SOLOSA ® - Glimepiride

SOLOSA ® is a Glimepiride-based drug.

THERAPEUTIC GROUP: Oral hypoglycemic agents - Sulfonamides, urea derivatives

Indications SOLOSA ® - Glimepiride

SOLOSA ® is useful in improving glycemic control in type II diabetic patients in whom diet and other non-pharmacological therapeutic approaches have not produced the expected effects.

Mechanism of action SOLOSA ® - Glimepiride

The hypoglycemic action of glimepiride contained in SOLOSA ® is due to the metabolically complex role of this active ingredient belonging to the vast category of sulfonamides.
Going into more detail, glimepiride is able to selectively act on pancreatic beta cells, promoting insulin secretion by inhibiting a potassium channel responsible for activating the beta cell and releasing this hormone.
Although the aforementioned mechanism of action may already be particularly effective in improving glycemic control, glimepiride seems to be involved in sensitizing the insulin receptors of insulin-sensitive tissues by improving blood glucose uptake and reducing the production of glucose mediated by pathways. such as glycogenolysis and hepatic gluconeogenesis.
SOLOSA ® also belongs to the therapeutic group of oral hypoglycemic drugs, so its compliance is significantly increased by the easy mode of administration (tablets taken orally), which allows the active ingredient to be absorbed at the gastrointestinal level in just 2.5 hours and be subsequently eliminated in the form of inactive metabolites both in the urine and in the faeces.

Studies carried out and clinical efficacy

1. GLIMEPIRIDE AND PREVENTION

Diabetes Obes Metab. 2011 Feb; 13: 185-8. doi: 10.1111 / j.1463-1326.2010.01331.x.

Can sulphonylurea addition to lifestyle changes help to delay diabetes development in subjects with impaired fasting glucose? The Nepi ANtidiabetes StudY (NANSY).

Lindblad U, Lindberg G, Mansson NO, Ranstam J, Tyrberg M, Jansson S, Lindwall K, Svärdh M, Kindmalm L, Melander A.


Randomized study conducted for 5 years, which unfortunately demonstrated that the assumption of low doses of sulfonylureas in patients with reduced fasting glycaemia, even if accompanied by an improvement in lifestyle, cannot statistically prevent the onset of diabetic disease.


2. METFORMIN AND GLIMEPIRIS AND ENDOTHELIAL FUNCTION

Arch Cardiol Mex. 2009 Oct-Dec; 79: 249-56.

Effects of the combined treatment with Metformin / Glimepiride on endothelial function of patients with type 2 diabetes mellitus. A positron emission tomography (PET) evaluation study

Alexánderson-Rosas E, de Jesús Martínez A, Ochoa-López JM, Calleja-Torres R, Sierra-Fernández C, Iñarra-Talboy F, Meave-González A, Alexánderson-Rosas G, González-Canudas J.


The alteration of endothelial function is one of the main health risks for the diabetic patient, associated with life-threatening ischemic events. The administration of metformin and glimepiride has been found to be particularly effective in improving the health of the coronary endothelium in patients with type diabetes. II, evaluated through innovative techniques such as PET.


3. COMBINED INSULIN AND GLIMEPIRIDE THERAPY

Diabetes Res Clin Pract. 2011 Feb; 91: 148-53. Epub 2010 Nov 9.

Contribution of glimepiride to basal-prandial insulin therapy in patients with type 2 diabetes.

Yokoyama H, Sone H, Yamada D, Honjo J, Haneda M.


In more advanced stages of type 2 diabetic disease, treatment with insulin may be necessary. This study reiterates the importance of continuing with glimepiride therapy, despite the postprandial and basal subcutaneous insulin intake, in order to continue to support the endogenous secretion of this hormone.

Method of use and dosage

SOLOSA ® 1, 2, 3, 4 and 6 mg tablets of Glimepiride: although the correct therapeutic approach provides for the initial intake of 1 mg of glimepiride per day taken in a single dose, the formulation of the correct dosage should be carried out by the doctor, only after a careful evaluation of the patient's glycemic levels and state of health.
In this case, glycemic control could be guaranteed by the minimum dose of the drug, or by increasing dosages up to a maximum of 6 mg per day.
The monitoring of glycemic concentrations should also be carried out during the therapeutic intervention to correct the dosage of the drug in case of significant glycemic decompensation.
In the case of combined therapies, one should start from the minimum therapeutic dose, to increase it, if necessary, until a good glycemic control is achieved.

SOLOSA ® warnings - Glimepiride

Pharmacological therapy with SOLOSA ® or hypoglycemic atria should be preceded and accompanied by a significant improvement in the lifestyle and eating habits of the type II diabetic patient.
Periodic monitoring of glycemic levels is particularly important, both in the formulation of the initial dosage and in the maintenance of therapy, in order to avoid the risk of hypoglycemia caused by excessive doses and characterized by tiredness, headache, hunger, reduced alertness, bradycardia or from excessive compensatory responses such as sweating, cold skin, tachycardia and tachypnea.
The administration of SOLOSA ® in patients with G6PD enzyme deficiency could be associated with the risk of acute haemolytic crisis.
SOLOSA ® contains lactose, therefore it is not recommended in patients with lactase enzyme deficiency or glucose / galactose malabsorption syndrome.
Excessive intake of glimepiride could lead to episodes of hypoglycemia which can reduce the patient's perceptive abilities, making the use of machinery and driving cars dangerous.


PREGNANCY AND BREASTFEEDING

Gestational diabetes is a disease that affects about 3% of pregnant women, exposing the unborn child to serious risks. For this reason, the therapeutic approach of this pathology involves the administration of well-characterized drugs such as insulin, preferring it to active principles such as glimepiride not yet fully studied.
The possible secretion of this active ingredient in breast milk could expose the infant to the risk of hypoglycaemia; therefore it is preferable to avoid breastfeeding during therapy with SOLOSA ®

Interactions

Before being eliminated through faeces and urine, the glimepiride contained in SOLOSA ® is metabolised in the liver by the enzyme CYP2C9, known for its particular susceptibility to various active ingredients.
In this case, in fact, inducers of this enzyme such as estrogens and progestogens, diuretics, glucorticoids, thyroid stimulants, adrenaline, nicotinic acid, laxatives, phenytoin, barbiturates could reduce the plasma concentrations of the active form of the active ingredient, making glycemic control less effective. while its inhibitors may increase blood concentrations, increasing the risk of hypoglycaemia.
Alcohol, H2 antagonists, beta-blockers and coumarin derivatives could interact with glimepiride giving rise to unpredictable side effects.

Contraindications SOLOSA ® - Glimepiride

SOLOSA ® is contraindicated in patients hypersensitive to the active substance or to other sulfonylureas, in patients with type I diabetes or at risk of keto acidosis or diabetic coma.
The use of SOLOSA ® is also contraindicated in patients with impaired hepatic and renal function.

Undesirable Effects - Side Effects

SOLOSA ® therapy has been shown to be very well tolerated both during the clinical trial and in the several years of post-marketing monitoring.
Like other sulfonylureas, complaining disorders have been rare and of modest clinical significance.
Among the most important to report, there is hypoglycemia, often due to the wrong dosage formulation or to the concomitant administration of drugs capable of altering the normal activity of glimepiride.
Side effects affecting the gastrointestinal tract, the nervous system, the immune system or allergic reactions have been observed very rarely.

Note

SOLOSA ® can only be sold under medical prescription.


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