Dexmedetomidine Hydrochloride (3 brand names, 3 dosage forms, 3 routes)
Available dosage forms: INJECTABLE, SOLUTION, FILM.
Routes of administration: INJECTION, INTRAVENOUS, BUCCAL, SUBLINGUAL.
Brand Names
- DEXMEDETOMIDINE HYDROCHLORIDE
- IGALMI
- PRECEDEX
Indications and Usage
Sedexodine™ 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. Sedexodine™ is also indicated for use as a preanesthetic to general anesthesia in dogs and cats.
Dosage and Administration
Dogs: Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 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. Sedexodine™ 0.5 mg/mL Sedation/analgesia in dogs Dog Weight Dexmedetomidine 375 mcg/m2 IV Dexmedetomidine 500 mcg/m2 IM lbs Kg mcg/kg mL mcg/kg mL 4.4-7 2-3 28.1 0.12 40 0.15 7.1-9 3.1-4 25 0.15 35 0.2 9.1-11 4.1-5 23 0.2 30 0.3 11.1-22 5.1-10 19.6 0.29 25 0.4 22.1-29 10.1-13 16.8 0.38 23 0.5 29.1-33 13.1-15 15.7 0.44 21 0.6 33.1-44 15.1-20 14.6 0.51 20 0.7 44.1-55 20.1-25 13.4 0.6 18 0.8 55.1-66 25.1-30 12.6 0.69 17 0.9 66.1-73 30.1-33 12 0.75 16 1 73.1-81 33.1-37 11.6 0.81 15 1.1 81.1-99 37.1-45 11 0.9 14.5 1.2 99.1-110 45.1-50 10.5 0.99 14 1.3 110.1-121 50.1-55 10.1 1.06 13.5 1.4 121.1-132 55.1-60 9.8 1.13 13 1.5 132.1-143 60.1-65 9.5 1.19 12.8 1.6 143.1-154 65.1-70 9.3 1.26 12.5 1.7 154.1-176 70.1-80 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. Sedexodine™ 0.5 mg/mL Preanesthesia in dogs Dog Weight Dexmedetomidine 125 mcg/m2 IM Dexmedetomidine 375 mcg/m2 IM lbs Kg mcg/kg mL mcg/kg mL 4.4-7 2-3 9.4 0.04 28.1 0.12 7.1-9 3.1-4 8.3 0.05 25 0.15 9.1-11 4.1-5 7.7 0.07 23 0.2 11.1-22 5.1-10 6.5 0.1 19.6 0.29 22.1-29 10.1-13 5.6 0.13 16.8 0.38 29.1-33 13.1-15 5.2 0.15 15.7 0.44 33.1-44 15.1-20 4.9 0.17 14.6 0.
Contraindications
Do not use Sedexodine™ 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 alpha2-adrenoceptor agonists, the potential for isolated cases of hypersensitivity, including paradoxical response (excitation), exists.
Adverse Reactions
Canine sedation/analgesia 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/analgesia 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/m2 n=32 125 mcg/m2 n=32 375 mcg/m2 n=32 0 mcg/m2 n=32 125 mcg/m2 n=32 375 mcg/m2 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