Safety for Zimeta® (dipyrone injection)

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Proven Safety Profile

Zimeta was proven safe when administered at 30 mg/kg by intravenous (IV) injection once or twice daily at 12-hour intervals for up to 3 days.¹

Dipyrone, the active ingredient in Zimeta, has been shown to have low peripheral cyclo-oxygenase (COX) inhibitory activity.^2*

*Equine clinical relevance has not been determined

In a study, clinical signs associated with adverse events were reported in ≤2% of Zimeta-treated horses.¹

The effect of Zimeta on the gastrointestinal system has not been specifically studied. While horses in the studies did not show clinical signs generally associated with gastrointestinal ulceration, researchers did not specifically examine for ulcers before or after treatment with Zimeta.^3,4†

Adverse Events Reported During Field Study (Treated Population)

Adverse Events	Zimeta (N=107) n%	Placebo (N=31) n%
Clinical
Anorexia	1 (1%)	1 (3%)
Injection Site Reaction	1 (1%)	0
Clinical Pathology / Pathology
Elevated serum sorbitol dehydrogenase (SDH)*	5 (5%)	5 (16%)
Hypoalbuminemia*	3 (3%)	1 (3%)
Gastric Ulcers*	2 (2%)	0
Prolonged Activated partial thromboplastin time (APTT)*	1 (1%)	0
Elevated creatinine*	1 (1%)	0
Hyperemic mucosa right dorsal colon	1 (1%)	0

*Please see the full prescribing information for complete adverse reaction information.

^†Two horses (out of 107) in our field study were diagnosed with gastric ulcers after the study concluded. Neither of these horses had gastroscopy performed prior to inclusion in our study, thus the correlation between treatment and ulcer formation is not known^1,4

Zimeta was safely used concomitantly with other therapies, including antibiotics and sedatives, in a field study.¹For more information, please call (866) 683-0660.

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Zimeta is indicated for the control of pyrexia in horses

Important Safety Information
As with all drugs, side effects may occur. Zimeta^®(dipyrone injection) should not be given more frequently than every 12 hours due to the prolongation of prothrombin time (PT) and associated clinical signs of coagulopathy. For use in horses only. Do not use in horses with a hypersensitivity to dipyrone, horses intended for human consumption or any food producing animals, including lactating dairy animals. Not for use in humans, avoid direct contact with skin and keep out of reach of children. Care should be taken to avoid accidental self-injection and routine precautions should be used when handling and using loaded syringes as dipyrone can cause a deficiency in specific white blood cells in humans. Prior to use, horses should undergo a thorough history and physical examination by a veterinarian. Monitor for signs of abnormal bleeding and use caution in horses at risk for hemorrhage. Concurrent use with other NSAIDs, corticosteroids and drugs associated with kidney toxicity, should be avoided. Safety has not been evaluated in horses less than three years of age, horses used for breeding, or in pregnant or lactating mares. As a class, NSAIDs may be associated with gastrointestinal, kidney, and liver toxicity. The most common adverse reactions observed during clinical trials were elevated glucose conversion enzymes, decreased blood protein, gastric ulcers, inflamed or reddened lining of the right dorsal colon, and increased clotting times. Please see product insert for full prescribing information or visit www.dechra-us.com.

References

Zimeta^® (dipyrone injection) [package insert], Rev. 12/2020.
Rogosch T, Sinning C, Podlewski A, et al. Novel bioactive metabolites of dipyrone (metamizol). Bioorg Med Chem. 2012;20(1):101-107.
Morresey PR, White GW, Poole HM, et al. Randomized blinded controlled trial of dipyrone as a treatment for pyrexia in horses. Am J Vet Res. 2019;80(3):294-299.
Data on file. REF-0283. Dechra Ltd.

Zimeta^® is a registered trademark of Kindred Biosciences, Inc. in the United States and/or other countries.