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:

General Injectables & Vaccines, Inc

INN (International Name):

BUTORPHANOL TARTRATE

Composition:

BUTORPHANOL TARTRATE 2 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTORPHANOL TARTRATE- BUTORPHANOL TARTRATE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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BUTORPHANOL TARTRATE INJECTION, USP
CIV
RX ONLY
PROTECT FROM LIGHT
GLASS FLIPTOP VIAL
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE THREATENING
RESPIRATORY DEPRESSION; AND NEONATAL OPIOID WITHDRAWL SYNDROME
Addiction, Abuse, and Misuse
Butorphanol tartrate injection exposes patients and other users to the
risks of opioid addiction,
abuse, and misuse, which can lead to overdose and death. Assess each
patient's risk prior to
prescribing butorphanol tartrate injection, and monitor all patients
regularly for the development
of these behaviors or conditions [see WARNINGS].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur
with use of butorphanol
tartrate injection. Monitor for respiratory depression, especially
during initiation of butorphanol
tartrate injection or following a dose increase [see WARNINGS].
NeonatalOpioid WithdrawalSyndrome
Prolonged use of butorphanol tartrate injection during pregnancy can
result in neonatal opioid
withdrawal syndrome, which may be life-threatening if not recognized
and treated, and requires
management according to protocols developed by neonatology experts. If
opioid use is required
for a prolonged period in a pregnant woman, advise the patient of the
risk of neonatal opioid
withdrawalsyndrome and ensure that appropriate treatment will be
available [see WARNINGS].
_DESCRIPTION_
Butorphanol tartrate is a synthetically derived opioid
agonist-antagonist analgesic of the phenanthrene
series. The chemical name is (-)-17-(cyclobutylmethyl) morphinan-3,
14-diol D-(-)- tartrate (1:1) (salt).
The molecular formula is C21H29NO2 • C4H6O6, which corresponds to a
molecular weight of
477.56 and the following structural formula:
Butorphanol tartrate is a white crystalline substance. The dose is
expressed as the tartrate salt. One
milligram of the salt is equivalent to 0.68 mg of the free base. The
n-octanol/aqueous buffer partition