Dapagliflozin + Metformin combination tablets?
The most common side effects include urinary tract infections, genital yeast infections, increased urination, and mild stomach upset such as nausea or diarrhea, especially in the first few weeks.
5. Can Dapagliflozin and Metformin be taken together safely?
Yes, this combination is commonly prescribed together and is considered a standard second-line option for Type 2 Diabetes, but it should only be taken as directed by your doctor after assessing kidney function and overall health.
6. Is Dapagliflozin 5mg a strong dose?
5mg is generally considered the standard starting dose of Dapagliflozin; doctors may increase it to 10mg if needed and tolerated, based on blood sugar response and kidney function.
7. Does Dapagliflozin cause weight loss?
Many patients experience modest weight loss with Dapagliflozin due to the calories lost through excreted glucose and mild fluid loss, though this varies from person to person.
8. What should I avoid while taking this medicine?
Avoid excessive alcohol, skipping meals for long periods, and dehydration. Always inform your doctor before any surgery or imaging procedure involving contrast dye, as metformin may need to be paused.
9. Can this medicine cause low blood sugar (hypoglycemia)? On its own, the risk of hypoglycemia is relatively low, but it increases if combined with insulin or sulfonylurea medicines — always follow your doctor's monitoring advice.
10. Is this medicine safe for kidney patients? It requires caution in kidney impairment and is generally avoided in significant renal dysfunction. Your doctor will check your eGFR before and during treatment.
11. How long does it take for Dapagliflozin + Metformin to start working?
Blood sugar improvements can often be seen within the first few days to weeks, but full glycemic benefit and HbA1c improvement are usually assessed after 8–12 weeks of consistent use.
12. Where can I buy GLIDAPAFLOZIN M 5/500 online in India?
It is available through Steris Healthcare's authorized distributor network. As a Schedule H medicine, purchase requires a valid prescription — contact Steris Healthcare or your local pharmacy for availability.
13. What is the price of GLIDAPAFLOZIN M 5/500?
Pricing may vary by pack size, order quantity, and distributor. Contact Steris Healthcare directly using the details below for current pricing and bulk order rates.
14. Is a prescription required to buy this medicine?
Yes. GLIDAPAFLOZIN M 5/500 is a Schedule H drug and cannot be legally sold without a valid prescription from a registered medical practitioner.
15. What should I know before buying this medicine?
Confirm your prescribed dosage with your doctor, check for any kidney or liver conditions that may affect suitability, and ensure the pack is sourced from an authorized distributor to guarantee authenticity.
16. How do I order GLIDAPAFLOZIN M 5/500 in bulk for a pharmacy or hospital?
Institutional and B2B buyers can contact Steris Healthcare Pvt. Ltd. directly through the contact information provided below to discuss bulk ordering, distribution, and franchise opportunities.
17. Can Dapagliflozin + Metformin tablets be taken by elderly patients?
Yes, but with extra caution — elderly patients are more prone to dehydration, urinary infections, and kidney function changes, so closer monitoring is usually recommended.
18. What is the difference between Dapagliflozin alone and this combination tablet?
Standalone Dapagliflozin only targets kidney-based glucose excretion, while this combination adds Metformin's liver and insulin-sensitivity effects, often providing more comprehensive blood sugar control in one tablet.
Conclusion
GLIDAPAFLOZIN M 5/500 brings together two well-established, complementary approaches to Type 2 Diabetes management — Dapagliflozin's kidney-based glucose excretion and Metformin's liver-focused glucose control — in a single, convenient tablet manufactured by Steris Healthcare Pvt. Ltd. For many patients who haven't achieved their target blood sugar on metformin alone, this fixed-dose combination can offer a meaningful step forward, along with potential secondary benefits like modest weight reduction. That said, this is a prescription-only medicine, and its suitability depends on individual factors like kidney function, other medications, and overall health status. Always consult your doctor before starting, stopping, or adjusting this medication, and never rely on this article as a substitute for personalized medical advice.
Prescription only – consult your doctor