ULTRATARD ® - Insulin zinc human suspension

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ULTRATARD ® a drug based on insulin zinc human suspension

THERAPEUTIC GROUP: Insulin zinc human suspension for injectable use - insulins and analogues

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

Indications ULTRATARD ® - Insulin zinc human suspension

ULTRATARD ® a drug used in the treatment of diabetes mellitus of the first type and second type in case of need for insulin therapy.

Mechanism of action ULTRATARD ® - Insulin zinc human suspension

ULTRATARD ® is a drug based on human insulin obtained through recombinant DNA technology in Saccharomyces cerevisiae and conveyed to rhomboid sugar crystals of the size of 10 - 40 microns.

This particular form of insulin, characterized by the structure in crystals, allows the hormone, once injected subcutaneously, to be gradually absorbed and to carry out its therapeutic action within 4 hours of administration, to reach maximum effectiveness around the eighth hour and to maintain its hypoglycemic effect for over 24 hours.

Once it reaches the circulatory stream, insulin has a very rapid half-life, recognizing and binding membrane receptors expressed on insulin-sensitive cell tissues such as adipose and muscle tissue, thus facilitating the entry and utilization of glucose.

At the same time this hormone is able to act on the liver by controlling some useful metabolic aspects and modulating the release of glucose in the circulation through the inhibition of both gluconeogenesis and glycogenolysis.

Studies carried out and clinical efficacy

1. INSULIN THERAPY, LEPTINE LEVELS AND PONDERAL INCREASE

In this study, the effects of daily administration of LUTRATARD insulin on leptin blood concentration and body weight were evaluated. Despite insulin therapy, which guaranteed a significant increase in leptin concentrations, it was nonetheless observed in significant weight gain. This suggests the presence of a central resistance to leptin.

2. EFFECTS OF THE ULTRALENT INSULIN ON THE FUNCTIONALITY OF BETA CELLULA

Subcutaneous administration of ultralent insulin has been defined by some authors as a possible useful strategy to prevent deterioration of pancreatic beta cell function. In this study we tried to understand how this treatment acts on the functionality of these cells, observing a particular trend with the reduction of endogenous fasting production and a significant post-prandial increase. This particular variation does not allow us to understand the real protective effects of exogenous insulin on beta cell function.

3. PHARMACOLOGICAL CHECK AND NOT OF GESTATIONAL DIABETES

Very interesting case report, which shows how diet and exercise can in some cases lead to good glycemic control, minimizing the need for drug treatment. This work in fact describes the results obtained with physical exercise and balanced diet in a woman suffering from gestational diabetes and at the same time from hypersensitivity to insulin. Both glycemic control and insulin resistance have definitely improved with the application of non-pharmacological therapies.

Method of use and dosage

ULTRATARD ® 40 IU / ml insulin zinc human suspension, 10 ml vials:

although in principle the dosage of insulin should fluctuate for type 1 diabetic patients between 0.5 - 1 IU / Kg and in those of type 2 between 0.3 - 0.6 IU / Kg die, it is not possible to formulate a specific dosage in advance, given the significant inter-individual variations.

Consequently the total effective dose, the modality and the timing of administration, should be formulated by the doctor, after a careful evaluation of the physio-pathological conditions of the patient and his glycemic balance.

The long absorption period allows the diabetic patient to perform a single daily administration, subcutaneously with ULTRATARD ® even if in many cases this is usually combined with fast-acting insulin analogues.

Warnings ULTRATARD ® - Insulin zinc human suspension

The correct management of antidiabetic therapy with insulin, cannot disregard the active participation of the patient in the conservation and execution of daily subcutaneous injections, given that the mode of intake could vary some pharmacokinetic characteristics, therefore also the efficacy of the therapy.

The same patient should also be able to recognize the first signs of hypoglycemia, in order to implement useful remedies to avoid the onset of more serious side reactions.

The suspension of therapy, the variation of the drug used, surgical interventions, infectious diseases and pregnancy, may require a further adjustment of the insulin dosage, which should be carried out by the doctor also based on the patient's glycemic picture.

ULTRATARD ® contains among its excipients methyl parahydroxybenzoate, probably responsible for the increase in hypersensitivity episodes linked to the administration of insulin zinc human suspension.

Episodes of hypoglycemia often are accompanied by a reduction in the patient's reactive and perceptive capacities, making it dangerous to use machinery and drive vehicles.

PREGNANCY AND BREASTFEEDING

At the moment insulin is the drug of first choice for the treatment of gestational diabetes, which, if badly compensated, can have important repercussions on correct fetal development.

In order for the therapeutic treatment to have the appropriate efficacy, it is necessary that the dosage used takes into account the adaptations imposed by the pregnancy period.

Interactions

Like all the various commercial insulin analogues, human insulin zinc suspension can also interact with oral hypoglycemic agents, octreotide, anti-MAO agents, beta-blocking agents, ACE inhibitors, salicylates, alcohol and anabolic steroids increasing their therapeutic effect. the relative risk of hypoglycemia.

Conversely, the use of oral contraceptives, thiazides, glucocorticoids, thyroid hormones and sympathomimetics could reduce the therapeutic effect of ULTRATARD ® by preventing the maintenance of good glucose homeostasis.

It is also useful to remember that sympatholytics can mask some important signs of hypoglycemia, increasing the risk of serious reactions.

Contraindications ULTRATARD ® - Insulin zinc human suspension

ULTRATARD ® contraindicated in case of hypoglycemia and hypersensitivity to human insulin or its excipients.

Undesirable effects - Side effects

Insulin therapy can be accompanied by side reactions of different clinical relevance.

Among the most frequent it is possible to observe the presence of hypoglycemic reactions accompanied by pallor, cold sweating, drowsiness, tremors and in the most serious cases loss of consciousness and coma, which can be readily recovered by the rapid intake of sugars.

Insulin zinc has also been associated with a greater number of cases of hypersensitivity with burning, redness and itching at the injection site and systemic effects in more severe cases.

Gastro-intestinal reactions, visual disturbances and changes in the hematological and immune status have only been observed in very rare cases.