TORPHAJECT- butorphanol tartrate injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

Butorphanol Tartrate (UNII: 2L7I72RUHN) (Butorphanol - UNII:QV897JC36D)

Tilgængelig fra:

Butler Animal Health Supply, LLC D/B/A Henry Schein Animal Health

INN (International Name):

Butorphanol Tartrate

Sammensætning:

Butorphanol Tartrate 10 mg in 1 mL

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION

Terapeutiske indikationer:

TORPHAJECT (butorphanol tartrate) Injection is indicated for the relief of pain associated with colic in adult horses and yearlings. Clinical studies in the horse have shown that butorphanol tartrate alleviates abdominal pain, associated with torsion, impaction, intussusception, spasmodic and tympanic colic, and postpartum pain.

Produkt oversigt:

TORPHAJECT (butorphanol tartrate) Injection, 10 mg base activity per mL. 11695-6836-2     20 mL vial in package of one 11695-6836-5     50 mL vial in package of one Store at controlled room temperature 20° to 25°C (68° to 77°F). Protect from light.

Autorisation status:

Abbreviated New Animal Drug Application

Produktets egenskaber

TORPHAJECT- BUTORPHANOL TARTRATE INJECTION, SOLUTION
BUTLER ANIMAL HEALTH SUPPLY, LLC D/B/A HENRY SCHEIN ANIMAL HEALTH
----------
ANADA # 200-332, Approved by FDA
TORPHAJECT CIV
(BUTORPHANOL TARTRATE INJECTION)
CAUTION
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian
DESCRIPTION
TORPHAJECT (butorphanol tartrate) Injection is a totally synthetic
centrally acting,
narcotic agonist- antagonist analgesic with potent antitussive
activity. It is a member of
the phenanthrene series. The chemical name is Morphinan-3, 14-diol,
17-
(cyclobutylmethyl)-,(-)-, (S-(R*,R*))-2,3-dihydroxybutanedioate (1:1)
(salt). It is a white,
crystalline, water soluble substance having a molecular weight of
477.55; its molecular
formula is C21H29NO2•C4H6O6.
CHEMICAL STRUCTURE:
Each mL of TORPHAJECT Injection contains butorphanol base (as
butorphanol tartrate,
USP) 10 mg, 3.3 mg citric acid, USP, 6.4 mg sodium citrate, USP, 4.7
mg sodium
chloride, USP, and 0.1 mg benzethonium chloride, USP, q.s. with water
for injection,
USP.
CLINICAL PHARMACOLOGY
COMPARATIVE PHARMACOLOGY
In animals, butorphanol has been demonstrated to be 4 to 30 times more
potent than
morphine and pentazocine (Talwin -V) respectively.
In humans, butorphanol has been
shown to have 5 to 7 times the analgesic activity of morphine and 20
times that of
pentazocine.
Butorphanol has 15 to 20 times the oral antitussive activity of
codeine or
dextromethorphan in dogs and guinea pigs.
As an antagonist, butorphanol is approximately equivalent to
nalorphine and 30 times
more potent than pentazocine.
®
1
2,3
4
1
Cardiopulmonary depressant effects are minimal after treatment with
butorphanol as
demonstrated in dogs,
humans
and horses.
Unlike classical narcotic agonist
analgesics which are associated with decreases in blood pressure,
reduction in heart
rate, and concomitant release of histamine, butorphanol does not cause
histamine
release.1 Furthermore, the cardiopulmonary effects of butorphanol are
not distinctly
dosage related but rather reac