BUTORPHANOL- 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:

Aspen Veterinary Resources

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Butorphanol (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.

Product summary:

Butorphanol (butorphanol tartrate injection) 10 mg base activity per mL. NDC 46066-752-01         20 mL vial in package of one NDC 46066-752-02         50 mL vial in package of one

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

BUTORPHANOL- BUTORPHANOL TARTRATE INJECTION, SOLUTION
ASPEN VETERINARY RESOURCES
----------
ANADA # 200-332, Approved by FDA
BUTORPHANOL CIV
(BUTORPHANOL TARTRATE) INJECTION
CAUTION
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian
DESCRIPTION
BUTORPHANOL (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 BUTORPHANOL 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.
Cardiopulmonary depressant effects are minimal after treatment with
butorphanol as
®
1
2,3
4
1
5
6,7
8
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 whi