- SIMBADOL (package insert), Florham Park, NJ, Zoetis, 2014.
- Data on file. Clinical Efficacy (Soft Tissue), 08-30-MC-D-CT-BP, and Clinical Efficacy (Orthopedic), 08-31-MC-D-CT-BP. Zoetis.
- Hellyer PW, Uhrig SR, Robinson NG. Colorado State University Veterinary Medical Center feline acute pain scale. 2006.
- Brondani, JT, Luna SP, Padovani CR. Refinement and initial validation of a multidimensional composite scale for use in assessing acute postoperative pain in cats. Am J Vet Res. 2011;72(2):174-183.
- Calvo G, Holden E, Reid J, et al. Development of a behaviour-based measurement tool with defined intervention level for assessing acute pain in cats. J Small Anim Pract. 2014;55(12):622-629.
- Freedom of Information Summary, NADA 141-434, SIMBADOL, July 18, 2014.
- Grim K, Tranquilli W, Lamont L, eds. Essentials of Small Animal Anesthesia and Analgesia. 2nd ed. Hoboken, NJ: Wiley-Blackwell; 2011:99.
- Heel RC, Brogden RN, Speight TM, et al. Buprenorphine: a review of its pharmacological properties and therapeutic efficacy. Drugs. 1979;17(2):81-110.
- Steagall PV, Pelligand L, Giordano T, et al. Pharmacokinetic and pharmacodynamic modelling of intravenous, intramuscular and subcutaneous buprenorphine in conscious cats. Vet Anaesth Analg. 2013;40(1):83-95.
Proven efficacy in two large clinical studies in cats
Treatment success defined as a cat not requiring rescue* analgesia during the 72-hour observation period1
SIMBADOL administered subcutaneously once daily on days 1 (60 minutes before surgery), 2 and 31
* A rescue protocol was implemented when a cat was assessed as being uncomfortable or painful. The rescue protocol included meloxicam (0.1 mg/kg. SC). If additional analgesia was required, hydromorphone (0.3 mg/kg, SC) was administered.
Treatment success in feline soft tissue surgery1,3
Randomized, double-blind, placebo-controlled, parallel group study. A total of 221 cats at 19 sites in the US received either a subcutaneous injection of 0.24 mg/kg of SIMBADOL™ (buprenorphine injection) or physiologic saline approximately 60 minutes prior to surgery, at the same time as preanesthetic medication. Subsequent once-daily doses were given at 24 hours and 48 hours after the initial treatment. Treatment success was defined as a cat that made it through an entire 72-hour period without rescue analgesia.3
Treatment success in feline orthopedic surgery1,4
Randomized, double-blind, placebo-controlled, parallel group study. A total of 221 cats at 19 sites in the US received either a subcutaneous injection of 0.24 mg/kg of SIMBADOL™ (buprenorphine injection) or physiologic saline approximately 60 minutes prior to surgery, at the same time as preanesthetic medication. Subsequent once-daily doses were given at 24 hours and 48 hours after the initial treatment. Treatment success was defined as a cat that made it through an entire 72-hour period without rescue analgesia.4
*Orthopedic surgical procedures included onychectomy, onychectomy and castration, or onychectomy and ovariohysterectomy.1,3
Safety profile established
In the Soft Tissue and Orthopedic Surgery studies, the majority of adverse events were mild in severity and either an expected opioid response (mydriasis, hyperactivity, hyperthermia) or similar to the placebo (hypothermia, anorexia, hypotension).2
Target animal safety study demonstrated safety
Well tolerated at up to 5x the labeled dose for up to 9 days6
In a 9-day target animal safety study, 4-month-old healthy cats (4/sex/group; n=32) were administered SIMBADOL™ (buprenorphine injection) subcutaneously at 0X (saline), 1X (0.24 mg/kg), 3X (0.72 mg/kg) or 5X (1.2 mg/kg) once daily.1
“Zoetis recommends use at label dose of 0.24 mg/kg and duration of up to 3 days.”
Surgical blood pressure study showed no effect on blood pressure
There were no differences in mean blood pressure between groups1,6
Arterial blood pressure was assessed in a study of 16 healthy 8.5- to 29.1-month-old cats (4/sex/group) who were subcutaneously administered SIMBADOL™ (buprenorphine injection) at 0.24 mg/kg (1X) or meloxicam (control), one hour prior to anesthetic induction for a 1-hour exploratory laparotomy. Arterial blood pressure was monitored following anesthetic induction and through laparotomy, with indirect blood pressure monitoring prior to anesthesia and for 8 hours following anesthetic recovery.1
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INDICATION: SIMBADOL is indicated for the control of postoperative pain associated with surgical procedures in cats.
See References for detailed information about research studies referenced on this website.
IMPORTANT SAFETY INFORMATION: Due to serious human safety and abuse concerns, including physical or psychological dependence, life-threatening respiratory depression and additive CNS depressant effects, read the full prescribing information before using this drug, including the complete Boxed Warning. Not for use in humans. Hospital staff should be trained in the handling of potent opioids and should avoid accidental exposure. SIMBADOL has not been evaluated in breeding, pregnant, or lactating cats, in cats younger than 4 months of age or moribund cats. Do not use in cats with known hypersensitivity to buprenorphine hydrochloride or any of the components of SIMBADOL, or known intolerance to opioids. Use with caution in cats with impaired hepatic function. Adverse reactions may include hyperthermia, tachycardia, hypotension, hypertension, hypothermia, anorexia, and hyperactivity. For more safety information, refer to the full Prescribing Information.
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