MONOTARD ® - Insulin zinc human suspension

PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED

MONOTARD ® 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 MONOTARD ® - Insulin zinc human suspension

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

Mechanism of action MONOTARD ® - Insulin zinc human suspension

MONOTARD ® is one of the analogues of intermediate and long-acting insulin, consisting of a soluble suspension of insulin zinc.

As is known, while the half-life of “hematic” insulin is a few minutes, as it is readily picked up by the receptors expressed by insulin-sensitive tissues such as adipose and muscular tissue, the pharmacokinetic properties, including the appearance and persistence of therapeutic effect, depend on the chemical-physical characteristics of the hormonal analogue and its absorption characteristics.

The different speed of action is therefore only associated with the structure of the insulin analogue and its ability to reach the circulatory stream, once injected subcutaneously.

In the case of MONOTARD ® in fact, the association of human insulin with rhomboid zinc crystals, allows the drug to act after about two and a half hours from the administration, to reach the 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 uptake and utilization of blood glucose and inhibiting glucose secretion at the hepatic level.

Studies carried out and clinical efficacy

1. INSULIN ZINCO HUMAN SUSPENSION AND ALLERGIES

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

2. INSULIN AND CYCLING

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

3. ZINC INSULIN IN VETERINARY SCOPE

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

Method of use and dosage

MONOTARD ® 100 IU / ml insulin zinc human suspension, 10 ml vials:

the particular formulation and the prolonged therapeutic effect, allow the diabetic patient to carry out a single daily subcutaneous administration, better if always at the same time.

Although there are general indications regarding the correct dosage of insulin to be used, timing, quantity and method of administration should be decided by the doctor after a careful evaluation of the patient's physiopathological conditions and his glycemic balance.

It should also be remembered that in some patients treatment with MONOTARD ® may be accompanied by the concomitant administration of rapid insulin with meals.

Warnings MONOTARD ® - Insulin zinc human suspension

In order for insulin therapy to obtain the maximum result it is advisable that the doctor carefully informs the patient of the correct methods of preparation, administration and storage of the insulin itself.

Furthermore, to reduce the appearance of serious side effects, the patient must be able to recognize the first signs of hypoglycemia and take prompt action to restore good glycemic control.

Surgical interventions, infectious diseases, concomitant administration of particular drugs, dietary and metabolic changes and changes to other forms of insulin may also require a significant adjustment of the dose used, which should be established by the doctor.

Therefore it is advisable that the doctor periodically monitors the health status of the diabetic patient and his habits in order to intervene promptly and effectively in rebalancing the glycemic control.

MONOTARD ® contains among its excipients methyl parahydroxybenzoate, often the cause of allergies.

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

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.

Gaining good glycemic control during pregnancy is of fundamental importance to safeguard correct fetal growth; therefore it is appropriate to adequately establish 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 hypoglycemic effect of human insulin zinc suspension, increasing the risk of hypoglycemia.

In contrast, the use of oral contraceptives, thiazides, glucocorticoids, thyroid hormones and sympathomimetics could reduce the therapeutic effect of MONOTARD ® and disturb the establishment of glycemic control.

It should be remembered, however, that sympatholytics can mask some important signs of hypoglycemia, increasing the risk of serious reactions.

Contraindications MONOTARD ® - Insulin zinc human suspension

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

Undesirable effects - Side effects

Numerous clinical trials and a thriving post-marketing monitoring have clearly defined the potential side effects of insulin therapy.

Definitely rare and limited to the first days of treatment, were the disorders affecting the gastro-intestinal tract, the immune system and the visual apparatus.

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 symptomatology and which in the most serious cases was manifested with loss of consciousness.