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HYDROMORPHONE (NEXJECT) (hydromorphone hydrochloride injection, USP)
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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.
HYDROMORPHONE (NEXJECT) Quick Finder
Highlights
Boxed Warning
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
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Indications and Usage
1 INDICATIONS AND USAGE
Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
- Use the lowest effective dosage for the shortest duration consistent with...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Hydromorphone Hydrochloride Injection, USP is available as:
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Contraindications
4 CONTRAINDICATIONS
Hydromorphone Hydrochloride Injection is contraindicated in patients with:
- Significant respiratory depression [see Warnings and Precautions (5...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Addiction, Abuse, and Misuse
Hydromorphone Hydrochloride Injection contains hydromorphone, a Schedule II controlled substance. As an...
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Drug Interactions
7 DRUG INTERACTIONS
Table 1 includes clinically significant drug interactions with Hydromorphone Hydrochloride Injection.
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Prolonged use of opioid...
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Drug Abuse and Dependence
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9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
Hydromorphone Hydrochloride Injection contains hydromorphone, a Schedule II controlled substance.
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Overdosage
10 OVERDOSAGE
Clinical Presentation
Acute overdose with Hydromorphone Hydrochloride Injection can be manifested by respiratory depression...
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Description
11 DESCRIPTION
Hydromorphone Hydrochloride Injection is an opioid agonist, available as an aqueous sterile solution. Each 1 mL of sterile solution contains 1 mg, 2 mg, or 4 mg hydromorphone hydrochloride for use in...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Hydromorphone is a full opioid agonist and is relatively selective for the mµ-opioid receptor, although it can bind...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Safety and Handling Instructions
Access to drugs with a potential for abuse such as Hydromorphone...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Serotonin Syndrome
Inform patients that opioids could cause a rare but potentially life-threatening...
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Instructions For Use
INSTRUCTIONS FOR USE
To Use NexJect™ Syringe
Instructions for use – NexJect Prefilled Syringe
...
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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.