May 24, 2017
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Dilaudid

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Dilaudid

DILAUDID®
(hydromorphone hydrochloride) Injection




WARNING

RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; LIFETHREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Risk of Medication Errors

DILAUDID-HP INJECTION is a more concentrated solution of hydromorphone than DILAUDID INJECTION, and is for use in opioid-tolerant patients only. Do not confuse DILAUDID-HP INJECTION with standard parenteral formulations of DILAUDID INJECTION or other opioids, as overdose and death could result [see WARNINGS AND PRECAUTIONS].

Addiction, Abuse, and Misuse

DILAUDID INJECTION and DILAUDID-HP INJECTION exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing DILAUDID INJECTION and DILAUDID-HP INJECTION and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS AND PRECAUTIONS].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of DILAUDID INJECTION or DILAUDID-HP INJECTION. Monitor for respiratory depression, especially during initiation of DILAUDID INJECTION or DILAUDID-HP INJECTION or following a dose increase [see WARNINGS AND PRECAUTIONS].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of DILAUDID INJECTION or DILAUDID-HP INJECTION during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS AND PRECAUTIONS].

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

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 [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS].

  • Reserve concomitant prescribing of DILAUDID or DILAUDID-HP Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

DRUG DESCRIPTION

DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid agonist.

DILAUDID INJECTION is available as a sterile, aqueous solution in clear and colorless pre-filled syringes for slow intravenous, subcutaneous, or intramuscular administration. Each 1 mL pre-filled syringe contains 0.5 mg, 1 mg, 2 mg, or 4 mg of hydromorphone hydrochloride.

DILAUDID-HP INJECTION is available as a sterile, aqueous solution in clear pre-filled syringes with a dark grey plunger rod, for slow intravenous, subcutaneous, or intramuscular administration. Each pre-filled syringe contains 10 mg/mL of hydromorphone hydrochloride.

The chemical name of DILAUDID is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.80. Its molecular formula is C17H19NO3·HCl, and it has the following chemical structure:

DILAUDID® INJECTION (hydromorphone hydrochloride) Structural Formula Illustration

Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride.

The inactive ingredients in DILAUDID (hydromorphone hydrochloride) include: 0.2% sodium citrate and 0.2% citric acid added as a buffer to maintain a pH between 3.5 and 5.5.

What are the possible side effects of hydromorphone (Dilaudid, Dilaudid-5, Exalgo)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • weak or shallow breathing;
  • pounding heartbeats or fluttering in your chest;
  • wheezing, chest tightness, trouble breathing;
  • seizure (convulsions);
  • confusion, severe weakness or drowsiness; or
  • feeling like you might pass out.

Less serious side effects are more likely to...

Read All Potential Side Effects and See Pictures of Dilaudid »

What are the precautions when taking hydromorphone hydrochloride (Dilaudid)?

Before taking hydromorphone, tell your doctor or pharmacist if you are allergic to it; or to hydrocodone; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to...

Read All Potential Precautions of Dilaudid »

Last reviewed on RxList: 3/20/2017
This monograph has been modified to include the generic and brand name in many instances.

Dilaudid - User Reviews

Dilaudid User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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