DILAUDID HYDROMORPHONE HYDROCHLORIDE
Refer to the “Also Known As” section to reference different products that include the same medication as DILAUDID.
Drug Basics
Brand Name: DILAUDID
Generic Name: HYDROMORPHONE HYDROCHLORIDE
Drug Type: HUMAN PRESCRIPTION DRUG
Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage Form: INJECTION, SOLUTION
Data Current As Of: 2018-10-05
indications & usage
DILAUDID INJECTION isindicated for the management of pain severe enough to require an opioidanalgesic and for which alternate treatments are inadequate.
DILAUDID-HP INJECTION is indicated for use in opioid-tolerant patientswho require higher doses of opioids for the management of pain severeenough to require an opioid analgesic and for which alternate treatmentsare inadequate.
Patients considered opioidtolerant are those who are taking for one week or longer, around-the-clockmedicine consisting of at least 60 mg oral morphine per day, or atleast 25 mcg transdermal fentanyl per hour, or at least 30 mg oraloxycodone per day, or at least 8 g oral hydromorphone per day, orat least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodoneper day. or an equianalgesic dose of another opioid for one week orlonger. Patients must remain on around-the-clock opioids while administeringDILAUDID-HP.
Limitationsof Use:
Because of the risksof addiction, abuse, and misuse with opioids, even at recommendeddoses [see Warnings and Precautions (5.2)], reserve DILAUDID INJECTION and DILAUDID-HPINJECTION 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 expectedto be tolerated
- Have not provided adequate analgesia,or are not expected to provide adequate analgesia
patient counselinginformation
Serotonin Syndrome
Inform patientsthat opioids could cause a rare but potentially life-threatening conditionresulting from concomitant administration of serotonergic drugs. Warnpatients of the symptoms of serotonin syndrome and to seek medicalattention right away if symptoms develop. Instruct patients to informtheir healthcare providers if they are taking, or plan to take serotonergicmedications, [see Drug Interactions (7)].
Constipation
Advise patients ofthe potential for severe constipation, including management instructionsand when to seek medical attention [see Adverse Reactions(6)].
Healthcare professionals can telephoneBD Rx Inc at 1-866-943-8534 for information or to report adverse eventson this product.
Rev. 12/2016
P0142
BD Rx Inc.
Franklin Lakes, NJ07417
Dilaudid isa licensed trademark of Purdue Pharma L.P.
instructions for use
Parenteral drug products shouldbe inspected visually for particulate matter and discoloration priorto administration, whenever solution and container permit. Do notuse if color is darker than pale yellow, if it is discolored in anyother way or if it contains a precipitate.
CAUTION: Certain glass syringes may malfunction,break or clog when connected to some Needleless Luer Access Devices(NLADs) and needles. This syringe has a larger internal syringe tipand an external collar (luer collar). The external collar must remainattached to the syringe. Data show that the syringe achieves acceptableconnections with the BD Eclipse™ Needle and the Terumo SurGuard2™Safety Needle and with the following non-center post NLADs: AlarisSMARTSITE™, B-Braun ULTRASITE™, BD-Q SYTE™, Maximum MAX PLUS™, andB-Braun SAFSITE™. The data also show acceptable connections are achievedto the center post ICU Medical CLAVE™. However, spontaneous disconnectionof this glass syringe from needles and NLADs with leakage of drugproduct may occur. Assure that the needle or NLAD is securely attachedbefore beginning the injection. Visually inspect the glass syringe-needleor glass syringe –NLAD connection before and during drug administration.Do not remove the clear plastic wrap around the external collar. (SeeFigure 1)
Figure 1
- Inspect the outer packaging (blister pack) by verifying:
- blister integrity
- drug name
- drug strength
- dose volume
- route of administration
-expiry date to be sure that the drug has not expired
-sterile field applicability
- Peel open the paper (top web) of the outer packaging thatdisplays the product information to access the syringe.
Do not pop syringe through. (See Figure 2) - Bend the plastic part of the outer packaging (thermoform)so as to present the plunger rod for syringe removal. Once the syringeis removed, if applicable, discard the StabilOx® CANISTER contained at the end of the blister pack.
Figure 2
- Perform visual inspection on the syringe by verifying:
- absence of syringe damage
- absence of external particles
- absence of internal particles
- proper drug color
- expiration date to be sure that the drug has not expired
- drug name, drug strength
- dose volume
-route of administration
- sterile field applicability
- integrity of the plastic wrap around the external collar
- Do not remove plastic wrap around the external collar. Push plunger rod slightly to break the stopper loose while tip capis still on.
- Do not remove plastic wrap around the external collar. Removetip cap by twisting it off. (See Figure 3)
Figure 3
- Discard the tip cap.
- Expel air bubble.
- Adjust dose into sterile material (if applicable).
- Connect the syringe to appropriate injection connectiondepending on route of administration. Before injection, ensure thatthe syringe is securely attached to the needle or NLAD.
- Depress plunger rod to deliver medication.
- Remove syringe from IV connector (if applicable) and discardinto appropriate receptacle. If delivering medication via IM route,do not recap needle. To prevent needle-stick injuries, needles shouldnot be recapped.
Healthcare professionalscan telephone BD Rx Inc at 1-866-943-8534 for information or to reportadverse events on this product.
Rev. 12/2016
P0142
BD Rx Inc.
FranklinLakes, NJ 07417
Dilaudidis a licensed trademark of Purdue Pharma L.P.
Box of ten 1 mg/mL ampules
NDC 59011-441-10
Box of ten 2 mg/mL ampules
NDC 59011-442-10
Label for one 50mL Single Dose Vial
Box of ten 4 mg/mL ampules
NDC 59011-444-10
Box of ten 1mL (10 mg) ampules
NDC 59011-445-01
Dilaudid Injection 5 mg/mL
NDC 59011-445-50
Dilaudid Injection 250 mg/vial
NDC 59011-446-25
also known as
- Dilaudid (tablet)
- EXALGO (tablet, extended release)
- Hydromorphone Hydrochloride (injection)
- Hydromorphone Hydrochloride (solution)
- Hydromorphone Hydrochloride (tablet, extended release)
- Hydromorphone Hydrochloride (tablet, film coated, extended release)
- Hydromorphone Hydrochloride Extended-Release (tablet, extended release)
- Hyrdomorphone Hydrochloride (tablet)
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