Pharmacological properties
Pharmacodynamics. The drug belongs to short-acting insulins. Provides a rapid and significant decrease in blood glucose levels, increases its absorption by tissues. The active ingredient of the drug is a neutral insulin solution.
Pharmacokinetics. Humodar P 100 P provides a rapid and significant decrease in blood glucose levels, the effect occurs after 30 minutes, the maximum level is reached 1-2 hours after s / c administration of the drug. Depending on the dosage, the duration of the effect lasts for 5-7 hours. Humodar P 100 P can be used in combination with other hypoglycemic agents, in particular with long-acting insulins (Humodar B 100 P, Humodar K25 100P).
Indication
Diabetes.
Application
Before first use, it is necessary to check sensitivity to the drug by intradermal testing.
The dose and time of injection are prescribed by the doctor individually depending on the diet, blood glucose level, and the patient's needs. When selecting a dose of Humodar P 100 R for adults, the daily insulin requirement is 0.5-1 IU / kg of body weight.
Humodar P 100 R is administered subcutaneously several times a day 15-20 minutes before meals. The injection site should be changed after each injection. Humodar P 100 R can be administered as an intravenous injection or infusion.
Cartridge. Before using the pen, wash your hands and disinfect the rubber membrane of the cartridge.
The cartridge is intended for use in pens only. When installing the cartridge in the pen, follow the manufacturer's instructions.
If air bubbles are found in the cartridge, hold the pen with the needle pointed upwards and tap the wall of the cartridge to release the bubbles to the surface. Continuing to hold the pen in an upright position, release 2 units of insulin through the needle. Repeat the procedure until the air is released from the cartridge and a drop of the drug appears at the end of the needle. The presence of very small air bubbles is allowed, however, a large number of bubbles can affect the accuracy of the insulin dose during administration.
Before injecting insulin, thoroughly wipe the skin at the injection site. Insert the needle into the subcutaneous layer to the desired depth. Be careful not to enter a vein. Do not massage the injection site.
Immediately after the injection, remove the needle from the pen. This will ensure sterility and prevent insulin leakage.
For subsequent injections, the mixing process should be repeated without removing the cartridge from the pen. Before each injection, make sure that there is a drop of the drug at the end of the needle. If the cartridge is almost empty and the leading edge of the plunger is on or beyond the colored line, do not use it.
Always check the cartridge label before injecting to make sure the name and prescription of the insulin match your doctor's prescription.
Vials. Before the first insulin withdrawal from the vial, remove the plastic cap (first opening control). According to the prescribed dose, draw air into the syringe and inject into the insulin vial (not into the liquid). Turn the insulin vial over with the syringe and draw the appropriate amount of insulin suspension. Remove air bubbles from the syringe. Disinfect the injection site, form a fold of skin and insert the needle under the skin. Then slowly inject the insulin. After the injection, carefully remove the needle from the skin, press the injection site with a cotton swab and hold for a few seconds.
The drug should always remain clear and colorless.
Replacing the drug with other insulin preparations is possible only under the supervision of a doctor. It is necessary to carefully follow the doctor's prescription: daily insulin dosage, diet, physical activity.
Contraindication
Severe immediate-type hypersensitivity to insulin. Allergy to any of the components of the drug. Hypoglycemia.
Side effects
Immune system disorders. In rare cases, insulin administration leads to the development of an allergy, which manifests itself as a local reaction in the form of redness, swelling or itching in the area of the drug injection. Very rarely, generalized allergic reactions occur, which are manifested by erosive lesions of the mucous membranes, nausea, chills. Severe manifestations of an allergic reaction to insulin are anaphylactic shock with cardiac and respiratory disorders, angioedema. Generalized hypersensitivity reactions are potentially life-threatening. Rarely, patients with diabetes mellitus who have been taking various insulin preparations for many years may experience insulin resistance (with a daily insulin dose of ≥60 IU).
Skin and subcutaneous tissue changes. At the beginning of insulin treatment, changes in the appearance of the skin may occur at the injection site: short-term fluid accumulation in the tissues (transient edema), slight redness of the skin, which disappear on their own during further treatment. You should immediately inform your doctor if you develop significant erythema, accompanied by itching and the appearance of blisters that quickly spread beyond the injection area, as well as if you experience other severe hypersensitivity reactions to any of the components of the drug (in some cases, such reactions can be life-threatening). The doctor will decide on the appropriate measures. Atrophy or hypertrophy of fatty tissue (lipodystrophy) may occur at the injection site. Constantly changing the injection site makes it possible to reduce the severity or completely avoid these phenomena during further treatment.
Neurological disorders: Reversible peripheral neuropathy may occasionally develop.
It is necessary to urgently consult a doctor in case of any adverse reactions.
Special instructions
In case of incorrect dose selection or drug replacement, irregular use of this medication, irregular meal intake, excessive fluctuations in blood glucose levels are possible, primarily in the downward direction, which reduce the ability to influence the reaction rate when driving or working with other mechanisms. This occurs at the beginning of treatment, as well as with simultaneous use of alcohol or drugs that act on the CNS (see interactions).
Sometimes complications arise due to damage to the innervation apparatus of the skin by the injection needle or chemicals contained in insulin preparations as preservatives.
Precautions for use. Any change in insulin preparations should be made with caution and only under medical supervision. Changes in concentration, manufacturer, type (rapid-acting, intermediate-acting, slow-acting, etc.), species (animal, human, human insulin analogues), or method of manufacture (rDNA-derived as opposed to animal-derived insulin) may require a change in dose.
Pregnancy and breastfeeding. Insulin does not cross the placental barrier, so there are no restrictions on the treatment of diabetes during pregnancy. Insulin requirements usually decrease in the first trimester of pregnancy and increase significantly in the second and third trimesters. Immediately after delivery, insulin requirements decrease sharply, which increases the risk of hypoglycemia. However, insulin requirements then quickly return to baseline. Insulin dosage or diet may need to be adjusted while breastfeeding.
Children: There is insufficient experience with the use of the drug in children.
Interactions
Additional prescription of other medications may enhance or weaken the effect of insulin on blood glucose levels. Therefore, they can only be taken as prescribed by a doctor.
Enhancement of the action of insulin is possible in case of simultaneous administration with MAO inhibitors, non-selective β-blockers, sulfonamides, anabolic steroids, tetracyclines, clofibrate, cyclophosphamide, fenfluramine, and drugs containing ethanol.
A decrease in the severity of insulin action is possible in the case of simultaneous administration with chlorprothixene, diazoxide, hormonal contraceptives, diuretics (saluretics), heparin, isoniazid, corticosteroids, lithium carbonate, nicotinic acid, phenolphthalein, phenothiazine derivatives, phenytoin, thyroid hormones, sympathomimetic agents, and tricyclic antidepressants.
In patients who simultaneously take insulin and clonidine, reserpine or salicylates can both reduce and increase the severity of insulin action.
Drinking alcohol can cause your blood glucose levels to drop dangerously low.
Causes: absolute overdose of insulin, drug replacement, skipping meals, vomiting, diarrhea, physical exertion, diseases that lead to a decrease in the need for insulin (kidney and liver diseases, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), change of injection site (for example, skin of the abdomen, forearm, thigh), as well as the interaction of insulin with other agents that lead to a sharp decrease in blood glucose levels. A diabetic patient with signs of hypoglycemia can independently eliminate this condition by taking glucose or sugar (preferably in the form of a solution) or food containing a large amount of sugar or carbohydrates. For this purpose, it is necessary to constantly carry ≥20 g of glucose (grape sugar). If the glucose level cannot be increased independently, it is necessary to urgently call a doctor. This condition is especially dangerous for patients with impaired cerebral circulation, severe coronary heart disease.
In more severe conditions caused by a decrease in blood glucose levels, it is necessary to administer glucose intravenously by a doctor or to administer glucagon intramuscularly. If the patient is able to function independently after these manipulations, he or she should eat.
Storage conditions
At a temperature of 2-8 °C. Do not freeze, avoid direct contact of the cartridge / vial with the freezer compartment or cold storage.
Store the cartridge in use for up to 3 weeks at room temperature, away from direct heat and light.
Store a vial of insulin in use for no more than 6 weeks at room temperature (not above 25°C) away from direct heat and light.
