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PHARMA DOCTOR: INSULIN GLARGINE



LANTUS (INSULIN GLARGINE): WARNINGS

Dosage adjustment and monitoring

Glucose monitoring is essential for all patients receiving insulin therapy. Changes to an insulin regimen should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral anti-diabetic treatment.

As with all insulin preparations, the time course of action for Insulin Glargine (Lantus) injections may vary in different individuals or at different times in the same individual and is dependent on many conditions, including the local blood supply, local temperature, and physical activity.

Administration

Do not administer Insulin Glargine (Lantus) injections 100 IU / ml intravenously or via an insulin pump. The intended duration of activity of Lantus injections is dependent on injection into subcutaneous tissue Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia.

Do not dilute or mix Insulin Glargine injections with any other insulin or solution. If Lantus is diluted or mixed, the solution may become cloudy, and the pharmacokinetic or pharmacodynamic profile (e.g., onset of action, time to peak effect) of Lantus Insulin and the mixed insulin may be altered in an unpredictable manner. When Insulin Glargine and regular human insulin were mixed immediately before injection in dogs, a delayed onset of action and a delayed time to maximum effect for regular human insulin was observed. The total bioavailability of the mixture was also slightly decreased compared to separate injections of Lantus (Insulin Glargine) and regular human insulin. The relevance of these observations in dogs to humans is unknown.

Do not share disposable or reusable insulin devices or needles between patients, because doing so carries a risk for transmission of blood-borne pathogens.



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