Apidra
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Prices in online pharmacies:
from 2015 rub.
Buy
Apidra is a recombinant analogue of human insulin, equal in strength to it, but with a faster and less lasting effect.
Release form and composition
Apidra's dosage form is a solution for subcutaneous (s / c) administration: almost colorless or colorless transparent liquid (10 ml in vials, 1 vial in a cardboard box; 3 ml in cartridges, in a blister pack: 5 cartridges for a pen "OptiPen" or 5 cartridges mounted in a disposable syringe pen "OptiSet", or 5 cartridge systems "Opticlik").
1 ml of solution contains:
- active substance: insulin glulisine - 3.49 mg (equivalent to 100 IU of human insulin);
- auxiliary components: trometamol, m-cresol, polysorbate 20, sodium chloride, concentrated hydrochloric acid, sodium hydroxide, water for injection.
Indications for use
Apidra is used to treat diabetes mellitus requiring insulin therapy in children over 6 years old, adolescents and adults.
Contraindications
- hypoglycemia;
- children under 6 years of age (limited clinical information on use);
- hypersensitivity to insulin glulisine or to any other component of the drug.
Apidru is recommended to be used with caution during pregnancy.
Patients with hepatic impairment may require a decrease in insulin dose due to a decrease in gluconeogenesis and a slowdown in insulin metabolism.
A decrease in the need for insulin is also possible with renal failure and in old age (due to impaired renal function).
Method of administration and dosage
Insulin Apidra is administered immediately before a meal (0-15 minutes) or immediately after a meal by subcutaneous injection or continuous infusion into the subcutaneous fat using a pump system.
The dose and mode of administration of the drug are selected individually.
Apidra solution is used in complex therapy regimens with medium-acting insulin or with long-acting insulin / insulin analogue, combined use with oral hypoglycemic drugs is allowed.
Recommended areas of the body for drug administration:
- n / a injection - produced in the area of the shoulder, thigh or abdomen, while the introduction into the abdominal wall gives a slightly faster absorption;
- continuous infusion - produced into the subcutaneous fat in the abdomen.
The sites of infusion and injection should be alternated with each subsequent administration of the drug.
Since the dosage form of Apidra is a solution, no resuspension is required before using it.
The rate of absorption and, accordingly, the onset and duration of action of the drug can change under the influence of physical activity, depending on the place of administration of the solution and other changing factors.
Care must be taken when administering the drug in order to exclude the likelihood of it entering directly into the blood vessels. After the procedure, do not massage the injection area.
Patients need to be trained in injection techniques.
When the drug is administered using a pump system for insulin infusion, the solution must not be mixed with any other drugs / agents.
Apidra solution is not miscible with any other drugs except for human isophane insulin. In this case, Apidru is drawn into the syringe first, and the injection is carried out immediately after mixing. There are no data on the use of solutions mixed long before the injection.
The cartridges must be used with the OptiPen Pro1 insulin pen or similar devices in strict accordance with the manufacturer's instructions for loading the cartridge, connecting the needle and administering insulin injection. Before using the cartridge, a visual check of the drug should be performed. Only a clear, colorless solution that does not contain visible solid inclusions is suitable for injection. Before installation, the cartridge must first be kept for 1-2 hours at room temperature, and before the introduction of the solution, air bubbles must be removed from the cartridge.
Used cartridges cannot be refilled. A damaged OptiPen Pro1 pen cannot be used.
In the event of a malfunction of the syringe pen, the solution can be drawn from the cartridge into a plastic syringe suitable for insulin at a concentration of 100 IU / ml, and then administered to the patient.
The reusable syringe pen is used for injection only to one patient (to avoid infection).
All of the above recommendations and rules should also be followed when using the cartridge system and the OptiKlik syringe pen for administration of Apidra solution, which is a glass cartridge with an attached piston mechanism, fixed in a transparent plastic container and containing 3 ml of insulin glulisine solution.
Side effects
The most common unwanted side effect of insulin therapy is hypoglycemia; it usually occurs when insulin is used in doses much higher than required.
Adverse adverse reactions associated with the administration of the drug from the organs and systems of patients registered in the course of clinical trials (the list is given using the following gradation of frequency of occurrence: more than 10% - very often; more than 1%, but less than 10% - often; more 0.1%, but less than 1% - sometimes; more than 0.01%, but less than 0.1% - rarely; less than 0.01% - very rare):
- metabolism: very often - hypoglycemia, accompanied by the following suddenly arising symptoms: cold sweat, pallor of the skin, fatigue, anxiety, tremors, nervous excitement, weakness, confusion, drowsiness, difficulty concentrating, visual disturbances, nausea, excessive hunger, headache, palpitations; the consequences of an increase in hypoglycemia can be: loss of consciousness and / or the appearance of seizures, temporary or permanent deterioration of brain function, in extreme cases, a lethal outcome is possible
- skin and subcutaneous tissue: often - allergic manifestations, such as swelling, hyperemia, itching at the injection site, with continued therapy, usually transient on their own; rarely - lipodystrophy, mainly due to a violation of the alternation of the places of insulin injection in any of the areas / repeated administration of the drug in the same place;
- hypersensitivity reactions: sometimes - suffocation, a feeling of tightness in the chest, urticaria, itching, allergic dermatitis; in severe cases of generalized allergic reactions (including anaphylactic reactions), life is possible.
There are no special data on the study of the symptoms of an insulin glulisine overdose, but due to the prolonged use of high doses of Apidra, hypoglycemia of varying severity may develop.
Therapy for the condition depends on the degree of the disease:
- episodes of mild hypoglycemia - are stopped by the use of glucose or foods containing sugar, in connection with which patients with diabetes are advised to constantly have cookies, sweets, lumps of refined sugar, sweet fruit juice with them;
- episodes of severe hypoglycemia (with loss of consciousness) - are stopped by intramuscular (intramuscular) or subcutaneous administration of 0.5-1 mg of glucagon, or intravenous (intravenous) administration of glucose (dextrose) in the absence of a response to the administration of glucagon to for 10-15 minutes. After recovering consciousness, the patient is advised to give carbohydrates orally in order to prevent a repeated attack of hypoglycemia, after which, to establish the cause of severe hypoglycemia, as well as to prevent the development of such episodes, the patient must be observed for some time in the hospital.
special instructions
In the case of transferring a patient to insulin from another manufacturer or a new type of insulin, strict medical supervision is necessary, since it may be necessary to correct the therapy in general.
The use of inadequate doses of insulin or unjustified discontinuation of therapy, especially in patients with type 1 diabetes mellitus, can cause the development of hyperglycemia and diabetic ketoacidosis - potentially life-threatening conditions. The time of the probable development of hypoglycemia directly depends on the rate of action of the applied insulins and may, therefore, change when correcting the therapy regimen.
The main conditions that can change or make less pronounced the symptoms of the development of hypoglycemia:
- long-term presence of diabetes mellitus in the patient;
- diabetic neuropathy;
- intensification of insulin therapy;
- concomitant use of certain drugs, for example, β-blockers;
- switching to human insulin from animal insulin.
Correction of insulin doses may also be necessary in the event of a change in the modes of physical activity or nutrition. Increased physical activity immediately after a meal can increase the likelihood of hypoglycemia. In comparison with the action of soluble human insulin, hypoglycemia may develop more quickly after administration of fast-acting insulin analogs.
Due to uncompensated hypo- or hyperglycemic reactions, loss of consciousness, coma, or death are possible.
Comorbidities or emotional stress can also alter the patient's need for insulin.
Drug interactions
There have been no studies on the pharmacokinetic drug interaction of Apidra, but based on the data available for similar drugs, it can be concluded that a clinically significant pharmacokinetic interaction is unlikely.
Some drugs / drugs can affect glucose metabolism, as a result of which it may be necessary to adjust the doses of insulin glulisine and more closely monitor the therapy and the patient's condition.
So when used together with Apidra solution:
- oral hypoglycemic drugs, angiotensin-converting enzyme inhibitors, disopyramide, fluoxetine, fibrates, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, sulfa antimicrobial agents, salicylates - can enhance the hypoglycemic effect of insulin and increase the predisposition;
- glucocorticosteroids, diuretics, danazol, diazoxide, isoniazid, somatropin, phenothiazine derivatives, sympathomimetics (epinephrine / adrenaline, terbutaline, salbutamol), estrogens, thyroid hormones, progestins (oral proteasapine drugs), antipsychotic drugs (olyzapine) are able to reduce the hypoglycemic effect of insulin;
- clonidine, β-blockers, ethanol, lithium salts - potentiate or weaken the hypoglycemic effect of insulin;
- pentamidine - capable of causing hypoglycemia with subsequent hyperglycemia;
- drugs with sympatholytic activity (β-blockers, guanethidine, clonidine, reserpine) - with hypoglycemia, they can reduce the severity or mask the symptoms of reflex adrenergic activation.
Insulin glulisine compatibility studies have not been conducted, therefore, Apidra should not be mixed with any other drugs, with the exception of human isophane insulin.
If the solution is administered using an infusion pump, Apidru must not be mixed with other drugs.
Analogs
The analogues of Apidra are: Vozulim-R, Actrapid (NM, MS), Gensulin R, Biosulin R, Insuman Rapid GT, Insulin MK, Insulin-Ferein CHR, Gansulin R, Humalog, Pensulin (SR, CHR), Monosuinsulin (MK, MP), Humulin Regular, NovoRapid (Penfill, FlexPen), Humodar R, Monoinsulin CHR, Insuran R, Rinsulin R, Rosinsulin R.
Terms and conditions of storage
Store in its own cardboard packaging, out of light, at a temperature of 2-8 ° C. Do not freeze. Keep out of the reach of children!
After opening the package, store in a place protected from light at temperatures up to 25 ° C. The shelf life of the drug after the first use is 4 weeks (it is recommended to mark the date of the first intake of the solution on the label).
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Apidra: prices in online pharmacies
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Drug name Price Pharmacy |
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Apidra SoloStar 100 U / ml solution for subcutaneous administration 3 ml 5 pcs. 2015 RUB Buy |
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
