Insuman Basal GT, 100 me/ml suspension 3 ml cartridges in Solostar syringe pens 5 pcs

Hypoglycemic drug, insulin of medium duration of action. Insuman Bazal GT contains insulin, identical in structure to human insulin, obtained by genetic engineering using E.coli K12 135 pINT90d.

Insulin reduces blood glucose concentrations, promotes anabolic effects and reduces catabolic effects. It increases intracellular glucose transport and glycogen synthesis in muscles and liver, improves pyruvate utilization, inhibits glycogenolysis and gluconeogenesis. Insulin increases lipogenesis in the liver and adipose tissue and inhibits lipolysis. It promotes the entry of amino acids into cells and protein synthesis, increases the intracellular potassium supply.

Insuman Bazal GT is a long-acting insulin with a gradual onset of action. After per oral administration, hypoglycemic effect occurs within 1 hour, reaches maximum in 3-4 hours, lasts for 11-20 hours.

Pharmacokinetics

In healthy patients the T1/2 of insulin from plasma is about 4-6 min. In renal insufficiency, the T1/2 is prolonged.

It should be noted that the pharmacokinetics of insulin does not reflect its metabolic action.

Indications

Diabetes mellitus requiring insulin treatment

Composition

Active ingredient:

Isophene insulin (human genetically engineered)3.571 mg (100 IU);

Supplementary substances:

protamine sulfate – 0.318 mg,

metacresol (m-cresol) – 1.5 mg,

phenol – 0.6 mg,

zinc chloride – 0.047 mg,

sodium dihydrophosphate dihydrate – 2.1 mg,

glycerol 85% – 18.824 mg,

sodium hydroxide (to adjust pH) – 0.576 mg,

hydrochloric acid (to adjust the pH) – 0.246 mg,

d/i water – up to 1 ml

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How to take, the dosage

The dose is chosen individually, under the supervision of a doctor. It is usually given every 8-12 hours.

Interaction

Concomitant use with oral hypoglycemic drugs, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, amphetamine, anabolic steroids and male sex hormones, cibenzoline, cyclophosphamide, phenfluramine, guanethidine, ifosfamide, phenoxybenzamine, phentolamine, somatostatin and its analogues, sulfonamides, tetracyclines, tritoqualine, or trophosphamide may increase the hypoglycemic effects of insulin and increase the predisposition to develop hypoglycemia.

. Concomitant use with corticotropin, GCS, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and gestagens (such as those present in PDA), phenothiazine derivatives, somatotropin, sympathomimetic agents (e.g., epinephrine, salbutamol, terbutaline), thyroid hormones, barbiturates, nicotinic acid, phenolphthalein, phenytoin derivatives, doxazosin may weaken the hypoglycemic effects of insulin.

Beta-adrenoblockers, clonidine, lithium salts may either potentiate or weaken the hypoglycemic effect of insulin.

Ethanol may either potentiate or weaken the hypoglycemic effects of insulin. Ethanol use can cause hypoglycemia or reduce already low blood glucose levels to dangerous levels. Tolerability of ethanol is reduced in patients receiving insulin. The physician should determine the allowable amounts of ethanol consumed.

Concomitant use with pentamidine may cause hypoglycemia, which may sometimes turn into hyperglycemia.

In concomitant use with sympatholytic agents, such as beta-adrenoblockers, clonidine, guanethidine and reserpine it is possible to reduce or completely eliminate symptoms of reflex (in response to hypoglycemia) sympathetic nervous system activation.

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Contraindications

• hypoglycemia;
• high sensitivity to insulin or any of the excipients of the drug, except when insulin therapy is vital.

With caution, the drug should be prescribed in renal failure (decreased insulin requirement due to decreased insulin metabolism may occur); in elderly patients (gradual decline in renal function may lead to an ever-increasing decrease in insulin requirement); Patients with hepatic impairment (insulin requirements may be reduced due to decreased gluconeogenesis capacity and reduced insulin metabolism); patients with severe coronary and cerebral artery stenosis (hypoglycemic episodes in these patients may be of particular clinical significance, as there is an increased risk of cardiac arrhythmias and cardiovascular events).because there is an increased risk of cardiac or cerebral complications of hypoglycemia); patients with proliferative retinopathy, especially those who haven’t received photocoagulation treatment (laser therapy), because in these patients with hypoglycemia there is a risk of transient amaurosis – total blindness; patients with intercurrent diseases (because there is an increased need for insulin).

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Side effects

Allergic reactions: infrequent – anaphylactic shock; frequency unknown – generalized skin reactions, angioneurotic edema, bronchospasm, formation of antibodies to insulin (in rare cases, the presence of antibodies to insulin may require changing the insulin dose to correct the tendency to hyper- or hypoglycemia). Immediate allergic reactions to insulin or to the excipients of the drug may be life-threatening and require immediate appropriate emergency measures.

Cardiovascular system disorders: frequency is unknown – decreased BP.

Metabolism and nutrition: frequently – edema; frequently unknown – sodium retention. Similar effects are possible with the improvement of previously insufficient metabolic control through the use of more intensive insulin therapy.

Visual side: frequency unknown – transient visual disturbances (due to temporary changes in eye lens turgor and refractive index), temporary worsening of the course of diabetic retinopathy (due to more intensive insulin therapy with dramatic improvement in glycemic control), transient amaurosis (in patients with proliferative retinopathy, especially if they are not treated with photocoagulation (laser therapy)).

Skin and subcutaneous tissues: frequency is unknown – development of lipodystrophy at the injection site and delayed local absorption of insulin. Constant change of injection sites within the recommended area of administration may help to reduce or stop these reactions.

General disorders and disorders at the injection site: frequency is unknown – redness, pain, itching, urticaria, swelling or inflammatory reaction at the injection site. The most pronounced reactions to insulin at the injection site usually disappear after a few days or a few weeks.

Overdose

Symptoms: an overdose of insulin, such as administering an excessive amount of insulin compared to food intake or energy expenditure, can lead to severe and sometimes prolonged and life-threatening hypoglycemia.

Treatment: mild episodes of hypoglycemia (patient is conscious) may be managed with oral carbohydrate intake. Correction of insulin dose, eating regimen and physical activity may be required. More severe episodes of hypoglycemia with coma, seizures or neurological disorders may be controlled by intravenous or p/c injection of glucagon or intravenous injection of concentrated dextrose solution. In children the amount of dextrose administered is determined in proportion to the body weight of the child.

After an increase in blood glucose concentrations, maintenance carbohydrate intake and monitoring may be required, since after the symptoms of hypoglycemia seem to be clinically resolved, they may reoccur.

In cases of severe or prolonged hypoglycemia following glucagon injection or dextrose administration, an infusion of a less concentrated dextrose solution is recommended to prevent recurrence of hypoglycemia. In young children, blood glucose concentrations should be closely monitored due to the possible development of severe hyperglycemia.

In certain conditions, hospitalization in an intensive care unit is recommended to monitor their condition more closely and monitor the therapy being given.

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Pregnancy use

Treatment with Insuman Bazal GT should be continued during pregnancy. Insulin does not penetrate the placental barrier.

Effective maintenance of metabolic control throughout pregnancy is mandatory for women who had diabetes before pregnancy or who have developed gestational diabetes.

The need for insulin in pregnancy may decrease in the first trimester of pregnancy and usually increases in the second and third trimesters of pregnancy. Immediately after delivery, the need for insulin decreases rapidly (increased risk of hypoglycemia). Close monitoring of blood glucose concentrations is mandatory during pregnancy and especially after delivery.

In case of pregnancy or if pregnancy is planned, it is necessary to inform the doctor.

There are no restrictions to insulin therapy during breastfeeding, but it may be necessary to adjust the insulin dose and diet.

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