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Actoplus MET (Pioglitazone Hydrochloride / Metformin Hydrochloride) - Summary

 
 



WARNING: CONGESTIVE HEART FAILURE

  • Thiazolidinediones, including pioglitazone, which is a component of ACTOPLUS MET, cause or exacerbate congestive heart failure in some patients (see WARNINGS, Pioglitazone hydrochloride ). After initiation of ACTOPLUS MET, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to the current standards of care. Furthermore, discontinuation or dose reduction of ACTOPLUS MET must be considered.
  • ACTOPLUS MET is not recommended in patients with symptomatic heart failure. Initiation of ACTOPLUS MET in patients with established NYHA Class III or IV heart failure is contraindicated (see CONTRAINDICATIONS and WARNINGS, Pioglitazone hydrochloride ).
 

ACTOPLUS MET SUMMARY

ACTOPLUS MET┬« (pioglitazone hydrochloride and metformin hydrochloride) tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: pioglitazone hydrochloride and metformin hydrochloride. The concomitant use of pioglitazone and metformin has been previously approved based on clinical trials in patients with type 2 diabetes inadequately controlled on metformin. Additional efficacy and safety information about pioglitazone and metformin monotherapies may be found in the prescribing information for each individual drug. Pioglitazone hydrochloride is an oral antihyperglycemic agent that acts primarily by decreasing insulin resistance. Pioglitazone is used in the management of type 2 diabetes. Pharmacological studies indicate that pioglitazone improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. Pioglitazone improves glycemic control while reducing circulating insulin levels. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride belongs to a different chemical class and has a different pharmacological action than the sulfonylureas, biguanides, or the α-glucosidase inhibitors. The molecule contains one asymmetric center, and the synthetic compound is a racemate. The two enantiomers of pioglitazone interconvert in vivo.

ACTOPLUS MET is a thiazolidinedione and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and metformin or who have inadequate glycemic control on a thiazolidinedione alone or metformin alone.


See all Actoplus MET indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Actoplus MET (Pioglitazone / Metformin)

PIOfix-study: effects of pioglitazone/metformin fixed combination in comparison with a combination of metformin with glimepiride on diabetic dyslipidemia. [2011.06]
CONCLUSIONS: With comparable glycemic control, the fixed PM combination was more efficacious on HDL cholesterol improvement than the GM combination. Additional positive effects were observed for biomarkers of lipid metabolism, beta-cell function, activity of the visceral adipose tissue, and chronic systemic inflammation.

Effects of pioglitazone and metformin fixed-dose combination therapy on cardiovascular risk markers of inflammation and lipid profile compared with pioglitazone and metformin monotherapy in patients with type 2 diabetes. [2010.12]
. Type 2 diabetes mellitus (T2DM) treatment should not increase cardiovascular (CV) risk and at best could provide benefit beyond lowering glucose... Thus, treatment with the FDC resulted in improved levels of CV biomarkers, which were better than or equal to monotherapy.

Efficacy and safety of pioglitazone/metformin fixed-dose combination therapy compared with pioglitazone and metformin monotherapy in treating patients with T2DM. [2009.12]
BACKGROUND: Studies have shown that many patients with type 2 diabetes do not achieve optimal glycemic control, and progression of diabetes over time requires more than one pharmacotherapy to achieve glycemic goal. OBJECTIVE: To examine the efficacy and safety of the fixed-dose combination (FDC) of pioglitazone 15 mg and metformin 850 mg versus its individual components in a twice-daily regimen over 24 weeks of treatment in type 2 diabetes patients who were currently not receiving antidiabetes therapy... CONCLUSIONS: Overall, treatment with pioglitazone/metformin FDC demonstrated greater efficacy than its individual components. The FDC therapy was well tolerated, with reduced or similar adverse event rates compared with each individual monotherapy.

Efficacy and safety of pioglitazone/metformin fixed-dose combination therapy compared with pioglitazone and metformin monotherapy in treating patients with T2DM. [2009.10.14]
Abstract Background: Studies have shown that many patients with type 2 diabetes do not achieve optimal glycemic control, and progression of diabetes over time requires more than one pharmacotherapy to achieve glycemic goal. Objective: To examine the efficacy and safety of the fixed-dose combination (FDC) of pioglitazone 15 mg and metformin 850 mg versus its individual components in a twice-daily regimen over 24 weeks of treatment in type 2 diabetes patients who were currently not receiving antidiabetes therapy...

Effects of pioglitazone and metformin fixed-dose combination therapy on cardiovascular risk markers of inflammation and lipid profile compared with pioglitazone and metformin monotherapy in patients with type 2 diabetes. [2010]
. Type 2 diabetes mellitus (T2DM) treatment should not increase cardiovascular (CV) risk and at best could provide benefit beyond lowering glucose... Thus, treatment with the FDC resulted in improved levels of CV biomarkers, which were better than or equal to monotherapy.

more studies >>

Clinical Trials Related to Actoplus MET (Pioglitazone / Metformin)

Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets Under Fed Conditions [Completed]
Objective: subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met« (pioglitazone hydrochloride and metformin hydrochloride) Tablets 15 mg/850 mg of Takeda Pharmaceuticals America, Inc. USA. Dosing periods of studies were separated by a washout period of 14 days. Study Design: Randomized, Two-Way Crossover, Single-Dose, and Open-Label

Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets Under Fasting Conditions [Completed]
Objective: subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met« (pioglitazone hydrochloride and metformin hydrochloride) Tablets 15 mg/850 mg of Takeda Pharmaceuticals America, Inc. USA. Dosing periods of studies were separated by a washout period of 14 days. Study Design: Randomized, Two-Way Crossover, Single-Dose, and Open-Label

Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus. [Completed]
The purpose of this study is to determine the efficacy of pioglitazone, twice daily (BID), combined with metformin versus pioglitazone taken alone and metformin taken alone in treating Type 2 Diabetes Mellitus.

more trials >>

Reports of Suspected Actoplus MET (Pioglitazone / Metformin) Side Effects

Bladder Cancer (26)Bladder Transitional Cell Carcinoma (3)Metastases TO Lymph Nodes (2)Blood Glucose Abnormal (2)Intervertebral Disc Degeneration (2)Myocardial Infarction (2)Renal Disorder (2)Ischaemic Stroke (2)Urinary Tract Infection (2)Volvulus (2)more >>


Page last updated: 2013-02-10

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