ProZinc now approved for use in dogs

Nearly a decade ago, ProZinc (protamine zinc recombinant human insulin) was approved by the FDA for the reduction of hyperglycemia and associated clinical signs in cats with diabetes mellitus. Last week, the FDA announced that the product is now approved for use in dogs as well, making it the second approved product available to veterinarians for managing canine diabetes. Vetsulin (porcine insulin zinc suspension), manufactured by Merck Animal Health, is the other.

Available by prescription only, ProZinc is packaged in 10-ml multidose vials at a concentration of 40 IU/ml. It is administered via subcutaneous injection using a U-40 syringe, according to an FDA release. The recommended starting dose in dogs is 0.2 to 0.5 IU/pound of body weight (0.5-1.0 IU/kg) once daily. The starting dose for cats is 0.1 to 0.3 IU/pound (0.2-0.7 IU/kg) given twice daily. In both species, the drug should be given with or just after a meal.

The FDA says that because compounded drugs vary in quality and potency, it strongly encourages the use of FDA-approved veterinary insulin for newly diagnosed diabetic dogs or when transitioning patients from one product to another.

Pets given any insulin product should be re-evaluated at appropriate intervals with the dose and frequency adjusted as needed based on clinical signs and laboratory parameters until adequate glycemic control has been attained.

ProZinc is contraindicated in dogs and cats that are sensitive to protamine zinc recombinant human insulin or any other ingredients in ProZinc, according to the FDA. The drug should not be given during episodes of hypoglycemia. The most common adverse effects in the canine clinical trial were lethargy, anorexia, hypoglycemia, vomiting, seizures, shaking, diarrhea and ataxia.