Actomeg Tablet

Introduction

Actomeg Tablet 15 mg+500 mg is a combination medication used to manage type 2 diabetes mellitus. Pioglitazone is a thiazolidinedione (TZD) that improves insulin sensitivity, while Metformin is a biguanide that decreases glucose production in the liver. Together, they help control blood sugar levels in people with type 2 diabetes, particularly when diet and exercise alone are insufficient.

Uses

This combination medication is used for:

• Managing blood glucose levels in type 2 diabetes mellitus.
• Improving glycemic control in conjunction with diet and exercise.
• Enhancing insulin sensitivity and reducing hepatic glucose production.

Brand Name	Actomeg
Type	Tablet
Weight	15 mg+500 mg
Generic	Pioglitazone + Metformin Hydrochloride
Manufacturer	UniMed UniHealth
Available in	English বাংলা

Mechanism of Action

The mechanism of action involves two complementary processes:

• Pioglitazone: Enhances insulin sensitivity in muscle and adipose tissue by activating peroxisome proliferator-activated receptor-gamma (PPAR-γ). This increases glucose uptake and utilization by these tissues.
• Metformin: Reduces hepatic glucose production, particularly by decreasing gluconeogenesis in the liver. It also improves insulin sensitivity and enhances peripheral glucose uptake.

How Long Does It Take to Work?

Patients may start to see improvements in blood glucose levels within 1-2 weeks of starting the medication, though optimal control may take up to 3 months. Full benefits, including better glycemic control, may take several months of consistent use.

Absorption

Both components of the combination are absorbed through the gastrointestinal tract:

• Pioglitazone: Rapidly absorbed with peak plasma concentrations occurring within 2 hours after oral administration.
• Metformin: Absorbed primarily from the small intestine, with peak plasma concentrations occurring approximately 2-3 hours after ingestion.

Route of Elimination

The elimination routes for each component are as follows:

• Pioglitazone: Metabolized primarily in the liver and excreted in the urine (approximately 15%) and feces (approximately 55%).
• Metformin: Excreted unchanged in the urine.

Dosage

General: The use of antihyperglycemic therapy in the management of type 2 diabetes should be individualized on the basis of effectiveness and tolerability while not exceeding the maximum recommended daily dose of Pioglitazone 45 mg and Metformin 2550 mg.

Dosage Recommendations: Selecting the starting dose of Pioglitazone & Metformin should be based on the patient's current regimen of Pioglitazone and/or Metformin. Pioglitazone & Metformin should be given in divided daily doses with meals to reduce the gastrointestinal side effects associated with Metformin.

Starting dose for patients inadequately controlled on Metformin monotherapy Based on the usual starting dose of Pioglitazone (15-30 mg daily), Pioglitazone & Metformin may be initiated at either the 15 mg/500 mg or 15 mg/850 mg tablet strength once or twice daily, and gradually titrated after assessing adequacy of therapeutic response. Starting dose for patients who initially responded to Pioglitazone monotherapy and require additional glycemic control

Based on the usual starting doses of Metformin (500 mg twice daily or 850 mg daily), Pioglitazone & Metformin may be initiated at either the 15 mg/500 mg twice daily or 15 mg/850 mg tablet strength once daily, and gradually titrated after assessing adequacy of therapeutic response.

Starting dose for patients switching from combination therapy of Pioglitazone plus Metformin as separate tablets Pioglitazone & Metformin may be initiated with either the 15 mg/500 mg or 15 mg/850 mg tablet strengths based on the dose of Pioglitazone and Metformin already being taken.

Maximum Recommended Dose: Pioglitazone & Metformin tablets are available as a 15 mg Pioglitazone plus 500 mg Metformin or a 15 mg Pioglitazone plus 850 mg Metformin formulation for oral administration. The maximum recommended dose for Pioglitazone is 45 mg daily. The maximum recommended daily dose for Metformin is 2550 mg in adults. Special Patient Populations: The initial and maintenance dosing of combination of Pioglitazone and Metformin should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of combination of Pioglitazone and Metformin. Monitoring of renal function is necessary to aid in prevention of Metformin associated lactic acidosis, particularly in the elderly. Therapy with combination of Pioglitazone and Metformin should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serumtransaminase levels (ALT greater than 2.5 times the upper limit of normal) at start of therapy. Liver enzyme monitoring is recommended in all patients prior to initiation of therapy with combination of Pioglitazone and Metformin and periodically thereafter

The dosage of Actomeg Tablet 15 mg+500 mg varies based on the specific formulation and patient needs. A common starting dose is one tablet containing 15 mg of Pioglitazone and 500 mg of Metformin, taken twice daily with meals. Dosage may be adjusted based on blood glucose levels and tolerance, up to a maximum of 45 mg of Pioglitazone and 2000 mg of Metformin per day.

Administration

Administer the medication orally with meals to reduce gastrointestinal side effects. Tablets should be swallowed whole and not crushed or chewed. Adhere to the dosage prescribed by a healthcare provider and follow any specific instructions regarding timing and meal intake.

Side Effects

Common side effects include:

• Gastrointestinal issues such as nausea, diarrhea, and abdominal pain.
• Headache, dizziness, and fatigue.
• Edema and weight gain (particularly with Pioglitazone).

Serious side effects may include:

• Lactic acidosis (associated with Metformin).
• Heart failure (associated with Pioglitazone).
• Severe hypoglycemia.

Toxicity

Overdose or toxicity may present with symptoms such as severe gastrointestinal distress, lactic acidosis, and hypoglycemia. Seek immediate medical attention if an overdose is suspected or if severe symptoms occur. The treatment for toxicity involves supportive care and symptomatic management.

Precautions

Precautions include:

• Monitoring for signs of lactic acidosis, especially in patients with renal impairment.
• Regular monitoring of liver function and blood glucose levels.
• Avoiding use in patients with significant hepatic dysfunction or a history of heart failure.

Interaction

Drug interactions include:

• Pioglitazone may interact with drugs that affect hepatic enzyme activity (e.g., CYP3A4 inhibitors and inducers).
• Metformin may interact with other medications that affect renal function or blood glucose levels.

Consult a healthcare provider to manage potential drug interactions effectively.

Disease Interaction

Patients with the following conditions should use this medication with caution:

• Renal impairment (risk of lactic acidosis).
• Hepatic dysfunction (risk of exacerbation of liver disease).
• Heart failure (particularly with Pioglitazone).

Drug Interaction

Potential drug interactions include:

• Insulin and other antidiabetic drugs may increase the risk of hypoglycemia.
• Medications that affect renal function can influence Metformin clearance and increase the risk of lactic acidosis.

Consult with a healthcare provider to address and manage these interactions.

Food Interactions

Taking the medication with food can help reduce gastrointestinal side effects. Avoid excessive alcohol consumption as it can increase the risk of hypoglycemia and lactic acidosis.

Pregnancy Use

The safety of Actomeg Tablet 15 mg+500 mg during pregnancy has not been established. It is generally advised to use alternative medications or insulin therapy to manage blood glucose levels during pregnancy. Consult a healthcare provider for personalized advice.

Lactation Use

The use of Actomeg Tablet 15 mg+500 mg during lactation is not well-studied. It is recommended to consult a healthcare provider to assess the risks and benefits before using this medication while breastfeeding.

Acute Overdose

In case of acute overdose, symptoms may include severe gastrointestinal distress, hypoglycemia, or lactic acidosis. Immediate medical attention is required. Treatment may involve supportive care, glucose administration, and management of lactic acidosis if present.

Contraindication

This medication is contraindicated in:

• Patients with severe renal impairment.
• Patients with a history of hypersensitivity to Pioglitazone, Metformin, or any component of the formulation.
• Patients with active liver disease or significant heart failure.

Use Direction

Follow the prescribed dosage and administration instructions provided by a healthcare provider. Generally, take one tablet or as directed, with meals to minimize gastrointestinal side effects. Adhere to regular monitoring and follow-up appointments to assess efficacy and safety.

Storage Conditions

Store the medication in a cool, dry place away from direct sunlight and moisture. Keep out of reach of children and follow any specific storage instructions on the product label to maintain efficacy.

Volume of Distribution

The volume of distribution for Pioglitazone is approximately 0.2 L/kg, indicating distribution into body tissues. Metformin has a volume of distribution of about 1.6 L/kg, reflecting its distribution in tissues and limited plasma binding.

Half Life

The half-life of each component is as follows:

• Pioglitazone: Approximately 3-7 hours.
• Metformin: Approximately 6-7 hours.

Clearance

Pioglitazone is primarily cleared through hepatic metabolism, while Metformin is excreted unchanged in the urine. The clearance rate for Metformin is significantly influenced by renal function, whereas Pioglitazone clearance is less affected by renal impairment.

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Some Frequently Asked Questions About Actomeg Tablet 15 mg+500 mg

1. What is Actomeg Tablet 15 mg+500 mg?

Actomeg Tablet 15 mg+500 mg is an oral antidiabetic combination used to treat Type 2 Diabetes Mellitus. Pioglitazone belongs to the thiazolidinedione class, which improves insulin sensitivity, while Metformin is a biguanide that reduces glucose production in the liver and enhances insulin action in the body.

2. How does Actomeg Tablet 15 mg+500 mg work?

This combination works by targeting two major problems in Type 2 Diabetes:

• Pioglitazone: Enhances the body's response to insulin, reducing insulin resistance and helping muscles utilize glucose more efficiently.
• Metformin: Decreases the amount of glucose produced by the liver and increases glucose uptake by the muscles, reducing blood sugar levels.

3. What conditions does this medication treat?

It is primarily prescribed for Type 2 Diabetes Mellitus when diet, exercise, and single-drug therapy (monotherapy) are not enough to control blood sugar levels.

4. Who should take Actomeg Tablet 15 mg+500 mg?

It is recommended for patients with Type 2 Diabetes who require better blood sugar control, especially those with insulin resistance. It is usually prescribed when Metformin alone is not enough to achieve optimal glucose control.

5. Who should NOT take this medication?

• Patients with Type 1 Diabetes
• People with severe kidney disease or on dialysis
• Patients with heart failure or a history of heart-related issues
• People with liver disease
• Those with a history of bladder cancer
• Pregnant or breastfeeding women without medical supervision

6. What are the benefits of using this combination therapy?

• Better blood sugar control compared to single-drug therapy
• Reduction in insulin resistance
• Lower risk of hypoglycemia compared to some other diabetes medications
• Improvement in cholesterol levels and possible cardiovascular benefits
• Weight neutrality or slight weight gain, which may benefit some patients

7. How should I take this medication?

It should be taken with meals to reduce the risk of stomach upset. Follow your doctor's instructions on dosage and timing.

8. What is the usual dosage of Actomeg Tablet 15 mg+500 mg?

Dosage varies based on individual needs. A common starting dose is:

• Pioglitazone 15-30 mg + Metformin 500-850 mg per day
• Dosage adjustments are made based on blood sugar levels and tolerance.

9. What are the possible side effects?

Common side effects include:

• Weight gain (due to fluid retention from Pioglitazone)
• Edema (swelling in legs and feet)
• Stomach discomfort, nausea, diarrhea
• Muscle pain
• Headache and dizziness

Serious side effects may include liver issues, lactic acidosis (a rare but serious condition linked to Metformin), or bladder cancer risk (with long-term Pioglitazone use).

10. Can this medication cause low blood sugar (hypoglycemia)?

Pioglitazone + Metformin alone does not usually cause hypoglycemia, but the risk increases when combined with insulin or sulfonylureas.

11. Can I take this medication with other diabetes drugs?

Yes, but it should be done under a doctor’s supervision. It may be combined with insulin, sulfonylureas, or DPP-4 inhibitors if additional blood sugar control is needed.

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

Take the missed dose as soon as you remember. If it’s close to the next dose, skip the missed dose—do not double up.

13. Can I drink alcohol while taking this medication?

Limit alcohol consumption, as it can increase the risk of lactic acidosis and blood sugar fluctuations.

14. Can I take this medication during pregnancy?

It is generally not recommended in pregnancy. Insulin is preferred for blood sugar control in pregnant women.

15. Can I breastfeed while on this medication?

Metformin is excreted in breast milk, so consult a doctor before using this medication while breastfeeding.

16. Does this medication affect kidney function?

Metformin can cause lactic acidosis in patients with kidney disease. Routine kidney function tests are recommended.

17. Can I stop taking this medication if I feel better?

No, diabetes is a chronic condition. Stopping medication can cause uncontrolled blood sugar levels and complications.

18. What precautions should I take?

• Monitor blood sugar regularly
• Have routine kidney and liver function tests
• Stay hydrated
• Avoid excessive alcohol

19. Can I take this medication if I have liver disease?

Patients with liver impairment should avoid Pioglitazone, as it can worsen liver conditions.

20. Can this medication help with weight loss?

Metformin may cause slight weight loss, but Pioglitazone may lead to weight gain due to fluid retention.

21. What are the signs of lactic acidosis?

Symptoms include:

• Severe fatigue
• Muscle pain
• Breathing difficulty
• Irregular heartbeat

22. Does this medication affect the heart?

Pioglitazone may increase the risk of heart failure in some patients. Monitor for swelling and shortness of breath.

23. How long does it take to see the effects?

Metformin works within days, while Pioglitazone may take weeks to show full effects.

24. Can this medication interact with other drugs?

Yes, it may interact with blood pressure medications, insulin, corticosteroids, and some antibiotics.

25. Can I take this medication with thyroid disease?

Yes, but regular monitoring is required as it may affect thyroid hormone levels.

26. Can I exercise while taking this medication?

Yes, exercise improves blood sugar control and insulin sensitivity.

27. What should I eat while on this medication?

Focus on a balanced diet with controlled carbohydrates, fiber, and healthy fats.

28. Can this medication cause bone fractures?

Long-term use of Pioglitazone may increase fracture risk, especially in women.

29. Is this medication available as a generic?

Yes, generic versions are available.

30. What happens if I take too much?

Overdose can lead to severe low blood sugar or lactic acidosis. Seek immediate medical attention.

31. Can I take it with blood pressure medication?

Yes, but some blood pressure drugs may increase the risk of low blood sugar.

32. Can I travel while on this medication?

Yes, but carry your medication and monitor your blood sugar regularly.

33. Can this medication cause headaches?

Headaches are a possible side effect but usually mild.

34. Does this medication affect cholesterol?

Pioglitazone can improve HDL (good cholesterol) but may raise LDL (bad cholesterol).

35. Can I take it with aspirin?

Yes, but consult your doctor if you are on blood thinners.

36. Can it cause stomach ulcers?

It does not usually cause ulcers but may cause stomach discomfort.

37. Does this medication cure diabetes?

No, but it helps control blood sugar effectively.

38. Can it be taken long-term?

Yes, if monitored properly.