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Ethiqa XR is the ONLY pharmaceutical grade, FDA-indexed extended-release buprenorphine analgesic indicated for the control of post-procedural pain in mice and rats.1
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*current Good Manufacturing Practices regulated by the FDA
IMPORTANT SAFETY INFORMATION For Rats and Mice: Only administer Ethiqa XR by subcutaneous injection. Ethiqa XR is not intended for intravenous, intra-arterial, intrathecal, intramuscular, or intra-peritoneal injection. Do not use on mice or rats with pre-existing respiratory deficiencies. Do not keep rats on wood chip-type bedding after administration of Ethiqa XR. Use caution with concomitant administration of Ethiqa XR with drugs that cause respiratory depression. For Humans: Ethiqa XR should only be administered by a veterinarian or laboratory staff trained in the handling of potent opioids. Protective clothing is recommended to avoid direct contact with human skin or mucus membranes which could result in absorption of buprenorphine and adverse reactions. Not for use in humans. For more information, consult the Prescribing Information including the Boxed Warning.
Not for use in humans. Keep out of reach of children. For more information, consult the Prescribing Information, including the Boxed Warning.
WARNING: ABUSE POTENTIAL and LIFE-THREATENING RESPIRATORY DEPRESSION and ACCIDENTAL EXPOSURE
Ethiqa XR contains buprenorphine, a high-concentration (1.3 mg/mL) opioid agonist and Schedule III controlled substance with an abuse potential similar to other Schedule III opioids. The high concentration may be a particular target for human abuse. Buprenorphine has opioid properties that in humans may lead to dependence of the morphine type. Abuse of buprenorphine may lead to low or moderate physical dependence or high psychological dependence. The risk of abuse by humans should be considered when storing, administering, and disposing of Ethiqa XR. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (suicidal depression). Because of human safety risks, this drug should be used only with veterinary supervision.
Do not dispense Ethiqa XR.
Life-Threatening Respiratory Depression
The concentration of buprenorphine in Ethiqa XR is 1.3 mg/mL. Respiratory depression, including fatal cases, may occur with abuse of Ethiqa XR. Ethiqa XR has additive CNS depressant effects when used with alcohol, other opioids, or illicit drugs that cause central nervous system depression. Because of the potential for adverse reactions associated with accidental injection, Ethiqa XR should only be administered by a veterinarian or laboratory staff trained in the handling of potent opioids. For more information, consult the prescribing information including the boxed warning.
References: 1. Data on file at Fidelis Pharmaceuticals, North Brunswick, NJ; November 2021. 2. FDA Expert Panel Report MIF Z-9000008-A-0000, p.6. 3. Guidelines for the use of non-pharmaceutical grade compounds in laboratory animals. National Institutes of Health, Office of Intramural Research, Office of Animal Care and Use Website. https://oacu.oir.nih.gov/sites/default/files/uploads/arac-guidelines/pharmaceutical_compounds.pdf. Accessed September 29, 2021. 4. FDA. Compounding animal drugs from bulk drug substances guidance for industry. CVM GFI #256; April, 2022. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances. 5. ACLAM Position Statement on Pain and Distress in Research Animals. J Am Assoc Lab Anim Sci. 2016;55(6):821. Available at https://www.aclam.org/about/position-statements. Updated December 8, 2016. Accessed September 29, 2021. 6. Nohara M, Tohei A, Sato T, Amao H. Evaluation of response to restraint stress by salivary corticosterone levels in adult male mice. J Vet Med Sci. 2016 Jun 1;78(5):775-80. 7. Bowers SL, Bilbo SD, Dhabhar FS, Nelson RJ. Stressor-specific alterations in corticosterone and immune responses in mice. Brain Behav Immun. 2008 Jan;22(1):105-13. 8. Gong S, Miao YL, Jiao GZ, Sun MJ, Li H, Lin J, Luo MJ, Tan JH. Dynamics and correlation of serum cortisol and corticosterone under different physiological or stressful conditions in mice. PLoS One. 2015 Feb 20;10(2):e0117503. 9. Jameel MK, Joshi AR, Dawane J, Padwal M, Joshi A, Pandit VA, Melinkeri R. Effect of various physical stress models on serum cortisol level in Wistar rats. J Clin Diagn Res. 2014 Mar;8(3):181-3. 10. Carbone ET, Lindstrom KE, Diep S, Carbone L. Duration of Action of Sustained-Release Buprenorphine in 2 Strains of Mice. JAALAS. 2012;51(6):815-819. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC3508187/pdf/jaalas2012000815.pdf. Accessed on July 20, 2019. 11. FDA Expert Panel Report—Rat Efficacy and Safety, p. 3. 12. Haupt J, Fabian N. Dosing accuracy of sustained-release buprenorphine formulations for rodent analgesia: Where is buprenorphine going? Poster presented at: 72nd Annual AALAS Meeting; Kansas City, MO; Oct 17-21, 2021.