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:

Dechra Veterinary Products

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. Store at controlled room temperature 20°-25°C (68°-77°F).

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

BUTORPHANOL TARTRATE- BUTORPHANOL TARTRATE INJECTION
DECHRA VETERINARY PRODUCTS
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BUTORPHANOL TARTRATE INJECTION CIV
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 .
Each mL of Butorphanol Tartrate Injection 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 5-7 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 result in relatively lesser effects.
Reproduction: Studies performed in mice and rabbits revealed no