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Roxee Medication Guide
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
These are the reference facts Roxee uses on browse cards and quick facts.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Generic profile • No FDA branded products linked
Species: Both
Manufacturer: Boehringer Ingelheim Animal Health USA, Inc.
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs with diabetes mellitus. For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus. Species commonly shown: Both, Dog, Cat.
For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs with diabetes mellitus. For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus.
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use of a syringe other than a U-40 syringe will result in incorrect dosing. For subcutaneous injection in cats only.
Top reported reactions (openFDA): Hyperglycaemia, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Weight loss, Hyperkalaemia.
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Used for:
For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus.
Dosing note:
Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.
What to watch for:
When to call the vet:
Regulatory restrictions are shown in Vet View.
What to tell or ask your vet today:
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
Roxee has limited cited overview evidence for Insulin; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 27 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.
Elevated cholesterol (1 reports), Elevated alanine aminotransferase (1 reports), Dry mucous membrane (1 reports), Distress (1 reports), Dilated pupils (1 reports)
Digestive (2), Neurologic (1), Behavior (1), Other (28)
Cat (23 reports), Dog (9 reports)
Domestic Shorthair (4), Samoyed (1), Maltese (1), Domestic Longhair (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Insulin fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
Use of a syringe other than a U-40 syringe will result in incorrect dosing, For subcutaneous injection in cats only, Elevated cholesterol, Elevated alanine aminotransferase, Dry mucous membrane
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: February 12, 2026, 10:44 PM UTC
Side effects to monitor:
Most reported reactions:
Emergency warning signs:
Source-backed clinical checkpoints for quick review.
Official label facts first, then secondary summaries. Marketing content is separated below.
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use of a syringe other than a U-40 syringe will result in incorrect dosing. For subcutaneous injection in cats only.
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Received 2026-02-11 · MSK · MSK
Received 2026-01-20 · MSK · MSK
Received 2025-12-16 · MSK · MSK
Received 2025-12-10 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 |
Species coverage: Cat (23) Dog (9)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Neurologic | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Digestive | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Behavior | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 |
The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.
Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.
Full source previews and metadata remain in the veterinary/professional layer.
Owner handouts · Official label
Official label / PI · Labeling
Official label / PI · Labeling
Official label / PI · Official label
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs with diabetes mellitus.
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 (the blood glucose curve values and shape, nadir, and fructosamine) until adequate glycemic control has been attained. In the effectiveness field study, glycemic control was considered adequate if the glucose nadir from a 9-hour blood glucose curve was between 80 and 125 mg/dL, the maximum blood glucose was lessThanEqualTo 300 mg/dL, and clinical signs of hyperglycemia such as polyuria, polydipsia, or weight loss were improved.
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 because ProZinc® may have prolonged duration of action in some dogs. The veterinarian should closely monitor the duration of action using blood glucose curves to avoid the increased risk of hypoglycemia. 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. For example, if a dog receiving 10 units of ProZinc® once daily has an acceptable nadir but inadequate duration of activity, the dose should be changed to 7 units twice daily (round down to the nearest whole unit).
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.
FOI · FOI
FOI · FOI
FOI · FOI summary
FOI · FOI summary
FOI · FOI summary
FOI · FOI summary
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
Quick facts and links to official labeling and safety signals.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 0010-4499-01 | 0010 | - | |
| 0010-4499-02 | 0010 | - | |
| 57926-490-62 | 57926 | - | |
| 57926-490-69 | 57926 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
ProZinc®
RX
Insulin
Liquid (Suspension)
• Subcutaneous
|
Boehringer Ingelheim Animal Health USA, Inc. | NADA 141-297 | Approved | Nov 13, 2023 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs with diabetes mellitus.
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 (the blood glucose curve values and shape, nadir, and fructosamine) until adequate glycemic control has been attained. In the effectiveness field study, glycemic control was considered adequate if the glucose nadir from a 9-hour blood glucose curve was between 80 and 125 mg/dL, the maximum blood glucose was lessThanEqualTo 300 mg/dL, and clinical signs of hyperglycemia such as polyuria, polydipsia, or weight loss were improved.
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 because ProZinc® may have prolonged duration of action in some dogs. The veterinarian should closely monitor the duration of action using blood glucose curves to avoid the increased risk of hypoglycemia. 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. For example, if a dog receiving 10 units of ProZinc® once daily has an acceptable nadir but inadequate duration of activity, the dose should be changed to 7 units twice daily (round down to the nearest whole unit).
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.
FDA page: Open in Animal Drugs @ FDA
For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs with diabetes mellitus. For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus.
Source: FDA Animal Drugs @ FDA • Reference
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use of a syringe other than a U-40 syringe will result in incorrect dosing. For subcutaneous injection in cats only.
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Showing top 5 for Digestive.
Showing top 5 for Neurologic.
Showing top 5 for Behavior.
Showing top 5 for Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Cat, Domestic Shorthair, Female, 11 year, 5.534 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vocalisation, Agonal breathing, Death • Outcome: Died
Dog, Samoyed, Female, 13 year, 27.216 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Unsteady walking (ataxia), Unable to rise • Outcome: Outcome Unknown
Cat, Domestic Shorthair, Male, 13 year, 8.845 kilogram • Drug: MSK, Injection, suspension, Subcutaneous • Reactions: Injection site abscess, Injection site lump • Outcome: Ongoing
Cat, Domestic Shorthair, Female, 17 year, 4.082 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Hind limb paralysis, Death, Unable to walk, Injection site reaction NOS • Outcome: Died
Dog, Maltese, Female, 12 year, 3.3 kilogram • Drug: MSK, Injection, Unknown • Reactions: Syncope, Hypertension, Heart murmur, Heart valve disorder, Weakness… • Outcome: Ongoing
Cat, Domestic Shorthair, Female, 14.5 year, 4.536 kilogram • Drug: MSK, Subcutaneous • Reactions: Open mouth breathing, Unable to walk, Balance impaired, Dilated pupils, Abnormal posture NOS… • Outcome: Ongoing
Cat, Domestic Longhair, Male, 12 year, 4.7 kilogram • Drug: MSK, Unknown • Reactions: Elevated betahydroxybutyrate, Hyperglycaemia, Decreased drinking • Outcome: Outcome Unknown
Dog, Terrier - Yorkshire, Male, 6 year, 7.73 kilogram • Drug: MSK, Subcutaneous • Reactions: Not eating, Tiredness (lethargy), Wobbliness, Laboured breathing, Ketonuria • Outcome: Outcome Unknown
Data source: FDA openFDA Animal & Veterinary adverse event reports.
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.