diabetes drugs

COMPETACT ® - Pioglitazone + Metformin

COMPETACT ® a drug based on Pioglitazone hydrochloride and Metformin hydrochloride

THERAPEUTIC GROUP: Oral hypoglycemic agents in association

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications COMPETACT ® - Pioglitazone + Metformin

COMPETACT ® used in the treatment of hyperglycemia of the second type diabetic patient, in case of failure of therapy with metformin alone at the maximum tolerated doses.

Mechanism of action COMPETACT ® - Pioglitazone + Metformin

The hypoglycemic action of is due to the combination of two active ingredients particularly useful in the treatment of hyperglycemia, belonging to the pharmaceutical category of thiazolidinediones and biguanides, such as pioglitazone and metformin.

The excellent therapeutic success is to be found in the synergistic action that these drugs present in the control of glycaemia, improving the use and uptake of glucose by insulin-sensitive peripheral tissues and reducing their endogenous synthesis.

This ability, which is realized at the molecular level through the activation of specific intracellular pathways, and more precisely that of the PPARs for pioglitazone and of the AMP-dependent protein kinase for metformin, translates to the metabolic level in a greater availability and use of glucose at the peripheral level and a reduction in the activation of those metabolic pathways such as gluconeogenesis and hepatic glycogenolysis capable of increasing blood glucose concentrations.

Furthermore, the same method of administration, ie the oral one, makes the therapy with COMPETACT ® particularly easy while maintaining the pharmacokinetic properties of the individual active ingredients unaltered.

Studies carried out and clinical efficacy

1. METFORMIN / PIOGLITAZONE COMBINATION IN THE LONG-TERM TREATMENT

The synergy between these two active ingredients, which can significantly improve the peripheral availability of glucose and its use, improving insulin sensitivity, has proved to be particularly useful both in controlling long-term blood glucose, and in reducing the presence of some markers of vascular and cardiac damage.

2. METABOLIC ROLE OF COMEATACT

COMPETACT finds the main therapeutic indication in the treatment of second-type diabetic disease, poorly managed by metformin alone. This study demonstrates that after 4 months of therapy in patients not responding to metformin alone, the intake of this medicine has guaranteed a reduction in blood pressure, glycosylated hemoglobin, non-HDL cholesterol, triglycerides, thus showing a fundamental metabolic role and quote.

3. METFORMIN / PIOGLITAZONE ASSOCIATION AND CARDIOVASCULAR RISK

The combined treatment of metformin and pioglitazone, has proved particularly effective not only in improving the glycemic profile, but also in reducing a number of risk factors such as LDL cholesterol, triglycerides and reactive oxygen species, involved in the onset of cardiovascular diseases . This type of treatment was able to significantly reduce the number of patients with micro and macrovascular alterations.

Method of use and dosage

COMPETACT ® 15 mg Pioglitazone hydrochloride tablets and 850 mg metformin hydrochloride:

the dose most commonly used is that of two tablets of COMPETACT ® per day, taken with two distinct administrations with food or after a meal.

It is very important before starting therapy with this medicine to test the most effective dose in combination therapy to avoid unpleasant problems and thus reduce the risk of hypoglycemia.

In any case, the correct dosage and method of administration should be indicated by your doctor, following a careful evaluation of the biochemical-metabolic parameters.

Warnings COMPETACT ® - Pioglitazone + Metformin

Also in this case, the warnings relating to the recruitment of COMPETACT ® must essentially refer to those that can be described for the two active principles considered separately.

In this regard, therefore, it should be remembered that the pharmacological therapy of type II diabetes must necessarily be accompanied by non-pharmacological measures such as a healthy lifestyle and adequate nutrition.

COMPETACT ® therapy is associated with the periodic control of glycaemia, transaminases, hemoglobin and creatininemia to assess the adequate metabolic balance and the possible presence of side effects, especially on organs such as the kidneys and liver.

Constant medical supervision is therefore essential to avoid the occurrence of serious side effects such as hepatic, renal, cardiac and metabolic acidosis.

In case of excessive doses it is possible that hypoglycemic crises occur, such as to make driving of vehicles and the use of machinery dangerous.

PREGNANCY AND BREASTFEEDING

COMPETACT ® is commonly contraindicated, like other oral hypoglycemic drugs, during pregnancy and lactation, preferring drugs such as insulin with the best safety profile and the most characterized therapeutic efficacy.

Interactions

At the moment there are no studies in the literature that test the pharmacokinetic properties of COMPETACT ® and any interactions, so all the possible pharmacokinetic interactions are due to those of the individual active ingredients.

It is therefore important to remember that in the case of pioglitazone the concomitant intake of gemfibrozil and rifampicin could alter the therapeutic characteristics and require an adjustment of the dosage, while the intake of glucocorticoids, beta-agonists, diuretics, ACE inhibitors, could alter the hypoglycemic effect of metformin.

It is therefore important to evaluate the possible intake of other drugs and if it is necessary, under strict medical indication, to adjust the COMPETACT ® dosage

Contraindications COMPETACT ® - Pioglitazone + Metformin

COMPETACT ® is contraindicated in case of hypersensitivity to active ingredients or excipients, liver failure, alcohol intoxication or alcoholism, dehydration, serious infections, shock, administration of iodinated contrast agents (potential nephrotoxic action and risk of metabolic acidosis), functional alterations cardiac, hepatic and renal .

Undesirable effects - Side effects

In case of hypersensitivity to one of its components, reactions may occur. The administration of COMPETACT ® revealed the same side effects observed following the concomitant intake of metformin and pioglitazone.

More specifically, among the most frequently reported side effects anemia, visual disturbances probably associated with hypoglycemia, weight gain, arthralgia, gastro-intestinal disorders, hematuria, erectile dysfunction and edema have been observed.

More rarely there have been cases of impaired hepatic and cardiac function.

Note

COMPETACT ® can only be sold under strict medical prescription