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ProZinc

ProZinc

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Description

ProZinc is the first protamine zinc insulin that is approved by the FDA specifically for use in cats. When you give your cat a ProZinc injection, make sure you use the correct type of syringe. ProZinc is a U-40 insulin, meaning that there are 40 units of insulin per milliliter (ml) of product. That is why ProZinc must be injected with a U-40 syringe. This is very important because using another type of syringe will deliver the wrong dose.

Key Benefits

  • Helps control blood glucose and alleviate symptoms of diabetes.
  • It is the first and only FDA-approved insulin for cats made from recombinant DNA (DNA molecules created from the DNA of two unrelated organisms) that is identical to human insulin.
  • Now FDA-approved for use in dogs
  • The ingredients in ProZinc (protamine zinc insulin) are classified as long-acting with duration of effect for 10-14 hours.

How It Works

Like other insulins, ProZinc controls blood glucose by stimulating carbohydrate metabolism in heart, bone and fat tissue, helping these cells to use glucose for energy.

Indications

PROZINC (protamine zinc recombinant human insulin) is indicated for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs with diabetes mellitus.

Directions

View ProZinc Drug Facts Sheet.

  • ProZinc is the first and only FDA-approved protamine zinc insulin for cats containing human recombinant insulin.
  • ProZinc is now FDA-approved for use in dogs too.
  • ProZinc helps control blood glucose by stimulating carbohydrate metabolism in heart, bone and fat tissue, helping these cells to use glucose for energy.
  • The ingredients in ProZinc (protamine zinc insulin) are classified as long-acting with a duration of effect for 10-14 hours.

Tip: Speak to your veterinarian about your pet's exercise and diet, as these can help maintain healthy glucose levels.

Dosage for Cats
Weight Dosage
All weights Before using ProZinc you should have your vet the proper way to inject insulin. Your cat's injection should be given at feeding time or just afterward. Give the injections at the same time every day, approximately 12 hours apart to help your cat maintain the most stable blood glucose levels. The initial recommended dose is 0.1 - 0.3 IU insulin/pound of body weight (0.2-0.7 IU/kg) every 12 hours.
Dosage for Dogs
Weight Dosage
All weights Before using ProZinc you should have your vet the proper way to inject insulin. Your dog's injection should be given at feeding time or just afterward. Give the injections at the same time every day, to help your dog maintain the most stable blood glucose levels. The initial recommended dose is 0.2 - 0.5 IU insulin/pound of body weight (0.5-1.0 IU/kg) daily.

Cautions:

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

Contraindications:

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

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 (see Client Information Sheet). Use of this product, even at established doses, has been associated with hypoglycemia. A cat 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:

Cats 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.

Glucocorticoids, progestogens, and certain endocrinopathies can have an antagonistic effect on insulin activity. Glucocorticoid and progestogen use should be avoided.

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

The safety and effectiveness of PROZINC in kittens has not been evaluated.

Adverse Reactions:

Effectiveness Field Study

In a 45-day effectiveness field study, 176 cats received PROZINC. Hypoglycemia (defined as a blood glucose value of < 50 mg/dL) occurred in 71 of the cats at various times throughout the study. Clinical signs of hypoglycemia were generally mild in nature (described as lethargic, sluggish, weak, trembling, uncoordinated, groggy, glassy-eyed or dazed). In 17 cases, the veterinarian provided oral glucose supplementation or food as treatment. Most cases were not associated with clinical signs and received no treatment. One cat had a serious hypoglycemic event associated with stupor, lateral recumbency, hypothermia and seizures.

All cases of hypoglycemia resolved with appropriate therapy and if needed, a dose reduction.

Three cats had injection site reactions which were described as either small, punctate, red lesions; lesions on neck; or palpable subcutaneous thickening. All injection site reactions resolved without cessation of therapy.

Four cats developed diabetic neuropathy during the study as evidenced by plantigrade stance. Three cats entered the study with plantigrade stance, one of which resolved by Day 45. Four cats were diagnosed with diabetic ketoacidosis during the study. Two were euthanized due to poor response to treatment. Five other cats were euthanized during the study, one of which had hypoglycemia. Four cats had received PROZINC for less than a week and were euthanized due to worsening concurrent medical conditions.

The following additional clinical observations or diagnoses were reported in cats during the effectiveness field study: vomiting, lethargy, diarrhea, cystitis/hematuria, upper respiratory infection, dry coat, hair loss, ocular discharge, abnormal vocalization, black stool, and rapid breathing.

Extended Use Field Study

Cats that completed the effectiveness study were enrolled into an extended use field study. In this study, 145 cats received PROZINC for up to an additional 136 days. Adverse reactions were similar to those reported during the 45-day effectiveness study and are listed in order of decreasing frequency: vomiting, hypoglycemia, anorexia/poor appetite, diarrhea, lethargy, cystitis/hematuria, and weakness. Twenty cats had signs consistent with hypoglycemia described as: sluggish, lethargic, unsteady, wobbly, seizures, trembling, or dazed. Most of these were treated by the owner or veterinarian with oral glucose supplementation or food; others received intravenous glucose. One cat had a serious hypoglycemic event associated with seizures and blindness. The cat fully recovered after supportive therapy and finished the study. All cases of hypoglycemia resolved with appropriate therapy and if needed, a dose reduction.

Fourteen cats died or were euthanized during the extended use study. In two cases, continued use of insulin despite anorexia and signs of hypoglycemia contributed to the deaths. In one case, the owner decided not to continue therapy after a presumed episode of hypoglycemia. The rest were due to concurrent medical conditions or worsening of the diabetes mellitus.

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Boehringer Ingelheim at 1-888-637-4251.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

Information for Cat Owners:

Please refer to the Client Information Sheet for Cats for more information about PROZINC. PROZINC, 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.

Effectiveness:

A total of 187 client-owned cats were enrolled in a 45-day field study, with 176 receiving PROZINC. One hundred and fifty-one cats were included in the effectiveness analysis. The patients included various purebred and mixed breed cats ranging in age from 3 to 19 years and in weight from 4.6 to 20.8 pounds. Of the cats included in the effectiveness analysis, 101 were castrated males, 49 were spayed females, and 1 was an intact female.

Cats were started on PROZINC at a dose of 0.1-0.3 IU/lb (0.2-0.7 IU/kg) twice daily. Cats were evaluated at 7, 14, 30, and 45 days after initiation of therapy and the dose was adjusted based on clinical signs and results of 9-hour blood glucose curves on Days 7, 14, and 30.

Effectiveness was based on successful control of diabetes which was defined as improvement in at least one blood glucose variable (glucose curve mean, nadir, or fructosamine) and at least one clinical sign (polyuria, polydipsia, or body weight). Based on this definition, 115 of 151 cases (76.2%) were considered successful. Blood glucose curve means decreased from 415.3 mg/dL on Day 0 to 203.2 mg/dL by Day 45 and the mean blood glucose nadir decreased from 407.9 mg/dL on Day 0 to 142.4 mg/dL on Day 45. Mean fructosamine values decreased from 505.9 µmol/L on Day 0 to 380.7 µmol/L on Day 45.

Cats that completed the effectiveness study were enrolled in an extended use field study. The mean fructosamine value was 342.0 µmol/L after a total of 181 days of PROZINC therapy.

Storage:

Store in an upright position under refrigeration at 36-46°F (2-8°C). Do not freeze. Protect from light. Use the 10 mL vial within 60 days of first puncture. Use the 20 mL vial within 80 days of first puncture.

FAQ

Diabetes mellitus is a disease where the body produces insufficient insulin. The low insulin levels may result in high blood glucose that could produce the following changes in a pet; increased thirst, urination and appetite; weight loss; high levels of glucose in the urine. ProZinc is not a cure for diabetes mellitus, it can control the levels of glucose in the blood to help alleviate the clinical signs. Follow any diet or exercise plan developed by your Veterinarian.
Insulin is a hormone naturally produced by the pancreas. Insulin enables the body to use the sugar in food as a source of energy. When the body does not produce enough insulin, or when the insulin produced by the body is not effective enough, this condition is called diabetes mellitus. This condition allows sugar levels in the body to become very high. ProZinc is a protamine zinc insulin, a type of long-acting insulin derived from recombinant human insulin used to reduce hyperglycemia (high blood glucose or sugar) in pets with diabetes mellitus. A licensed veterinarian must prescribe ProZinc insulin for your pet. ProZinc insulin should be given to dogs and cats only. Seek medical attention immediately if you accidentally inject yourself with ProZinc insulin. ProZinc is available by prescription as a sterile injectable suspension in 10 ml multidose vials. Each ml of ProZinc product contains 40 International Units (U) of recombinant human insulin and is given to pets by subcutaneous injection.
Do not give ProZinc to pets sensitive to Protamine zinc recombinant human insulin or any other ingredients in the ProZinc product. Do not give ProZinc during episodes of hypoglycemia. Before using ProZinc, tell your veterinarian if your pet has any other medical conditions or allergies, or if your pet takes any other prescription or over the counter medications, including vitamins, minerals, and herbal supplements. Tell your veterinarian if your pet is pregnant, nursing, or if you plan to breed your pet.
Do not switch from one type insulin to another unless under the directions of a veterinarian. Changing from one insulin to another may require an adjustment in the dose. ProZinc should be given according to your veterinarian's instructions. ProZinc is given using a U-40 syringe only. Use of a syringe other than a U-40 syringe will result in incorrect dosing. ProZinc should not be shaken. Just prior to use, the vial should be mixed by rolling the vial between the palms of your hands. Do not reuse a syringe. Dispose of all syringes in an appropriate puncture-resistant disposal container. Dosage regimens of ProZinc will vary among patients. The recommended starting dose for cats is 0.1 to 0.3 units per lb of body weight every 12 hours. The recommended starting dose for dogs is 0.2 to 0.5 units per lb of body weight once daily. This dose should be adjusted based on changes in blood glucose levels and resolution of clinical signs. Further adjustments may be necessary with changes in the pet's diet, body weight or other medications, or if the pet develops an infection, inflammation, neoplasia or an additional endocrine or other medical disorder. Store ProZinc in an upright position, in the refrigerator, between 36°-46° F. Do not freeze. Protect from light. Keep this medication out of the reach of children and pets.
Contact and follow your veterinarian's directions if you miss giving a dose of ProZinc. If you cannot contact your veterinarian and your pet is eating and acting normally, give your pet the usual dose at the next regularly scheduled time. To prevent missed doses, be sure to always have enough ProZinc on hand.
Contact your veterinarian immediately if you inject more than the prescribed amount of ProZinc. Signs of hypoglycemia that may occur include; weakness; depression, lethargy, sluggishness; staggering gait; behavioral changes; muscle twitching; seizures; coma; death.
ProZinc should be given to dogs and cats only. ProZinc should not be administered to humans. Call a physician immediately if you accidentally inject yourself with ProZinc. Do not give a dose of ProZinc to a pet experiencing an episode of low blood glucose (hypoglycemia). Common causes for hypoglycemia include excessive doses of insulin, failure to eat, accidental doubling of insulin dose, strenuous exercise, correction of obesity or diabetes-inducing disease, drug effects. Do not give a dose of PROZINC if the pet has not eaten or is vomiting.
Rarely, allergic reactions to insulin can occur. Seek emergency veterinary medical attention if an allergic reaction is experienced (difficulty breathing, swelling of the lips, tongue, or face; or hives). Other serious side effects can occur with or without warning. The most common insulin-related side effect is low blood sugar (hypoglycemia) with symptoms that include; weakness; depression, lethargy, sluggishness; staggering gait; behavioral changes; muscle twitching; seizures; coma; death. Contact your veterinarian immediately if your pet has a medical problem or side effect from ProZinc therapy. Other side effects may occur. Talk to your veterinarian about any side effect that seems unusual or bothersome to the pet.
ProZinc can be given with other medications, but the dose may need to be adjusted due to the medication resulting in either increased or decreased insulin requirements. Do not give any other prescription or over the counter medications, including vitamins, minerals and herbal products, without first talking to your veterinarian or pharmacist during treatment with ProZinc.

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