Bougeton (Solution) Instructions for Use

Marketing Authorization Holder

Pharmasintez-Nord, JSC (Russia)

ATC Code

A10AB04 (Insulin lispro)

Active Substance

Insulin lispro (Rec.INN registered by WHO)

Dosage Form

Bougeton

Solution for intravenous and subcutaneous administration 100 IU/ml: cartridges or cartridges in pen-injectors 3 ml 1 or 5 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and subcutaneous administration colorless, transparent.

Excipients: zinc oxide, disodium phosphate, glycerol, metacresol, hydrochloric acid, sodium hydroxide, water for injections.

3 ml – cartridges of colorless glass (1) – contour cell packaging (1) – cardboard packs.
3 ml – cartridges of colorless glass (5) – contour cell packaging (1) – cardboard packs.
3 ml – cartridges in disposable pen-injectors (1) – cardboard packs.
3 ml – cartridges in disposable pen-injectors (5) – cardboard packs.

Clinical-Pharmacological Group

Short-acting human insulin analogue

Pharmacotherapeutic Group

Drugs for the treatment of diabetes mellitus; insulins and their analogues; short-acting insulins and their analogues for injectable administration

Pharmacological Action

An analogue of human insulin, differing from it by the reversed sequence of proline and lysine amino acid residues at positions 28 and 29 of the B-chain of insulin.

Compared to short-acting insulin preparations, insulin lispro is characterized by a faster onset and termination of effect, which is due to increased absorption from the subcutaneous depot due to the preservation of the monomeric structure of insulin lispro molecules in solution.

Onset of action is within 15 minutes after subcutaneous administration, maximum effect is between 0.5 hours and 2.5 hours; duration of action is 3-4 hours.

Pharmacokinetics

After subcutaneous administration, insulin lispro is rapidly absorbed, with C_max in blood plasma reached within 30-70 minutes.

When administered subcutaneously, the half-life of insulin lispro is about 1 hour.

Indications

Type 1 diabetes mellitus (insulin-dependent), including in cases of intolerance to other insulin preparations, for postprandial hyperglycemia not corrected by other insulin preparations, acute subcutaneous insulin resistance (accelerated local degradation of insulin).

Type 2 diabetes mellitus (non-insulin-dependent): in case of resistance to oral hypoglycemic agents, as well as in case of impaired absorption of other insulin preparations, uncorrected postprandial hyperglycemia, during surgery, intercurrent diseases.

ICD codes

Dosage Regimen

Determine the dosage and administration route individually based on blood glucose concentration.

Administer subcutaneously, intramuscularly, or intravenously as appropriate for the clinical situation.

For subcutaneous administration, inject within 15 minutes before a meal due to the rapid onset of action.

Adjust the dose based on metabolic needs, blood glucose monitoring results, and glycemic control targets.

Individualize the insulin administration regimen for each patient.

When transferring from other short-acting insulins, consider that a dose adjustment may be required.

Transfer patients receiving a daily insulin dose exceeding 100 units to this preparation in a hospital setting.

Increase the dose during intercurrent illnesses, emotional stress, or with concomitant use of hyperglycemic agents like glucocorticoids or thiazide diuretics.

Decrease the dose in cases of renal impairment, hepatic impairment, increased physical activity, or reduced carbohydrate intake.

During pregnancy, the insulin requirement typically decreases in the first trimester and increases in the second and third trimesters.

Monitor patients closely and adjust the regimen as necessary during childbirth and the postpartum period.

Adverse Reactions

Possible: hypoglycemia (pallor, increased sweating, palpitations, tremor, sleep disorders, neurological disorders), hypoglycemic precoma and coma, transient refractive disorders (more likely in patients not previously treated with insulin).

Rarely: allergic reactions, lipodystrophy.

Contraindications

Hypersensitivity to insulin preparations; hypoglycemia.

Use in Pregnancy and Lactation

During pregnancy, the insulin requirement usually decreases in the first trimester and increases in the second and third trimesters.

During childbirth and immediately after it, the insulin requirement may sharply decrease.

It is not known whether insulin lispro is excreted in breast milk in significant amounts. In patients with diabetes during breastfeeding, adjustment of the insulin dose and/or diet may be required.

Use in Hepatic Impairment

The insulin requirement may decrease in hepatic insufficiency.

Use in Renal Impairment

The insulin requirement may decrease in renal insufficiency.

Pediatric Use

Can be used in children according to indications in age-appropriate recommended doses and dosage forms.

Special Precautions

The route of administration intended for the used dosage form of insulin lispro must be strictly observed.

When transferring patients from fast-acting insulin preparations of animal origin to insulin lispro, dose adjustment may be required.

Transfer of patients receiving insulin in a daily dose exceeding 100 units from one type of insulin to another is recommended to be carried out in a hospital setting.

The insulin requirement may increase during infectious diseases, emotional stress, with an increase in the amount of carbohydrates in food, during additional intake of drugs with hyperglycemic activity (thyroid hormones, glucocorticoids, oral contraceptives, thiazide diuretics).

The insulin requirement may decrease in renal and/or hepatic insufficiency, with a decrease in the amount of carbohydrates in food, during increased physical activity, during additional intake of drugs with hypoglycemic activity (MAO inhibitors, non-selective beta-blockers, sulfonamides).

Correction of hypoglycemia in a relatively acute form can be carried out by intramuscular and/or subcutaneous administration of glucagon or intravenous administration of glucose.

Drug Interactions

The hypoglycemic effect of insulin lispro is enhanced by MAO inhibitors, non-selective beta-blockers, sulfonamides, acarbose, ethanol and ethanol-containing drugs.

The hypoglycemic effect of insulin lispro is reduced by glucocorticosteroids, thyroid hormones, oral contraceptives, thiazide diuretics, diazoxide, tricyclic antidepressants.

Beta-blockers, clonidine, reserpine may mask the manifestations of hypoglycemia symptoms.

When using insulin preparations in combination with drugs of the thiazolidinedione group in patients with type 2 diabetes mellitus, fluid retention in the body may occur, resulting in an increased risk of development and progression of chronic heart failure, especially in patients with cardiovascular diseases and the presence of risk factors for chronic heart failure.

Patients receiving such therapy should be regularly examined for signs of heart failure. If heart failure occurs, therapy should be carried out in accordance with current treatment standards.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.