WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Life-Threatening Respiratory Depression
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nalbuphine hydrochloride injection
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
nalbuphine hydrochloride injection Quick Finder
Indications and Usage
INDICATIONS AND USAGE
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...
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Dosage and Administration
DOSAGE AND ADMINISTRATION
Important Dosage and Administration Instructions
Nalbuphine Hydrochloride Injection should be administered as a...
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Warnings and Precautions
WARNINGS
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used...
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Adverse Reactions
ADVERSE REACTIONS
The most frequent adverse reaction in 1066 patients treated in clinical studies with Nalbuphine Hydrochloride Injection was sedation 381 (36%).
Less frequent reactions were: sweaty/clammy 99 (9%),...
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Drug Abuse and Dependence
DRUG ABUSE AND DEPENDENCE
Abuse
Nalbuphine Hydrochloride Injection contains nalbuphine, which can be abused and is subject to misuse, addiction, and criminal diversion...
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Overdosage
OVERDOSAGE
Clinical Presentation
Acute overdose with Nalbuphine Hydrochloride Injection alone can be manifested by respiratory depression and dysphoria. Acute overdose...
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Description
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...
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Clinical Pharmacology
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CLINICAL PHARMACOLOGY
Mechanism of Action
Nalbuphine is an agonist at kappa opioid receptors and an antagonist at mµ opioid receptors.
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How Supplied/Storage and Handling
HOW SUPPLIED
Nalbuphine Hydrochloride Injection for intramuscular, subcutaneous, or intravenous use is a sterile solution available in:
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.