Contents
Insulin glulisine.
Description
Each mL of the solution for injection contains insulin glulisine 100 units equivalent to 3.49 mg. Each pen contains 3 mL of solution, equivalent to 300 units.
It contains sodium <1> Insulin glulisine is made by biotechnology.
It has rapid onset of action (within 10-20 min) and short duration of action (about 4 hrs).
Action
Pharmacotherapeutic Group: Antidiabetic.
Indications/Uses
Apidra is an antidiabetic agent, used to reduce high blood sugar in adults, adolescents and children ≥6 years with diabetes mellitus. Diabetes mellitus is a disease where the body does not produce enough insulin to control the level of blood sugar.
Dosage/Direction for Use
Based on the patient's lifestyle, the results of blood sugar (glucose) tests and previous insulin usage, the physician will determine how much Apidra the patients needs. Always use Apidra exactly as the physician prescribed.
Apidra Solostar is a short-acting insulin. The physician may advise to use it in combination with an intermediate, long-acting insulin, a basal insulin or with tablets used to treat high blood sugar levels.
Switching from another insulin to insulin glulisine may require dosage adjustment by the physician.
If the patient missed a dose of Apidra Solostar or has injected enough insulin, blood sugar level may become too high (hyperglycemia). Check blood sugar frequently. Do not take a double dose to make up for a forgotten dose.
Administration: Apidra Solostar should be taken shortly (0-15 min) before or soon after meals. Apidra Solostar is injected under the skin (SC). The physician will show Apidra Solostar can be injected in the abdominal wall, the thigh or upper arm or by continuous infusion in the abdominal wall. The effect will be slightly quicker if the insulin is injected into the abdomen. As for all insulins, injection sites and infusion sites within an injection area (abdomen, thigh or upper arm) must be rotated from one injection to the next.
Overdosage
If too much Apidra Solostar is injected, blood sugar level may become too low (hypoglycemia).
Check blood sugar frequently. In general, to prevent hypoglycemia, the patient must eat more food and monitor blood sugar.
Contraindications
Hypersensitivity to insulin glulisine or to any of the excipients of Apidra Solostar. Hypoglycemia.
Special Precautions
Follow closely the instructions for dose, monitoring (blood tests), diet and physical activity (physical work and exercise) as discussed by the physician.
If the patient has liver or kidney problems, inform the physician as a lower dose may be needed.
Travel: Before traveling consult the physician. The patient may need to talk about the availability of the insulin in the country the patient is visiting; supplies of insulin, injection syringes; correct storage of the insulin while traveling; timing of meals and insulin administration while traveling; the possible effects of changing to different time zones; possible new health risks in the countries to be visited; what to do in emergency situations when the patient feels unwell or becomes ill.
Illnesses and Injuries: In the following situations, management of diabetes may require extra care: If the patient is ill or has a major injury, the blood sugar level may increase (hyperglycemia); not eating enough, blood sugar level may become too low (hypoglycemia).
If the patient has type 1 diabetes (insulin-dependent diabetes mellitus), do not stop taking insulin and continue taking enough carbohydrates.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Inform the physician as soon as possible if the patient experience signs of heart failure eg, unusual shortness of breath or rapid increase in weight or localized swelling (edema).
Apidra Solostar contains metacresol, which may cause allergic reactions.
If the patient stopped using Apidra Solostar, this could lead to severe hyperglycemia (very high blood sugar) and ketoacidosis (build up of acid in the blood because the body is breaking down fat instead of sugar). Do not stop taking Apidra Solostar without consulting a physician.
Effects on the Ability to Drive or Operate Machinery: The ability to concentrate or react may be reduced if the patient have hypoglycemia (low blood sugar levels) or hyperglycemia (high blood sugar levels).
Keep this possible problem in mind in all situations where the patient might put himself and others at risk (eg, driving a car or operating machines). Contact the physician for advice on driving if there are frequent episodes of hypoglycemia and/or the first warning symptoms which help recognize hypoglycemia are reduced or absent.
