NALBUPHINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Nalbuphine Hydrochloride (UNII: ZU4275277R) (Nalbuphine - UNII:L2T84IQI2K)

Available from:

General Injectables & Vaccines, Inc

INN (International Name):

Nalbuphine Hydrochloride

Composition:

Nalbuphine Hydrochloride 10 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nalbuphine hydrochloride injection is indicated for the management of moderate to pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine hydrochloride can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS ), reserve nalbuphine hydrochloride for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products). - Have not been tolerated, or are not expected to be tolerated - Have not provided adequate analgesia, or are not expected to provide adequate analgesia Nalbuphine Hydrochloride Injection in contraindicated in patients with: - Significant respiratory depression [see WARNINGS ] ) - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscit

Product summary:

Nalbuphine Hydrochloride Injection for intramuscular, subcutaneous, or intravenous use is a sterile solution available in: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from excessive light. Store in carton until contents have been used. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-0839-6.0 Revised: 02/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NALBUPHINE HYDROCHLORIDE- NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
----------
NALBUPHINE HYDROCHLORIDE 10 MG INJECTION, USP 1 ML SINGLE DOSE AMPULE
INJECTION
AMPUL
FLIPTOP VIAL
PROTECT FROM LIGHT.
RX ONLY
BOXED WARNING
WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION AND RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur
with use of
Nalbuphine Hydrochloride Injection, particularly when used
concomitantly with
other opioids or central nervous system depressants. Monitor for
respiratory
depression, especially during initiation of Nalbuphine Hydrochloride
Injection or
following a dose increase [see WARNINGS].
Risks from Concomitant Use With Benzodiazepines Or Other CNS
Depressants
Concomitant use of opioids with benzodiazepines or other central
nervous system
(CNS) depressants, including alcohol, may result in profound sedation,
respiratory
depression, coma, and death [see WARNINGS, PRECAUTIONS; DRUG
INTERACTIONS].
•Reserve concomitant prescribing of nalbuphine hydrochloride and
benzodiazepines or other CNS depressants for use in patients for whom
alternative
treatment options are inadequate.
•Limit dosages and durations to the minimum required.
•Follow patients for signs and symptoms of respiratory depression
and sedation.
DESCRIPTION
Nalbuphine hydrochloride is a synthetic opioid agonist-antagonist
analgesic of the
phenanthrene series. It is chemically related to both the widely used
opioid antagonist,
naloxone, and the potent opioid analgesic, oxymorphone. Chemically
nalbuphine
hydrochloride is
17-(cyclobutylmethyl)-4,5a-epoxymorphinan-3,6a,14-triol
hydrochloride. Nalbuphine hydrochloride molecular weight is 393.91 and
is soluble in
H2O (35.5 mg/mL at 25ºC) and ethanol (0.8%); insoluble in CHCl3 and
ether. Nalbuphine
hydrochloride has pKa values of 8.71 and 9.96. The molecular formula
is C21H27NO4 •
HCl. The structural formula is:
Na