diabetes drugs

ACTRAPHANE ® Soluble insulin + isophane insulin

ACTRAPHANE ® a drug based on soluble insulin + human insulin

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

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

Directions ACTRAPHANE ® Insulin soluble + Isophane insulin

ACTRAPHANE ® indicated as a drug therapy for diabetes mellitus that requires the administration of insulin to ensure good glycemic control.

Mode of action ACTRAPHANE ® Soluble insulin + isophane insulin

ACTRAPHANE ® a medicinal product consisting of a mixture of insulin with rapid and prolonged absorption in different percentages depending on the therapeutic needs of the patient.

As is known, insulin has a very rapid half-life, acting on specific receptors expressed by insulin-sensitive tissues and favoring both the uptake and utilization of blood glucose; therefore the different times of action are dictated by the chemical-physical characteristics of the various insulin analogues and by the relative kinetics of absorption.

In ACTRAPHANE ® we find both the soluble form of fast-acting insulin, responsible for the rapid therapeutic effect estimated around 30 minutes from subcutaneous administration, and the isophane form which shows its hypoglycemic action after about 2 hours from the intake but which persists for well 18-24 hours.

This type of formulation allows at the same time to adequately control both post-prandial and basal glycaemia, regularizing glycemic concentrations and minimizing the appearance of hypo and hyperglycemic peaks.

Studies carried out and clinical efficacy

1. BIPHASIC ISOPHANES INSULIN AND WEIGHT INCREASE

The weight gain associated with insulin therapy in patients with type II diabetes is a negative factor that can reduce the effectiveness of the therapy itself. In this study, the effect promoting weight gain of biphasic isophane in a period of 6 - 12 months was observed. The average weight gain observed was 3 - 5 kg after the treatment was completed.

2. INSULIN THERAPY AND THERAPEUTIC OBJECTIVES

This Italian study evaluated the efficacy of therapeutic treatment with insulin in restoring glycated hemoglobin values ​​below 7% in patients with second-type diabetes. Treatment with biphasic insulin allowed the achievement of this therapeutic target in 37% of patients compared to 35% with basal insulin.

3. THE PRE-EMPTY PENS IN THE INSULIN TREATMENT

The marketing of pre-filled pens has proved particularly advantageous in the management of diabetic disease. In addition to significantly increasing the acceptability of the therapy, it has proved useful in improving the efficacy of the therapy by minimizing the errors related to the formulation of insulin mixtures with incorrect dosages. These advantages were observed especially among patients who required multiple administrations of various insulin analogues.

Method of use and dosage

ACTRAPHANE ® 100 IU / ml insulin consisting of soluble insulin and isophane insulin in ratios 30/70, 50/50 in cartridges of 3 ml or 10/90, 20/80, 30/70, 40/60, 50/50 in pre-filled pens:

although generally the daily insulin requirement is between 0.5 - 1 IU per Kg of body mass for type I diabetic patients and between 0.3 - 0.6 IU per Kg of body mass for patients with type II diabetes but who require insulin, the correct dosage and timing of intake should be formulated by your doctor, based on the physio-pathological characteristics of the patient, his glycemic balance and his needs.

Warnings ACTRAPHANE ® Insulin soluble + Isophane insulin

The continuous and direct relationship between doctor and diabetic patient represents today one of the most important prerogatives for a good therapeutic success.

In fact, the doctor must inform the patient about the correct preparation, storage and intake of the drug, about the possible side effects of insulin therapy and about rapid intervention strategies to minimize the most important risks for human health.

The patient must actively participate in the therapy following the doctor's instructions and constantly monitoring his metabolic status, referring solely to him as a therapeutic guide.

At the same time it is important to consider that the insulin dosage could be revised in case of impaired glycemic control, infectious diseases, surgical interventions, suspensions or therapeutic variations, renal liver diseases.

The potential risk of hypoglycaemia could reduce the patient's perceptive and reactive capacities, making it dangerous to use machinery and drive vehicles.

PREGNANCY AND BREASTFEEDING

Insulin currently represents the only possible therapeutic approach to the treatment of gestational diabetes, given the inability of this hormone to cross the placental barrier and induce hypoglycemia in the fetus.

Blood glucose control in pregnancy is essential in ensuring proper fetal growth.

Interactions

The insulin contained in ACTRAPHANE ® could interact with oral hypoglycemic agents, octreotide, anti-MAO agents, beta blockers, ACE inhibitors, salicylates, alcohol and anabolic steroids, increasing its hypoglycemic effect and the relative risk of hypoglycemia.

On the contrary, the concomitant administration of oral contraceptives, thiazides, glucocorticoids, thyroid hormones and sympathomimetics could reduce the therapeutic effect of insulin thus requiring a further adjustment of the dosage.

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

Contraindications ACTRAPHANE ® Soluble insulin + isophane insulin

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

Undesirable effects - Side effects

Insulin therapy may be accompanied by more or less serious side effects of a local or systemic nature.

Among those limited to the site of inoculation of the drug it is possible to describe some of them of a transitory nature and often linked to hypersensitivity to the drug, such as itching, redness and pain and others instead determined by the prolonged intake of the hormone always in the same site such as for example lipoatrophy .

Among the side effects of a systemic nature, the most frequent and dangerous is hypoglycemia, accompanied by symptoms such as cold sweat, drowsiness, tremors, asthenia which, if not promptly treated, can lead to loss of consciousness and coma.

Rather more rare are the reactions associated with hypersensitivity to the drug and which can manifest themselves with a wide range of symptoms ranging from bronchoconstriction to hypotension.

Note

ACTRAPHANE ® can only be sold under medical prescription.

ACTRAPHANE ® falls into the doping class: Hormones and related substances (prohibited in and out of the race).