Lantus® SoloStar® is not a drug of choice for the treatment of diabetic ketoacidosis. In such cases, intravenous insulin administration is recommended.
Due to the limited experience with Lantus® SoloStar®, it was not possible to evaluate its efficacy and safety in the treatment of patients with impaired hepatic function or patients with moderate to severe or severe renal insufficiency.
In patients with impaired renal function the need for insulin may decrease due to a slowdown in its elimination. In elderly patients, progressive deterioration of kidney function can lead to a persistent decrease in insulin requirements.
In patients with severe hepatic insufficiency the need for insulin can be lowered due to a decrease in the ability to gluconeogenesis and slowing down the biotransformation of insulin.
In case of ineffective control of blood glucose level, as well as in the presence of a tendency to develop hypo- or hyperglycemia, before proceeding with correction of the dosing regimen, it is necessary to check the accuracy of the prescribed treatment regimen, adherence to the directions for the injection site and the correctness of the technique Subcutaneous injection taking into account all the factors affecting it.
Hypoglycaemia
The time of development of hypoglycemia depends on the profile of the insulin used and can, therefore, change with a change in the treatment regimen. Due to an increase in the time of insulin administration of long-acting with Lantus® SoloStar®, we should expect a lower probability of developing nocturnal hypoglycemia, whereas in the early morning hours this probability of hypoglycemia is higher.If hypoglycemia occurs in patients receiving Lantus® SoloStar®, the possibility of slowing the release from hypoglycemia due to the prolonged action of insulin glargin should be considered.
Patients who have episodes of hypoglycemia may be of particular clinical relevance, such as patients with severe stenosis of the coronary arteries or the vessels of the brain (risk of cardiac and cerebral hypoglycemia complications), as well as in patients with proliferative retinopathy, particularly if they do not receive treatment photocoagulation (risk transient loss of vision after hypoglycemia) should be very careful and to intensify the monitoring of blood glucose levels.
Patients should be warned about conditions in which symptoms-precursors of hypoglycemia may decrease. In patients of certain risk groups, the symptoms of hypoglycemia may change, become less pronounced or absent. These include:
- patients who have significantly improved blood glucose regulation;
- Patients who develop hypoglycemia gradually;
- patients of advanced age;
- patients transferred from insulin of animal origin to human insulin;
- patients with neuropathy;
- patients with a long history of diabetes mellitus;
- patients suffering from mental disorders;
- patients receiving concomitant treatment with other medications (see "Interaction with other drugs").
Such situations can lead to the development of severe hypoglycemia (with possible loss of consciousness) before the patient realizes that he is developing hypoglycemia.
In the event that normal or decreased glycosylated hemoglobin levels are noted, the possibility of developing recurrent unrecognized episodes of hypoglycemia (especially at night) should be considered.
Patient compliance with the dosing regimen and diet, proper insulin administration and knowledge of hypoglycaemic precursors contribute to a significant reduction in the risk of developing hypoglycemia.
Factors that increase the tendency to hypoglycemia, in the presence of which a particularly careful observation is required and correction of the insulin dose may be necessary:
- change the place of insulin administration;
- increased sensitivity to insulin (for example, when stress factors are eliminated);
- unusual, increased or prolonged physical activity;
- intercurrent diseases, accompanied by vomiting, diarrhea;
- violation of diet and diet;
- missed food intake;
- alcohol consumption;
- Some uncompensated endocrine disorders (eg, hypothyroidism, adenohypophysis deficiency or adrenal cortex);
- concomitant medication with some other medicines.
Intercurrent diseases
When intercurrent diseases require more intensive monitoring of blood glucose levels. In many cases, the analysis of the presence of ketone bodies in the urine is shown, and often a correction of the insulin dosage regimen is required. The need for insulin often increases. Patients with type 1 diabetes should continue to regularly consume at least a small amount of carbohydrates, even if they are able to consume only small amounts of food or can not eat at all or if they have vomiting, etc., and they should never completely stop the introduction of insulin.
Instructions for use and handling of a pre-filled SoloStar® pen
Before first use The Lantus® SoloStar® syringe should be kept at room temperature for 1-2 hours.
Before use, inspect the cartridge inside the syringe pen. It should only be used if the solution is clear, colorless, contains no visible solid particles and resembles water in a consistency.
Empty SoloStar® pen need not be reused and must be destroyed.
To prevent infection, a pre-filled syringe pen should only be used by one patient and not transferred to another person.
Handling of the syringe handle SoloStar
Carefully read the usage information before using the SoloStar® pen.
Important information on using the SoloStar pen®
Before each use, it is necessary to carefully connect a new needle to the syringe pen and conduct a safety test. Only needles that are compatible with SoloStar® should be used.
It is necessary to take special precautions to avoid accidents involving the use of a needle and the possibility of transfer of infection.
Do not use the SoloStar® pen when it is damaged or if you are not sure that it will work properly.
Always have a spare SoloStar® pen in case you lose or damage your copy of the SoloStar® pen.
Storage Instruction
Please read the "Storage conditions" section for the storage rules for the SoloStar® pen.
If the SoloStar® pen is stored in the refrigerator, remove it from there for 1-2 hours before the proposed injection so that the solution will take room temperature. The introduction of chilled insulin is more painful.
The used SoloStar® pen must be destroyed.
Exploitation
The SoloStar® syringe handle must be protected from dust and dirt.
The outer side of the SoloStar® pen can be cleaned by wiping it with a damp cloth.
Do not immerse in liquid, do not rinse or lubricate the SoloStar® syringe, as this can damage it.
The syringe handle SoloStar® accurately doses insulin and is safe to work with. It also requires careful handling. Avoid situations in which the SoloStar® pen can be damaged.If you suspect that your copy of the SoloStar® pen can be damaged, use a new syringe pen.
Step 1. Insulin control
It is necessary to check the label on the SoloStar® syringe pen to ensure that it contains the appropriate insulin. For Lantus®, the SoloStar® pen is gray with a purple button for injecting. After removing the cap of the syringe-pen, monitor the appearance of the insulin contained in it: the insulin solution must be transparent, colorless, free of visible solid particles and resemble water in a consistency.
Stage 2. Connecting the needle
Use only needles that are compatible with the SoloStar® syringe handle.
For each subsequent injection, a new sterile needle is always used. After removing the cap, the needle must be carefully installed on the syringe handle.
Stage 3. Performance of the safety test
Before each injection, a safety test must be carried out and make sure that the syringe pen and needle work well and air bubbles are removed.
Measure the dose equal to 2 units.
The outer and inner needle caps must be removed.
With the needle pen up, gently tap the cartridge with the insulin finger so that all air bubbles are directed toward the needle.
Fully press the injection injection button.
If insulin appears at the tip of the needle, it means that the pen and needle work correctly.
If no insulin appears on the tip of the needle, stage 3 can be repeated until insulin appears on the tip of the needle.
Step 4. Dose selection
The dose can be set to an accuracy of 1 unit from a minimum dose of 1 unit to a maximum dose of 80 units. If it is necessary to enter a dose exceeding 80 units, two or more injections should be given.
The dosage window should indicate "0" after the completion of the safety test. After this, the required dose can be set.
Stage 5. Dosing Introduction
The patient should be informed about the technique of injection by a medical professional.
The needle must be inserted under the skin.
The injection button must be pressed completely. It is held in this position for another 10 seconds until the needle is removed.Thus, the introduction of a selected dose of insulin is fully ensured.
Stage 6. Extraction and ejection of a needle
In all cases, the needle after each injection should be removed and discarded. This ensures the prevention of contamination and / or infection, air entering the insulin tank and leakage of insulin.
When removing and discarding the needle, special precautions must be taken. Observe the recommended safety measures for removing and disposing of needles (for example, the technique of putting the cap on with one hand) in order to reduce the risk of accidents involving the use of the needle, and to prevent infection.
After removing the needle, close the SoloStar® syringe with the cap.