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Black Box Warning
WARNING: RISK OF RESPIRATORY DEPRESSION, ABUSE, AND MEDICATION ERRORS
See full prescribing information for complete Boxed Warning.
HYDROMORPHONE HCl INJECTION (high potency formulation) IS FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
Hydromorphone HCl Injection (high potency formulation) is a more concentrated solution of hydromorphone than Hydromorphone HCl Injection, and is for use in opioid-tolerant patients only. Do not confuse Hydromorphone HCl Injection (high potency formulation) with standard parenteral formulations of Hydromorphone Hydrochloride or other opioids, as overdose and death could result.
Hydromorphone HCl Injection (high potency formulation) contain hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Hydromorphone HCl Injection (high potency formulation) can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing Hydromorphone HCl Injection (high potency formulation) in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion.
Schedule II opioid agonists, including morphine, oxymorphone, hydromorphone, oxycodone, fentanyl, and methadone, have the highest potential for abuse and risk of producing fatal overdose due to respiratory depression. Ethanol, other opioids, and other central nervous system depressants (e.g., sedative-hypnotics, skeletal muscle relaxants) can potentiate the respiratory-depressant effects of hydromorphone and increase the risk of adverse outcomes, including death.
There is limited information regarding Hydromorphone hydrochloride (injection) FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Hydromorphone hydrochloride (injection) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydromorphone hydrochloride (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Hydromorphone hydrochloride (injection) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Hydromorphone hydrochloride (injection) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydromorphone hydrochloride (injection) in pediatric patients.
Contraindications
There is limited information regarding Hydromorphone hydrochloride (injection) Contraindications in the drug label.
Warnings
WARNING: RISK OF RESPIRATORY DEPRESSION, ABUSE, AND MEDICATION ERRORS
See full prescribing information for complete Boxed Warning.
HYDROMORPHONE HCl INJECTION (high potency formulation) IS FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
Hydromorphone HCl Injection (high potency formulation) is a more concentrated solution of hydromorphone than Hydromorphone HCl Injection, and is for use in opioid-tolerant patients only. Do not confuse Hydromorphone HCl Injection (high potency formulation) with standard parenteral formulations of Hydromorphone Hydrochloride or other opioids, as overdose and death could result.
Hydromorphone HCl Injection (high potency formulation) contain hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Hydromorphone HCl Injection (high potency formulation) can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing Hydromorphone HCl Injection (high potency formulation) in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion.
Schedule II opioid agonists, including morphine, oxymorphone, hydromorphone, oxycodone, fentanyl, and methadone, have the highest potential for abuse and risk of producing fatal overdose due to respiratory depression. Ethanol, other opioids, and other central nervous system depressants (e.g., sedative-hypnotics, skeletal muscle relaxants) can potentiate the respiratory-depressant effects of hydromorphone and increase the risk of adverse outcomes, including death.
There is limited information regarding Hydromorphone hydrochloride (injection) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Hydromorphone hydrochloride (injection) in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Hydromorphone hydrochloride (injection) in the drug label.
Drug Interactions
There is limited information regarding Hydromorphone hydrochloride (injection) Drug Interactions in the drug label.
There is limited information regarding Patient Counseling Information of Hydromorphone hydrochloride (injection) in the drug label.
Precautions with Alcohol
Alcohol-Hydromorphone hydrochloride (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.