Humulin Regular, 100 me/ml 10 ml

Humulin Regular is a DNA recombinant human insulin. It is a medium-acting insulin preparation. The main action of the drug is regulation of glucose metabolism. In addition, it has an anabolic effect. In muscle and other tissues (except brain) insulin causes rapid intracellular transport of glucose and amino acids, accelerates protein anabolism. Insulin promotes conversion of glucose into glycogen in the liver, inhibits gluconeogenesis and stimulates conversion of excess glucose into fat.

Pharmacokinetics

Humulin Regular is a short-acting insulin drug.

The onset of action of the drug is 30 minutes after administration, the maximum effect of action is between 1 and 3 hours, the duration of action is 5-7 hours.

Individual differences in insulin activity depend on factors such as the dose, choice of injection site, physical activity of the patient.

Indications

• diabetes mellitus with indications for insulin therapy;
• first-time diagnosed diabetes mellitus;
• pregnancy in type 2 diabetes (insulin-independent).

Composition

1 ml of the solution for injection contains:
active substance: soluble insulin (human genetically engineered) 100 ME,
excipients: methacresol, glycerol, water for injection, hydrochloric acid (10% solution) and/or sodium hydroxide (10% solution) to create the required pH level.

How to take, the dosage

The dose is set by the doctor individually depending on the level of glycemia.

The drug should be injected subcutaneously, intramuscular injection is possible. Intravenous administration of Humulin Regular is contraindicated!

The drug is injected subcutaneously into the shoulder, thigh, buttock, or abdomen. The injection site should be alternated so that the same site is not used more often than about once/month.

When injecting subcutaneously, care should be taken to avoid entering a blood vessel. The injection site should not be massaged after injection. Patients should be trained in the proper use of insulin injection devices.

Regulations for preparation and administration

Cartridges and vials of Humulin Regular should be rolled 10 times between the palms of the hands before use and shaken by turning 180° also 10 times to resuspend insulin until it appears as a homogenous cloudy liquid or milk. Do not shake vigorously, as this may cause foam to form, which may interfere with proper dose delivery.

The cartridges and vials should be checked carefully. Insulin should not be used if there are flakes in it after mixing or if solid white particles are stuck to the bottom or walls of the vial, creating a frosty pattern effect.

The design of the cartridges does not allow the contents to be mixed with other insulin directly in the cartridge itself. The cartridges are not designed to be refilled.

The bottle must be drawn into an insulin syringe that has the appropriate concentration of insulin to be injected, and the correct dose of insulin must be injected as directed.

When using the cartridges, follow the manufacturer’s instructions regarding cartridge filling and needle attachment. The product should be injected according to the syringe manufacturer’s instructions.

Using the outer needle cap, immediately after injection, unscrew the needle and safely destroy it. Removing the needle immediately after injection ensures sterility and prevents leakage, air ingress and possible needle clogging. Then put the cap back on the handle.

The needles should not be reused. Needles and syringe pens should not be used by others. Cartridges and vials should be used until they are empty, at which point they should be discarded.

Humulin Regular can be injected in combination with Humulin NPC. To do this, the short-acting insulin should be drawn into the syringe first to prevent the longer-acting insulin from entering the vial. Preferably, the mixture should be injected immediately after mixing. A separate syringe for Humulin Regular and Humulin NPC can be used to inject the exact amount of each insulin type.

An insulin syringe appropriate for the concentration of insulin to be injected should always be used.

Interaction

Hypoglycemic effect of Humulin Regular is decreased by oral contraceptives, corticosteroids, thyroid hormone preparations, thiazide diuretics, diazoxide, tricyclic antidepressants.

The hypoglycemic effect of Humulin Regular is enhanced by oral hypoglycemic drugs, salicylates (e.g., acetylsalicylic acid), sulfonamides, MAO inhibitors, beta-adrenoblockers, ethanol and ethanol-containing drugs.

Beta-adrenoblockers, clopheline, reserpine may mask the symptoms of hypoglycemia.

Pharmaceutical interactions

The effects of mixing human insulin with animal insulins or human insulin produced by other manufacturers have not been studied.

Special Instructions

The transfer of a patient to another type of insulin or to an insulin preparation with a different brand name must take place under strict medical supervision. Changes in insulin activity, type (e.g., M3, NPH), species (porcine, human insulin, human insulin analogues), or method of production (DNA recombinant or animal insulin) may require a dose adjustment.

The need for a dose adjustment may be necessary as early as the first administration of a human insulin product after an animal insulin product or gradually over a period of weeks or months after transfer.

The need for insulin may decrease with insufficient adrenal, pituitary or thyroid function or with renal or hepatic insufficiency.

In some diseases or with emotional stress, the need for insulin may increase.

The dose may also need to be adjusted if physical activity increases or if the usual diet changes.

The precursor symptoms of hypoglycemia on human insulin administration in some patients may be less pronounced or different from those seen in patients on animal insulin administration. When blood glucose levels normalize, e.g., as a result of intensive insulin therapy, all or some of the precursor symptoms of hypoglycemia may disappear, and patients should be informed.

Hypoglycemic precursor symptoms may change or be less pronounced in the long-term course of diabetes mellitus, diabetic neuropathy, or with the simultaneous use of beta-adrenoblockers.

In some cases, local allergic reactions may be caused by causes unrelated to the action of the drug, such as skin irritation by a cleansing agent or improper administration of injections.

In rare cases of systemic allergic reactions, immediate treatment is required. Sometimes it may be necessary to change insulin or perform desensitization.

Impact on driving and operating machinery

Hypoglycemia may impair the patient’s ability to concentrate and decrease the speed of psychomotor reactions. This may be dangerous in situations in which these abilities are especially necessary (driving or operating machinery). Patients should be advised to take precautions to avoid hypoglycemia while driving. This is especially important for patients with mild or absent symptoms-predictors of hypoglycemia or with frequent development of hypoglycemia. In such cases, the physician should evaluate whether it is appropriate for the patient to drive.

Contraindications

Hypoglycemia, hypersensitivity to Humulin Regular

Side effects

A side effect associated with the main effect of the drug: hypoglycemia.

Severe hypoglycemia may lead to loss of consciousness and (in exceptional cases) death.

Allergic reactions: local allergic reactions are possible – hyperemia, swelling or itching at the injection site (usually stops within a few days to a few weeks); systemic allergic reactions (occurs less frequently, but are more serious) – generalized itching, difficulty in breathing, shortness of breath, BP decrease, pulse rate, increased sweating. Severe cases of systemic allergic reactions can be life-threatening.

Others: the possibility of developing lipodystrophy is minimal.

Overdose

Symptoms: hypoglycemia accompanied by lethargy, increased sweating, tachycardia, pale skin, headache, shivering, vomiting, confusion.

The precursor symptoms of hypoglycemia may change under certain conditions, such as long duration or intense control of diabetes mellitus.

Treatment: Mild states of hypoglycemia can usually be managed with oral glucose (dextrose) or sugar. Adjustment of insulin dose, diet, or physical activity may be necessary.

Correction of moderate hypoglycemia can be done with intramuscular or subcutaneous injection of glucagon, followed by oral carbohydrate intake.

Severe states of hypoglycemia accompanied by coma, seizures or neurological disorders are controlled by intramuscular or subcutaneous administration of glucagon or intravenous infusion of concentrated glucose solution (dextrose). After recovery of consciousness, the patient should be given food rich in carbohydrates, in order to avoid the recurrence of hypoglycemia.

Pregnancy use

In pregnancy, it is especially important to maintain good glycemic control in diabetic patients. In pregnancy, the need for insulin usually decreases in the first trimester and increases in the second and third trimesters.

Patients with diabetes are advised to inform their physician if they become pregnant or plan to become pregnant.

In diabetic patients during lactation (breastfeeding), adjustments in insulin dose, diet, or both may be necessary.

In genetic toxicity studies in in vitro and in vivo series, human insulin had no mutagenic effect.