INSUMAN ® Soluble human insulin

INSUMAN ® a drug based on human insulin

THERAPEUTIC GROUP: Human insulin for injectable use with regular action

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

Indications INSUMAN ® Soluble human insulin

INSUMAN ® is a hypoglycemic drug based on human insulin useful in the treatment of diabetes mellitus, hyperglycemic coma, ketoacidosis and gestational diabetes.

Mechanism of action INSUMAN ® Soluble human insulin

The insulin contained in INSUMAN ® produced by recombinant DNA technology in E.Coli perfectly reflects the structure of the endogenous hormone, thus constituting the so-called soluble human insulin.

As such it is injected subcutaneously, manifesting its therapeutic action after approximately 30 minutes, with an optimization of the activity within the first four hours and a maximum action duration of nine hours.

Despite the aforementioned pharmacokinetic characteristics, the half-life of blood insulin is very short, of about 4 - 6 minutes, as it is capable of rapidly binding insulin receptors expressed by insulin-sensitive tissues such as adipose and muscular tissues and activating intracellular pathways involved in optimization of the intake and consumption of blood glucose.

At the muscular level, in fact, glycolysis, proteosynthesis, glycogen synthesis is promoted and glycogenolysis and proteolysis are inhibited while at the adipocyte level the lipogenesis mechanism is triggered.

The hypoglycemic action of insulin also occurs at the hepatic level, where it acts as an enzyme-inducing hormone involved in glycogen synthesis and in lipogenesis, thus inhibiting lipolysis, glycogenolysis and gluconeogens, capable of inducing a glycemic increase.

Studies carried out and clinical efficacy

1. INSULIN AND DOPING

Different hormones are used by unfit professional athletes in the harmful and unsporting practice of doping. Recent evidence suggests the increasing role of IFG1 and insulin in sports practice useful for improving muscle structures by inducing both a protein synthesis and a significant increase in muscle glycogen stocks. Different tests, more and more precise and reliable, some of which also use the genetic aspect, try daily to fight against this incorrect practice.

2. INSULIN AND NEW MECHANISMS OF RECRUITMENT

The growing number of diabetic patients, both first and second type, who need insulin therapy to ensure good glycemic control is pushing pharmaceutical companies towards the formulation of new release tools that can allow a faster and simpler assumption of this hormone. Currently, there are new techniques such as insulin in aerosols and liquid insulin to be taken through the buccal mucosa, which however do not yet produce the expected results.

3. ACUTE ISCHEMIC ICTUS AND HYPERGLYCEMIA

The hyperglycemia following acute ischemic stroke is often characterized by a fatal course of difficult treatment. In this study we suggest a regular intravenous infusion protocol of insulin that can significantly improve glycemic levels bringing them back to normal.

Method of use and dosage

INSUMAN ® 100 IU / ml solution for injection 5 ml bottles: although there are reference ranges for insulin therapy, which generally range from 0.5 IU to 1 IU per kg of body weight per day for diabetic patients of the first type and from 0.3 to 0.6 UI pro Kg die for second type diabetic patients, the precise dosage formulation should be established by the doctor after a careful evaluation of the patient's physio-pathological state and his glycemic balance.

Intake of INSUMAN ® should be done by subcutaneous injections generally in the abdominal part about 30 minutes before a carbohydrate meal.

Uses other than subcutaneous use are intended for hospital medical personnel.

Warnings INSUMAN ® Soluble human insulin

The success of insulin therapy is strongly related to the patient's active participation in the therapeutic procedure, and therefore to medical supervision.

The patient should be informed and at the same time apply all the necessary provisions to ensure correct preparation, storage and injection of the drug, which can recognize the first signs of hypoglycemia and implement the actions useful to avoid an aggravation of the symptoms .

It is clear that a wrong formulation of the dosage could lead to serious consequences for the patient's health, with hypoglycemic crises in case of too high dosages and accompanied hyperglycemia in the most serious cases from diabetic ketoacidosis in too low dosages.

For the same reason, suspensions, changes or dosage adjustments should be supervised by your doctor.

In the case of reduced kidney function it may be necessary to reduce the dose of drug used.

The possible onset of hypoglycaemia could reduce the patient's perceptive capacities, making it dangerous to use machinery and drive vehicles.

PREGNANCY AND BREASTFEEDING

Insulin represents the only possible therapeutic approach to gestational diabetes.

The excellent safety profile observed for this hormone is evidently due to the inability to cross the placental barrier, safeguarding the metabolic characteristics of the fetus.

INSUMAN ® can therefore be used during pregnancy, naturally under strict medical supervision.

Interactions

The hypoglycemic effect of human insulin can be appreciably shaken by the concomitant intake of different active ingredients.

For example the concomitant administration of oral hypoglycemic agents, octreotide, anti-MAO, beta-blocking agents, ACE inhibitors, salicylates, alcohol and anabolic steroids, could increase the hypoglycemic effect of insulin by subjecting patients to numerous risks.

In contrast, the use of oral contraceptives, thiazides, glucocorticoids, thyroid hormones and sympathomimetics could reduce the therapeutic effect of INSUMAN ® .

In both cases therefore it is necessary to resort to an adjustment of the dosage to keep the glycemic balance under control.

Contraindications INSUMAN ® Soluble human insulin

INSUMAN ® contraindicated in case of hypoglycaemia and hypersensitivity to human insulin or its excipients.

Undesirable effects - Side effects

Subcutaneous administration of soluble human insulin is often associated with adverse reactions of different clinical and local or systemic character.

Among the most important side effects of localized interest it is possible to observe the presence of redness, pain and itching at the site of injection or lipoatrophy following failure to rotate the inoculation points.

The systemic effects, on the other hand, may be due to generalized hypersensitivity reactions with gastro-intestinal disorders, edema, respiratory difficulties, palpitations and hypotension.

However, hypoglycemia remains the most frequent and risky collateral reaction to human health, characterized by cold sweat, skin pallor, nervousness, tremors, anxiety, fatigue, weakness, confusion, difficulty concentrating, headache, nausea, palpitations, visual disturbances and in severe cases loss of consciousness and death.