Dilaudid

Generic name: hydromorphone (oral)
Brand names: Dilaudid, Exalgo, Hydrostat IR
Drug class: Narcotic analgesics

Medically reviewed by  A Ras MD.

What is Dilaudid?

Dilaudid tablets and Dilaudid oral solution are Strong prescription pain medicines that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid analgesic, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them, Opioid pain medicines that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

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 single-dose prefilled syringes for slow intravenous, subcutaneous, or intramuscular administration. Each 1 mL of solution contains 1 mg or 2 mg 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:

Structural Formula

 

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.

Mechanism of Action

Hydromorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of hydromorphone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.

 

The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

What is the most important information I should know about Dilaudid?

Important information about Dilaudid:

  • Get emergency help right away if you take too many Dilaudid tablets or too much Dilaudid oral solution (overdose). When you first start taking Dilaudid tablets or Dilaudid oral solution, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
  • Taking Dilaudid tablets or Dilaudid oral solution with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your Dilaudid tablets or Dilaudid oral solution. They could die from taking it. Selling or giving away Dilaudid tablets or Dilaudid oral solution is against the law.
  • Store Dilaudid tablets or Dilaudid oral solution securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Who should not take Dilaudid?

Do not take Dilaudid tablets or Dilaudid oral solution if you have:

  • Severe asthma, trouble breathing, or other lung problems.
  • A bowel blockage or have narrowing of the stomach or intestines.

What should I tell my healthcare provider before taking Dilaudid?

Before taking Dilaudid tablets or Dilaudid oral solution, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • problems urinating
  • liver, kidney, thyroid problems
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems

Tell your healthcare provider if you are:

  • Pregnant or planning to become pregnant. Prolonged use of Dilaudid tablets and Dilaudid oral solution during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • Breastfeeding. Dilaudid tablets or Dilaudid oral solution pass into breast milk and may harm your baby.
  • Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Dilaudid with certain other medicines can cause serious side effects that could lead to death.

How should I take Dilaudid?

When taking Dilaudid:

  • Do not change your dose. Take Dilaudid exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking Dilaudid tablets or Dilaudid oral solution regularly, do not stop taking Dilaudid tablets or Dilaudid oral solution without talking to your healthcare provider.
  • Dispose of expired, unwanted, or unused Dilaudid tablets or Dilaudid oral solution by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

What should I avoid while taking Dilaudid?

While taking Dilaudid do not:

  • Drive or operate heavy machinery, until you know how Dilaudid tablets or Dilaudid oral solution affects you. Dilaudid can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Dilaudid tablets or Dilaudid oral solution may cause you to overdose and die.

What are the possible side effects of Dilaudid?

The possible side effects of Dilaudid tablets and Dilaudid oral solution:

Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

  • trouble breathing
  • shortness of breath
  • fast heartbeat
  • chest pain
  • swelling of your face, tongue, or throat
  • extreme drowsiness
  • light-headedness when changing positions
  • feeling faint
  • agitation
  • high body temperature
  • trouble walking
  • stiff muscles
  • mental changes such as confusion.

These are not all the possible side effects of Dilaudid tablets and Dilaudid oral solution. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information, go to dailymed.nlm.nih.gov

How should I store Dilaudid?

  • Store Dilaudid securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
  • Protect from light.

What are the ingredients in Dilaudid?

Tablets

Active ingredient: hydromorphone hydrochloride

Inactive ingredients 2mg tablet: D&C Red No. 30, D&C Yellow No. 10, anhydrous lactose, magnesium stearate, sodium metabisulfite

Inactive ingredients 4mg tablet: D&C Yellow No. 10, anhydrous lactose, magnesium stearate, sodium metabisulfite

Inactive ingredients 8mg tablet: anhydrous lactose, magnesium stearate, sodium metabisulfite

Oral solution

Active ingredient: hydromorphone hydrochloride

Inactive ingredients: water, methylparaben, propylparaben, sucrose, glycerin, sodium metabisulfite

Label

PACKAGE LABEL – PRINCIPAL DISPLAY – Dilaudid 1mL Single-Dose Syringe Label

  •  For SC, IM, or slow IV use. 1mL Single-Dose.
    Rx only
    Dilaudid®CII
    HYDROmorphone HCl
    Injection, USP
  • 2 mg/mL
Dilaudid
Imprint K 2 - Dilaudid 2 mg

SRC: NLM .