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:

McKesson Corporation dba SKY Packaging

INN (International Name):

Nalbuphine Hydrochloride

Composition:

Nalbuphine Hydrochloride 20 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine Hydrochloride Injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve Nalbuphine Hydrochloride Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - 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 is contraindicated in patients with: - Significant respiratory depression [see WARNINGS ] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] - Known or su

Product summary:

Product: 63739-466 NDC: 63739-466-05 1 mL in a AMPULE / 5 in a BOX

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NALBUPHINE HYDROCHLORIDE- NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION
MCKESSON CORPORATION DBA SKY PACKAGING
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NALBUPHINE HYDROCHLORIDE
INJECTION
AMPUL
FLIPTOP VIAL
PROTECT FROM LIGHT.
RX ONLY
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)-4,5α-
epoxymorphinan-3,6α,14-triol hydrochloride. Nalbuphine hydrochloride
molecular weight is 393.91
and is soluble in H O (35.5 mg/mL at 25°C) and ethanol (0.8%);
insoluble in CHCl
and ether.
Nalbuphine hydrochloride has pKa values of 8.71 and 9.96. The
molecular formula is C
H NO ·
HCl. The structural formula is:
Nalbuphine Hydrochloride Injection is a sterile, nonpyrogenic solution
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