Apidra Dosage/Direction for Use

Posology: The potency of this preparation is stated in units. These units are exclusive to Apidra and are not the same as IU or the units used to express the potency of other insulin analogues (see Pharmacology: Pharmacodynamics under Actions).
Apidra should be give by injection within 15 minutes before or immediately after a meal.
Apidra should be used in regimens that include an intermediate or long acting insulin or basal insulin analogue and can be used with oral hypoglycemic agents.
The dosage of Apidra should be individualized and determined based on the physician's advice in accordance with the needs of patients.
Special population: Renal impairment: The pharmacokinetic properties of insulin glulisine are generally maintained in patients with renal impairment. However, insulin requirements may be reduced in the presence of renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: The pharmacokinetic properties of insulin glulisine have not been investigated in patients with decreased liver function. In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Elderly: Limited pharmacokinetic data are available in elderly patients with diabetes mellitus. Deterioration of renal function may lead to a decrease in insulin requirements.
Children and adolescents: There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Method of Administration: Apidra 100 Units/ml solution for injection in a vial: Intravenous use: Apidra can also be administered intravenously. This should be carried out by health care professionals.
Apidra must not be mixed with glucose or Ringer's solution or with any other insulin.
Continuous Subcutaneous Infusion Pump: Apidra may be used for Continuous Subcutaneous Insulin Infusion (CSII) in pump systems suitable for insulin infusion with the appropriate catheters and reservoirs. Patients using CSII should be comprehensively instructed on the use of the pump system.
The infusion set and reservoir used with Apidra must be changed at least every 48 hours using aseptic technique. These instructions may differ from general pump manual instructions. It is important that patients follow the Apidra specific instructions when using Apidra. Failure to follow Apidra specific instructions may lead to serious adverse events.
When used with an insulin infusion pump, Apidra must not be mixed with diluents or any other insulin.
Patients administering Apidra by CSII must have an alternative insulin delivery system available in case of pump system failure (see Precautions and Adverse Reactions).
Apidra 100 Units/ml solution for injection in a vial: For further details on handling, see Preparation and Handling under Cautions for Usage.
Apidra 100 Units/ml solution for injection in a cartridge: Apidra 100 Units/ml in cartridges is only suitable for subcutaneous injections from a reusable pen. If administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used (see Precautions). For further details on handling, see Preparation and Handling under Cautions for Usage.
Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen: Apidra SoloStar 100 Units/ml in pre-filled pen is only suitable for subcutaneous injections. If administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used (see Preparation and Handling under Cautions for Usage).
Subcutaneous use: Apidra should be administered subcutaneously in the abdominal wall, thigh or deltoid or by continuous infusion in the abdominal wall. Injection sites and infusion sites within an-injection area (abdomen, thigh or deltoid) should be rotated from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see Precautions and Adverse Reactions). The rate of absorption, and consequently the onset and duration of action, may be affected by the injection site, exercise and other variables. Subcutaneous injection in the abdominal wall ensures a slightly faster absorption than other injections sites (see Pharmacology: Pharmacokinetics under Actions).
Care should be taken to ensure that blood vessel has not been entered. After injection, the site of injection should not be massaged. Patients must be educated to use proper injection techniques.
Mixing with insulins: Apidra must not be mixed with any preparation other than NPH (Neutral Protamine Hagedorn) human insulin. If Apidra is mixed with NPH human insulin, Apidra should be drawn into the syringe first. Injection should be given immediately after mixing. Mixtures should not be administered intravenously. No data are available on mixing insulin glulisine with insulin preparations other than NPH human insulin.