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Overview

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This medicine contains an important and useful components, as it consists of
Gramicidin, Neomycin sulphate, Polymyxin B sulphateis available in the market in concentration

Name

Metformin Hydrochloride + Pioglitazone

Precaution

Before starting treatment with the combination of **Metformin Hydrochloride** and **Pioglitazone**, it is crucial that patients consult with their healthcare provider to ensure the drug combination is appropriate for their specific condition. Patients with **renal impairment** should exercise caution when using metformin, as it is primarily excreted by the kidneys, and dose adjustments may be necessary. Pioglitazone should also be used carefully in individuals with a history of **heart failure**, as it may increase the risk of fluid retention and exacerbate heart failure symptoms. Additionally, the combination of these drugs should be used with caution in patients who have **liver disease**, as pioglitazone may cause hepatotoxicity, and liver function should be regularly monitored. This combination is generally not recommended for pregnant or breastfeeding women unless specifically advised by a healthcare provider, as both drugs may pose risks to the fetus or infant. Close monitoring for **hypoglycemia**, especially in patients on other diabetes medications or insulin, is essential. Lastly, patients with **bladder cancer** or a history of bladder cancer should avoid pioglitazone due to an increased risk associated with the drug.

Indication

The combination of **Metformin Hydrochloride** and **Pioglitazone** is used in the management of **Type 2 diabetes mellitus** in patients who have not achieved adequate glycemic control with metformin or pioglitazone alone. Metformin works by reducing glucose production in the liver and improving insulin sensitivity, while pioglitazone, a **thiazolidinedione**, enhances insulin sensitivity in muscle and fat tissues. This dual action helps to lower blood glucose levels by improving the body’s response to insulin. The combination is particularly useful in patients who are overweight or obese and have insulin resistance. This drug combination may also help in reducing **A1c levels**, making it a viable option for patients who are not adequately controlled by lifestyle changes and single-agent therapies.

Contra indication

The combination of **Metformin Hydrochloride** and **Pioglitazone** should not be used in the following situations: - **Severe renal impairment (e.g., creatinine clearance < 30 mL/min)**: Metformin should not be used in patients with severely impaired kidney function due to the increased risk of lactic acidosis. - **Active liver disease** or **abnormal liver function tests**: Pioglitazone should not be used in these patients as it may worsen liver conditions. - **Severe heart failure** or **acute myocardial infarction**: Pioglitazone may cause fluid retention and exacerbate heart failure symptoms. - **History of bladder cancer**: Pioglitazone has been associated with an increased risk of bladder cancer, so it should not be used in patients with a history of bladder cancer. - **Diabetic ketoacidosis**: As this combination of drugs is not intended to treat acute metabolic complications of diabetes, it should not be used in patients experiencing diabetic ketoacidosis. - **Hypersensitivity** to either metformin or pioglitazone, or any of the excipients.

Side Effect

The combination of **Metformin Hydrochloride** and **Pioglitazone** can cause both common and serious side effects: - **Common side effects** of metformin include gastrointestinal symptoms such as **nausea**, **diarrhea**, **abdominal discomfort**, and a **metallic taste**. These are typically mild and can improve over time. - **Pioglitazone** may cause **fluid retention**, leading to **edema** (swelling), weight gain, and an increased risk of **heart failure** in vulnerable patients. - **Hypoglycemia** may occur, especially if the patient is also taking other antidiabetic drugs, such as insulin or sulfonylureas. - Serious side effects include **lactic acidosis**, a rare but potentially life-threatening condition characterized by symptoms like **muscle pain**, **fatigue**, **difficulty breathing**, **dizziness**, and **abdominal pain**. This requires immediate discontinuation of the drugs. - **Bladder cancer**: Pioglitazone has been associated with an increased risk of bladder cancer, and patients should be monitored for symptoms such as blood in the urine or painful urination. - **Bone fractures**: Pioglitazone may increase the risk of fractures, particularly in women. - **Hepatotoxicity**: Pioglitazone can cause liver damage, and liver function should be monitored regularly during treatment. Patients should contact their healthcare provider if they experience severe symptoms, particularly those of lactic acidosis, fluid retention, or unusual signs of bladder problems.

Pregnancy Category ID

3

Mode of Action

The combination of **Metformin Hydrochloride** and **Pioglitazone** works in complementary ways to lower blood glucose levels: - **Metformin** decreases hepatic glucose production and increases insulin sensitivity, particularly in the muscles, thereby reducing blood glucose levels and improving the body’s ability to utilize glucose efficiently. - **Pioglitazone**, a **thiazolidinedione**, works by activating peroxisome proliferator-activated receptor gamma (PPAR-γ), which increases insulin sensitivity in muscle and fat cells, facilitating more effective glucose uptake from the bloodstream. Pioglitazone also decreases the production of glucose by the liver and reduces the level of circulating free fatty acids, which contribute to insulin resistance. Together, these actions reduce blood sugar levels by enhancing insulin action and glucose utilization, thus improving glycemic control in Type 2 diabetes patients.

Interaction

The combination of **Metformin Hydrochloride** and **Pioglitazone** can interact with several medications, potentially altering their effectiveness or leading to adverse effects: - **Insulin and other antidiabetic agents**: When used together, there may be an increased risk of **hypoglycemia**. Dosage adjustments may be necessary. - **Corticosteroids**: These can increase blood glucose levels, reducing the efficacy of the combination. Close monitoring of blood glucose is recommended when corticosteroids are used concurrently. - **Diuretics**: May enhance the risk of **fluid retention** due to pioglitazone’s effects, especially in patients with cardiovascular issues. - **Drugs that alter renal function** (such as **ACE inhibitors**, **angiotensin receptor blockers**, and certain **NSAIDs**): May increase the risk of lactic acidosis when used with metformin. - **Oral contraceptives**: May reduce the effectiveness of pioglitazone in certain patients, although evidence is inconclusive. - **Rifampin**: A potent **CYP3A4 inducer**, which may decrease the effectiveness of pioglitazone by reducing its blood levels. - **Gemfibrozil**: This lipid-lowering drug may increase the concentration of pioglitazone in the bloodstream, increasing the risk of side effects. Patients should inform their healthcare provider about all medications they are taking, including over-the-counter drugs and supplements, to avoid harmful drug interactions.

Pregnancy Category Note

Information not available

Adult Dose

For adults, the typical dose of **Metformin Hydrochloride + Pioglitazone** combination tablets is as follows: - **Metformin**: Starting dose is usually **500 mg** once or twice daily with meals. If necessary, the dose can be gradually increased to **2,000-2,500 mg** per day, depending on the patient's blood glucose control and tolerance. - **Pioglitazone**: The starting dose is generally **15 mg** once daily. This can be increased to a maximum of **45 mg** daily, based on the patient’s response to treatment. The combination dose is typically formulated with fixed ratios (e.g., 500 mg of metformin and 15 mg of pioglitazone) and adjusted as needed for glycemic control. The dose should be individualized based on the patient’s blood glucose levels and tolerability.

Child Dose

The combination of **Metformin Hydrochloride + Pioglitazone** is not typically prescribed for pediatric patients under 18 years old due to insufficient safety and efficacy data. Metformin may be used in children aged 10 years and older with Type 2 diabetes, but its combination with pioglitazone is generally not recommended in this age group unless advised by a pediatric endocrinologist or diabetes specialist. The exact dosing for children, if prescribed, would need to be individualized, and careful monitoring of growth, blood glucose, and potential side effects would be necessary. Always consult a healthcare provider before starting or adjusting treatment with Metformin Hydrochloride and Pioglitazone to ensure the combination is safe and appropriate for the patient’s health profile.

Renal Dose

The combination of **Metformin Hydrochloride** and **Pioglitazone** is contraindicated in patients with **severe renal impairment** (creatinine clearance less than 30 mL/min). For patients with mild to moderate renal impairment, the use of metformin should be closely monitored. If the patient has **renal impairment** (creatinine clearance 30-45 mL/min), the dose of metformin should be reduced to avoid the risk of **lactic acidosis**. Pioglitazone can generally be used without dose adjustments in patients with mild to moderate renal impairment, but it should be prescribed cautiously. Regular renal function monitoring is essential when using this combination in such patients.

Administration

Information not available