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LANTUS (INSULIN GLARGINE): USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C: Subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and Himalayan rabbits. Insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg / kg per day, which is approximately 7 times the recommended human subcutaneous starting dose of 10 IU / day (0.008 mg / kg per day), based on mg / m2. In rabbits, doses of 0.072 mg / kg per day, which is approximately 2 times the recommended human subcutaneous starting dose of 10 IU / day (0.008 mg / kg per day), based on mg / m2, were administered during organogenesis. The effects of insulin glargine did not generally differ from those observed with regular human insulin in rats or rabbits. However, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal.

There are no well-controlled clinical studies of the use of Lantus (Insulin Glargine) injections 100 IU / ml in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is essential for patients with diabetes or a history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. Insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in these patients.

Nursing Mothers

It is unknown whether insulin glargine is excreted in human milk. Because many drugs, including human insulin, are excreted in human milk, caution should be exercised when Insulin Glargine (Lantus) injections is administered to a nursing woman. Use of Lantus injections is compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses.

Pediatric Use

The safety and effectiveness of subcutaneous injections of Insulin Glargine injections have been established in pediatric patients (age 6 to 15 years) with type 1 diabetes. Lantus has not been studied in pediatric patients younger than 6 years of age with type 1 diabetes. Lantus Insulin has not been studied in pediatric patients with type 2 diabetes.

Based on the results of a study in pediatric patients, the dose recommendation when switching to Insulin Glargine is the same as that described for adults. As in adults, the dosage of Lantus (Insulin Glargine) must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose.

Geriatric Use

In controlled clinical studies comparing Insulin Glargine (Lantus) to NPH insulin, 593 of 3890 patients (15%) with type 1 and type 2 diabetes were >= 65 years of age and 80 (2%) patients were >= 75 years of age. The only difference in safety or effectiveness in the subpopulation of patients >= 65 years of age compared to the entire study population was a higher incidence of cardiovascular events typically seen in an older population in both Lantus (Insulin Glargine) injections and NPH insulin-treated patients.

Nevertheless, caution should be exercised when Lantus insulin injections is administered to geriatric patients. In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in the elderly.

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