BUTORPHIC- butorphanol tartrate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Akorn

INN (International Name):

Butorphanol Tartrate

Composition:

Butorphanol Tartrate 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Butorphic (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.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

BUTORPHIC- BUTORPHANOL TARTRATE INJECTION, SOLUTION
AKORN
----------
BUTORPHIC CIV
(BUTORPHANOL TARTRATE INJECTION)
CAUTION
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian
DESCRIPTION
Butorphic (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
C
H
NO •C H O .
CHEMICAL STRUCTURE:
Each mL of Butorphic contains 10 mg butorphanol base (as butorphanol
tartrate), 3.3
mg citric acid, 6.4 mg sodium citrate, 4.7 mg sodium chloride, and 0.1
mg
benzethonium chloride, q.s, with water for injection.
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.
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.
Furthermore, the cardiopulmonary effects of butorphanol are not
distinctly
dosage related but rather reach a ceiling effect beyond which further
dosage increases
®
21
29
2
4
6
6
®
1
2,3
4
1
5
6,7
8
1
result in relatively lesser effects.
Reproduction: Studie