Metformin hydrochloride ER Tablets USP 1000mg Technical Specification:

Product Name:                                  Metformin hydrochloride ER Tablets USP 1000mg
Brand Name:Generics
Strength:500mg, 750mg, 1000mg
Dosage Form:Tablets (Un-coated)
Route of Administration:Via oral Route
Packing:28s,30s, 90s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antidiabetic, Diabetology
Indication: Metformin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes.
Storage:Store at controlled room temperature 20-25°C. Store all of your medicines in a cool, dry place.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Metformin hydrochloride ER 1000mg tablets  

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Metformin hydrochloride ER 1000mg tablets
    Each Uncoated tablet contains:
    Metformin hydrochloride USP……………….1000mg
    Excipients………………………………………. q.s.
    Colours: Quinoline Yellow

THERAPEUTIC INDICATIONS:

Metformin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems.

CAUTION & WARNING:

CAUTION:  Read enclosed leaflet before use.
Keep medicine out of reach of children.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage:  Store at controlled room temperature 20-25°C. Store all of your medicines in a cool, dry place.
Dosage:  As directed by the Physician.

Attach dispensing label as per end county.

Why Taj Pharmaceuticals?

Why choose Taj Pharma for Metformin hydrochloride ER Tablets? Taj Pharma is a trusted name in the pharmaceutical industry, known for its unwavering commitment to quality and innovation. When it comes to managing diabetes effectively, Metformin hydrochloride is a key medication, and Taj Pharma ensures that you receive the best in class. Our Metformin hydrochloride is manufactured with stringent quality standards and adheres to all regulatory requirements. We prioritize your health and safety, making sure that every batch is thoroughly tested and quality-checked before reaching your hands. With Taj Pharma, you can have peace of mind, knowing that you are using a reliable and trusted brand for your diabetes medication.

Taj Pharma is dedicated to advancing diabetes care. We continuously invest in research and development to bring you the latest and most effective formulations of Metformin hydrochloride. Our goal is to empower individuals with diabetes to lead healthier lives, and we are here to support you on your journey to better health. Choose Taj Pharma for Metformin hydrochloride and experience the difference in quality, reliability, and commitment to improving diabetes management. Your health is our priority, and we are proud to be your partner in diabetes care.

What is Metformin hydrochloride ER Tablets and its use?

Metformin hydrochloride is a medication commonly prescribed to manage and control high blood sugar levels, primarily in individuals with type 2 diabetes. It belongs to a class of drugs called biguanides and is one of the most widely prescribed oral medications for diabetes worldwide. Metformin hydrochloride works by improving the body’s sensitivity to insulin and reducing the amount of sugar produced by the liver. Here’s a breakdown of its uses and benefits:

  • Type 2 Diabetes Management: Metformin is primarily used to lower and stabilize blood glucose levels in people with type 2 diabetes, a condition characterized by insulin resistance (the body’s inability to use insulin effectively) and high blood sugar. It can be prescribed alone or in combination with other diabetes medications, such as sulfonylureas, to enhance blood sugar control.
  • Prediabetes: Metformin may also be prescribed for individuals with prediabetes, a condition in which blood sugar levels are higher than normal but not yet in the diabetic range. It can help prevent or delay the progression to type 2 diabetes in such cases, especially when combined with lifestyle modifications like diet and exercise.
  • Polycystic Ovary Syndrome (PCOS): Metformin is sometimes used off-label to treat women with PCOS, a hormonal disorder that can lead to irregular menstrual cycles, insulin resistance, and elevated insulin levels. By improving insulin sensitivity, Metformin can help regulate menstrual cycles and improve fertility in some women with PCOS.
  • Gestational Diabetes: In some cases, Metformin may be prescribed during pregnancy to manage gestational diabetes, a type of diabetes that develops during pregnancy. It is typically used when lifestyle changes alone are insufficient to control blood sugar levels.
  • Weight Management: Metformin may help some individuals with type 2 diabetes lose weight or prevent weight gain, although it is not a weight-loss medication. Its effect on weight can vary among individuals.

Metformin is generally considered safe and well-tolerated, but like any medication, it can have side effects. Common side effects include gastrointestinal symptoms such as nausea, diarrhea, and abdominal discomfort. These side effects can often be minimized by starting with a low dose and gradually increasing it. Rarely, more serious side effects like lactic acidosis can occur, especially in individuals with kidney or liver problems, so it’s important to use Metformin under the guidance of a healthcare professional.

Metformin hydrochloride works through several mechanisms to help lower and regulate blood sugar levels in individuals with type 2 diabetes and other related conditions. Its primary mode of action involves improving insulin sensitivity and reducing the amount of sugar produced by the liver. Here’s how Metformin works:

  • Enhancing Insulin Sensitivity: One of the key problems in type 2 diabetes is insulin resistance, where the body’s cells do not respond well to insulin, a hormone responsible for transporting sugar (glucose) from the bloodstream into cells for energy. Metformin helps improve insulin sensitivity in the body’s cells, allowing them to use insulin more effectively. This means that the body can transport glucose into cells more efficiently, reducing elevated blood sugar levels.
  • Reducing Hepatic Glucose Production: The liver plays a significant role in regulating blood sugar levels by producing glucose when needed. In people with type 2 diabetes, the liver often produces too much glucose, contributing to high blood sugar. Metformin suppresses the liver’s production of glucose, decreasing the amount of sugar released into the bloodstream. This action helps lower fasting blood sugar levels.
  • Slowing Intestinal Glucose Absorption: Metformin may also delay the absorption of glucose from the intestines into the bloodstream after eating. This helps prevent rapid spikes in blood sugar levels following meals.
  • Enhancing Muscle Glucose Uptake: Metformin can improve the ability of muscle tissue to take up and use glucose. This is particularly important during physical activity when muscles require more energy.
  • Reducing Appetite: Some individuals on Metformin may experience a decrease in appetite, leading to reduced calorie intake and potential weight loss. However, this effect can vary among individuals.

Metformin does not stimulate the pancreas to produce more insulin. Instead, it works to optimize the body’s existing insulin supply and improve its utilization. This makes Metformin particularly suitable for people with type 2 diabetes who often have impaired insulin function.

Metformin is generally considered a first-line treatment for type 2 diabetes because of its effectiveness, safety profile, and relatively low risk of causing low blood sugar (hypoglycemia) when used as a monotherapy. However, its use should be under the supervision of a healthcare provider who can determine the appropriate dosage and monitor for potential side effects or interactions with other medications.

Benefits of Metformin Hydrochloride ER Tablets:

  • Blood Sugar Control: Metformin is highly effective in lowering and stabilizing blood sugar levels in individuals with type 2 diabetes. It does so by improving insulin sensitivity and reducing the liver’s production of glucose.
  • Weight Management: Some people with type 2 diabetes may experience modest weight loss or prevention of weight gain while taking Metformin. It can be a helpful aspect of diabetes management for those who need to control their weight.
  • Reduced Risk of Heart Disease: Some studies suggest that Metformin may have cardiovascular benefits, such as reducing the risk of heart disease and improving lipid profiles (cholesterol levels). These effects can contribute to better overall heart health.
  • Lower Risk of Hypoglycemia: Unlike certain other diabetes medications, Metformin is not associated with a significant risk of causing low blood sugar (hypoglycemia). This makes it a safer option for many individuals.
  • Management of Polycystic Ovary Syndrome (PCOS): Metformin is sometimes used off-label to treat PCOS in women. It can help regulate menstrual cycles, reduce insulin levels, and improve fertility in some cases.

Side Effects of Metformin Hydrochloride ER Tablets:

  • Gastrointestinal Issues: The most common side effects of Metformin are gastrointestinal symptoms such as nausea, diarrhea, abdominal discomfort, and gas. These side effects can be minimized by starting with a low dose and gradually increasing it. Taking the medication with food may also help.
  • Vitamin B12 Deficiency: Long-term use of Metformin can lead to reduced absorption of vitamin B12, potentially causing deficiencies. Regular monitoring of vitamin B12 levels and supplementation when necessary may be recommended.
  • Lactic Acidosis (Rare): Although very rare, Metformin has been associated with a potentially life-threatening condition called lactic acidosis. This occurs when there is an accumulation of lactic acid in the blood. It is more likely to happen in individuals with kidney or liver problems, severe infections, or conditions that affect oxygen delivery to tissues. Symptoms of lactic acidosis include weakness, muscle pain, trouble breathing, and an irregular heartbeat. If you experience any of these symptoms, seek immediate medical attention.
  • Metallic Taste: Some people may experience a metallic or bitter taste in their mouth while taking Metformin.
  • Vitamin B6 Deficiency (Rare): Prolonged use of Metformin may lead to a reduction in vitamin B6 levels, although this is less common than B12 deficiency.

It’s essential to note that not everyone will experience these side effects, and many people tolerate Metformin well. The benefits of improved blood sugar control and potential weight management often outweigh the side effects for individuals with type 2 diabetes. However, any concerns or side effects should be discussed with a healthcare provider who can adjust the medication or recommend alternative treatments if necessary. Regular monitoring and communication with your healthcare team are key to successful Metformin therapy.

Frequently asked questions (FAQs) about Metformin hydrochloride ER Tablets:

  1. What is Metformin hydrochloride?

Metformin hydrochloride is a medication used to treat type 2 diabetes and other conditions. It helps lower and regulate blood sugar levels.

  1. How does Metformin work?

Metformin primarily works by improving insulin sensitivity, reducing the liver’s glucose production, and slowing intestinal glucose absorption.

  1. Is Metformin used for type 1 diabetes?

No, Metformin is not typically prescribed for type 1 diabetes. It is most effective for people with type 2 diabetes.

  1. What are the common brand names for Metformin?

Metformin is available under various brand names, including Glucophage, Glumetza, Fortamet, and Riomet.

  1. How should I take Metformin?

Metformin is usually taken orally with meals. The dosage and timing should be determined by your healthcare provider.

  1. What are the common side effects of Metformin?

Common side effects include gastrointestinal symptoms like nausea, diarrhea, and abdominal discomfort. Some people may also experience a metallic taste.

  1. Can Metformin cause low blood sugar (hypoglycemia)?

Metformin is not known to cause hypoglycemia on its own. However, when used in combination with other diabetes medications, it can increase the risk of low blood sugar.

  1. Can I drink alcohol while taking Metformin?

It’s generally safe to consume moderate amounts of alcohol while taking Metformin, but excessive alcohol consumption can affect blood sugar control and increase the risk of lactic acidosis.

  1. Can Metformin be used during pregnancy?

Metformin may be prescribed during pregnancy in some cases, but it should be discussed with a healthcare provider. It is often used when lifestyle changes alone are insufficient to control gestational diabetes.

  1. Does Metformin help with weight loss?

Some individuals with type 2 diabetes may experience modest weight loss or prevention of weight gain while taking Metformin. However, it is not a weightloss medication.

  1. Is Metformin safe for longterm use?

Metformin is generally considered safe for longterm use when used appropriately and under the supervision of a healthcare provider. Regular monitoring is essential.

  1. Can Metformin be used to treat polycystic ovary syndrome (PCOS)?

Yes, Metformin is sometimes used offlabel to manage PCOS in women. It can help regulate menstrual cycles, reduce insulin levels, and improve fertility in some cases.

  1. What should I do if I miss a dose of Metformin?

If you miss a dose, take it as soon as you remember. However, if it’s close to your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double up on doses.

As Metformin hydrochloride ER Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Metformin hydrochloride ER 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

Metformin hydrochloride ER 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 Metformin hydrochloride ER 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

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Metformin hydrochloride ER 500mg tablets
B. Metformin hydrochloride ER 750mg tablets
C. Metformin hydrochloride ER 1000mg tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Metformin hydrochloride ER 500mg tablets
Each Uncoated tablet contains:
Metformin hydrochloride USP……………….500mg
Excipients………………………………………. q.s.
Colours: Titanium dioxide USP

B. Metformin hydrochloride ER 750mg tablets
Each Uncoated tablet contains:
Metformin hydrochloride USP……………….750mg
Excipients………………………………………. q.s.
Colours: Titanium dioxide Red

C. Metformin hydrochloride ER 1000mg tablets
Each Uncoated tablet contains:
Metformin hydrochloride USP……………….1000mg
Excipients………………………………………. q.s.
Colours: Quinoline Yellow


THERAPEUTIC INDICATIONS:

Metformin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at controlled room temperature 20-25°C. Store all of your medicines in a cool, dry place.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.