WHAT IS ACTOPLUS MET XR?
ACTOplus Met XR (Pioglitazone Hydrochloride and Metformin Hydrochloride) is a combination tablet. It contains pioglitazone hydrochloride and metformin hydrochloride that is presented as an extended-release formulation. Both these drugs are used for the management of type 2 diabetes mellitus. They are taken orally and help to reduce blood glucose levels.
HOW DOES ACTOPLUS MET XR WORK?
ACTOplus Met XR contains pioglitazone. Pioglitazone acts by increasing the sensitivity to insulin in the fat tissue and the muscles. It also decreases the liver’s production of glucose. This has the effect of reducing the levels of circulating insulin and reducing the body’s glucose levels.
ACTOplus MET XR contains metformin. Metformin improves the body’s tolerance for glucose by reducing the absorption of glucose of the intestine, lowering the production of glucose in the liver, and improving the peripheral uptake and use of glucose.
WHAT ARE THE INDICATIONS FOR ACTOPLUS MET XR?
ACTOplus Met XR is indicated for the treatment of patients with type 2 diabetes mellitus. It is used together with diet control and exercise to improve blood glucose levels in adults.
WHAT IS THE DOSE OF ACTOPLUS MET XR?
ACTOplus MET XR comes as a combination of 15 mg pioglitazone and 1000 mg metformin, as well a combination of 30 mg pioglitazone and 1000 mg metformin. As a starting dose ACTOplus MET XR should be taken once a day – either the 15/1000 mg or the 30/1000 mg tablet. In patients who are not responding to the starting dose, the dosage can be increased to 15/1000 mg or 30/1000 mg twice a day. Dose titration should be done while watching for adverse events – particularly those of cardiac failure.
WARNINGS AND PRECAUTIONS
Congestive Cardiac Failure
ACTOplus Met XR contains pioglitazone. This drug may cause or worsen cardiac failure. Patients who are started on ACTOplus Met XR should be carefully monitored to determine if they develop signs or symptoms of cardiac failure. This includes fluid retention, development of edema, shortness of breath, or rapid weight gain. If this occurs, patients should be treated according to current treatment standards. In addition, stopping ACTOplus Met XR should be considered. In patients with symptomatic cardiac failure, the use of ACTOplus MET XR is not recommended. Patients who are classified as being in NYHA grade III or IV cardiac failure should not receive ACTOplus MET XR.
ACTOplus Met XT contains a drug called metformin. Metformin may accumulate in the body, causing a rare but potentially serious complication called lactic acidosis. The risk of developing lactic acidosis increases when the patient has liver failure, renal failure, congestive cardiac failure, sepsis, excessive alcohol intake or dehydration. The onset of lactic acidosis may initially not be noticed, presenting with symptoms of tiredness, muscle soreness, shortness of breath, and abdominal pain. Laboratory tests show a low pH, high blood lactate and an increase in the anion gap. In the diagnosis of lactic acidosis is considered the patient should be admitted to the hospital for further management, and ACTOplus Met XR should immediately be stopped.
Renal Failure or Impairment
Pioglitazone elimination is not affected by renal dysfunction. Metformin is retained longer in the body in patients with renal dysfunction. Because of the accumulation, the use of ACTOplus MET XR is contraindicated in patients with renal dysfunction or renal failure.
Pioglitazone has lower blood levels in patients with hepatic failure. As a result, ACTOplus MET XR should not be used in patients who have ongoing liver dysfunction or who have elevations in their hepatic liver enzymes (ALT). Metformin has not been studied in patients with hepatic dysfunction.
Pioglitazone blood concentrations are not significantly affected in elderly patients.
Metformin blood levels are increased in elderly patients. This seems to be primarily driven by the loss of renal function seen in elderly patients. As a result, ACTOplus MET XR should not be started in patients who are older than 80 years of age without first checking their renal function.
There is little long term clinical data to determine the safety of pioglitazone in pediatric patients. There is little data to guide the use of metformin extended-release formulations in the pediatric population.
ACTOplus Met XR is contraindicated in:
- Patients with hypersensitivity to pioglitazone or metformin
- Established cardiac failure – NYHA grade III or IV
- Established renal failure – eGFR < 30 ml/min/1.73m2
- Metabolic acidosis
- Diabetic ketoacidosis
Common side effects of ACTOplus Met XR include:
- Weight gain
- Symptoms similar to a cold – stuffy nose, sinus pain, sneezing
- Mild swelling of the lower limbs
Less common side effects include:
- New or unusual pain in the muscles
- Difficulty breathing
- Pain in the stomach or vomiting
- Abnormal heart rate
- Changes in vision
- Problems with your heart – a gain of weight, swelling of feet or hands, shortness of breath
- Problems with your liver – abdominal pain, dark urine, jaundice, vomiting, nausea or tiredness. Suppression of the immune system
- Possible increased risk of bladder cancer
- Possible increased risk of prostate cancer
- Possible increased risk of pancreatic cancer
- Increased risk for bone fractures
- Changes in eyesight due to edema of the retina
If any of these side effects are noticed, a doctor should be contacted immediately.
Certain drugs may interact with ACTOplus Met XR. These include:
- Iodine contrast
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