ROMPUN- xylazine injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

XYLAZINE (UNII: 2KFG9TP5V8) (XYLAZINE - UNII:2KFG9TP5V8)

Available from:

Dechra Vet Products, LLC

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATIONS: Rompun (xylazine injection) should be used in horses and Cervidae (Fallow Deer, Mule Deer, Sika Deer, White-Tailed Deer and Elk) when it is desirable to produce a state of sedation accompanied by a shorter period of analgesia. Horses: Rompun (xylazine injection) has been used successfully as follows: - Diagnostic procedures–oral and ophthalmic examinations, abdominal palpation, rectal palpation, vaginal examination, catheterization of the bladder and radiographic examinations. - Orthopedic procedures, such as application of casting materials and splints. - Dental procedures. - Minor surgical procedures of short duration such as debridement, removal of cutaneous neoplasms and suturing of lacerations. - To calm and facilitate handling of fractious animals. - Therapeutic medication for sedation and relief of pain following injury or surgery. - Major surgical procedures: When used as a preanesthetic to general anesthesia. When used in conjunction with local anesthetics. - When used as a preanesthet

Product summary:

HOW SUPPLIED: Rompun (xylazine injection) 100 mg/mL Injection for intravenous or intramuscular use is available in 50 mL multiple dose vials. STORAGE: Do not Freeze. Store at 20°C - 25°C (68°F - 77°F), excursions permitted up to 40°C (104°F).

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ROMPUN- XYLAZINE INJECTION, SOLUTION
DECHRA VET PRODUCTS, LLC
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ROMPUN
(XYLAZINE INJECTION)
100 MG/ML
SEDATIVE AND ANALGESIC FOR USE IN HORSES AND_ CERVIDAE_ ONLY
DESCRIPTION: Rompun (xylazine injection) is supplied in 50 mL multiple
dose vials as a
sterile solution. Each mL contains 100 mg Rompun (xylazine base
equivalent); 0.9 mg
methylparaben; 0.1 mg propylparaben; water for injection; citric acid
and sodium citrate
for pH adjustment to 5.5 + 0.3.
ACTIVE INGREDIENT:
xylazine hydrochloride
(Equivalent to 10%
base)
11.4%
INERT INGREDIENTS:
88.6%
100.0%
CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the
order of a
licensed veterinarian. Do not use in _Cervidae_ less than 15 days
before or during the
hunting season.
PHARMACOLOGY: Rompun, a non-narcotic compound, is a sedative and
analgesic as
well as muscle relaxant. Its sedative and analgesic activity is
related to central nervous
system depression. Its muscle-relaxant effect is based on inhibition
of the intraneural
transmission of impulses in the central nervous system. The principal
pharmacological
activities develop within 10 to 15 minutes after intramuscular
injection, and within 3 to 5
minutes following intravenous administration in horses.
A sleeplike state, the depth of which is dose-dependent, is usually
maintained for 1 to 2
hours, while analgesia lasts from 15 to 30 minutes. The
centrally-acting muscle relaxant
effect causes relaxation of the skeletal musculature, complementing
sedation and
analgesia.
In horses and _Cervidae_ under the influence of Rompun the respiratory
rate is reduced
as in natural sleep. Following treatment with Rompun the heart rate is
decreased and a
transient change in the conductivity of the cardiac muscle may occur,
as evidenced by a
partial atrioventricular block. This resembles the atrioventricular
block often observed in
normal horses.
Although a partial A-V block may occasionally occur following
intramuscular injection of Rompun (xylazine injection), the incidence
is less than when it
is administ