GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+500mg)
B. Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+1000mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+500mg)
Each uncoated bilayered tablet contains:
Teneligliptin Hydrochloride Hydrate
Equivalent to Teneligliptin……………….20mg
Metformin Hydrochloride IP…………….500mg
(As Extended Release)
Excipients………………………………………q.s
Colours: Ferric oxide Yellow USP-NF(Yellow Oxide of iron)
(In Teneligliptin layer)

B) Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 1000mg Tablets
Each uncoated bilayered tablet contains:
Teneligliptin Hydrochloride Hydrate
Equivalent to Teneligliptin……………….20mg
Metformin Hydrochloride IP…………….1000mg
(As Extended Release)
Excipients………………………………………q.s
Colours: Ferric oxide Red USP-NF(Red Oxide of iron)
(In Teneligliptin layer)


THERAPEUTIC INDICATIONS:

METFORMIN+TENELIGLIPTIN belongs to the group of medications called 'antidiabetic agents' used to treat Type 2 diabetes mellitus. This medication improves glycaemic control in diabetic patients in those patients who do not react well to Metformin alone.

CAUTION & SCHEDULE:

CAUTION: Tablet to be swallowed as a whole, and not to be chewed or crushed.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store below 25℃.
Store in cool, dry & dark place Protect from Light & moisture.
Dosage: As directed by the Physician.

Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+1000mg) Technical Specification:

Product Name:Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+1000mg)
Brand Name:Tenitaj-M Forte
Strength:(20mg+500mg), (20mg+1000mg)
Dosage Form:Tablets (film-coated)
Route of Administration:Via Oral Route
Packing:10 strips of 10 tablets each
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Antidiabetic
Indication: METFORMIN+TENELIGLIPTIN belongs to the group of medications called ‘antidiabetic agents’ used to treat Type 2 diabetes mellitus. This medication improves glycaemic control in diabetic patients in those patients who do not react well to Metformin alone.
Storage:Store below 25℃.  Store in cool, dry & dark place Protect from Light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+1000mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Teneligliptin and Metformin Hydrochloride Extended Release Tablets (20mg+1000mg)
    Each uncoated bilayered tablet contains:
    Teneligliptin Hydrochloride Hydrate
    Equivalent to Teneligliptin……………….20mg
    Metformin Hydrochloride IP…………….1000mg
    (As Extended Release)
    Excipients………………………………………q.s
    Colours: Ferric oxide Red USP-NF(Yellow
    Oxide of iron)
    (In Teneligliptin layer)

THERAPEUTIC INDICATIONS:

METFORMIN+TENELIGLIPTIN belongs to the group of medications called ‘antidiabetic agents’ used to treat Type 2 diabetes mellitus. This medication improves glycaemic control in diabetic patients in those patients who do not react well to Metformin alone.

CAUTION & SCHEDULE:

CAUTION:  Tablet to be swallowed as a whole, and not to be chewed or crushed.

Read enclosed leaflet before use.

WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Store below 25℃. Store in cool, dry & dark place Protect from Light & moisture.

Dosage:  As directed by the Physician.

Why Taj Pharmaceuticals?

Experience the unparalleled quality and reliability of Taj Pharma’s Teneligliptin and Metformin Hydrochloride Extended Release Tablets, meticulously crafted to enhance your diabetes management regimen. With a rich legacy of pharmaceutical excellence, Taj Pharma is committed to delivering healthcare solutions that prioritize safety, efficacy, and patient well-being. Our state-of-the-art manufacturing facilities adhere to the highest industry standards, ensuring that each tablet is produced with precision and consistency. Rigorous quality control measures are implemented at every stage of the production process, guaranteeing that you receive a product you can trust. What sets Taj Pharma apart is our unwavering dedication to research and development. We constantly strive to innovate and improve our formulations, staying at the forefront of medical advancements to provide you with the most effective treatment options. Our team of experienced scientists and healthcare professionals work tirelessly to create pharmaceutical solutions that make a real difference in the lives of those managing diabetes. Choosing Taj Pharma for your Teneligliptin and Metformin Hydrochloride Extended Release Tablets means choosing a partner in your journey towards better health. With a commitment to excellence and a legacy of trust, Taj Pharma is your reliable source for cutting-edge diabetes management solutions. Embrace a brighter, healthier future with Taj Pharma.

What is Teneligliptin and Metformin Hydrochloride Extended Release Tablets and its Use?

Teneligliptin and Metformin Hydrochloride Extended Release Tablets are a combination medication used for the treatment of type 2 diabetes mellitus. Let’s break down the components and their uses:

  • Teneligliptin: Teneligliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It works by inhibiting the DPP-4 enzyme, which is responsible for breaking down incretin hormones like GLP-1 (glucagon-like peptide-1). By inhibiting DPP-4, Teneligliptin increases the levels of these hormones in the body. This, in turn, enhances the release of insulin from the pancreas in response to elevated blood sugar levels, and it also reduces the amount of glucose produced by the liver. Teneligliptin helps lower blood sugar levels after meals, making it easier to control diabetes.
  • Metformin Hydrochloride: Metformin is a biguanide medication that primarily works by decreasing the amount of sugar produced by the liver and increasing the sensitivity of muscle cells to insulin. It also helps improve the utilization of glucose in the body’s cells. These actions contribute to lower blood sugar levels and improved glycemic control.

Indications and Uses:

  • Control Blood Sugar: The combination of Teneligliptin and Metformin helps lower and maintain blood sugar levels within the target range in people with type 2 diabetes.
  • Improve Insulin Sensitivity: Metformin enhances the body’s sensitivity to insulin, making it more effective at lowering blood sugar levels.
  • Reduce Complications: By effectively managing blood sugar levels, this medication can help reduce the risk of diabetes-related complications such as heart disease, kidney problems, and nerve damage.

How Does Teneligliptin and Metformin Hydrochloride Extended Release Tablets Work?

Teneligliptin and Metformin Hydrochloride Extended Release Tablets work through their respective active ingredients, Teneligliptin and Metformin, to help manage type 2 diabetes mellitus. Here’s how each component works:

Teneligliptin:

  • DPP4 Inhibition: Teneligliptin is a dipeptidyl peptidase4 (DPP4) inhibitor. DPP4 is an enzyme in the body that breaks down incretin hormones, such as GLP1 (glucagonlike peptide1). These hormones play a crucial role in regulating blood sugar levels.
  • Enhanced Incretin Hormones: By inhibiting DPP4, Teneligliptin allows incretin hormones like GLP1 to remain active for a longer time. This leads to increased insulin secretion from the pancreas in response to elevated blood sugar levels.
  • Reduced Blood Sugar Levels: With the increased insulin release, more glucose from the bloodstream is taken up by the body’s cells, leading to a decrease in blood sugar levels after meals. This helps stabilize and control blood sugar in individuals with type 2 diabetes.

Metformin Hydrochloride:

  • Liver Glucose Production: Metformin primarily acts on the liver, reducing its production of glucose. In individuals with type 2 diabetes, the liver can produce excessive amounts of glucose, contributing to high blood sugar levels.
  • Improved Insulin Sensitivity: Metformin also enhances the sensitivity of muscle cells to insulin. This means that insulin becomes more effective in helping cells take in glucose from the bloodstream.
  • Reduced Intestinal Glucose Absorption: Metformin may also reduce the absorption of glucose from the intestines, further helping to lower blood sugar levels.

Combined Effects:

When Teneligliptin and Metformin are used together in a single tablet, they work synergistic-ally to address various aspects of blood sugar regulation in individuals with type 2 diabetes. Here’s how they combine their effects:

  • Enhanced Insulin Release: Teneligliptin stimulates insulin secretion from the pancreas, primarily in response to meal-related glucose increases.
  • Reduced Glucose Production: Metformin reduces the liver’s production of glucose, which is especially important during fasting or between meals.
  • Improved Insulin Action: Metformin improves the body’s response to insulin, allowing cells to take up glucose more efficiently.

By targeting multiple pathways involved in blood sugar regulation, this combination medication helps achieve better overall glycemic control, reducing hyperglycemia (high blood sugar) and its associated complications in individuals with type 2 diabetes mellitus. However, the specific dosage and treatment plan should be determined by a healthcare professional based on the individual’s medical history and needs. Regular monitoring of blood sugar levels is essential to ensure the medication is effectively managing diabetes.

Benefits of Teneligliptin and Metformin Hydrochloride Extended Release Tablets:

  • Blood Sugar Control: The primary benefit of this combination medication is its ability to help lower and control blood sugar levels in individuals with type 2 diabetes. Teneligliptin works by increasing insulin release and reducing glucagon secretion, while metformin helps improve insulin sensitivity and reduce glucose production in the liver.
  • Combination Therapy: Combining two different classes of anti-diabetic medications can often be more effective than using a single drug alone. This combination addresses multiple aspects of glucose regulation, which can result in better glycemic control.
  • Weight Neutral: Unlike some other diabetes medications that may lead to weight gain, metformin is generally considered weight-neutral, and teneligliptin is not associated with significant weight changes. This can be beneficial for individuals who are concerned about weight management.
  • Cardiovascular Benefits: Some studies suggest that metformin may have cardiovascular benefits, such as reducing the risk of heart disease in individuals with type 2 diabetes.

Side Effects of Teneligliptin and Metformin Hydrochloride Extended Release Tablets:

It’s important to note that not everyone will experience side effects, and the severity and likelihood of side effects can vary from person to person. Common side effects of this combination medication may include:

  • Gastrointestinal Disturbances: Both teneligliptin and metformin can cause gastrointestinal side effects, such as nausea, diarrhea, and abdominal discomfort. Starting with a lower dose and gradually increasing it can help reduce these symptoms.
  • Hypoglycemia (Low Blood Sugar): While metformin alone rarely causes low blood sugar, the addition of teneligliptin could potentially increase the risk of hypoglycemia, especially when used in combination with other diabetes medications or if not taken as prescribed.
  • Hypersensitivity Reactions: Although rare, some individuals may experience allergic reactions to teneligliptin or metformin, which can include skin rashes, itching, or swelling. If any allergic reactions occur, seek medical attention promptly.
  • Lactic Acidosis: Metformin, especially in higher doses or in individuals with kidney impairment, may rarely lead to a serious condition called lactic acidosis. Symptoms can include muscle pain, weakness, trouble breathing, and stomach discomfort. Immediate medical attention is necessary if these symptoms occur.
  • Vitamin B12 Deficiency: Long-term use of metformin has been associated with a potential risk of vitamin B12 deficiency. Regular monitoring and supplementation may be required.
  • Other Side Effects: Some individuals may experience other side effects like headache, dizziness, or changes in taste.

Frequently asked questions (FAQs) about Teneligliptin and Metformin Hydrochloride Extended Release Tablets:

  1. What is Teneligliptin and Metformin Hydrochloride Extended Release Tablet used for?

These tablets are used to treat type 2 diabetes mellitus. They help control blood sugar levels by combining two different classes of antidiabetic medications.

  1. How does this medication work?

Teneligliptin is a DPP4 inhibitor that helps increase insulin release and reduce glucagon secretion. Metformin improves insulin sensitivity and reduces glucose production in the liver, leading to better blood sugar control.

  1. What are the common side effects of Teneligliptin and Metformin Hydrochloride Extended Release Tablets?

Common side effects may include gastrointestinal symptoms like nausea, diarrhea, and abdominal discomfort. Other possible side effects include headache, dizziness, and changes in taste.

  1. Is it safe to take this medication during pregnancy?

It is generally not recommended to use this medication during pregnancy unless advised by a healthcare professional. Pregnant women with diabetes should consult their doctor for a suitable treatment plan.

  1. Can I drink alcohol while taking these tablets?

Alcohol can affect blood sugar levels and interact with some diabetes medications. It’s important to consult your healthcare provider regarding alcohol consumption while taking Teneligliptin and Metformin Hydrochloride Extended Release Tablets.

  1. How should I take this medication?

Follow your healthcare provider’s instructions regarding dosage and administration. Typically, it is taken orally with or immediately after a meal. Do not crush or chew extendedrelease tablets.

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

Inform your doctor about all the medications, including overthecounter drugs and supplements, that you are taking. Some medications may interact with Teneligliptin and Metformin Hydrochloride Tablets, so your doctor can adjust your treatment plan accordingly.

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

If you miss a dose, take it as soon as you remember, unless it’s close to the time for your next scheduled dose. Do not double up on doses to make up for a missed one.

  1. Is it safe for people with kidney problems to take this medication?

Metformin can affect kidney function, so it’s essential to inform your healthcare provider if you have kidney issues. They will determine the appropriate dosage based on your kidney function.

  1. How long should I take Teneligliptin and Metformin Hydrochloride Extended Release Tablets?

Your healthcare provider will determine the duration of treatment based on your diabetes management needs. It’s essential to follow their guidance and attend regular checkups for monitoring.

  1. Can I stop taking this medication if my blood sugar levels improve?

Do not stop or change the dose of this medication without consulting your healthcare provider. Diabetes management often requires ongoing treatment, and your doctor will help you make any necessary adjustments.

As about Teneligliptin and Metformin Hydrochloride Extended Release Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our about Teneligliptin and Metformin Hydrochloride Extended Release 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

about Teneligliptin and Metformin Hydrochloride Extended Release 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 about Teneligliptin and Metformin Hydrochloride Extended Release 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