MicroVault™ Packaging

Dilaudid^®

(HYDROmorphone Hydrochloride) Injection, USP

available strengths

0.5 mg per 0.5 mL

1 mg per 1 mL

2 mg per 1 mL

Package Insert

Horizontal Syringe image for 0.5 mg per 0.5 mL of Dilaudid

Horizontal Syringe image for 1 mg per 1 mL of Dilaudid

Horizontal Syringe image for 2 mg per 1 mL of Dilaudid

Please click for full Prescribing Information, including BOXED WARNING, for Dilaudid^® (HYDROmorphone Hydrochloride) Injection, USP.

Dilaudid^® (HYDROmorphone Hydrochloride) Injection, USP

Product
Strength	0.5 mg per 0.5 mL
Concentration	0.5 mg per 0.5 mL
Fill Volume	0.5 mL
Unit of Sale NDC	76045-009-06
Unit of Sale Bar Code
Product
Strength	1 mg per 1 mL
Concentration	1 mg per 1 mL
Fill Volume	1 mL
Unit of Sale NDC	76045-009-11
Unit of Sale Bar Code
Product
Strength	2 mg per 1 mL
Concentration	2 mg per 1 mL
Fill Volume	1 mL
Unit of Sale NDC	76045-010-11
Unit of Sale Bar Code

Features

Therapeutic Class: Analgesics/Anesthetics
Preservative Free
AP Rated

Packaging

MicroVault Syringe image for 0.5 mg per 0.5 mL of Dilaudid

MicroVault Syringe image for 1 mg per 1 mL of Dilaudid

MicroVault Syringe image for 2 mg per 1 mL of Dilaudid

MicroVault Carton image for 0.5 mg per 0.5 mL of Dilaudid

3.125” x 2.625” x 4.375”

MicroVault Carton image for 1 mg per 1 mL of Dilaudid

3.125” x 2.625” x 4.375”

MicroVault Bundle image for 1 mg per 1 mL of Dilaudid

10 per Carton (Bundles of 5)

MicroVault Features

MicroVault packaging supports secure dispensing and diversion deterrence. That’s medication management made easier.

Diversion-deterrent

Polypropylene shell is rigid and transparent allowing for inspection of visible tampering. The outer shrink-wrapped drug label has no seam and cannot be peeled off.

Space-savings

Slimmer packaging takes up less room to fit in locked compartments in automated dispensing cabinets (ADCs) than a syringe blister pack.

Twist-and-go

Twist to open cap makes accessing the syringe a step away from delivering to a patient.

Dilaudid® (HYDROmorphone HCl) Injection, USP

Please see complete Important Safety Information including Boxed Warning.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

See full Prescribing Information for complete Boxed Warning.

Important Safety Information

Dilaudid Injection

Indications and use

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, even at recommended doses, reserve DILAUDID INJECTION for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: have not been tolerated, are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia.

IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

See full prescribing information for complete boxed warning.

DILAUDID INJECTION exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.
Prolonged use of DILAUDID INJECTION during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

DILAUDID INJECTION is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment, known or suspected gastrointestinal obstruction, known hypersensitivity to hydromorphone, hydromorphone salts, sulfite-containing medications, or any other components of the product.

Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients: Monitor closely, particularly during initiation and titration.

Adrenal insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.

Severe hypotension: Monitor during dosage initiation and titration. Avoid use in patients with circulatory shock.

Risks of use in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness: Monitor for sedation and respiratory depression. Avoid use in patients with impaired consciousness or coma.

Additional serious adverse reactions: Apnea, circulatory depression, respiratory arrest, shock, cardiac arrest, seizures, withdrawal, anaphylaxis. Most common adverse reactions: Lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DILAUDID INJECTION contains sodium metabisulfite.

Overdosage: Acute overdose can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, miosis (or mydriasis when hypoxia is present), and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death.

This Important Safety Information does not include all the information needed to use DILAUDID safely and effectively. Please see full prescribing information, including BOXED WARNING, for Dilaudid Injection.

resources and downloads

Package Insert MicroVault™ brochure Product catalog Packaging options catalog Instructions for use

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(HYDROmorphone Hydrochloride) Injection, USP

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