GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/500mg
B. Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg
C. Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/250mg
D. Glibenclamide and Metformin Hydrochloride Tablets 5mg/500mg
E. Glibenclamide and Metformin Hydrochloride Tablets 5mg/850mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/500mg
Each film-coated tablet contains:
Glibenclamide IP……………………….2.5mg
Metformin Hydrochloride IP………………….500mg
Excipients…………………………………………...q.s.
Colours: Iron oxide Red

B. Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg
Each film-coated tablet contains:
Glibenclamide IP………………………...2.5m
Metformin Hydrochloride IP…………………...400mg
Excipients……………………………………………q. s
Colours: Iron oxide Yellow


C. Glibenclamide and Metformin Hydrochloride Tablets 2.5.mg/250mg
Each film-coated tablet contains:
Glibenclamide IP………………………...2.5m
Metformin Hydrochloride IP…………………...250mg
Excipients……………………………………………q. s
Colours: Iron oxide Black

D. Glibenclamide and Metformin Hydrochloride Tablets 5mg/500mg
Each film-coated tablet contains:
Glibenclamide IP………………………...5mg
Metformin Hydrochloride IP……………...…...500mg
Excipients …………………………………………... q.s.
Colours: Quinoline Yellow

E. Glibenclamide and Metformin Hydrochloride Tablets 5mg/850mg
Each film-coated tablet contains:
Glibenclamide IP………………………...5mg
Metformin Hydrochloride IP……………...…...850mg
Excipients …………………………………………... q.s.
Colours: Titanium Dioxide

THERAPEUTIC INDICATIONS:

Treatment of type 2 diabetes in adults, as replacement for previous combination therapy with metformin and Glibenclamide in patients whose glycaemia is stable and well-controlled.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
ANY UNUSED PRODUCT OR WASTE MATERIAL SHOULD BE DISPOSED OF IN ACCORDANCE WITH LOCAL REQUIREMENTS.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C.
Do not freeze.
Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.

Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg Technical Specification:

Product Name:
Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg
Brand Name:Glucotaj-ZET
Strength:2.5mg/500mg, 2.5mg/400mg, 2.5mg/250mg, 5mg/500mg, 5mg/850mg
Dosage Form:Tablets (Film coated)
Route of Administration:Via Oral Route
Packing:30s, 90s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Anti-diabetic, sulfonylureas
Indication: This combination medication is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes.
Storage:Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg
    Each film-coated tablet contains:
    Glibenclamide IP……………………….2.5mg
    Metformin Hydrochloride IP………………….400mg
    Excipients……………………………………………q.s.
    Colours: Iron oxide Yellow

THERAPEUTIC INDICATIONS:

Treatment of type 2 diabetes in adults, as replacement for previous combination therapy with metformin and Glibenclamide in patients whose glycaemia is stable and well-controlled.

CAUTION & SCHEDULE :

CAUTION:
Read enclosed leaflet before use.
Any unused product or waste material should be disposed of in accordance with local requirements.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

At Taj Pharma, we are dedicated to providing effective and reliable medications for diabetes management. Our Glibenclamide and Metformin Hydrochloride Tablets exemplify our commitment to improving the lives of individuals living with diabetes. With a focus on innovation and quality control, we strive to deliver medications that not only help control blood sugar levels but also enhance overall well-being. We understand the challenges of diabetes and the importance of maintaining a healthy and active lifestyle. That’s why our pharmaceutical solutions are designed to support you on your journey to better health. Choose Taj Pharma for Glibenclamide and Metformin Hydrochloride Tablets, and you’re choosing a partner in diabetes care. Our rigorous quality standards, experienced professionals, and patient-centric approach make us a trusted name in diabetes management. Together, we can work towards a healthier, more fulfilling life for individuals managing diabetes.

What is Glibenclamide and Metformin Hydrochloride Tablets and its Use?

Glibenclamide and Metformin Hydrochloride Tablets are a combination medication used in the management of type 2 diabetes mellitus. This medication contains two active ingredients: Glibenclamide (also known as Glyburide) and Metformin Hydrochloride. Let’s explore their uses:

  • Glibenclamide (Glyburide): Glibenclamide is an oral antidiabetic medication belonging to the sulfonylurea class. It works by stimulating the release of insulin from the pancreas, specifically the beta cells in the islets of Langerhans. This increased insulin production helps lower blood sugar levels by allowing the body to use glucose more effectively.
  • Metformin Hydrochloride: Metformin is an oral antidiabetic medication classified as a biguanide. It primarily works by reducing the production of glucose in the liver and improving the body’s sensitivity to insulin. It also helps decrease the absorption of glucose from the gastrointestinal tract. Metformin does not stimulate insulin release from the pancreas.

Uses of Glibenclamide and Metformin Hydrochloride Tablets:

These tablets are prescribed to individuals with type 2 diabetes mellitus, particularly those who have not achieved adequate blood sugar control with lifestyle changes (such as diet and exercise) alone. Here’s how this combination medication is used:

  • Blood Sugar Control: Glibenclamide and Metformin Hydrochloride Tablets are used to lower and control blood sugar levels in people with type 2 diabetes. By increasing insulin release (Glibenclamide) and improving insulin sensitivity and reducing glucose production (Metformin), this combination helps maintain glucose levels within a target range.
  • Combination Therapy: This medication is often used when monotherapy (using a single antidiabetic medication) is insufficient in achieving glycemic control. Combining the two different classes of drugs (sulfonylurea and biguanide) can provide a more comprehensive approach to managing diabetes.
  • Maintenance of Long-Term Glycemic Control: For many individuals with type 2 diabetes, diabetes management is a long-term commitment. Glibenclamide and Metformin Hydrochloride Tablets are used to help maintain stable blood sugar levels over an extended period, reducing the risk of complications associated with uncontrolled diabetes.

How does Glibenclamide and Metformin Hydrochloride Tablets Work?

Glibenclamide and Metformin Hydrochloride Tablets work through the combined actions of their two active ingredients, Glibenclamide (Glyburide) and Metformin Hydrochloride, to help manage type 2 diabetes by lowering and controlling blood sugar levels. Here’s how each component contributes to their mechanism of action:

Glibenclamide (Glyburide):

Glibenclamide belongs to a class of medications called sulfonylureas. Its primary mode of action is to stimulate the release of insulin from the beta cells in the islets of Langerhans in the pancreas. This release of insulin is triggered by Glibenclamide’s interaction with specific receptors on the beta cells.

  • Insulin Release: When Glibenclamide is taken orally, it enters the bloodstream and reaches the pancreas. There, it binds to specific receptors on the beta cells, leading to an increase in the release of insulin into the bloodstream.
  • Increased Insulin Availability: The additional insulin helps facilitate the uptake of glucose by cells throughout the body, allowing them to use glucose for energy. This process reduces the concentration of glucose in the bloodstream, thereby lowering blood sugar levels.

Metformin Hydrochloride:

Metformin Hydrochloride is classified as a biguanide and has a different mechanism of action from sulfonylureas like Glibenclamide. It primarily works to reduce the production of glucose in the liver and improve the body’s sensitivity to insulin.

  • Liver Glucose Production: Metformin decreases the liver’s production of glucose, particularly during fasting or between meals. It inhibits certain enzymes involved in this process, reducing the liver’s contribution to elevated blood sugar levels.
  • Improved Insulin Sensitivity: Metformin enhances the body’s response to insulin, making cells more receptive to insulin’s action. This improves the uptake of glucose by cells, further lowering blood sugar levels.
  • Reduced Intestinal Glucose Absorption: Metformin may also reduce the absorption of glucose from the gastrointestinal tract.

Combination Effect: When Glibenclamide and Metformin Hydrochloride are combined in a single tablet, their complementary actions provide a comprehensive approach to managing type 2 diabetes:

  • Glibenclamide stimulates insulin release, especially after meals when blood sugar levels tend to rise due to food intake.
  • Metformin Hydrochloride helps control fasting and basal glucose levels, primarily by reducing liver glucose production and improving insulin sensitivity.

By addressing both postmeal and fasting blood sugar levels, this combination medication helps individuals achieve better overall glycemic control, reducing the risk of hyperglycemia (high blood sugar) and its associated complications.

Benefits of Glibenclamide and Metformin Hydrochloride Tablets:

  • Blood Sugar Control: These tablets are effective in lowering and controlling blood sugar levels in individuals with type 2 diabetes. By combining two different mechanisms of action (insulin release stimulation and improved insulin sensitivity), they help maintain glucose levels within a target range.
  • Improved Insulin Sensitivity: Metformin Hydrochloride, one of the active ingredients, enhances the body’s sensitivity to insulin. This means that cells are more responsive to insulin’s signal to take up glucose, which contributes to better blood sugar control.
  • Reduced Risk of Hyperglycemia: Glibenclamide and Metformin Hydrochloride Tablets can help prevent hyperglycemia (high blood sugar), which can lead to symptoms such as excessive thirst, frequent urination, and fatigue.
  • Lowered Fasting Blood Sugar: Metformin, in particular, is effective at reducing fasting blood sugar levels, which are important for overall glycemic control.
  • Convenience: Combining two antidiabetic medications with different mechanisms of action into a single tablet can be more convenient for individuals who require both insulin release stimulation and improved insulin sensitivity.

Side Effects of Glibenclamide and Metformin Hydrochloride Tablets:

  • Hypoglycemia: Glibenclamide can cause low blood sugar levels (hypoglycemia) when taken inappropriately, especially if meals are skipped or delayed. Symptoms may include shakiness, sweating, confusion, and rapid heartbeat.
  • Nausea and Upset Stomach: Gastrointestinal side effects such as nausea, vomiting, diarrhea, and abdominal discomfort can occur, especially when starting the medication. Taking the tablets with food or as directed by a healthcare provider can help minimize these side effects.
  • Weight Gain: Some individuals may experience weight gain while taking Glibenclamide and Metformin Hydrochloride Tablets, particularly due to the sulfonylurea component (Glibenclamide).
  • Hypersensitivity Reactions: Allergic reactions, while rare, can occur and may include rash, itching, swelling, and difficulty breathing. Seek immediate medical attention if these symptoms occur.
  • Lactic Acidosis: A rare but serious side effect associated with Metformin is lactic acidosis, which can cause symptoms like muscle pain, difficulty breathing, abdominal discomfort, and an irregular heartbeat. This condition requires immediate medical attention.
  • Vitamin B12 Deficiency: Long-term use of Metformin can lead to vitamin B12 deficiency in some individuals. Regular monitoring and supplementation may be necessary.
  • Metallic Taste: Some people may experience a metallic taste in their mouth as a side effect.

It’s crucial for individuals taking Glibenclamide and Metformin Hydrochloride Tablets to be aware of potential side effects and to use the medication as prescribed by their healthcare provider. Hypoglycemia (low blood sugar) is a significant concern, and patients should be educated on its symptoms, prevention, and management.

Frequently asked questions (FAQs) about Glibenclamide and Metformin Hydrochloride Tablets:

  1. What are Glibenclamide and Metformin Hydrochloride Tablets used for?

These tablets are used in the management of type 2 diabetes to lower and control blood sugar levels.

  1. How do Glibenclamide and Metformin Hydrochloride work together to manage diabetes?

Glibenclamide stimulates insulin release, while Metformin Hydrochloride improves insulin sensitivity and reduces liver glucose production. Together, they help maintain glycemic control.

  1. When should I take Glibenclamide and Metformin Hydrochloride Tablets?

Follow your healthcare provider’s instructions for dosing, but typically, these tablets are taken with meals to help control postmeal blood sugar levels.

  1. Can these tablets be used in type 1 diabetes?

No, Glibenclamide and Metformin Hydrochloride Tablets are intended for use in type 2 diabetes and are not suitable for individuals with type 1 diabetes, who require insulin therapy.

  1. What should I do if I experience low blood sugar (hypoglycemia) while taking Glibenclamide?

If you experience symptoms of hypoglycemia, such as shakiness, sweating, confusion, or rapid heartbeat, consume a source of glucose (e.g., candy, fruit juice) and seek medical attention if needed. Discuss strategies to prevent hypoglycemia with your healthcare provider.

  1. Are there any dietary restrictions while taking these tablets?

It’s important to follow a balanced diet recommended by your healthcare provider. Avoid excessive consumption of alcohol, as it can increase the risk of hypoglycemia.

  1. Can I take other medications along with Glibenclamide and Metformin Hydrochloride Tablets?

Inform your healthcare provider about all medications and supplements you are taking, as there can be potential interactions. They will assess and adjust your treatment plan accordingly.

  1. How often should I have my blood sugar levels monitored while taking these tablets?

The frequency of blood sugar monitoring will depend on your individual treatment plan and the recommendations of your healthcare provider. Regular monitoring is essential to assess the effectiveness of the medication.

  1. Can I continue taking Glibenclamide and Metformin Hydrochloride Tablets during pregnancy or while breastfeeding?

Consult your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding, as they will assess the risks and benefits and may adjust your treatment plan.

  1. Can I switch to these tablets from other diabetes medications?

Transitioning to Glibenclamide and Metformin Hydrochloride Tablets should be done under the guidance of a healthcare provider. They will determine the appropriate dosage and timing based on your current treatment regimen.

  1. What are the signs of lactic acidosis, a potential side effect of Metformin?

Signs of lactic acidosis may include muscle pain, difficulty breathing, abdominal discomfort, and an irregular heartbeat. If you experience these symptoms, seek immediate medical attention.

As Glibenclamide and Metformin Hydrochloride Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Glibenclamide and Metformin Hydrochloride Tablets product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Glibenclamide and Metformin Hydrochloride Tablets Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Glibenclamide and Metformin Hydrochloride Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274