Dexmedetomidine

Indications

Dexmedetomidine Hydrochloride Injection is indicated for use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. Dexmedetomidine Hydrochloride Injection is also indicated for use as a preanesthetic to general anesthesia in dogs and cats.

Dosage and Administration

Dogs: Sedation and Analgesia: 500 mcg/m 2 intramuscularly (IM) or 375 mcg/m 2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m 2 IM. The choice of preanesthetic dose depends on the duration and severity of the procedure, as well as the anesthetic regime. The following two tables may be used to determine the correct dexmedetomidine dosage. Note that the mcg/kg dosage decreases as body weight increases. For example, dogs weighing 2 kg are dosed at 28.1 mcg/kg dexmedetomidine IV, compared to dogs weighing 80 kg that are dosed at 8.7 mcg/kg. Due to the small volume of administration, accurate dosing is not possible in dogs weighing less than 2 kg (4.4 lb). Table 1: CANINE SEDATION/ANALGESIA DOSE TABLE: Intravenous (IV) and Intramuscular (IM) dosing on the basis of body weight Dexmedetomidine Hydrochloride Injection 0.5 mg/mL Sedation/analgesia in dogs Dog Weight Dexmedetomidine 375 mcg/m 2 IV Dexmedetomidine 500 mcg/m 2 IM lbs kg mcg/kg ml mcg/kg mL 4.4 to 7 2 to 3 28.1 0.12 40 0.15 7.1 to 9 3.1 to 4 25 0.15 35 0.2 9.1 to 11 4.1 to 5 23 0.2 30 0.3 11.1 to 22 5.1 to 10 19.6 0.29 25 0.4 22.1 to 29 10.1 to 13 16.8 0.38 23 0.5 29.1 to 33 13.1 to 15 15.7 0.44 21 0.6 33.1 to 44 15.1 to 20 14.6 0.51 20 0.7 44.1 to 55 20.1 to 25 13.4 0.6 18 0.8 55.1 to 66 25.1 to 30 12.6 0.69 17 0.9 66.1 to 73 30.1 to 33 12 0.75 16 1 73.1 to 81 33.1 to 37 11.6 0.81 15 1.1 81.1 to 99 37.1 to 45 11 0.9 14.5 1.2 99.1 to 110 45.1 to 50 10.5 0.99 14 1.3 110.1 to 121 50.1 to 55 10.1 1.06 13.5 1.4 121.1 to 132 55.1 to 60 9.8 1.13 13 1.5 132.1 to 143 60.1 to 65 9.5 1.19 12.8 1.6 143.1 to 154 65.1 to 70 9.3 1.26 12.5 1.7 154.1 to 176 70.1 to 80 9 1.35 12.3 1.8 >176 >80 8.7 1.42 12 1.9 Table 2: CANINE PREANESTHESIA DOSE TABLE: Intramuscular (IM) dosing on the basis of body weight Dexmedetomidine Hydrochloride Injection 0.5 mg/mL Preanesthesia in dogs Dog Weight Dexmedetomidine 125 mcg/m 2 IM Dexmedetomidine 375 mcg/m 2 IM lbs kg mcg/kg mL mcg/kg mL 4.4 to 7 2 to 3 9.4 0.04 28.1 0.12 7.1 to 9 3.1 to 4 8.3 0.05 25 0.15 9.1 to 11 4.1 to 5 7.7 0.07 23 0.2 11.1 to 22 5.1 to 10 6.5 0.1 19.6 0.29 22.1 to 29 10.1 to 13 5.6 0.13 16.8 0.38 29.1 to 33 13.1 to 15 5.2 0.15 15.7 0.44 33.1 to 44 15.1 to 20 4.9 0.17 14.6 0.51 44.1 to 55 20.1 to 25 4.5 0.2 13.4 0.6 55.1 to 66 25.1 to 30 4.2 0.23 12.6 0.69 66.1 to 73 30.1 to 33 4 0.25 12 0.75 73.1 to 81 33.1 to 37 3.9 0.27 11.6 0.81 81.1 to 99 37.1 to 45 3.7 0.3 11 0.9 99.1 to 110 45.1 to 50 3.5 0.33 10.5 0.99 110.1 to 121 50.1 to 55 3.4 0.35 10.1 1.06 121.1 to 132 55.1 to 60 3.3 0.38 9.8 1.13 132.1 to 143 60.1 to 65 3.2 0.4 9.5 1.19 143.1 to 154 65.1 to 70 3.1 0.42 9.3 1.26 154.1 to 176 70.1 to 80 3 0.45 9 1.35 >176 >80 2.9 0.47 8.7 1.42 The use of dexmedetomidine as a preanesthetic markedly reduces anesthetic requirements in dogs. Injectable induction drug requirements for intubation will be reduced between 30% and 60%, depending on the choice of anesthetic and the dexmedetomidine preanesthetic dose. The concentration of inhalation maintenance anesthetic will be reduced between 40% and 60%, depending on the dose of dexmedetomidine. The anesthetic dose should always be titrated against the response of the patient. The choice of anesthetic is left to the discretion of the veterinarian. Cats: Sedation, Analgesia and Preanesthesia: 40 mcg/kg intramuscularly (IM). This dose can also be used as a preanesthetic and has been shown to markedly reduce anesthetic requirements in cats. Injectable anesthetic drug requirements for intubation were reduced up to 49%, depending on the choice of induction drug. The concentration of inhalation maintenance anesthetic was reduced between 35% and 44%, depending on the choice of induction drug. The anesthetic dose should always be titrated against the response of the patient. The following table may be used to determine the correct dexmedetomidine dosage for cats based on body weight. Table 3: FELINE DOSE TABLE: Intramuscular (IM) dosing on the basis of body weight in cats Dexmedetomidine Hydrochloride Injection 0.5 mg/mL Sedation/analgesia and preanesthesia in cats Cat Weight Dexmedetomidine 40 mcg/kg IM lbs kg mcg/kg mL 2 to 4 1 to 2 40 0.1 4.1 to 7 2.1 to 3 40 0.2 7.1 to 9 3.1 to 4 40 0.3 9.1 to 13 4.1 to 6 40 0.4 13.1 to 15 6.1 to 7 40 0.5 15.1 to 18 7.1 to 8 40 0.6 18.1 to 22 8.1 to 10 40 0.7 It is recommended that dogs and cats be fasted for 12 hours before treatment with Dexmedetomidine Hydrochloride Injection. An eye lubricant should be applied to cats to prevent corneal desiccation that may result from a reduction in the blink reflex. Following injection of Dexmedetomidine Hydrochloride Injection, the animal should be allowed to rest quietly for 15 minutes; sedation and analgesia occur within 5 to 15 minutes, with peak effects at 30 minutes after dexmedetomidine.

Contraindications

Do not use Dexmedetomidine Hydrochloride Injection in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. As with all alpha 2 -adrenoceptor agonists, the potential for isolated cases of hypersensitivity, including paradoxical response (excitation), exists.

Warnings

Human safety: Not for human use. Keep out of reach of children. Dexmedetomidine Hydrochloride can be absorbed following direct exposure to skin, eyes, or mouth, and may cause irritation. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. Appropriate precautions should be taken while handling and using filled syringes. Accidental topical (including ocular) exposure, oral exposure, or exposure by injection could cause adverse reactions, including sedation, hypotension, and bradycardia. Seek medical attention immediately. Users with cardiovascular disease (for example, hypertension or ischemic heart disease) should take special precautions to avoid any exposure to this product. Caution should be exercised when handling sedated animals. Handling or any other sudden stimuli, including noise, may cause a defense reaction in an animal that appears to be heavily sedated. The safety data sheet (SDS) contains more detailed occupational safety information. To report adverse reactions in users or to obtain a copy of the SDS for this product call 1-800-932-5676. Note to physician: This product contains an alpha 2 -adrenergic agonist. Animal safety: Dexmedetomidine should not be administered in the presence of preexisting hypotension, hypoxia, or bradycardia. Due to the pronounced cardiovascular effects of dexmedetomidine, only clinically healthy dogs and cats (ASA classes I and II) should be treated. Animals should be frequently monitored for cardiovascular function and body temperature during sedation or anesthesia. Dexmedetomidine sedation is not recommended for cats with respiratory disease. The use of dexmedetomidine as a preanesthetic in dogs and cats significantly reduces the amount of induction and maintenance anesthetic requirements. Careful patient monitoring during anesthetic induction and maintenance is necessary to avoid anesthetic overdose.

Precautions

Apnea may occur with dexmedetomidine use. In the event of apnea, additional oxygen should be supplied. Administration of atipamezole to dogs is warranted when apnea is accompanied by bradycardia and cyanotic mucous membranes. Adverse reaction reports for dexmedetomidine in cats include rare events of severe dyspnea and respiratory crackles diagnosed as acute pulmonary edema. Dyspnea due to the delayed onset of pulmonary edema could develop in rare instances up to three days after dexmedetomidine administration. Some of these acute and delayed pulmonary edema cases have resulted in death although this was not observed in the feline clinical field studies with dexmedetomidine. In dogs, intramuscular atipamezole may be routinely used to rapidly reverse the effects of dexmedetomidine. Since analgesic as well as sedative effects will be reversed, pain management may need to be addressed. In cats, atipamezole has not been evaluated as a routine dexmedetomidine reversal agent. In cats, cases of dyspnea following atipamezole administration have been reported. Dexmedetomidine has not been evaluated in the presence of other preanesthetics in cats. Although not observed in the feline field studies, death has been reported in cats receiving dexmedetomidine in conjunction with ketamine and butorphanol. Analgesia resulting from preanesthetic dexmedetomidine may not provide adequate pain control during the postoperative or postprocedural period. Additional pain management should be addressed as needed. Following administration of dexmedetomidine, a decrease in body temperature is likely to occur unless externally maintained. Once established, hypothermia may persist longer than sedation and analgesia. To prevent hypothermia, treated animals should be kept warm and at a constant temperature during the procedure, and until full recovery. Nervous or excited animals with high levels of endogenous catecholamines may exhibit a reduced pharmacological response to alpha 2 -adrenoceptor agonists like dexmedetomidine (ineffectiveness). In agitated animals, the onset of sedative/analgesic effects could be slowed, or the depth and duration of effects could be diminished or nonexistent. Therefore, allow dogs and cats to rest quietly for 10 to 15 minutes after injection. Repeat dosing has not been evaluated. Administration of anticholinergic agents in dogs or cats at the same time or after dexmedetomidine could lead to adverse cardiovascular effects (secondary tachycardia, prolonged hypertension, and cardiac arrhythmias 1, 2, 3 ). However, an anticholinergic drug may be administered to dogs at least 10 minutes before dexmedetomidine for the prevention of the dexmedetomidine-induced reduction in heart rate. Therefore, the routine use of anticholinergics simultaneously with, or after dexmedetomidine in dogs or cats, is not recommended (see ANIMAL SAFETY ). Spontaneous muscle contractions (twitching) can be expected in some dogs sedated with dexmedetomidine. Dexmedetomidine has been evaluated only in fasted dogs; therefore, its effects on fed dogs (for example, the occurrence of vomiting) have not been characterized. In cats, there is a high frequency of vomition whether fed or fasted; therefore, fasting is recommended to reduce stomach contents. Dexmedetomidine has not been evaluated in dogs younger than 16 weeks of age, in cats younger than 12 weeks of age, or in geriatric dogs and cats. Dexmedetomidine has not been evaluated for use in breeding, pregnant, or lactating dogs or cats.

Adverse Reactions

Canine sedation/anaigesia field study: In the field study safety analysis, 106 dogs received dexmedetomidine and 107 received medetomidine. Dogs ranged from 16 weeks to 16 years of age, representing 49 breeds. The following table shows the number of dogs displaying each clinical observation (some dogs experienced more than one adverse reaction). Table 4: Adverse reactions during the canine sedation/anaigesia field study Dexmedetomidine Total n=106 Medetomidine Total n=107 Ausculted unidentified arrhythmias 19 20 Severe bradycardia requiring treatment 1 1 Apnea requiring treatment 1 0 Slow onset of sedation (exceeding 30 minutes) 1 1 Ineffectiveness (dog standing throughout the study) 3 2 Severe hypothermia requiring treatment 2 0 Prolonged recovery 1 4 The occurrence of ausculted unidentified arrhythmias (some at multiple time points) decreased following the administration of atipamezole. Canine preanesthesia field study: The preanesthesia field study safety analysis included 192 dogs, between 5 months and 15 years of age, representing 43 breeds enrolled for elective procedures conducted under general anesthesia. The following table shows the number of dogs within a treatment group that showed each clinical sign (dogs may have experienced more than one adverse reaction). Table 5: Adverse reactions during the canine preanesthesia field study Treatment Groups Induction Anesthetic: Propofol Barbiturate Preanesthetic Dose: 0 mcg/m 2 n=32 125 mcg/m 2 n=32 375 mcg/m 2 n-32 0 mcg/m 2 n=32 125 mcg/m 2 n=32 375 mcg/m 2 n=32 Emesis 4 7 4 2 3 6 Ventricular premature contractions 0 2 0 4 1 0 Diarrhea 1 0 0 3 1 1 Self trauma 0 2 1 2 1 0 Severe bradycardia 0 0 1 0 0 1 Tachycardia 0 0 0 1 1 0 Urinary incontinence 0 0 0 0 0 1 Other clinical signs observed in dogs treated with dexmedetomidine include decreased respiratory rate and hypothermia. Feline sedation/analgesia field study: The field study safety analysis included 242 cats (122 received dexmedetomidine; 120 received xylazine), 6 months to 17 years of age, and representing 19 breeds. The following table shows the number of cats reported with an adverse reaction (cats may have experienced more than one adverse reaction). Table 6: Adverse reactions during the feline field study Dexmedetomidine n = 122 Xylazine n = 120 Vomiting 70 82 Urinary incontinence 6 11 Hypersalivation 4 5 Involuntary defecation 4 1 Hypothermia 2 1 Diarrhea 2 0 Arrhythmia 1 2 Corneal ulcer 1 0 Cyanosis 1 0 Dyspnea 1 0 The most frequently observed adverse reaction was vomiting in both fasted and fed cats. Other infrequent clinical signs observed in cats treated with dexmedetomidine included fatigue, anorexia, cystitis, and peripheral vascular disorder. One incidence of dyspnea was reported, 43 minutes after dexmedetomidine administration during an oral examination/dental procedure. Prior to dexmedetomidine, the cat was free of clinical signs, but had a history of asthma and respiratory infection. The cat responded successfully to treatment. Feline preanesthesia field study: The field study safety analysis included 184 cats (116 received dexmedetomidine; 68 received saline), 12 weeks to 16 years of age, and representing 11 breeds. The following table shows the number of cats reported with an adverse reaction (cats may have experienced more than one adverse reaction). Table 7: Adverse reactions during the feline preanesthesia field study Induction Anesthetic Ketamine Propofol Preanesthetic Saline n=37 Dexmedetomidine n=64 Saline n=31 Dexmedetomidine n=52 Emesis 2 20 1 12 Pale mucous membranes 11 9 Decreased body temperature 4 Retching 1 1 3 Heart Murmur 2 Loose Stool 2 Corneal Injury 1 Apnea 1 Behavioral change 1 Fluid in endotracheal tube 1 One case of apnea was reported in a cat that received ketamine as the induction agent. This cat required artificial ventilation from the start of the procedure until 30 minutes into recovery when the cat began to breathe on its own. The cat recovered without further problems. POST APPROVAL EXPERIENCE: The following adverse events were obtained from post-approval adverse drug events reported for dexmedetomidine hydrochloride sterile injectable solution from 2007 to 2009. Not all adverse reactions are reported. Some adverse reactions occurred when dexmedetomidine hydrochloride was used alone for sedation; most occurred when dexmedetomidine hydrochloride was used in the presence of anesthetics and/or other preanesthetics. It is not always possible to reliably estimate the frequency of an adverse event or to establish a causal relationship to the drug, especially when multiple drugs are administered. The following reported adverse events are listed in decreasing order of frequency: Dogs: ineffective for sedation, death, bradycardia, cardiac arrest, apnea, convulsions, vomiting, prolonged sedation, elevated temperature, and delayed sedation. Cats: ineffective for sedation, death, cardiac arrest, vomiting, apnea, prolonged sedation, hypersalivation, hypothermia, bradycardia, cyanotic mucous membranes, sedation too brief, and dyspnea. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Covetrus at 1-855-724-3461 or www.covetrus.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Description

Dexmedetomidine Hydrochloride Injection is a synthetic alpha 2 -adrenoceptor agonist with sedative and analgesic properties. The chemical name is (+)-4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. It is a white, or almost white, crystalline, water soluble substance having a molecular weight of 236.7. The molecular formula is C 13 H 16 N 2 •HCl and the structural formula is: Each mL of Dexmedetomidine Hydrochloride Injection contains 0.5 mg dexmedetomidine hydrochloride, 1.6 mg methylparaben, 0.2 mg propylparaben, 9.0 mg sodium chloride, water for injection, q.s. Structural Formula

Information for Owners

Owners should notify their veterinarian immediately if their cat experiences difficulty breathing due to the rare possibility of delayed onset of pulmonary edema which has been associated with administration of alpha 2 -adrenergic agonists in cats.

Storage

Store at controlled room temperature 20° to 25°C (68° to 77°F). Protect from freezing. Use contents within 90 days of first puncture.

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

• Sedexodine™ (dexmedetomidine hydrochloride) Injection 0.5 mg/mL Sterile Injectable Solution, MWI Veterinary Supply. Set id 87bbc362-1900-4c7c-96dd-085cd5c33c31.
• DEXVETRA (dexmedetomidine hydrochloride) Injection 0.5 mg/mL Sterile Injectable Solution, Parnell Technologies Pty Ltd. Set id 00cfb834-affb-4550-8648-69dbbef11b63.
• Dexmedetomidine Hydrochloride 0.5 mg/mL, FELIX PHARMACEUTICALS PRIVATE LIMITED. Set id d9f09009-4f9c-46a8-b1e2-7af4efab1171.
• DexmedVet™, Cronus Pharma LLC. Set id 9c6e6a62-2a0f-4db8-a999-c9b8a3a98a74.
• Sedexodine™, MWI Animal Health. Set id 18777323-f836-497f-93b3-1d0ce31c43be.
• Dexased™, ASPEN VETERINARY RESOURCES®, LTD. Set id ead855f6-1cb7-4f90-a813-473fe9abb8d7.
• DEXDOMITOR ®, Zoetis Inc.. Set id 9afc5d50-8df7-46e9-b5a0-5573627fc1bc.
• SILEO ®, Zoetis Inc.. Set id 8113cc85-cd1e-4edc-b933-51bdbd1d8b64.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming dexmedetomidine as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.