hydromorphone

Generic Name: hydromorphone (oral) (HYE droe MOR fone)

Brand Names: Dilaudid, Dilaudid-5, Exalgo

What is hydromorphone?

Hydromorphone is in a group of drugs called narcotic pain relievers, also called opioids. It is similar to morphine.

Hydromorphone is used to treat moderate to severe pain. The extended-release form of this medication is for around-the-clock treatment of pain.

Hydromorphone may also be used for other purposes not listed in this medication guide.

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

Hydromorphone may be habit-forming and should be used only by the person it was prescribed for. Never share hydromorphone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take hydromorphone in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Hydromorphone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not stop using hydromorphone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using hydromorphone.

What should I discuss with my healthcare provider before using hydromorphone?

Do not use this medication if you have ever had an allergic reaction to a narcotic medicine (examples include codeine, methadone, morphine, Oxycontin, Darvocet, Percocet, Vicodin, Lortab, and many others). You should also not take hydromorphone if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus. Hydromorphone may be habit-forming and should be used only by the person it was prescribed for. Never share hydromorphone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

If you have any of these other conditions, you may need a hydromorphone dose adjustment or special tests:

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  asthma, COPD, sleep apnea, or other breathing disorders;

  
  


• liver or kidney disease;


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  underactive thyroid;

  
  


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  curvature of the spine;

  
  


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  a history of head injury or brain tumor;

  
  


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  epilepsy or other seizure disorder;

  
  


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  low blood pressure;

  
  


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  gallbladder disease;

  
  


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  Addison's disease or other adrenal gland disorders;

  
  


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  enlarged prostate, urination problems;

  
  


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  mental illness; or

  
  


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  a history of drug or alcohol addiction.

  
  

FDA pregnancy category C. It is not known whether hydromorphone will harm an unborn baby. Hydromorphone may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using hydromorphone. Hydromorphone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

You should not use an extended-release form of hydromorphone (such as Palladone) unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Older adults may be more sensitive to the effects of this medicine.

How should I use hydromorphone?

Take exactly as prescribed. Never take hydromorphone in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take the pill form of this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Avoid getting hydromorphone liquid on your skin. It can be absorbed through your skin, and you may get too large a dose.

Do not stop using hydromorphone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using hydromorphone. Store this medication at room temperature, away from heat, moisture, and light. Keep track of the amount of medicine used from each new bottle. Hydromorphone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

After you have stopped using this medication, flush any unused pills down the toilet.

Throw away any unused liquid hydromorphone that is older than 90 days.

What happens if I miss a dose?

Since hydromorphone is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Extended-release hydromorphone is not for use on an as-needed basis for pain.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydromorphone can be fatal.

Overdose symptoms may include extreme drowsiness, pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while using hydromorphone?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol. Hydromorphone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Hydromorphone side effects

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 any of these serious side effects:

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  shallow breathing, slow heartbeat;

  
  


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  seizure (convulsions);

  
  


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  cold, clammy skin;

  
  


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  confusion;

  
  


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  severe weakness or dizziness; or

  
  


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  feeling light-headed, fainting.

  
  

Less serious side effects are more likely to occur, such as:

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  nausea, vomiting, constipation, loss of appetite;

  
  


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  warmth, tingling, or redness under your skin;

  
  


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  dizziness, headache;

  
  


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  dry mouth;

  
  


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  sweating; or

  
  


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  itching.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Hydromorphone Dosing Information

Usual Adult Dose for Pain:

Doses should be titrated to appropriate analgesic effects while minimizing adverse effects. When changing routes of administration, it should be noted that oral doses are less than one-half as effective as parenteral doses. Oral doses may be only one fifth as effective as parenteral doses.

Oral: Initial: Opiate-naive: 1 to 2 mg/dose every 3 to 4 hours as needed; patients with prior opiate exposure may tolerate higher initial doses
Usual dose: 2 to 4 mg/dose; oral doses up to 8 mg have been used

Note: The American Pain Society recommends an initial oral dose of 4 to 8 mg for severe pain in adults.

Chronic pain: Oral: Patients taking opioids chronically may become tolerant and require doses higher than the usual dosage range to maintain the desired effect. Tolerance can be managed by appropriate dose titration. There is no optimal or maximal dose for hydromorphone in chronic pain. The appropriate dose is one that relieves pain throughout its dosing interval without causing unmanageable side effects.

IV: Initial: Opiate-naive: 0.2 to 0.6 mg/dose every 2 to 4 hours as needed; patients with prior opiate exposure may tolerate higher initial doses.

Patient-controlled analgesia (PCA):
All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Doses, lockouts, and limits should be adjusted based on required loading dose, age, state of health, and presence of opioid tolerance. The lower end of dosing range should be used for opioid-naive patients. Assess patient and pain control at regular intervals and adjust settings if needed.
Usual concentration: 0.2 mg/mL
Demand dose: Usual initial: 0.1 to 0.2 mg; usual range: 0.05 to 0.4 mg
Lockout interval: Usual initial: 6 minutes; usual range: 5 to 10 minutes

IM, subcutaneous:
Note: IM use may result in variable absorption and a lag time to peak effect.
Initial: Opiate-naive: 0.8 to 1 mg every 4 to 6 hours as needed; patients with prior opioid exposure may require higher initial doses; usual dosage range: 1 to 2 mg every 3 to 6 hours as needed.

Rectal: 3 mg (1 suppository) every 4 to 8 hours as needed.

IV: Critically ill adult patients: 0.7 to 2 mg (based on 70 kg patient) every 1 to 2 hours as needed. More frequent dosing may be needed (e.g., mechanically ventilated patients).
IV continuous infusion: Usual dosage range: 0.5 to 1 mg/hour (based on 70 kg patient) or 7 to 15 mcg/kg/hour

Epidural:
Bolus dose: 0.8 to 1.5 mg
Infusion concentration: 0.05 to 0.075 mg/mL
Infusion rate: 0.04 to 0.4 mg/hour
Demand dose: 0.15 mg
Lockout interval: 30 minutes

Hydromorphone extended release tablets:
Hydromorphone extended release tablets are indicated for opioid tolerant patients only. Patient must not be started on hydromorphone extended release tablets as their first opioid.

Hydromorphone extended release tablets should be swallowed whole and should not be broken, crushed, dissolved, or chewed before swallowing. The tablets are to be administered every 24 hours with or without food.

The dose range of hydromorphone extended release tablets studied in clinical trials is 8 mg to 64 mg.

Patients receiving oral immediate-release hydromorphone may be converted to hydromorphone extended release tablets by administering a starting dose equivalent to the patient's total daily oral hydromorphone dose, taken once daily. The dose of hydromorphone extended release tablets can be titrated every 3 to 4 days until adequate pain relief with tolerable side effects has been achieved.

It is critical to accurately initiate the dosing regimen individually for each patient. Overestimating the hydromorphone extended release tablets dose when converting patients from another opioid medication can result in fatal overdose with the first dose. In the selection of the initial dose of hydromorphone extended release tablets, the following should be noted:
-the daily dose, potency, and specific characteristics of the opioid the patient has been taking previously;
-the reliability of the relative potency estimate used to calculate the equivalent hydromorphone dose needed;
-the patient's degree of opioid tolerance;
-the age, general condition, and medical status of the patient;
-concurrent non-opioid analgesics and other medications, such as those with central nervous system activity;
-the type and severity of the patient's pain;
-the balance between pain control and adverse effects;
-risk factors for abuse, addiction, or diversion, including a prior history of abuse, addiction, or diversion.

Dosing recommendations, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Conversion from Oral Opioids to hydromorphone extended release tablets:
For conversion from other opioids to hydromorphone extended release tablets, physicians and other healthcare professionals are advised to refer to published relative potency data, keeping in mind that conversion ratios are only approximate. In general, therapy with hydromorphone extended release tablets should be started by administering 50% of the calculated total daily dose of hydromorphone extended release tablets every 24 hours. The initial dose of hydromorphone extended release tablets can be titrated until adequate pain relief with tolerable side effects has been achieved.

Conversion from transdermal fentanyl to hydromorphone extended release tablets:
Eighteen hours following the removal of the transdermal fentanyl patch, hydromorphone extended release tablets treatment can be initiated. For each 25 mcg/hr fentanyl transdermal dose the equianalgesic dose of hydromorphone extended release tablets is 12 mg every 24 hours. An appropriate starting dose of hydromorphone extended release tablets is 50% of the calculated total daily dose every 24 hours.

Individualization of Dosage:
Once therapy is initiated, assess pain relief and other opioid adverse reactions frequently.

Titrate patients to adequate analgesia with dose increases not more often than every 3 to 4 days, in order to attain steady-state plasma concentrations of hydromorphone at each dose.

As a guideline, consider dosage increases of 25% to 50% of the current daily dose of hydromorphone extended release tablets for each titration step.

If more than two doses of rescue medication are needed within a 24 hour period for two consecutive days, the dose of hydromorphone extended release tablets may need to be titrated upward.

Administer hydromorphone extended release tablets no more frequently than every 24 hours.

During periods of changing analgesic requirements, including initial titration, maintain frequent contact between physician, other members of the healthcare team, the patient and the caregiver/family.

Maintenance of Therapy:
During chronic therapy with hydromorphone extended release tablets, assess the continued need for around-the-clock opioid therapy periodically. Continue to assess patients for their clinical risks for opioid abuse, addiction, or diversion particularly with high-dose formulations. If patients need to titrate while on maintenance therapy, follow the same method outlined above to reestablish pain control.

Usual Adult Dose for Cough:

1 mg orally every 3 to 4 hours as needed.

Usual Pediatric Dose for Pain:

Doses should be titrated to appropriate analgesic effects while minimizing adverse effects. When changing routes of administration, it should be noted that oral doses are less than one-half as effective as parenteral doses. Oral doses may be only one fifth as effective as parenteral doses.

Greater than 6 months and greater than 10 kg:
Oral: Usual initial dose: 0.03 mg/kg/dose every 4 hours as needed; usual dose range: 0.03 to 0.06 mg/kg/dose
IV: Usual initial dose: 0.01 mg/kg/dose every 3 to 6 hours as needed
IV continuous infusion: Usual initial dose: 0.003 to 0.005 mg/kg/hour

Children and Adolescents less than 50 kg:
Oral: 0.03 to 0.08 mg/kg/dose every 3 to 4 hours as needed
The American Pain Society recommends an initial oral dose of 0.06 mg/kg for severe pain in children.
IV: 0.015 mg/kg/dose every 3 to 6 hours as needed.
IV continuous infusion: Usual initial dose: 0.003 to 0.005 mg/kg/hour (maximum: 0.2 mg/hour)
IV: Patient-controlled analgesia (PCA): Opiate-naive:
5 to 12 years and less than 50 kg:
PCA has been used in children as young as 5 years of age. However, clinicians need to assess children 5 to 8 years of age to determine if they are able to use the PCA device correctly. All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Adjust doses, lockouts, and limits based on required loading dose, age, state of health, and presence of opioid tolerance. Use lower end of dosing range for opioid-naive. Assess patient and pain control at regular intervals and adjust settings if needed.
Usual concentration: 0.2 mg/mL
Demand dose: Usual initial dose: 0.003 to 0.004 mg/kg/dose; usual dose range: 0.003 to 0.005 mg/kg/dose
Lockout: Usual initial: 5 doses/hour
Lockout interval: Range: 6 to 10 minutes
Usual basal rate: up to 0.004 mg/kg/hour

Greater than 50 kg:
Oral: Initial: Opiate-naive: 1 to 2 mg/dose every 3 to 4 hours as needed
Patients with prior opiate exposure may tolerate higher initial doses.

IV: Initial: Opiate-naive: 0.2 to 0.6 mg/dose every 2 to 4 hours as needed.
Patients with prior opiate exposure may tolerate higher initial doses.

Patient-controlled analgesia (PCA):
All patients should receive an initial loading dose of an analgesic (to attain adequate control of pain) before starting PCA for maintenance. Doses, lockouts, and limits should be adjusted based on required loading dose, age, state of health, and presence of opioid tolerance. The lower end of dosing range should be used for opioid-naive patients. Assess patient and pain control at regular intervals and adjust settings if needed.
Usual concentration: 0.2 mg/mL
Demand dose: Usual initial: 0.1 to 0.2 mg; usual range: 0.05 to 0.4 mg
Lockout interval: Usual initial: 6 minutes; usual range: 5 to 10 minutes
IM, subcutaneous:
Note: IM use may result in variable absorption and a lag time to peak effect.
Initial dose for opiate-naive patients: 0.8 to 1 mg every 4 to 6 hours as needed; patients with prior opioid exposure may require higher initial doses; usual dosage range: 1 to 2 mg every 3 to 6 hours as needed.
Rectal: 3 mg (1 suppository) every 4 to 8 hours as needed.

Usual Pediatric Dose for Cough:

6 to 12 years: 0.5 mg orally every 3 to 4 hours as needed.

Greater than 12 years: 1 mg orally every 3 to 4 hours as needed.

What other drugs will affect hydromorphone?

Do not take hydromorphone with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Before taking hydromorphone, tell your doctor if you are using pentazocine (Talwin), nalbuphine (Nubain), butorphanol (Stadol), or buprenorphine (Buprenex, Subutex). If you are using any of these drugs, you may not be able to use hydromorphone, or you may need dosage adjustments or special tests during treatment.

This list is not complete and other drugs may interact with hydromorphone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More hydromorphone resources

• Hydromorphone Side Effects (in more detail)
• Hydromorphone Dosage
• Hydromorphone Use in Pregnancy & Breastfeeding
• Drug Images
• Hydromorphone Drug Interactions
• Hydromorphone Support Group
• 165 Reviews for Hydromorphone - Add your own review/rating

• hydromorphone Advanced Consumer (Micromedex) - Includes Dosage Information


• Dilaudid Prescribing Information (FDA)


• Dilaudid Consumer Overview


• Dilaudid-HP Prescribing Information (FDA)


• Dilaudid-HP Advanced Consumer (Micromedex) - Includes Dosage Information


• Dilaudid-HP MedFacts Consumer Leaflet (Wolters Kluwer)


• Exalgo Prescribing Information (FDA)


• Exalgo MedFacts Consumer Leaflet (Wolters Kluwer)


• Exalgo Consumer Overview


• Hydromorphone Prescribing Information (FDA)


• Hydromorphone MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydromorphone Hydrochloride Monograph (AHFS DI)


• Palladone Prescribing Information (FDA)


• Palladone Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare hydromorphone with other medications

• Anesthetic Adjunct
• Cough
• Pain

Where can I get more information?

• Your pharmacist can provide more information about hydromorphone.

See also: hydromorphone side effects (in more detail)