ACTOSMET 15mg/850mg Tablets/Film-coated

What is ACTOSMET 15mg/850mg

ACTOSMET 15mg/850mg is an oral antidiabetic medication that combines two active ingredients: Pioglitazone and Metformin. This fixed-dose combination is used to manage blood glucose levels in adults with type 2 diabetes mellitus, especially when diet, exercise, and monotherapy do not provide adequate glycemic control.

• Pioglitazone: A thiazolidinedione that improves insulin sensitivity in muscle and adipose tissue.
• Metformin: A biguanide that reduces hepatic glucose production and increases peripheral glucose uptake.
• Designed for patients inadequately controlled on Metformin alone or who require combination therapy.
• Not used in the treatment of type 1 diabetes or diabetic ketoacidosis.

ACTOSMET addresses multiple aspects of glucose metabolism and is typically prescribed as part of a comprehensive management plan including dietary changes, physical activity, and regular monitoring of blood glucose.

How to use ACTOSMET 15mg/850mg

ACTOSMET should be taken exactly as prescribed by your healthcare provider. Proper administration helps improve blood sugar control and reduce the risk of complications.

• Administration route: Oral, with meals to reduce gastrointestinal side effects.
• Timing: Typically once or twice daily depending on clinical response and patient tolerance.
• Swallow whole: Do not crush, split, or chew the tablet.
• Adherence: Take consistently at the same time each day to maintain steady drug levels.
• Missed dose: Take as soon as remembered unless close to the next dose. Do not double the dose.

Routine blood glucose monitoring and regular follow-up with your healthcare provider are essential during treatment. Inform your doctor of any signs of lactic acidosis (e.g., muscle pain, abdominal pain, fatigue).

Mode of Action ACTOSMET 15mg/850mg

ACTOSMET combines the complementary actions of Pioglitazone and Metformin to exert a synergistic antihyperglycemic effect:

• Pioglitazone: Activates peroxisome proliferator-activated receptor gamma (PPAR-γ), enhancing insulin sensitivity in adipose tissue, muscle, and liver.
• Metformin: Primarily reduces hepatic gluconeogenesis and increases insulin-mediated glucose uptake in peripheral tissues.
• Effect: Together, these agents reduce fasting and postprandial blood glucose levels without stimulating insulin secretion.

This dual mechanism helps to improve glycemic control, reduce insulin resistance, and potentially provide cardiovascular benefits in patients with type 2 diabetes.

ACTOSMET 15mg/850mg Interactions ACTOSMET 15mg/850mg

Several drug interactions may affect the efficacy or safety of ACTOSMET. Always inform your healthcare provider about all medications and supplements you are taking.

• Cationic drugs: (e.g., amiloride, digoxin, morphine) may compete for renal tubular transport and increase metformin levels.
• Diuretics and corticosteroids: May raise blood sugar and reduce the effect of ACTOSMET.
• Alcohol: Increases the risk of lactic acidosis and should be avoided.
• Rifampin: May decrease plasma levels of Pioglitazone and reduce efficacy.
• Insulin or insulin secretagogues: May increase risk of hypoglycemia when used concurrently.

Routine monitoring and possible dosage adjustment may be required when ACTOSMET is used with these or other medications.

Dosage of ACTOSMET 15mg/850mg

Dosage must be individualized based on the patient's current regimen, glycemic control, and tolerance.

• Starting dose: One tablet (15mg/850mg) once or twice daily with meals.
• Dose adjustments: Should be done gradually based on therapeutic response and risk of side effects, particularly gastrointestinal or hypoglycemic reactions.
• Maximum dose: Should not exceed 45 mg of Pioglitazone and 2550 mg of Metformin per day.
• Renal function: Contraindicated in patients with significant renal impairment (eGFR <30 mL/min/1.73m²).

Blood sugar levels, renal function, and liver enzymes should be monitored periodically to guide dosing and ensure patient safety.

Possible side effects of ACTOSMET 15mg/850mg

ACTOSMET may cause both common and serious adverse effects. It is important to recognize them early and report concerning symptoms to a healthcare provider.

• Common side effects:
  • Gastrointestinal upset (nausea, diarrhea, abdominal discomfort)
  • Weight gain
  • Edema or fluid retention
• Serious side effects:
  • Lactic acidosis (rare but potentially fatal) – symptoms include deep, rapid breathing, weakness, and confusion
  • Heart failure – more likely in patients with a history of cardiac disease
  • Hepatic dysfunction
  • Bladder cancer: Long-term use of pioglitazone may carry a risk

Routine follow-up, laboratory monitoring, and symptom awareness can help mitigate these risks.

ACTOSMET 15mg/850mg Contraindications ACTOSMET 15mg/850mg

ACTOSMET is contraindicated in certain populations due to safety risks:

• Severe renal impairment: Risk of metformin-associated lactic acidosis.
• Heart failure (NYHA Class III/IV): Pioglitazone may exacerbate fluid retention.
• Acute or chronic metabolic acidosis: Including diabetic ketoacidosis.
• Hepatic impairment: Increased risk of liver-related toxicity.
• Hypersensitivity: Known allergy to Pioglitazone, Metformin, or any tablet excipients.

Careful medical evaluation is required before initiating therapy, especially in patients with comorbidities or risk factors.

Storage of ACTOSMET 15mg/850mg

Proper storage of ACTOSMET ensures its effectiveness and prevents degradation.

• Temperature: Store below 30°C (86°F).
• Humidity: Keep in a dry place, away from moisture and direct sunlight.
• Packaging: Store in the original blister packaging to protect from light and air.
• Keep out of reach of children.
• Disposal: Expired or unused medicine should be disposed of safely, following local regulations or pharmacy take-back programs.

Never use ACTOSMET beyond the expiration date printed on the package.