DEXMEDESED- dexmedetomidine hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Dexmedetomidine Hydrochloride (UNII: 1018WH7F9I) (Dexmedetomidine - UNII:67VB76HONO)

Available from:

Dechra Veterinary Products LLC

INN (International Name):

Dexmedetomidine Hydrochloride

Composition:

Dexmedetomidine 0.5 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATIONS: Dexmedesed 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. Dexmedesed is also indicated for use as a preanesthetic to general anesthesia in dogs and cats. CONTRAINDICATIONS: Do not use Dexmedesed 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.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

DEXMEDESED- DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION
DECHRA VETERINARY PRODUCTS LLC
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DEXMEDESED
(DEXMEDETOMIDINE HYDROCHLORIDE)
STERILE INJECTABLE SOLUTION-0.5 MG/ML
FOR INTRAMUSCULAR AND INTRAVENOUS USE IN DOGS
FOR 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: Dexmedesed (dexmedetomidine hydrochloride) is a synthetic
alpha -
adrenoreceptor 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
H
N ∙ HCl and the structural formula is:
Each mL of Dexmedesed contains 0.5 mg dexmedetomidine hydrochloride,
1.6 mg
methylparaben (NF), 0.2 mg propylparaben (NF), 9.0 mg sodium chloride
(USP), and
water for injection (USP), q.s.
INDICATIONS: Dexmedesed 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. Dexmedesed 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 INTRAMUSCULARLY (IM) OR 375
MCG/M INTRAVENOUSLY (IV).
PREANESTHESIA: 125 OR 375 MCG/M 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
®
2
13
16
2
2
2
2
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: INTRAVEN