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Glibenclamide and Metformin HCl SR Tablets

Glibenclamide & Metformin HCl SR Tablets

Glibenclamide & Metformin Hydrochloride SR Tablets
Each sustained-release tablet contains Glibenclamide 5 mg + Metformin Hydrochloride 500 mg; excipients q.s.

Related Glibenclamide-only presentations: IP 5 mg, BP 5 mg (Gilben; Trippleace Glibenclamide-5), each uncoated.

Usage: Along with diet and exercise to improve blood glucose control in selected adults with type 2 diabetes.

Category: Anti Diabetic Drugs

Therapeutic Category: Anti Diabetic

SKU: Glibenclamide & Metformin HCl SR Tablets

Categories: Contract Manufacturer, Formulations Exporter India, Manufacturing Pharmaceutical Company India, Pharmaceutical Exporter India, Pharmaceutical Formulations India, Tablets Manufacturer, WHO GMP Certified Formulations

Product Information

Glibenclamide & Metformin HCl SR Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Glibenclamide 5 mg + Metformin Hydrochloride 500 mg SR Tablets

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. lists Glibenclamide & Metformin Hydrochloride SR Tablets for the management of type 2 diabetes when prescribed alongside diet and exercise. The supplied fixed-dose combination contains glibenclamide 5 mg and metformin hydrochloride 500 mg in a sustained-release tablet. Separate glibenclamide-only 5 mg tablets (IP and BP) are also listed and must not be confused with the combination.

2. Product Specifications

Product / BrandComposition per TabletDosage FormStandard
Glibenclamide + Metformin HCl SRGlibenclamide 5 mg + Metformin Hydrochloride 500 mgSustained-release tabletCombination; standard not specified
Glibenclamide IP 5 mgGlibenclamide IP 5 mg; excipients q.s.Uncoated tabletIP
GilbenGlibenclamide BP 5 mgUncoated tabletBP
Trippleace Glibenclamide-5Glibenclamide BP 5 mgUncoated tabletBP

The 2.5 mg / 500 mg combination is mentioned in the description but no composition was supplied for it. Availability and registration require confirmation.

3. Manufacturing Technology

Modified-release tablets require formulation-specific controls for uniform distribution of low-dose glibenclamide and the intended metformin release profile. Matrix or multilayer technologies are possible approaches, but the exact process, release duration and whether both ingredients are modified-release must be verified from the approved product specification. Moisture-protective packaging may be selected according to stability data.

4. Quality Assurance

Quality testing may include identity, assay and uniformity of both active ingredients, impurities, tablet integrity, and multipoint dissolution testing for the modified-release component. Acceptance criteria, stability and shelf life depend on the registered product.

5. Pharmacology and Clinical Use

Glibenclamide (glyburide) is a sulfonylurea that increases pancreatic insulin secretion and can cause significant hypoglycaemia. Metformin primarily reduces hepatic glucose production and improves insulin sensitivity. This combination may be considered for selected adults with type 2 diabetes when individualised therapy is appropriate. Glibenclamide carries a relatively high risk of prolonged hypoglycaemia, particularly in older adults and people with renal impairment; alternative treatments may be preferred under current clinical guidance.

6. Export and Regulatory Support

Product-specific regulatory dossiers, certificates of analysis and applicable export documents may be provided subject to availability. Local registration requirements and the approved modified-release specifications must be confirmed before supply.

7. Frequently Asked Questions

Who manufactures these tablets?
Healthy Life Pharma Pvt. Ltd., India.

Are glibenclamide-only tablets the same as the combination?
No. The combination additionally contains metformin hydrochloride 500 mg.

Can this cause low blood sugar?
Yes. Glibenclamide can cause serious or prolonged hypoglycaemia. Patients should know the symptoms and follow their diabetes care plan.

What does SR mean?
Sustained release indicates a designed release profile, but the exact release characteristics must be confirmed for the registered product.

8. Dosage and Administration

Use only as prescribed after assessment of blood glucose, kidney function, diet, concomitant medicines and hypoglycaemia risk. Follow the approved label for administration with meals. Do not crush or chew sustained-release tablets unless the specific product instructions permit it. The 2.5 mg/500 mg and 5 mg/500 mg strengths are not interchangeable.

9. Side Effects and Precautions

  • Hypoglycaemia: Glibenclamide may cause severe and prolonged low blood glucose, particularly with missed meals, older age or impaired kidney function.
  • Metformin: Gastrointestinal effects may include nausea, diarrhoea and abdominal discomfort; vitamin B12 deficiency may develop with long-term use.
  • Lactic acidosis: Rare but serious metformin-associated lactic acidosis risk increases with significant renal impairment, hypoxia, dehydration and certain acute illnesses. Kidney function monitoring is important.
  • Interactions: Alcohol and certain medicines can alter glucose control or increase adverse effects. Seek individual medical advice.

10. Storage Instructions

Store under conditions stated on the approved product label, protected from excessive moisture and heat. Keep out of reach of children.