ACTRAPHANE ® a drug based on soluble insulin + human insulin
THERAPEUTIC GROUP: Biphasic insulin for injectable use - insulins and analogues
Indications ACTRAPHANE ® Soluble insulin + isophane insulin
ACTRAPHANE ® indicated as drug therapy of diabetes mellitus which requires the administration of insulin to ensure good glycemic control.
Mechanism of action ACTRAPHANE ® Soluble insulin + isophane insulin
ACTRAPHANE ® a medicine consisting of a mixture of fast and prolonged absorption insulins in different percentages depending on the patient's therapeutic needs.
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 the utilization of blood glucose; therefore the different action times are dictated by the chemical-physical characteristics of the various insulin analogues and related absorption kinetics.
In ACTRAPHANE ® we find both the soluble form of fast-acting insulin, responsible for the rapid therapeutic effect estimated at around 30 minutes after subcutaneous administration, and the isophane form which manifests its hypoglycemic action after about 2 hours from intake but which persists for a full 18-24 hours.
This type of formulation allows at the same time to adequately control both post-prandial and basal glycaemia, regulating glycemic concentrations and minimizing the appearance of hypo and hyperglycemic peaks.
Studies carried out and clinical efficacy
1. BIPHASIC ISOPHANE INSULIN AND WEIGHT INCREASE
J Diabetes. 2010 Dec; 2: 250-5.
Evaluation of the weight-increasing effects of biphasic analog and regular NPH insulin mixtures in patients with Type 2 diabetes mellitus.
Temizel M, Mert M, Bozbey C, Arman Y, Cevizci E, Altintaş N, Cetin Ölek A.
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 weight gain-promoting effect of biphasic isophane insulin was observed over a period of 6 to 12 months. The mean weight gain observed was 3 to 5 kg upon completion of treatment.
2. INSULIN THERAPY AND THERAPEUTIC OBJECTIVES
Metab Syndr Relat Disord. 2011 Mar 16.
Insulin Analogs and Glycosylated Hemoglobin Target of Less Than 7% in Type 2 Diabetes: A Systematic Review of Randomized Trials.
Esposito K, Maiorino MI, Bellastella G, Chiodini P, Giugliano D.
This Italian study evaluated the efficacy of therapeutic treatment with insulin in restoring glycated hemoglobin values below 7% in patients with type 2 diabetes. Treatment with biphasic insulin allowed the achievement of this therapeutic target in 37% of patients. compared to 35% recorded with basal insulin.
3. PRE-FILLED PENS IN INSULIN TREATMENT
Curr Med Res Opin. 2000; 16: 125-33.
Patient acceptability of a new 3.0 ml pre-filled insulin pen.
D "Eliseo P, Blaauw J, Milicević Z, Wyatt J, Ignaut DA, Malone JK.
The placing on the market of pre-filled pens has been shown to be particularly advantageous in the management of diabetic disease. In addition to significantly increasing the acceptability of therapy, it has been shown to be useful in improving the efficacy of therapy by minimizing errors related to the formulation of insulin mixtures with Incorrect dosages These advantages have been seen especially among patients who required multiple administrations of various insulin analogues.
Method of use and dosage
ACTRAPHANE ® 100 IU / ml of insulin consisting of soluble insulin and isophane insulin in the 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 I.U. per kg of body mass for type I diabetic patients and between 0.3 - 0.6 I.U.per kg of body mass for patients with type II diabetes but who need 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 ® Soluble insulin + 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 methods of preparing, storing and taking the drug, about the possible side effects of insulin therapy and about rapid intervention strategies useful for minimizing the most important risks for human health.
The patient must actively participate in therapy following the doctor's instructions and constantly monitoring his metabolic state, referring only 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 changes, kidney liver diseases.
The potential risk of hypoglycaemia could reduce the patient's perceptive and reactive abilities making it dangerous to use machinery and drive vehicles.
PREGNANCY AND BREASTFEEDING
Insulin is currently 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.
The control of blood glucose during pregnancy is essential in ensuring proper fetal growth.
Interactions
The insulin contained in ACTRAPHANE ® could interact with oral hypoglycemic agents, octreotide, anti-MAO, beta blocking agents, 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, glucorticoids, thyroid hormones and sympathomimetics could reduce the therapeutic effect of insulin thus requiring a further dosage adjustment.
It is known from the literature that sympatholytics can mask some important signs of hypoglycemia, 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 could be accompanied by more or less serious local or systemic side effects.
Among those limited to the site of inoculation of the drug, it is possible to describe some 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 systemic side effects, the most frequent and dangerous is hypoglycemia, accompanied by symptoms such as cold sweat, sleepiness, tremors, asthenia which, if not promptly treated, can lead to loss of consciousness and coma.
On the other hand, reactions associated with hypersensitivity to the drug are decidedly rarer and can manifest themselves with a wide range of symptoms ranging from bronchoconstriction to hypotension.
Note
ACTRAPHANE ® sold only under medical prescription.
ACTRAPHANE ® falls within the doping class: Hormones and related substances (prohibited in and out of competition).
The information on ACTRAPHANE ® Soluble Insulin + Isophane Insulin published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
