Vetsulin [porcine insulin zinc suspension] is the only FDA-approved insulin for use in diabetic dogs and cats in the USA.
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vetsulin is a sterile aqueous zinc suspension of purified porcine insulin.
Each mL contains:
Purified porcine insulin 40 IU 35% amorphous and 65% crystalline
Zinc as chloride 0.08 mg
Sodium acetate trihydrate 1.36 mg
Sodium chloride 7.0 mg
Methylparaben preservative 1.0 mg
pH is adjusted with hydrochloric acid and/or sodium hydroxide.
DOSAGE AND ADMINISTRATION:
USE OF A SYRINGE OTHER THAN A U-40 SYRINGE WILL RESULT IN INCORRECT DOSING.
FOR SUBCUTANEOUS INJECTION IN DOGS AND CATS ONLY:
Shake the vial thoroughly until a homogeneous, uniformly milky suspension is obtained.
Foam on the surface of the suspension formed during shaking should be allowed to disperse before the product is used and, if required, the product should be gently mixed to maintain a homogeneous, uniformly milky suspension before use.
Clumps or white particles can form in insulin suspensions: do not use the product if visible clumps or white particles persist after shaking thoroughly.
Using a U-40 insulin syringe, the injection should be administered subcutaneously, 2 to 5 cm 3/4 to 2 in from the dorsal midline, varying from behind the scapulae to the mid-lumbar region and alternating sides.
Always provide the Owner Information Sheet with each prescription.
The initial recommended vetsulin dose is 0.5 IU insulin/kg body weight. Initially, this dose should be given once daily concurrently with, or right after a meal.
Twice daily therapy should be initiated if the duration of insulin action is determined to be inadequate. If twice daily treatment is initiated, the two doses should each be 25% less than the once daily dose required to attain an acceptable nadir. For example, if a dog receiving 20 units of vetsulin once daily has an acceptable nadir but inadequate duration of activity, the vetsulin dose should be changed to 15 units twice daily.
The veterinarian should re-evaluate the dog at appropriate intervals and adjust the dose based on clinical signs, urinalysis results, and glucose curve values until adequate glycemic control has been attained. Further adjustments in 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.
The initial recommended dose in cats is 1 to 2 IU per injection. The injections should be given twice daily at approximately 12 hour intervals. For cats fed twice daily, the injections should be given concurrently with, or right after each meal. For cats fed ad libitum, no change in feeding schedule is needed. The veterinarian should re-evaluate the cat at appropriate intervals and adjust the dose based on clinical signs, urinalysis results, and glucose curve values until adequate glycemic control has been attained.
Further adjustments in 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.
Dogs and cats known to have a systemic allergy to pork or pork products should not be treated with vetsulin. vetsulin is contraindicated during periods of hypoglycemia.
For use in animals only.
Keep out of the reach of children.
Avoid contact with eyes.
In case of contact, immediately flush eyes with copious amounts of water for 15 minutes. Accidental injection may cause clinical 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 see 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, subsequently, the dosage should be adjusted, if indicated. Any change in insulin should be made cautiously and only under a veterinarian's supervision. Changes in insulin strength, manufacturer, type, species animal, human 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 endocrinopathies in pets that are difficult to regulate e.g., hyperadrenocorticism in dogs and hyperthyroidism in cats.
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 are essential to attain and maintain adequate glycemic control and prevent associated complications.
Overdosage can result in profound hypoglycemia and death. Progestogens, certain endocrinopathies, and glucocorticoids can have an antagonistic effect on insulin activity.
Intact bitches should be ovariohysterectomized.
Progestogen and glucocorticoid use should be avoided.
In the US clinical effectiveness studies, dogs and cats received various medications while being treated with vetsulin including antimicrobials, antivirals, antifungals, antihistamines, analgesics, anesthetics/tranquilizers, diuretics, bronchodilators, corticosteroids cats, NSAIDs, thyroid hormone supplementation, hyperthyroid medication methimazole, internal and external parasiticides, anti-emetics, dermatological topical treatments and oral supplements, ophthalmic preparations containing antimicrobials and antiinflammatories, and various vaccines. No medication interactions were reported. This drug was not studied in dogs receiving corticosteroids.
Reproductive Safety: The safety and effectiveness of vetsulin® in breeding, pregnant, and lactating dogs and cats has not been evaluated.
Use in puppies and kittens: The safety and effectiveness of vetsulin in puppies and kittens has not been evaluated.
In the field effectiveness and safety study, 66 dogs were treated with vetsulin. Sixty-two dogs were included in the assessment of safety. Hypoglycemia defined as blood glucose < 50 mg/dL with or without associated clinical signs occurred in 35.5% 22/62 of the dogs at various times during the study. Clinical signs of hypoglycemia were generally mild in nature described as weakness, lethargy, stumbling, falling down, and/or depression. Disorientation and collapse were reported less frequently and occurred in 16.1% 10/62 of the dogs. Two dogs had a seizure and one dog died during the seizure. Although never confirmed, the presumptive diagnosis was hypoglycemia-induced seizures. In the rest of the dogs, hypoglycemia resolved with appropriate therapy and adjustments in insulin dosage. Seven owners recorded the following observations about the injection site on the home monitoring forms: swollen, painful, sore, and a bleb under the skin.
The following clinical observations occurred in the field study following treatment with vetsulin and may be directly attributed to the drug or may be secondary to the diabetic state or other underlying conditions in the dogs: hematuria, vomiting, diarrhea, pancreatitis, non-specific hepatopathy/pancreatitis, development of cataracts, and urinary tract infections.
In a field effectiveness and safety study, safety data was reported for 78 cats receiving vetsulin. Hypoglycemia defined as blood glucose < 50 mg/dL was reported in 61 cats 88 total incidences. Fifteen of the occurrences involving 13 cats were associated with clinical signs described as lethargy, diarrhea, decreased appetite/anorexia, vomiting, and hypothermia. One cat had seizures following accidental overdosing by the owner and again during the subsequent dose adjustment period. The cat responded to supportive therapy and had no further hypoglycemic episodes. In all cases of hypoglycemia, the clinical signs resolved following symptomatic treatment and/or dose adjustment. Polyneuropathy was reported in 4 cats. Two injection site reactions were reported: one as a mildly thickened subcutaneous tissue reaction and the second as a mild bruising.
The following clinical observations occurred in the field study following treatment with vetsulin and may be directly attributed to the drug or may be secondary to the diabetic state or other underlying conditions in the cats: vomiting, lethargy, diarrhea, decreased appetite/anorexia, pancreatitis, dermal events, respiratory disease, urinary tract disorder, renal disease, dehydration, weight loss, polydipsia, polyuria, behavioral change, and ocular discharge/conjunctivitis. In a smaller field effectiveness and safety study, 14 cats were treated with vetsulin. Hypoglycemia was reported in 6 cats 8 total occurrences. Lethargy not associated with hypoglycemia was reported in 4 cats 6 total occurrences. The following clinical observations occurred in the field study following treatment with vetsulin and may be directly attributed to the drug or may be secondary to the diabetic state or other underlying conditions in the cats: foul odor to stool, diarrhea, dull coat, rapid, shallow breathing, stiff gait in rear, gallop rhythm, and pruritus with alopecia.
During the 1998-2007 period, the following adverse events in 50 cats treated with porcine insulin zinc suspension were reported to Intervet International and Intervet Inc: Death, seizures, lack of effectiveness/dysregulation, hypoglycemia, allergic or skin reaction, lethargy, vomiting/diarrhea, injection pain, hyperthermia, nystagmus, PU/PD, and abnormal behavior. To report suspected adverse drug experiences, call Merck at 1-800-224-5318. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or http://www.fda.gov/AnimalVeterinary
Store in an upright position under refrigeration at 2° to 8° C 36° to 46° F. Do not freeze. Protect from light. Use contents within 42 days of first vial puncture.
Distributed by: Intervet Inc d/b/a Merck Animal Health
Summit, NJ 07901
Made in Germany 02/13