HUMULIN R ® - Insulin

HUMULIN R ® a drug based on human insulin.

THERAPEUTIC GROUP: Rapid-acting human insulin for injectable use.

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

Indications HUMULIN R ® - Insulin

HUMULIN R ® is used as a drug treatment in diabetic patients who require insulin and in patients with gestational diabetes

Mechanism of action HUMULIN R ® - Insulin

HUMULIN R ® is a human soluble insulin-based medicine obtained through molecular biology techniques in E.Coli cultures, which have over the years supplanted animal extraction insulin (porcine).

Insulin is a polypeptide hormone, produced under physiological conditions by pancreatic beta cells and lacking in quantity or efficacy in pathological conditions such as diabetes, and as such can only be administered parenterally since oral intake would cause its degradation to protease diffuse work in the gastro-enteric apparatus.

Its role is of fundamental importance in maintaining the correct glucose homeostasis, given that it acts, through specific receptors, on insulin-sensitive tissues, improving the uptake and utilization of glucose and on the liver, significantly reducing the release of this sugar into the circulation .

Over time the pharmaceutical industry has developed analogues of human insulin, with very low immunogenicity and complexed with molecules of different nature capable of modulating the absorption and release of this hormone, making it functional to the needs of the clinic.

In this case, HUMULIN R ® consists of soluble human insulin which acts, after subcutaneous administration, in about 30 minutes with optimum at 120 minutes and prolonged activity for several hours.

In spite of the hypoglycemic effects even prolonged over time, the dynamics of interaction and cellular activation by insulin is very rapid which results in a ready molecular action and a short half-life.

Studies carried out and clinical efficacy

1. EFFECTIVENESS OF COMBINED THERAPY

The association between oral hypoglycemic agents such as glimepiride and preprandial insulin in ill-compensated second-type diabetic patients has proven to be particularly effective in ensuring both good post-prandial glycemic control and reproducing a physiological insulin secretion curve.

2. IPERSENSIBILITY TO INSULIN

Despite the fact that despite the hypersensitivity to a certain active ingredient is in most cases a useful indication for the change of therapy, there are some cases like that of insulin, in which it becomes necessary at all costs to administer the hormone. To overcome this problem, several centers around the world are developing desensitization techniques to reduce the potential side effects of therapy and of the allergic reaction induced.

3. NEW SUPPORTS FOR DIABETIC THERAPY

The marketing of medical devices for subcutaneous injections of rapid and simple use, has greatly simplified the life of the diabetic patient forced to insulin therapy. Several studies agree on the excellent effect that this type of device has guaranteed on the quality of life of the patient and on the efficacy of the therapy.

Method of use and dosage

HUMULIN R ® 100 IU / ml insulin: solution for injection, 1 ampoule of 10 ml or 5 cartridges of 3 ml or pre-filled pen of 3 ml: the correct dosage relative to the use of HUMULIN R ® in the treatment of diabetic disease should be formulated by the doctor based on the physical and physiological characteristics of the patient and his clinical condition.

In principle the dosage should be between 0.5-1 IU / kg body weight per day for first-type diabetic patients, and lower in type II diabetes patients.

The doctor should also provide all the necessary information for the correct use of the medicine.

Warnings HUMULIN R ® - Insulin

The correct doctor-patient relationship represents the starting point for the success of insulin therapy.

It is in fact advisable for the doctor to inform the patient on the correct preparation, administration and storage of the medicine, on the possible side effects and on the signs useful to recognize hypoglycemic conditions in order to intervene promptly and avoid hypoglycemic crises.

Periodic monitoring of glycemic levels should complement therapy and guide the doctor towards the correct dosage formulation.

Dosage adjustments, variations in the type of drug or suspension of therapy should always be supervised by medical personnel.

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 is at the expense of all the numerous oral hypoglycemic drugs, the only active ingredient that can be used in pregnancy for the treatment of gestational diabetes.

Numerous studies in fact agree on the absence of toxicity for the fetus and on the good safety profile for the mother's health, provided that the dosages used take into account the duration and the period of pregnancy.

Interactions

The hypoglycemic effect of insulin could be enhanced by the concomitant administration of oral hypoglycemic agents, octreotide, anti-MAO, beta-blocking agents, ACE inhibitors, salicylates, alcohol and anabolic steroids to the extent that they require a significant dose adjustment.

Beta blocker drugs may also mask the signs of hypoglycemia making the hypoglycaemia condition particularly dangerous.

On the other hand, the simultaneous intake of oral contraceptives, thiazides, glucocorticoids, thyroid hormones and sympathomimetics could reduce the therapeutic effect of HUMULIN R ®

Contraindications HUMULIN R ® - Insulin

HUMULIN R ® is contraindicated in case of hypoglycemia and hypersensitivity to human insulin or its excipients.

Undesirable effects - Side effects

Subcutaneous administration of insulin may result in transient redness, swelling and itching during injection. It is therefore important to rotate the administration points also to avoid the appearance of lipoatrophy at the inoculation stage.

Excessive doses of HUMULIN R ® could cause hypoglycemia due to cold sweat, skin pallor, nervousness, tremor, anxiety, fatigue, weakness, confusion, difficulty concentrating, headache, nausea, palpitations, visual disturbances and in more severe cases loss of consciousness and death.

Rarely, hypersensitivity reactions to the drug have been observed with disseminated rash, dyspnoea and hypotension.