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indicated for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs and cats with diabetes mellitus.

N. Effect(s) of Supplement:

This supplement provides for a new starting dose in dogs and for the use of VETSULIN in cats

  • II.

    EFFECTIVENESS:

    • A.

      Dosage Characterization: Dog

In the original approval (Freedom of Information (FOI) Summary dated April 1, 2004) the starting VETSULIN dose was 1 IU/kg plus a weight dependent supplement. Based on a review of existing literature and a re-evaluation of the data from the US field study, the new starting dose is 0.5 IU/kg.

Several insulin therapy starting dose recommendations have been described in the literature.1-5 It is preferable to begin therapy at a low dose because it is easier to adjust for hyperglycemia than to treat an acute hypoglycemic crisis. Ettinger recommends 0.5 to 1 IU/kg body weight as an initial dose of insulin in dogs administered in the morning followed by 10 to 25 percent of the patient’s daily food intake.1 Fleeman and Rand suggest an initial insulin dose of 0.5 IU/kg if the blood glucose value is 360 mg/dL or greater and an initial dose of 0.25 IU/kg in those dogs with blood glucose levels less than this.2 Nelson and Feldman recommend a starting dosage of 0.5 IU/kg given as a single morning injection when intermediate-acting insulin is used as initial treatment of diabetic dogs.3 This dose can also be administered as a divided dose, approximately 12 hours apart to mimic physiologic insulin concentrations and provide greater availability.4 An even more conservative treatment regimen recommends a starting insulin dose of 0.4 to 0.7 IU/kg given once or twice daily; and for most dogs, if intermediate acting insulin is used twice daily, lowering the starting dosage to 0.4 to 0.5 IU/kg.5 Most authors agree that initial insulin therapy should be conservative and that incremental increases should be based on resolution of clinical signs and blood glucose monitoring.

In the US field study which provided substantial evidence of effectiveness supporting the original approval, the majority of VETSULIN doses administered were less than 1.0 IU/kg during the period effectiveness was evaluated. See Table 1 below.

Table 1: Doses of VETSULIN (IU/kg) by dose ranged administered during the US field study in dogs completing the study

Dose = d (IU/kg)

Number of

Total

Doses

Doses

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