DORMOSEDAN STERILE- detomidine hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DETOMIDINE HYDROCHLORIDE (UNII: 95K4LKB6QE) (DETOMIDINE - UNII:7N8K34P2XH)

Available from:

Zoetis Inc.

INN (International Name):

detomidine hydrochloride

Composition:

detomidine 10 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Dormosedan® is indicated for use as a sedative and analgesic to facilitate minor surgical and diagnostic procedures in mature horses and yearlings. It has been used successfully for the following: to calm fractious horses, to provide relief from abdominal pain, to facilitate bronchoscopy, bronchoalveolar lavage, nasogastric intubation, nonreproductive rectal palpations, suturing of skin lacerations, and castrations. Additionally, an approved, local infiltration anesthetic is indicated for castration. Dormosedan® should not be used in horses with pre-existing AV or SA block, with severe coronary insufficiency, cerebrovascular disease, respiratory disease, or chronic renal failure. Intravenous potentiated sulfonamides should not be used in anesthetized or sedated horses as potentially fatal dysrhythmias may occur. Information on the possible effects of detomidine hydrochloride in breeding horses is limited to uncontrolled clinical reports; therefore, this drug is not recommended for use in breeding animals.

Product summary:

Dormosedan® is supplied in 5- and 20-mL multidose vials.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

DORMOSEDAN STERILE- DETOMIDINE HYDROCHLORIDE SOLUTION
ZOETIS INC.
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DORMOSEDAN
(DETOMIDINE HYDROCHLORIDE)
_Sedative and Analgesic For Use in Horses Only_
_Sterile Solution_
_10mg/mL_
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
Dormosedan® is a synthetic alpha-2 adrenoreceptor agonist with
sedative and analgesic
properties. The chemical name is 1H imidazole, 4-[(2,3-dimethylphenyl)
methyl]-
hydrochloride and the generic name is detomidine hydrochloride. It is
a white, crystalline,
water-soluble substance having a molecular weight of 222.7. The
molecular formula is
C
H
N ∙HCl.
CHEMICAL STRUCTURE:
Each mL of Dormosedan® contains 10.0 mg detomidine hydrochloride, 1.0
mg methyl
paraben, 5.9 mg sodium chloride, and water for injection, q.s.
CLINICAL PHARMACOLOGY
Dormosedan®, a non-narcotic sedative and analgesic, is a potent α
-adrenoreceptor
agonist which produces sedation and superficial and visceral analgesia
which is dose
dependent in its depth and duration. Profound lethargy and a
characteristic lowering of
the head with reduced sensitivity to environmental stimuli (sounds,
etc.) are seen with
detomidine. A short period of incoordination is characteristically
followed by immobility
and a firm stance with front legs well spread. The analgesic effect is
most readily seen as
®
12
14
2
2
an increase in the pain threshold at the body surface. Sensitivity to
touch is little affected
and in some cases may actually be enhanced.
With detomidine administration, heart rate is markedly decreased,
blood pressure is
initially elevated, and then a steady decline to normal is seen. A
transient change in the
conductivity of the cardiac muscle may occur, as evidenced by partial
atrioventricular
(AV) and sinoauricular (SA) blocks. This change in the conductivity of
the cardiac muscle
may be prevented by IV administration of atropine at 0.02 mg/kg of
body weight.
No effect on blood clotting time or other hematological parameters was
encountered at
dosages o