NOVOMIX ® a drug based on soluble insulin as protamine-crystallized insulin aspart
THERAPEUTIC GROUP: Biphasic insulin for injectable use - insulins and analogues
IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications NOVOMIX ® Insulin soluble aspart + protamine-crystallized insulin aspart
NOVOMIX ® indicated in the treatment of diabetic pathology that requires insulin therapy.
Mechanism of action NOVOMIX ® Insulin soluble aspart + protamine-crystallized insulin aspart
NOVOMIX ® is a hypoglycemic drug consisting of soluble insulin aspart and protamine-crystallized insulin aspart in the 30/70 ratio.
These are respectively fast-acting and intermediate insulin analogues that allow the medicine to carry out the hypoglycemic effect about 10 - 20 minutes from subcutaneous administration, reaching the maximum therapeutic activity within the first 4 hours and guaranteeing a coverage of about 24 hours.
The most rapid kinetics of action is guaranteed by the substitution of the proline with aspartic acid in the B28 position, which reduces the tendency of the insulin to form hexamers, thus facilitating the passage of the hormone from the subcutaneous tissue to the bloodstream.
Through the blood circulation the hormone reaches the insulin-sensitive tissues such as the muscular and adipose tissue, activating specific receptors involved in the regulation of cellular activity and useful to improve uptake and utilization of blood glucose.
At the same time, insulin acts metabolically on the liver, inhibiting the enzymatic pathways necessary to produce glucose and circulating it.
In this way the hypoglycemic effect of insulin is therefore guaranteed.
Studies carried out and clinical efficacy
1. BIPHASIC ASPART INSULIN AND DIABETIC PATHOLOGY
Numerous studies in the literature demonstrate the particular efficacy of biphasic insulin aspart in the management of diabetic pathology both in patients with first-type and second-type diabetes. The excellent results obtained in terms of glycated hemoglobin reduction and glycemic control make NOVOMIX an ideal drug for the modern management of diabetic pathology.
2. EFFECTIVENESS AND SAFETY OF BIPHASIC ASPART THERAPY
Study conducted on 1154 patients with type II diabetes and treated with biphasic insulin aspart. Prolonged treatment for six months was completed by 89% of enrolled patients, indicating excellent compliance, guaranteeing a reduction in glycated hemoglobin of more than 1% with only two hypoglycemic episodes.
3. BIPHASIC ASPART INSULIN AND DIABETES OF A SECOND TYPE
The treatment of type II diabetes, in most cases entrusted with the use of oral hypoglycemic agents, is often ineffective in restoring correct glycemic control. The addition of biphasic insulin aspart to metformin or pioglitazone therapy was useful in optimizing glycemic control.
Method of use and dosage
NOVOMIX ® 100 IU / ml insulin consisting of soluble insulin aspart and protamine-crystallized insulin aspart in the ratio 30/70:
the correct dosage and the relative timing of the assumption should be established by the doctor after a careful evaluation of the patient's state of health and his metabolic balance.
Like other biphasic insulins, NOVOMIX ® must necessarily be administered subcutaneously but unlike the others, it can be taken just before a meal.
Warnings NOVOMIX ® Insulin soluble aspart + protamine-crystallized insulin aspart
The dosage d NOVOMIX ® should be established by the doctor after a careful evaluation of the patient's physiopathological state, his eating and athletic habits and clearly his glycemic balance.
Variations of the formulated dose should be taken into consideration in the case of liver and kidney diseases, infectious diseases, surgical interventions, changes in dietary habits and lifestyle and various needs, in order to maintain good homeostasis.
The active participation of the patient in therapeutic daily life is of fundamental importance for the success of the therapy, while the correct awareness of the disease and of the potential side effects could minimize the occurrence of clinically dangerous adverse reactions.
Hypoglycaemia, which certainly remains the most serious problem associated with insulin therapy, could reduce the patient's normal perceptive and reactive capacities, making it dangerous to use machinery and drive vehicles.
PREGNANCY AND BREASTFEEDING
Although the trial concerning the use of insulin aspart in pregnant women is still not very significant, insulin remains the only safe and effective drug remedy for the treatment of gestational diabetes.
However, in order for the therapy to carry out the expected therapeutic effect, it is important that the dosage used also takes into account the week of pregnancy, given the variable requirement in this period.
It is clear that insulin treatment, especially in this case, must be carried out under strict medical supervision.
Interactions
Insulin aspart, as well as human insulin, lends itself in a similar way to the same drug interactions.
In fact the concomitant intake of oral hypoglycemic agents, octreotide, anti-MAO, beta-blocking agents, ACE inhibitors, salicylates, alcohol and anabolic steroids could potentiate the hypoglycemic effect of NOVOMIX ® thus increasing the risk of hypoglycemia.
Conversely, the simultaneous administration of oral contraceptives, thiazides, glucorticoids, thyroid hormones and sympathomimetics could reduce the therapeutic effect of this hormone, altering the normal glycemic control required.
In both cases it would be necessary to provide for an appropriate adjustment of the dosage.
It is known from the literature how sympatholytic drugs can mask some important signs of hypoglycemia by increasing the risk of serious reactions.
Contraindications NOVOMIX ® Insulin soluble aspart + protamine-crystallized insulin aspart
NOVOMIX ® contraindicated in case of hypoglycemia and hypersensitivity to human insulin or its excipients.
Undesirable effects - Side effects
Therapeutic treatment with insulin aspart also exposes the diabetic patient to the same side effects observed in therapy with human insulin.
Among the most common local side effects it is possible to describe irritation, redness and itching at the injection site, which in particular cases, such as missed rotation of the inoculation point, could also be associated with lipoatrophy.
Gastrointestinal and visual disorders, or those related to hypersensitivity reactions to the hormone, were less frequent, while hypoglycemia is certainly the adverse reaction which is of major concern from the clinical point of view.
This in fact initially characterized by mild but highly indicative symptoms such as cold sweating, drowsiness, asthenia, loss of attention could subsequently be responsible for loss of consciousness and coma.
Note
NOVOMIX ® sold only under medical prescription.
NOVOMIX ® is part of the doping class: Hormones and related substances (prohibited in and out of competition)
