Dexmedetomidine Hydrochloride: Product Information

DEXMEDETOMIDINE HYDROCHLORIDE- dexmedetomidine hydrochloride injection, solution
BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA

Intramuscular and Intravenous use in Dogs

Intramuscular use in Cats

Sedative, Analgesic, Preanesthetic

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

Dexmedetomidine Hydrochloride Injection is a synthetic alpha2 -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 C13 H16 N2 •HCl and the structural formula is:

Structural Formula

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.

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
DogWeight Dexmedetomidine375 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
DogWeight Dexmedetomidine125 mcg/m 2 IM Dexmedetomidine375 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
CatWeight Dexmedetomidine40 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.

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