MONOTARD ® - Human Insulin Zinc Suspension

PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED

MONOTARD ® a drug based on human insulin zinc suspension

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


Indications MONOTARD ® - Human Insulin Zinc Suspension

MONOTARD ® is indicated for the treatment of insulin dependent diabetic patients.

Mechanism of action MONOTARD ® - Human insulin zinc suspension

MONOTARD ® is one of the analogues of intermediate and long-acting insulin as it consists of a soluble suspension of zinc insulin.
As is known, while the "blood" insulin half-life is a few minutes, as it is readily captured by receptors expressed by insulin-sensitive tissues such as adipose and muscle tissue, the pharmacokinetic properties, including the appearance and persistence of " therapeutic effect, depend on the chemical and physical characteristics of the hormonal analogue and its absorption characteristics.
The different speed of action is therefore uniquely associated with the structure of the insulin analogue and its ability to reach the bloodstream, once injected subcutaneously.
In fact, in the case of MONOTARD ®, the association of human insulin with rhomboid crystals of zinc allows the drug to act approximately two and a half hours after administration, to reach maximum therapeutic efficacy between the fourth and fifteenth hour and to maintain the hypoglycemic action for about 24 hours.
Evidently the mechanism of action of this insulin analogue remains identical to that of the endogenous hormone, acting on insulin sensitive tissues, promoting the uptake and utilization of blood glucose and inhibiting the secretion of glucose in the liver.

Studies carried out and clinical efficacy

1. INSULIN ZINC HUMAN SUSPENSION AND ALLERGIES

Clin Dermatol. 2011 May-Jun; 29: 300-5.

Insulin allergy.

Ghazavi MK, Johnston GA.


Although recombinant DNA technology has reduced, thanks to the marketing of insulin identical to the endogenous one, allergic episodes, the presence of additives such as zinc, useful for varying the pharmacokinetic characteristics of this hormone, it seems to be associated with a greater risk of hypersensitivity that can be resolved over time with specific prophylaxis.


2. INSULIN AND SCAR

J Surg Res. 2007 Sep; 142: 90-6.

Local insulin-zinc injection accelerates skin donor site wound healing.

Zhang XJ, Wu X, Wolf SE, Hawkins HK, Chinkes DL, Wolfe RR.


Interesting work that shows how the local administration of zinc insulin, therefore of long-acting insulin, can accelerate the healing of wounds, without particular repercussions from the metabolic point of view. This application could be particularly important for the treatment of burns.


3.ZINC INSULIN IN VETERINARY FIELD

J Vet Intern Med. 2005 Sep-Oct; 19: 675-82.

Efficacy and safety of a purified porcine insulin zinc suspension for managing diabetes mellitus in dogs.

Monroe WE, Laxton D, Fallin EA, Richter KP, Santen DR, Panciera DL, Towell TL, Williams KA, Hart JR, Hill S, Finkler MR, Shinn JS.


The advantageous times of action of zinc insulin have allowed this analogue to be widely used in the treatment of diabetes in the veterinary field, allowing also thanks to single daily administrations to obtain good glycemic control. In these cases the insulin used is of porcine extraction since it has a 100% analogy with canine insulin.

Method of use and dosage

MONOTARD ® 100 IU / ml human insulin zinc suspension, 10 ml vials:
the particular formulation and the prolonged therapeutic effect allow the diabetic patient to carry out a single daily subcutaneous administration, preferably always at the same time.
Although there are general indications relating to the correct dosage of insulin to be used, it is advisable that the timing, quantity and method of administration be decided by the doctor after a "careful evaluation of the patient's physio-pathological conditions and his glycemic balance.
It should also be remembered that in some patients the treatment with MONOTARD ® could be accompanied by the concomitant administration of rapid insulin with meals.

Warnings MONOTARD ® - Human Insulin Zinc Suspension

In order for insulin therapy to achieve the best results, the doctor should carefully inform the patient of the correct methods of preparing, administering and storing the insulin itself.
Furthermore, to reduce the occurrence of serious side effects, the patient must be able to recognize the first signs of hypoglycemia and intervene promptly to restore good glycemic control.
Surgical interventions, infectious diseases, simultaneous administration of particular drugs, dietary and metabolic changes and changes to other forms of insulin, may require an adjustment, even significant, of the dose used, which should be established by the doctor.
Therefore it is advisable for the doctor to periodically monitor the state of health of the diabetic patient and his habits in order to intervene promptly and effectively in rebalancing glycemic control.
MONOTARD ® contains among its excipients methyl parahydroxybenzoate, often the cause of allergies.
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

The inability of insulin to cross the placental barrier and induce hypoglycemia in the fetus allows this hormone to be effectively used in the treatment of gestational diabetes.
Obtaining good glycemic control during pregnancy is of fundamental importance to safeguard correct fetal growth; therefore it is advisable to adequately establish the insulin doses in order to reduce pathological glycemic excursions.

Interactions

The concomitant administration of oral hypoglycemic agents, octreotide, anti-MAO, beta blocking agents, ACE inhibitors, salicylates, alcohol and anabolic steroids, could potentiate the blood glucose lowering effect of human insulin zinc suspension, increasing the risk of hypoglycaemia.
On the contrary, the assumption of oral contraceptives, thiazides, glucorticoids, thyroid hormones and sympathomimetics could reduce the therapeutic effect of MONOTARD ®, disturbing the established glycemic control.
However, it should be remembered that sympatholytics can mask some important signs of hypoglycemia, increasing the risk of serious reactions.

Contraindications MONOTARD ® - Human insulin zinc suspension

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

Undesirable Effects - Side Effects

Numerous clinical trials and robust post-marketing monitoring have well defined the potential side effects of insulin therapy.
Disturbances affecting the gastro-intestinal system, the immune system and the visual system were decidedly rare and limited to the first days of treatment.
On the contrary, the most significant and frequent side effects were those related to glycemic control, with the onset of hypoglycemic episodes, defined by the classic symptoms and which in the most serious cases manifested itself with loss of consciousness.

Note

MONOTARD ® sold only under medical prescription.

falls within the doping class: Hormones and related substances (prohibited in and out of competition)


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