AHFS Class:

28:08.08 Opioid Agonists

Generic Name

• HYDROmorphone Hydrochloride

Hydromorphone hydrochloride is available in prefilled syringes with each mL of the solution containing hydromorphone hydrochloride 1, 2, or 4 mg with sodium citrate 0.2% and citric acid 0.2%.³³⁰² Although no preservatives have been added to the formulation, residual amounts of sodium metabisulfite, a reagent used in the purification process of the drug, may be present.³³⁰⁷

Hydromorphone hydrochloride also is available in ampuls, cartridges, and prefilled syringes with each mL of the solution containing hydromorphone hydrochloride 1, 2, or 4 mg with sodium lactate 5.4 mg and sodium chloride; lactic acid or sodium hydroxide is used for pH adjustment.³³⁰³ Hydromorphone hydrochloride also is available in 1-mL vials and 20-mL multidose vials with each mL of the solution containing hydromorphone hydrochloride 2 mg with edetate disodium 0.5 mg, methylparaben 1.8 mg, and propylparaben 0.2 mg in water for injection; sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH.³³⁰⁶

A high potency formulation of hydromorphone hydrochloride is available packaged in ampuls, prefilled syringes, and single-dose vials; each mL of the solution contains 10 mg of hydromorphone hydrochloride with citric acid 0.2% and sodium citrate 0.2%.³³⁰²; ³³⁰⁴; ³³⁰⁵ Such formulations are noted to have no added preservatives;³³⁰²; ³³⁰⁴; ³³⁰⁵ however, sodium metabisulfite may be present in some formulations.³³⁰⁴

Care should be taken to avoid confusion between the various standard concentrations of hydromorphone hydrochloride and the more concentrated high potency formulation in order to reduce the risk of medication errors.³³⁰²; ³³⁰⁴; ³³⁰⁵

pH

From 3.5 to 5.5.³³⁰²; ³³⁰³; ³³⁰⁴; ³³⁰⁵; ³³⁰⁶

Trade Name(s)

Dilaudid, Dilaudid-HP

Hydromorphone hydrochloride may be administered by subcutaneous, intramuscular, or slow direct intravenous injection over at least 2 to 3³³⁰²; ³³⁰³; ³³⁰⁴; ³³⁰⁵ or 3 to 5 minutes.³³⁰⁶ Administration by rapid intravenous injection increases the risk of adverse reactions.³³⁰²; ³³⁰³; ³³⁰⁴; ³³⁰⁵; ³³⁰⁶

Hydromorphone hydrochloride products should be stored at controlled room temperature and should be protected from light until time of use.³³⁰²; ³³⁰³; ³³⁰⁴; ³³⁰⁵; ³³⁰⁶ Hydromorphone hydrochloride should not be stored under refrigeration because of possible precipitation or crystallization. Resolubilization at room temperature or upon warming may be performed without affecting the stability of the drug.⁵⁹³

Hydromorphone hydrochloride solution should be visually inspected for particulate matter and discoloration prior to administration.³³⁰²; ³³⁰³; ³³⁰⁴; ³³⁰⁵ The solution may develop a slight yellowish discoloration; however, no associated loss of potency has been demonstrated.³³⁰²; ³³⁰³; ³³⁰⁴; ³³⁰⁵ If the solution is darker than pale yellow, more than slightly discolored, discolored in any other way, or if it contains a precipitate, it should not be used.³³⁰²; ³³⁰⁶ Any unused portions should be discarded.³³⁰²; ³³⁰³; ³³⁰⁴; ³³⁰⁵

Hydromorphone hydrochloride is physically compatible and chemically stable for at least 24 hours in most common large volume parenteral solutions when stored at 25°C protected from light.³³⁰²; ³³⁰³; ³³⁰⁴; ³³⁰⁵

Extemporaneously prepared hydromorphone hydrochloride 10 and 50 mg/mL, stored in 100-mL glass vials or polyvinyl chloride (PVC) bags, exhibited no loss in 42 days at 4 and 23°C.¹³⁹⁴

Syringes

In 2015, reports of decreased potency of certain drugs (e.g., hydromorphone hydrochloride) stored in Becton Dickinson syringes for extended periods (i.e., exceeding 24 hours) were confirmed by the manufacturer of these syringes; the cause of this change was later identified to be the inclusion of an alternate rubber stopper in the plunger of certain product lots of syringes.³⁰²⁹; ³⁰³⁶; ³⁰³⁷; ³⁰³⁹; ³⁰⁴¹; ³⁰⁴² Decreased potency was not observed when the syringes were filled and used promptly.³⁰³⁷ Use of the alternate stopper was later discontinued and use of the primary stopper in such syringes was resumed; however, Becton Dickinson states that its general-use syringes are cleared by FDA for immediate use in fluid aspiration and injection and that such syringes, regardless of the stopper material, have not been cleared by FDA for use as a closed-container system.³³⁹¹

Hydromorphone hydrochloride (Knoll) 10 mg/mL undiluted and diluted to 0.1 mg/mL in sodium chloride 0.9% was packaged as 3 mL in 10-mL polypropylene infusion pump syringes (Pharmacia Deltec). No loss occurred over 30 days at 30°C.¹⁹⁶⁷

Hydromorphone hydrochloride (Westward) diluted to 0.1 mg/mL in sodium chloride 0.9% was packaged as 5 mL in 10-mL polypropylene syringes (Becton Dickinson) and stored at ambient room temperature protected from light.³⁸⁸⁷ The solutions remained clear and colorless with approximately 10% loss of drug in 100 days.³⁸⁸⁷

Hydromorphone hydrochloride 1.5 and 80 mg/mL in sodium chloride 0.9% packaged as 20 mL in 30-mL polypropylene syringes was evaluated for physical and chemical stability. Sample solutions were stored for 60 days at 4°C protected from light and 23°C exposed to normal fluorescent light. Other sample solutions were stored frozen at -20°C and at elevated temperature of 37°C for 2 days to simulate more extreme conditions during express shipping. About 2 to 5% loss occurred in 60 days at 4 and 23°C. The frozen and 37°C samples exhibited little change in concentration in 2 days. However, samples stored frozen at -20°C exhibited the formation of microparticulates in the thousands per mL, possibly shed by the syringe components.²³⁷⁷

Implantable Pumps

The stability of hydromorphone hydrochloride 2 (Dilaudid) and 10 (Dilaudid-HP) mg/mL was evaluated in SynchroMed implantable pumps over 16 weeks at 37°C. Little or no drug loss and no adverse effects on the pumps occurred.²⁵⁸⁴

Central Venous Catheter

Hydromorphone hydrochloride (Knoll) 0.5 mg/mL in dextrose 5% was found to be compatible with the ARROWg+ard Blue Plus (Arrow International) chlorhexidine-bearing triple-lumen central catheter. Essentially complete delivery of the drug was found with little or no drug loss occurring. Furthermore, chlorhexidine delivered from the catheter remained at trace amounts with no substantial increase due to the delivery of the drug through the catheter.²³³⁵

Standardize 4 Safety

One or more standardized concentrations for this drug have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. (See Standardize 4 Safety in Users Guide.) Recommendations developed to date through this initiative are available at www.ashp.org/pharmacy-practice/standardize-4-safety-initiative.

Table 1. Standardize 4 Safety Continuous IV Infusion Standard Concentrations for Hydromorphone³⁶³⁵; ³⁶³⁶

^aThese concentrations are for continuous infusions not delivered by a PCA device.

Table 2: Standardize 4 Safety PCA Standard Concentrations for Hydromorphone³⁹⁹⁰

Table 3: Standardize 4 Safety Epidural Standard Concentrations for Hydromorphone as a Single Drug³⁹⁹⁰

Table 4: Standardize 4 Safety ADULT Epidural Combination Drug Standard Concentrations for Hydromorphone³⁹⁹⁰

Table 5: Standardize 4 Safety PEDIATRIC (50 kg) Epidural Combination Drug Standard Concentrations for Hydromorphone³⁹⁹⁰

Solution Compatibility

Additive Compatibility

Drugs in Syringe Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions December 5, 2024. © Copyright, 2025. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.