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Overview

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This medicine contains an important and useful components, as it consists of
Gramicidin, Neomycin Sulfate, Polymixin B Sulfateis available in the market in concentration

Name

Metformin Hydrochloride + Vildagliptin

Precaution

Before initiating treatment with **Metformin Hydrochloride** and **Vildagliptin**, it is crucial for patients to consult their healthcare provider to evaluate whether this combination is suitable for their specific medical condition. Special care should be taken in individuals with **renal impairment**, as both medications are eliminated via the kidneys. **Metformin** should be avoided in patients with **severe renal impairment** (creatinine clearance < 30 mL/min) due to the increased risk of **lactic acidosis**, a serious condition characterized by an accumulation of lactic acid in the bloodstream. In patients with **mild to moderate renal impairment**, dose adjustments of metformin and close monitoring of renal function are required. **Vildagliptin** is also excreted through the kidneys, and its dose should be reduced in patients with **moderate renal impairment** (creatinine clearance 30-50 mL/min) to **50 mg once daily**, and in those with severe renal impairment (creatinine clearance < 30 mL/min), it should be avoided. This combination should be used cautiously in patients with **liver disease** as vildagliptin has been associated with **hepatotoxicity** in rare cases. Regular monitoring of liver function tests is recommended. Additionally, patients using this combination should be monitored for **pancreatitis**, as vildagliptin has been linked to an increased risk of this condition, with symptoms such as severe abdominal pain and nausea.

Indication

The combination of **Metformin Hydrochloride** and **Vildagliptin** is primarily indicated for the treatment of **Type 2 diabetes mellitus** in adults who have not achieved adequate glycemic control with diet and exercise alone or when monotherapy with either metformin or vildagliptin is insufficient. This combination is particularly helpful in patients with **insulin resistance**, a hallmark of Type 2 diabetes. - **Metformin** works by decreasing **hepatic glucose production**, improving **insulin sensitivity**, and increasing the **peripheral uptake** of glucose by muscle and fat tissues. - **Vildagliptin**, a **DPP-4 (dipeptidyl peptidase-4) inhibitor**, enhances the body’s natural ability to regulate blood sugar by increasing the levels of **incretin hormones** (such as GLP-1), which stimulate insulin release in response to food intake and decrease the secretion of glucagon, thus reducing glucose production by the liver. The combination of metformin and vildagliptin works synergistically to improve blood glucose control by addressing both insulin resistance and impaired insulin secretion, providing a comprehensive approach to managing Type 2 diabetes.

Contra indication

The use of **Metformin Hydrochloride** and **Vildagliptin** is contraindicated in the following situations: - **Severe renal impairment** (creatinine clearance < 30 mL/min): Both metformin and vildagliptin are primarily eliminated by the kidneys. Use in this population increases the risk of **lactic acidosis** (from metformin) and **drug accumulation** (from vildagliptin), making this combination unsuitable. - **Acute or chronic metabolic acidosis**, including **diabetic ketoacidosis**: The combination should not be used in patients with these conditions. - **Hypersensitivity** to metformin, vildagliptin, or any other ingredients of the combination: A hypersensitivity reaction may lead to severe adverse effects, including skin rashes or anaphylaxis. - **Liver disease**: Patients with active liver disease or elevated liver enzymes should avoid this combination. Vildagliptin has been associated with rare cases of liver injury. - **Pregnancy**: The combination of metformin and vildagliptin should not be used during pregnancy unless clearly needed. There is limited safety data on its use during pregnancy. - **Breastfeeding**: Both metformin and vildagliptin are excreted in breast milk, and breastfeeding is generally not recommended while using this combination unless the benefit outweighs the risks.

Side Effect

The combination of **Metformin Hydrochloride** and **Vildagliptin** may cause various side effects, both common and serious: - **Common side effects of metformin** include **gastrointestinal symptoms** such as **nausea**, **diarrhea**, **abdominal discomfort**, and a **metallic taste**. These symptoms usually subside as the body adjusts to the medication. - **Vildagliptin** may cause mild **headaches**, **nasopharyngitis**, or **upper respiratory tract infections**. These are typically short-lived. - **Hypoglycemia**: While vildagliptin alone does not typically cause hypoglycemia, the risk is increased when combined with other hypoglycemic agents such as insulin or sulfonylureas. - **Lactic acidosis**: A rare but serious side effect of metformin, especially in patients with **renal impairment** or other risk factors. Symptoms of lactic acidosis include **muscle pain**, **fatigue**, **difficulty breathing**, **abdominal discomfort**, and **dizziness**. If any of these symptoms occur, immediate medical attention is required. - **Pancreatitis**: Although rare, vildagliptin has been associated with an increased risk of **pancreatitis**, characterized by **severe abdominal pain**, nausea, and vomiting. Patients should seek medical help if these symptoms occur. - **Hepatotoxicity**: Vildagliptin can cause elevated liver enzymes, and **liver function tests** should be monitored regularly during treatment. - **Allergic reactions**: Both drugs can lead to allergic reactions, including **rash**, **itching**, or in severe cases, **angioedema** (swelling of the throat or face). - **Peripheral edema**: Some patients may experience swelling in their lower extremities, which should be reported if persistent or severe. It is important that patients monitor for any unusual or severe symptoms and inform their healthcare provider promptly.

Pregnancy Category ID

0

Mode of Action

**Metformin Hydrochloride** works primarily by decreasing **hepatic glucose production** and enhancing **insulin sensitivity** in peripheral tissues, such as muscle and fat, facilitating glucose uptake. By doing so, metformin lowers **blood glucose** levels and improves insulin resistance in patients with Type 2 diabetes. **Vildagliptin**, a **DPP-4 inhibitor**, works by blocking the action of the **DPP-4 enzyme**, which is responsible for breaking down incretin hormones like **GLP-1** (glucagon-like peptide-1). These incretins stimulate insulin release from the pancreas in response to meals and suppress glucagon secretion, which reduces hepatic glucose production. By enhancing incretin action, vildagliptin helps to increase insulin secretion and reduce glucose production, resulting in better blood sugar control. Together, metformin and vildagliptin provide a complementary mechanism for improving glucose control in patients with Type 2 diabetes by addressing both insulin resistance (metformin) and impaired insulin secretion (vildagliptin).

Interaction

The combination of **Metformin Hydrochloride** and **Vildagliptin** may interact with several drugs and substances, altering their effectiveness or increasing the risk of side effects: - **Other antidiabetic drugs** (e.g., insulin, sulfonylureas): Increased risk of **hypoglycemia**, particularly if insulin or sulfonylureas are used in combination with this therapy. Careful monitoring and possible dose adjustments of these agents are required. - **Corticosteroids** and **diuretics**: These medications can raise blood glucose levels, potentially decreasing the effectiveness of metformin and vildagliptin in controlling blood sugar. - **Rifampin**: A **CYP3A4 inducer**, rifampin may reduce the effectiveness of vildagliptin by decreasing its plasma concentration. - **Cimetidine**: This acid-suppressing drug can increase metformin levels in the blood, increasing the risk of **lactic acidosis**. - **ACE inhibitors** and **angiotensin II receptor blockers (ARBs)**: These can enhance the glucose-lowering effect of metformin, requiring closer monitoring of blood glucose levels. - **Alcohol**: Drinking alcohol excessively while on metformin can increase the risk of **lactic acidosis**. Patients are advised to limit alcohol intake. As with all medications, it is essential that patients inform their healthcare provider about all other drugs, supplements, and herbal products they are taking to avoid harmful interactions.

Pregnancy Category Note

Information not available

Adult Dose

For adults, the typical dose of the combination of **Metformin Hydrochloride + Vildagliptin** is as follows: - **Metformin**: The starting dose is typically **500 mg** once or twice daily with meals. The dose may be gradually increased by **500 mg** increments weekly to a maximum of **2,000-2,500 mg** per day, depending on the patient’s glycemic control and tolerance. - **Vildagliptin**: The standard dose is **50 mg** once daily. For patients with **moderate renal impairment** (creatinine clearance 30-50 mL/min), the dose should be reduced to **50 mg once daily**. In patients with **severe renal impairment** or those undergoing dialysis, vildagliptin is contraindicated.

Child Dose

The combination of **Metformin Hydrochloride + Vildagliptin** is not recommended for use in children under the age of 18. Although **metformin** is approved for use in pediatric patients with Type 2 diabetes, the safety and efficacy of the combination with vildagliptin in children have not been established. If considered necessary for pediatric use, it should be done with caution and under close medical supervision. Consult a healthcare provider before starting this combination therapy to ensure the treatment plan is appropriate based on individual health needs and conditions.

Renal Dose

For patients with **renal impairment**, dosage adjustments are necessary: - **Severe renal impairment (creatinine clearance < 30 mL/min)**: Both metformin and vildagliptin are contraindicated due to the risk of **lactic acidosis** and drug accumulation. - **Moderate renal impairment (creatinine clearance 30-50 mL/min)**: Metformin should be used with caution, and the dose should be adjusted based on renal function. **Vildagliptin** should be reduced to **50 mg once daily**. - **Mild renal impairment (creatinine clearance 50-80 mL/min)**: Both drugs can generally be used at their standard doses, but regular monitoring of renal function is recommended.

Administration

Information not available