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HYDROMORPHONE (NEXJECT) (hydromorphone hydrochloride injection, USP)

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HYDROMORPHONE (NEXJECT) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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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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3 DOSAGE FORMS AND STRENGTHS

Hydromorphone Hydrochloride Injection, USP is available as:

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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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6 ADVERSE REACTIONS

The following serious adverse reactions are described, or described in greater detail, in other sections:

  • Addiction, Abuse, and Misuse [see...
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7 DRUG INTERACTIONS

Table 1 includes clinically significant drug interactions with Hydromorphone Hydrochloride Injection.

Table 1: Clinically Significant Drug Interactions with...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Prolonged use of opioid...

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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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10 OVERDOSAGE

Clinical Presentation

Acute overdose with Hydromorphone Hydrochloride Injection can be manifested by respiratory depression...

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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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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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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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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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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

To Use NexJect™ Syringe

Figure

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Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

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