Safety Information for Pet Owners

 

For use in cats only. Keep out of the reach of children. 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.

Owners should be advised to observe for signs of hypoglycemia. Use of PROZINC insulin, even at established doses, has been associated with hypoglycemia. Signs of hypoglycemia may occur suddenly and can include: weakness, depression, lethargy, sluggishness, staggering gait, behavioral changes, muscle twitching, seizures, coma, death. An animal 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.

The safety and effectiveness of PROZINC insulin in kittens and in breeding, pregnant, and lactating cats has not been evaluated.

Please refer to package insert for complete product information. 


  • Caution

    Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Warnings

    User Safety: For use in cats 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 (see Cat Owner Information Sheet).

    Use of this product, even at established doses, has been associated with hypoglycemia. An animal 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.

    Any change in insulin should be made cautiously and only under a veterinarian’s supervision. Changes in insulin strength, manufacturer, type, species (human, animal) or method of manufacture (rDNA versus animal-source insulin) may result in the need for a change in dosage.
    Appropriate diagnostic tests should be performed to rule out other endocrinopathies in diabetic cats that are difficult to regulate.

  • 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. Overdosage can result in profound hypoglycemia and death. Progestogens, certain endocrinopathies and glucocorticoids can have an antagonistic effect on insulin activity. Progestogen and glucocorticoid use should be avoided.

    Reproductive Safety: The safety and effectiveness of PROZINC insulin in breeding, pregnant, and lactating cats has not been evaluated.

    Use in Kittens: The safety and effectiveness of PROZINC insulin in kittens has not been evaluated.

  • Adverse Reactions

    PROZINC insulin, like other drugs, may cause side effects. Serious side effects can occur with or without warning. Pet owners should contact their veterinarian immediately if they think their cat has a medical problem or side effect from PROZINC therapy. Possible side effects include hypoglycemia, insulin antagonism/resistance, rapid insulin metabolism, insulin-induced hyperglycemia (Somogyi effect), and local or systemic reactions.

    As with all insulin therapies, the most common side effect of PROZINC is hypoglycemia. The use of PROZINC even at established doses has been associated with hypoglycemia. Hypoglycemia can be fatal without prompt treatment. In cats, hypoglycemia is defined by the US Food and Drug Administration as a blood glucose concentration less than 50 mg/dL. Take caution when a cat’s blood glucose level drops to 80 mg/dL, has too much insulin, too little food, or much more exercise than usual.

    In cats, hyperglycemia is defined as a blood glucose concentration higher than 200-300 mg/dL. Take caution if a cat’s glucose appears elevated or if the cat has experienced stress, illness or injury, or a change in routine.

  • Contraindications

    PROZINC insulin is contraindicated in cats sensitive to protamine zinc recombinant human insulin or any other ingredients in the PROZINC product. PROZINC insulin is contraindicated during episodes of hypoglycemia.

    Pet owners should not administer the prescribed dose of PROZINC insulin if a cat:

    • Is experiencing an episode of hypoglycemia.
    • Is not eating or is vomiting.
    • Is sensitive to protamine zinc recombinant human insulin or any other ingredients in PROZINC product.
  • Information for cat owners

    PROZINC insulin, like other insulin products, is not free from adverse reactions. Owners should be advised of the potential for adverse reactions and be informed of the associated clinical signs. Potential adverse reactions include: hypoglycemia, insulin antagonism/resistance, rapid insulin metabolism, insulin-induced hyperglycemia (Somogyi effect), and local or systemic reactions. The most common adverse reaction observed is hypoglycemia. Signs may include: weakness, depression, behavioral changes, muscle twitching, and anxiety. In severe cases of hypoglycemia, seizures and coma can occur.

    Hypoglycemia can be fatal if an affected cat does not receive prompt treatment. Appropriate veterinary monitoring of blood glucose, adjustment of insulin dose and regimen as needed, and stabilization of diet and activity help minimize the risk of hypoglycemic episodes. The attending veterinarian should evaluate other adverse reactions on a case-by-case basis to determine if an adjustment in therapy is appropriate or if alternative therapy should be considered.

  • User warning

    For use in cats 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 the product may induce a local or systemic allergic reaction in sensitized individuals.