ULTRATARD ® - Human Insulin Zinc Suspension

PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED

ULTRATARD ® a drug based on human insulin zinc suspension

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


Indications ULTRATARD ® - Human Insulin Zinc Suspension

ULTRATARD ® a drug used in the treatment of type 1 and type 2 diabetes mellitus in case of need for insulin therapy.

Mechanism of action ULTRATARD ® - Human Insulin Zinc Suspension

ULTRATARD ® is a human insulin-based drug obtained through recombinant DNA technology in Saccharomyces cerevisiae and conveyed to rhomboid sugar crystals of 10 - 40 microns.
This particular form of insulin, characterized by its crystal structure, allows the hormone, once injected subcutaneously, to be absorbed gradually and carry out its therapeutic action within 4 hours of administration, reach maximum effectiveness around the eighth hour and maintain its hypoglycemic effect for over 24 hours.
Once reached the bloodstream, insulin has a very rapid half-life, recognizing and binding membrane receptors expressed on the cells of insulin sensitive tissues such as adipose and muscle tissue, thus facilitating the entry and use 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 into the circulation through the inhibition of both gluconeogenesis and glycogenolysis.

Studies carried out and clinical efficacy

1. INSULIN THERAPY, LEPTIN LEVELS AND WEIGHT INCREASE

Horm Metab Res. 2003 Jun; 35: 372-6.

Effect of insulin therapy on plasma leptin and body weight in patients with type 2 diabetes.

Carey PE, Stewart MW, Ashworth L, Taylor R.


The effects of daily administration of LUTRATARD insulin on blood leptin concentration and body weight were evaluated in this study. Although insulin therapy ensured a significant increase in leptin concentrations, significant weight gain was nevertheless observed. This also suggests the presence of central leptin resistance.


2. EFFECTS OF "ULTRALENTA INSULIN ON THE FUNCTIONALITY" OF THE BETA CELL

Metabolism. 2000 Oct; 49: 1243-6.

Effects of prolonged administration of ultralente insulin on fasting and postbreakfast beta-cell function in normal adults.

Coutant R, Carel JC, Aubry V, Lahlou N, Krokowski M, Boitard C, Bougnères PF.


The subcutaneous administration of ultralent insulin has been defined by some authors as a possible strategy to prevent the deterioration of the function of the pancreatic beta cell. In this study we tried to understand how this treatment affects 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 to understand the real protective effects of exogenous insulin on beta cell function.

3. PHARMACOLOGICAL AND NOT CONTROL OF GESTATIONAL DIABETES

Ginekol Pol. 2005 May; 76: 403-8.

Outcome of non-pharmacologic treatment in a gestational diabetic woman with high insulin resistance HOMA-IR index and allergy to human insulin. Case report

Sokup A, Swiatkowski M, Tyloch M, Szymanski W.


Very interesting case report, which demonstrates 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 a balanced diet in a woman suffering from gestational diabetes and at the same time from hypersensitivity to insulin. Both glycemic control and insulin resistance are significantly improved with the application of non-pharmacological therapies. .

Method of use and dosage

ULTRATARD ® 40 IU / ml human insulin zinc suspension, 10 ml vials:
although in principle the insulin dosage should fluctuate for type 1 diabetic patients between 0.5 - 1 IU / kg day and in type 2 patients between 0.3 - 0.6 IU / kg day, it is not possible a priori to formulate a specific dosage , given the significant inter-individual variations.
Consequently, the total effective dose, the modality and 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 period of absorption allows the diabetic patient to carry out a single daily subcutaneous administration of ULTRATARD ® even if in many cases this is usually combined with fast-acting insulin analogues.

Warnings ULTRATARD ® - Human Insulin Zinc Suspension

The correct management of antidiabetic therapy with insulin cannot be separated from the active participation of the patient in the conservation and execution of the daily subcutaneous injections, given that the modality of assumption 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.
Discontinuation of therapy, variation of the drug used, surgery, infectious diseases and pregnancy, may require a further adjustment of the insulin dosage, which should be carried out by the doctor based also on the patient's glycemic profile.
ULTRATARD ® contains among its excipients methyl-parahydroxybenzoate, probably responsible for the increase in hypersensitivity episodes related to the administration of human insulin zinc suspension.
Episodes of hypoglycemia are often accompanied by a reduction in the patient's reactive and perceptive abilities, making the use of machinery and driving vehicles dangerous.

PREGNANCY AND BREASTFEEDING

At the moment, insulin is the drug of first choice for the treatment of gestational diabetes, which, if poorly compensated, can have important repercussions on correct fetal development.
In order for the therapeutic treatment to present the appropriate efficacy, it is necessary that the dosage used takes into account the adaptations imposed by the period of pregnancy.

Interactions

Like all the various insulin analogues available on the market, human insulin zinc suspension can also interact with oral hypoglycemic agents, octreotide, anti-MAO, beta blocking agents, ACE inhibitors, salicylates, alcohol and anabolic steroids increasing its therapeutic effect and the relative risk of hypoglycemia.
On the contrary, taking oral contraceptives, thiazides, glucorticoids, 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 how sympatholytics can mask some important signs of hypoglycemia, increasing the risk of serious reactions.

Contraindications ULTRATARD ® - Human Insulin Zinc 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 varying clinical significance.
Among the most frequent it is possible to observe the presence of hypoglycemic reactions accompanied by pallor, cold sweat, 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 haematological and immune picture have been observed only in very rare cases.

Note

ULTRATARD ® sold only under medical prescription.
ULTRATARD ® falls within the doping class: Hormones and related substances (prohibited in and out of competition)


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