Drugplain

Dilaudid 1 mg/mL

Hydromorphone hydrochloride · INJECTION, SOLUTION · Fresenius Kabi USA, LLC

No Recall HistoryCurrently in Shortage
Plain English

Dilaudid is a prescription opioid pain reliever available as an injection that contains hydromorphone hydrochloride and is used to manage moderate to severe pain. It is administered by intramuscular injection at a strength of 1 mg/mL.

Key Facts

Brand Name
Dilaudid
Generic Name
Hydromorphone hydrochloride
NDC Code (Product)
76045-009
Manufacturer
Fresenius Kabi USA, LLC
Strength
1 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
NDA019034
Marketing Start
12/04/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug dependence35,090 reports
overdose23,022 reports
pain22,205 reports
emotional distress17,688 reports
death14,893 reports
drug withdrawal syndrome14,323 reports
toxicity to various agents10,069 reports
nausea4,674 reports
drug ineffective4,409 reports
fatigue3,567 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE DILAUDID INJECTION is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. ( 1 ) Limitations of Use: ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve Hydromorphone Hydrochloride Injection for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): • Have not been tolerated, or are not expected to be tolerated • Have not provided adequate analgesia or are not expected to provide adequate analgesia DILAUDID INJECTION should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. DILAUDID INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 )] , reserve …

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • DILAUDID INJECTION should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 ) • Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of Hydromorphone Hydrochloride Injection for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) • Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. ( 2.1 ) • Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 2.1 , 5.1 ) • Respiratory depression can occur at any time during opioid therapy, especially when initiating and follow…

Contraindications

4 CONTRAINDICATIONS DILAUDID 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 ( 5.6 )] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.10 )] • Hypersensitivity to hydromorphone, hydromorphone salts, any other components of the product, or sulfite containing medications (e.g., anaphylaxis) [see Warnings and Precautions ( 5.14 )] • Significant respiratory depression. ( 4 ) • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) • Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 ) • Known hypersensitivity to hydromorphone, hydromorphone salts, sulfite-containing medications, or any other components of the product. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with DILAUDID INJECTION. Table 1. Clinically Significant Drug Interactions with DILAUDID INJECTION Benzodiazepines and other Central Nervous System Depressants (CNS) Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. [see Warnings and Precautions ( 5.3 )] Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor patients closely for signs of respiratory depression and sedation [see Warnings and Precautions ( 5.3 )]. Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol. Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Intervention: If concomitant use is war…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.1 )] • Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.2 )] • Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions ( 5.3 )] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.4 )] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.5 )] • Adrenal Insufficiency [see Warnings and Precautions ( 5.7 )] • Severe Hypotension [see Warnings and Precautions ( 5.8 )] • Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.10 )] • Seizures [see Warnings and Precautions ( 5.11 )] • Withdrawal [see Warnings and Precautions ( 5.12 )] The following adverse reactions associated with the use of hydromorphone were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious adve…

Frequently Asked Questions

What is Dilaudid used for?

Dilaudid is a prescription opioid pain reliever available as an injection that contains hydromorphone hydrochloride and is used to manage moderate to severe pain. It is administered by intramuscular injection at a strength of 1 mg/mL.

Is Dilaudid a controlled substance?

Yes, Dilaudid is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Dilaudid?

The generic name for Dilaudid is Hydromorphone hydrochloride. There are 10 other brand versions of Hydromorphone hydrochloride.

What is the NDC code for Dilaudid 1 mg/mL?

The NDC (National Drug Code) for Dilaudid 1 mg/mL is 76045-009, listed by Fresenius Kabi USA, LLC.

Product NDC

76045-009

Package NDC

76045-009-06

Other Hydromorphone Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)