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hydromorphone hydrochloride injection, USP (HIGH POTENCY)

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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 hydrochloride injection, USP (HIGH POTENCY) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

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1 INDICATIONS AND USAGE

Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to...

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2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

  • Always initiate dosing in opioid-naïve patients using Hydromorphone Hydrochloride...
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3 DOSAGE FORMS AND STRENGTHS

Hydromorphone Hydrochloride Injection, USP [high potency formulation (HPF)] is a clear, colorless to nearly colorless aqueous sterile solution.

Each amber vial contains 10 mg/mL of...

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4 CONTRAINDICATIONS

Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is contraindicated in patients with:

  • Significant respiratory depression [see...
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5 WARNINGS AND PRECAUTIONS

5.1 Risk of Medication Errors

Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is a 10 mg/mL concentrated solution of...

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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 [high potency formulation (HPF)].

Table 1: Clinically Significant...
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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 [high potency formulation (HPF)] contains hydromorphone, which is a...

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10 OVERDOSAGE

Clinical Presentation

Acute overdose with Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] can be...

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11 DESCRIPTION

Hydromorphone Hydrochloride, a hydrogenated ketone of morphine, is an opioid agonist.

Hydromorphone Hydrochloride Injection, USP [high potency formulation (HPF)] is available as a sterile, aqueous...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Hydromorphone is a full opioid agonist and is relatively selective for the mu-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

Hydromorphone Hydrochloride Injection, USP (HPF) is supplied in single-dose amber vials. Each single-dose vial of sterile aqueous solution contains 10 mg per mL of 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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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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