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 cats with diabetes mellitus.

PROZINC^® (protamine zinc recombinant human insulin) is the ONLY AAHA-recommended and FDA-approved first-line insulin treatment for feline diabetes.

Following regulation, PROZINC works to safely maintain stable glycemic control with twice-daily administration.¹ To deliver precise, accurate doses and reduce the risk of under- or overdosing, PROZINC insulin is used with U-40 syringes, which are specifically calibrated for use in pets.²

A recent comparative study found that PROZINC and glargine³:

• Delivered comparable glycemic control

• Produced no detectable difference in remission rates

A systematic review of relevant studies determined that diabetic remission rate was independent of insulin formulation, and no single factor predicted remission.⁴ However, cats that experienced remission were more likely to have achieved rapid glycemic control:

• In a field study, 76.2% of cats that received PROZINC achieved diabetic control in 45 days^1,5

• The mean time to achieving glycemic control using PROZINC promotes conditions that favor remission^1,5,6

Backed by the largest prospective insulin study in feline diabetes to date, PROZINC offers predictable glycemic control and efficacy proven to improve clinical signs associated with diabetes mellitus.¹

• 76% of cats showed improvement in excessive thirst^1,5

• 74% of cats showed improvement in excessive urination^1,5

• Approximately half of the cats treated with PROZINC showed improvement in as soon as 7 days^1,5

PROZINC^® (protamine zinc recombinant human insulin) uses U-40 syringes to facilitate more precise measurements of small doses required to treat cats, reducing the risk of under- or overdosing.²

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 should be mixed by gently rolling the vial prior to withdrawing each dose from the vial. One 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 cat. Always provide the cat owner a Client Information Sheet with each prescription.

Starting dose: 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.

Further adjustments in the dosage may be necessary with changes in the cat’s diet, body weight, or concomitant medication, or if the cat 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.