ProZinc®
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
- Sponsor
- Boehringer Ingelheim Animal Health USA, Inc.
- NADA
- 141-297
- Status
- RX
- Form
- Liquid (Suspension)
- Route
- Subcutaneous
- Species
- Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Cats
Dogs
For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs with diabetes mellitus.
Starting dose: 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 naïve 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® 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 lessThanEqualTo 300 mg/dL, and clinical signs of hyperglycemia such as polyuria, polydipsia, or weight loss were improved.
Changing to twice daily dosing: Twice daily dosing 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® may have prolonged duration of action in some dogs. 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. For example, if a dog receiving 10 units of ProZinc® once daily has an acceptable nadir but inadequate duration of activity, the dose should be changed to 7 units twice daily (round down to the nearest whole unit).
Further adjustments in the dosage may be necessary with changes in the dog’s diet, body weight, or concomitant medication, or if the dog develops concurrent infection, inflammation, neoplasia, or an additional endocrine or other medical disorder.