Transferring a patient to a new type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, etc), species (animal) and/or method of manufacturing may result in a change in dosage. Concomitant oral antidiabetic treatment may need to be adjusted.
The use of inadequate dosages or discontinuation of treatment, especially in insulin-dependent diabetic, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
Hypoglycaemia: The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed.
Conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease, medicinal products eg, β-blockers or after transfer from animal source insulin to human insulin.
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual meal plan. Exercise taken immediately after a meal may increase the risk of hypoglycaemia.
When compared with soluble human insulin, if hypoglycaemia occurs after an injection with rapid-acting analogues, it may occur earlier.
Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma or death.
Insulin requirements may be altered during illness or emotional disturbances.
Effects on the Ability to Drive or Operate Machinery: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or eg, as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (eg, driving a car or operating machinery).
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.
Use in Pregnancy: There are no adequate data on the use of insulin glulisine in pregnant women.
Animal reproduction studies have not revealed any differences between insulin glulisine and human insulin regarding pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology under Actions).
Caution should be exercised when prescribing to pregnant women. Careful monitoring of glucose control is essential.
It is essential for patients with preexisting or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the 1st trimester and generally increase during the 2nd and 3rd trimesters. Immediately after delivery, insulin requirements decline rapidly.
Use in Lactation: In general insulin does not pass into breastmilk and is not absorbed after oral administration, but it is unknown whether insulin glulisine is excreted in human milk.
Breastfeeding mothers may require adjustments in insulin dose and diet.