PROZINC^® (protamine zinc recombinant human insulin) 

PROZINC^® (protamine zinc recombinant human insulin) is a sterile aqueous solution of protamine zinc recombinant human insulin that is indicated for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs with diabetes mellitus.

Following regulation, PROZINC^® (protamine zinc recombinant human insulin) works to safely maintain glycemic control with once-daily dosing in most dogs.

PROZINC is backed by the largest US canine insulin study to date¹, including over 200 diabetic patients:

Results demonstrated efficacy and control of clinical signs associated with diabetes mellitus in both naive and previously treated diabetic dogs¹

• 88% of dogs showed improvement in excessive thirst¹ 

• 90% of dogs showed improvement in excessive urination¹

• 72% of dogs achieved diabetic control¹

PROZINC insulin is used with U-40 syringes, which are specifically calibrated for use with dogs to deliver precise, accurate doses, reducing the risk of under- or overdosing.²

Available in two presentations: 10 mL and 20 mL vials (40 IU/mL).

PROZINC^® (protamine zinc recombinant human insulin) should only be administered to the dog for which it was prescribed, and at the dosage and frequency for which it was prescribed. PROZINC requires refrigeration, as well as the use of U-40 syringes, which are sold separately.³

It is recommended that PROZINC be administered once daily. However, some dogs require twice-daily dosing 12 hours apart.

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 should be mixed by gently rolling the vial prior to withdrawing each dose from the vial. Once mixed, PROZINC 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 dog. Always provide the Client Information Sheet with each prescription.

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 until adequate glycemic control has been attained. 

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. 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. 

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.

Contraindications: PROZINC^® (protamine zinc recombinant human insulin) is contraindicated during episodes of hypoglycemia and in animals sensitive to protamine zinc recombinant human insulin or any other ingredients in PROZINC.

Warnings:

User Safety: For use in cats and dogs only. Keep out of the reach of children. Avoid contact with eyes. In case of contact, immediately flush eyes with running water for at least 15 minutes. Accidental injection may cause hypoglycemia. In case of accidental injection, seek medical attention immediately. Exposure to product may induce a local or systemic allergic reaction in sensitized individuals.

Animal Safety: Owners should be advised to observe for signs of hypoglycemia. Use of this product, even at established doses, has been associated with hypoglycemia. Animals with signs of hypoglycemia should be treated immediately. Glucose should be given orally or intravenously as dictated by clinical signs. Insulin should be temporarily withheld and, if indicated, the dosage adjusted.

Precautions: Animals presenting with severe ketoacidosis, anorexia, lethargy, and/or vomiting should be stabilized with short-acting insulin and appropriate supportive therapy until their condition is stabilized. As with all insulin products, careful patient monitoring for hypoglycemia and hyperglycemia is essential to attain and maintain adequate glycemic control and to prevent associated complications. Overdose can result in profound hypoglycemia and death. Glucocorticoid and progestogen use should be avoided. The safety and effectiveness of PROZINC in breeding, pregnant, and lactating animals has not been evaluated.

Adverse Reactions: The most common adverse reactions were lethargy, anorexia, hypoglycemia, vomiting, seizures, shaking, diarrhea, and ataxia. Many of the adverse reactions, such as lethargy, seizures, shaking, and ataxia, are associated with hypoglycemia. 

For more information, see full prescribing information.