Apidra

Apidra Dosage/Direction for Use

insulin glulisine

Manufacturer:

sanofi-aventis

Distributor:

sanofi-aventis
Full Prescribing Info
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 used in regimens that include an intermediate or long acting insulin or basal insulin analogue and can be used with oral hypoglycaemic agents.
The dose of Apidra should be individually adjusted.
Special populations: 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.
Paediatric population: There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Method of administration: Intravenous use: Apidra can be administered intravenously. This should be carried out by healthcare professionals. Apidra must not be mixed with glucose or Ringer's solution or with any other insulin.
Continuous subcutaneous insulin infusion.
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 a subcutaneous 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).
For further details on handling, see Special precautions for disposal and other handling under Cautions for Usage.