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HYDROMORPHONE (NEXJECT) (hydromorphone hydrochloride injection, USP)
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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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