Protamine zinc recombinant human insulin.

Not for oral administration. USE OF A SYRINGE OTHER THAN A U-40 SYRINGE WILL RESULT IN INCORRECT DOSING. FOR SUBCUTANEOUS INJECTION ONLY. DO NOT SHAKE OR AGITATE THE VIAL. PROZINC® insulin requires refrigeration at all times.

PROZINC® (protamine zinc recombinant human insulin) should be mixed by gently rolling the vial prior to withdrawing each dose from the vial. Once mixed, PROZINC® insulin suspension has a white, cloudy appearance. Clumps or visible white particles can form in insulin suspensions: do not use the product if clumps or visible white particles persist after gently rolling the vial. Using a U-40 insulin syringe, the injection should be administered subcutaneously on the back of the neck or on the side of the cat or dog.

Further adjustments in the dosage may be necessary with changes in the pet's diet, body weight, or concomitant medication, or if the cat develops concurrent infection, inflammation, neoplasia, or an additional endocrine or other medical disorder.

FOR CATS:

The initial recommended PROZINC® dose is 0.1 - 0.3 IU insulin/pound of body weight (0.2 - 0.7 IU/kg) every 12 hours. The dose should be given concurrently with or right after a meal. The veterinarian should re-evaluate the cat at appropriate intervals and adjust the dose based on both clinical signs and glucose nadirs until adequate glycemic control has been attained. In the effectiveness field study, glycemic control was considered adequate if the glucose nadir from a 9-hour blood glucose curve was between 80 and 150 mg/dL and clinical signs of hyperglycemia such as polyuria, polydipsia, and weight loss were improved.

FOR DOGS:

The recommended starting dose for PROZINC® is 0.2-0.5 IU insulin/pound of body weight (0.5- 1.0 IU/kg) once daily. The recommended starting dose for nave dogs is the lower end of the dose range. The recommended starting dose for dogs with poorly controlled diabetes mellitus and transitioning from another insulin product is the mid to higher end of the dose range based on the veterinarian's experience with the dog's medical history and previous insulin dose. When transitioning from another insulin, the dog's blood glucose and general condition should be closely monitored. When transitioning from another insulin, PROZINC® insulin should be started once daily, regardless of the frequency of prior insulin use.

The dose should be given concurrently with or right after a meal. The veterinarian should re-evaluate the dog at appropriate intervals and adjust the dose and frequency based on both clinical signs and laboratory test results (the blood glucose curve values and shape, nadir, and fructosamine) until adequate glycemic control has been attained. In the effectiveness field study, glycemic control was considered adequate if the glucose nadir from a 9-hour blood glucose curve was between 80 and 125 mg/dL, the maximum blood glucose was < 300 mg/dL, and clinical signs of hyperglycemia such as polyuria, polydipsia, or weight loss were improved.

Changing to twice daily dosing: This should be considered if the duration of insulin action is determined to be inadequate with once daily dosing. Use caution when adjusting from once daily to twice daily dosing because PROZINC® insulin may have prolonged duration of action in some dogs (see Clinical Pharmacology). The veterinarian should closely monitor the duration of action using blood glucose curves to avoid the increased risk of hypoglycemia. If twice daily dosing is initiated, the two doses should each be approximately 25% less than the once daily dose required to attain an acceptable glucose nadir.