HYDROMORPHONE (NEXJECT) Contraindications (hydromorphone hydrochloride injection, USP) | Pfizer Medical Information - US

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4 CONTRAINDICATIONS

Hydromorphone Hydrochloride Injection is contraindicated in patients with:

Significant respiratory depression [see Warnings and Precautions (5.2)]
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.5)]
Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.9)]
Hypersensitivity to hydromorphone (e.g., anaphylaxis) [see Adverse Reactions (6)]

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.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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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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4 CONTRAINDICATIONS

Hydromorphone Hydrochloride Injection is contraindicated in patients with:

Significant respiratory depression [see Warnings and Precautions (5...

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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.

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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

Instructions for use – NexJect Prefilled Syringe

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Pfizer Safety

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:

Pfizer Safety Reporting Site

*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.

FDA Medwatch

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.