DEXDOMITOR- dexmedetomidine hydrochloride injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

dexmedetomidine hydrochloride (UNII: 1018WH7F9I) (dexmedetomidine - UNII:67VB76HONO)

Tilgjengelig fra:

Zoetis Inc.

INN (International Name):

dexmedetomidine hydrochloride

Sammensetning:

dexmedetomidine 0.5 mg in 1 mL

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION

Indikasjoner:

DEXDOMITOR 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. DEXDOMITOR is also indicated for use as a preanesthetic to general anesthesia in dogs and cats. Do not use DEXDOMITOR 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.

Produkt oppsummering:

DEXDOMITOR 0.1 mg/mL is supplied in 20-mL multidose vials with filling volume of 15 mL containing 0.1 mg of dexmedetomidine hydrochloride per mL. DEXDOMITOR 0.5 mg/mL is supplied in 10-mL, multidose vials containing 0.5 mg of dexmedetomidine hydrochloride per mL.

Autorisasjon status:

New Animal Drug Application

Preparatomtale

DEXDOMITOR- DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION
ZOETIS INC.
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DEXDOMITOR
DEXDOMITOR®
(dexmedetomidine hydrochloride)
Sterile Injectable Solution – 0.1 mg/mL
Sterile Injectable Solution – 0.5 mg/mL
Intramuscular and Intravenous use in Dogs
Intramuscular use in Cats
Sedative, Analgesic, Preanesthetic
This listing contained the combined text for the 0.1 mg/mL and 0.5
mg/mL solutions.
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
DEXDOMITOR (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:
0.1 - Each mL of DEXDOMITOR 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.
0.5 - Each mL of DEXDOMITOR 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
®
2
13
16
2
DEXDOMITOR 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. DEXDOMITOR is also indicated for use as a
preanesthetic to general
anesthesia in dogs and cats.
DOSAGE AND ADMINISTRATION
DOGS - 0.1
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. Fo