BUTORPHANOL TARTRATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUTORPHANOL TARTRATE (UNII: 2L7I72RUHN) (BUTORPHANOL - UNII:QV897JC36D)

Available from:

Elanco US Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

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 Injection alleviates abdominal pain associated with torsion, impaction, intussusception, spasmodic and tympanic colic and postpartum pain.

Product summary:

50 mL vials Butorphanol Tartrate Injection. 10 mg base activity per mL.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

BUTORPHANOL TARTRATE- BUTORPHANOL TARTRATE INJECTION
ELANCO US INC.
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CIV
BUTORPHANOL TARTRATE INJECTION
_ELANCO_™
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
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 Butorphanol Tartrate Injection contains 10 mg butorphanol
base (as
butorphanol tartrate), 3.3 mg citric acid, USP, 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 5-7 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
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2, 3
4
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dosage-related but rather reach a ceiling effect beyond which further
dosage increases
result in relatively lesser effects.
Repr