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hydromorphone hydrochloride injection, USP (HIGH POTENCY)
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.
hydromorphone hydrochloride injection, USP (HIGH POTENCY) Quick Finder
Highlights
Boxed Warning
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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Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
4 CONTRAINDICATIONS
Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is contraindicated in patients with:
- Significant respiratory depression [see...
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Warnings and Precautions
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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Drug Interactions
7 DRUG INTERACTIONS
Table 1 includes clinically significant drug interactions with Hydromorphone Hydrochloride Injection [high potency formulation (HPF)].
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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
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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Overdosage
10 OVERDOSAGE
Clinical Presentation
Acute overdose with Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] can be...
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Description
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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Clinical Pharmacology
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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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
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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Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
Serotonin Syndrome
Inform patients that opioids could cause a rare but potentially life-threatening...
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Report Adverse Event
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*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.