HUMALOG MIX ® - Insulin lispro + insulin lispro protamine

HUMALOG MIX ® a drug based on insulin lispro + insulin lispro protamine

THERAPEUTIC GROUP: Biphasic insulin for injectable use - insulins and analogues

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

Indications HUMALOG MIX ® - Insulin lispro + insulin lispro protamine

HUMALOG MIX ® is indicated in the treatment of diabetes mellitus that requires insulin therapy to ensure good glycemic control.

Mechanism of action HUMALOG MIX ® - Insulin lispro + insulin lispro protamine

HUMALOG MIX ® is a drug based on insulin analogues with different times of action, consisting of insulin lispro and insulin lispro protamine.

These two different forms of insulin respectively allow a rapid action of action, therefore useful for the control of post-prandial hyperglycemia, and an intermediate one, necessary for the prolonged maintenance of the hypoglycemic action.

In principle, therefore, insulin lispro is rapidly absorbed reaching maximum plasma concentrations within about 50 minutes, although the onset of its biological effect is decidedly anticipated 15 minutes after its intake, while insulin lispro protamine can maintain the its own therapeutic effect even for a good 18 hours.

It is evident that although the two different insulin forms present very different absorption profiles and timing of action, the molecular mechanism of action remains the same for both, acting on sensitive insulin tissues allowing a better uptake and utilization of blood glucose.

Studies carried out and clinical efficacy

1. BIPHASIC INSULIN AND INFLAMMATORY MARKERS

The administration of biphasic insulin in second type diabetic patients for 24 weeks has proved particularly useful in reducing some inflammatory markers such as the C reactive protein, interleukin 6 and TNF alpha in the immediate post-prandial period, evidently allowing for best metabolic control.

2. BIPHASIC INSULIN AND SECOND TYPE DIABETIC PATIENTS

The administration of insulin lispro / insulin lispro protamine, according to the percentages present in HUMALOG MIX, in second type diabetic patients guaranteed a better glycemic control with a longer duration of action of the drug, compared to the combined therapy insulin glargine - oral hypoglycemic. These effects were more significant in diabetic patients with a good glycemic control starting.

3. BIPHASIC THERAPY AND PONDERAL INCREASE

Unfortunately, biphasic insulin therapy has not shown particular advantages in managing the diabetic patient's body weight compared to classic insulin therapies. This remains an important issue to consider carefully as it is detrimental to the patient's physical and psychological health.

Method of use and dosage

HUMALOG MIX ® 100 IU / ml insulin consisting of 25% of insulin lispro and 75% of insulin lispro protamine or 50% of insulin lispro and 50% of insulin lispro protamine, 3 ml packs:

The correct formulation and relative dosage to be used varies significantly from patient to patient, therefore, although it is possible to define an optimal therapeutic range, it is advisable for the doctor to formulate the correct dose based on the patient's therapeutic needs, his glycemic levels and his physio-pathological state.

In principle, subcutaneous administration should be performed approximately 15 minutes before main meals.

Warnings HUMALOG MIX ® - Insulin lispro + insulin lispro protamine

In order for insulin therapy to have the maximum therapeutic success, it is advisable that the diabetic patient, adequately trained by their doctor, actively participate in the entire treatment.

The correct preparation and administration of insulin represent the first step towards the correct management of the disease, while the ability to recognize the signs of hypoglycemia and to put in place adequate remedies protects the patient from potentially dangerous adverse reactions.

Although the patient is the nerve center of the treatment, it is advisable for the doctor to carefully supervise his work, guiding the patient and possibly correcting the dosages used in the event of incidence of infectious diseases, surgical interventions, lifestyle changes and eating habits and all those other conditions that can alter the normal insulin requirement.

The possible onset of hypoglycemia could be accompanied by a significant decrease in the patient's perceptive capacities, making it dangerous to use machinery and drive vehicles.

PREGNANCY AND BREASTFEEDING

The various clinical trials seem to agree on the excellent safety profile of insulin lispro when taken during pregnancy, for the health of the fetus.

It is of fundamental importance to treat the diabetic pregnant woman adequately to safeguard pregnancy and the correct development of the fetus.

Interactions

The concomitant intake of oral hypoglycemic agents, octreotide, anti-MAO, beta-blocking agents, ACE inhibitors, salicylates, alcohol and anabolic steroids could potentiate the therapeutic effect of insulin lispro, requiring a reduction in the dosage used.

On the contrary, the concomitant administration of oral contraceptives, thiazides, glucocorticoids, thyroid hormones and sympathomimetics could reduce the hypoglycemic effect of HUMALOG MIX ® increasing the need for this hormone.

It is known from the literature how sympatholytic drugs can mask some important signs of hypoglycemia by increasing the risk of serious reactions.

Contraindications HUMALOG MIX ® - Insulin lispro + insulin lispro protamine

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

Undesirable effects - Side effects

Subcutaneous insulin intake may be responsible for different side effects, both local and systemic.

It is in fact possible that bruises, edemas, redness and intense itching as a sign of hypersensitivity to the drug occur at the injection site, whereas the condition of lipoatrophy which can generally be observed following the clinical course is more relevant with a classic clinical course. missed rotation of inoculation sites.

The side effects observed on the gastrointestinal tract, the visual system and the hematologic condition, particularly present in the initial phase of the therapy and easily regressable, were rare and without particular complications.

The most frequent and most significant adverse reaction is the condition of hypoglycemia accompanied by the classic symptomatology that could rapidly evolve towards loss of consciousness and coma.