hydromorphone

Pronunciation

Generic Name: hydromorphone (rectal) (hye dro MOR fone)
Brand Name: Dilaudid

What is rectal hydromorphone?

Hydromorphone is an opioid pain medication. An opioid is sometimes called a narcotic.

Hydromorphone rectal is used to treat moderate to severe pain.

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

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

Hydromorphone can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose. Hydromorphone may be habit-forming, even at regular doses. Never share this medicine 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.

MISUSE OF NARCOTIC MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

You should not use rectal hydromorphone if you have a brain tumor or head injury, severe asthma, or breathing problems caused by curvature of the spine, emphysema, COPD, or other lung problems.

Tell your doctor if you are pregnant. Hydromorphone may cause life-threatening addiction and withdrawal symptoms in a newborn.

Do not drink alcohol. Dangerous side effects or death can occur when you drink alcohol while using rectal hydromorphone.

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

You should not use rectal hydromorphone if you have ever had an allergic reaction to a narcotic medicine, or if you have:

  • severe asthma or breathing problems;

  • a brain tumor or head injury; or

  • curvature of the spine that affects breathing.

To make sure rectal hydromorphone is safe for you, tell your doctor if you have:

  • any type of breathing problem or lung disease;

  • a history of seizures;

  • a history of drug abuse, alcohol addiction, or mental illness;

  • urination problems;

  • a stomach or intestinal disorder;

  • liver or kidney disease;

  • sulfite allergy;

  • Addison's disease or other adrenal gland disorders; or

  • a thyroid disorder.

Hydromorphone is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

FDA pregnancy category C. It is not known whether rectal hydromorphone will harm an unborn baby. Hydromorphone may cause breathing problems, behavior changes, or life-threatening addiction and withdrawal symptoms in your newborn if you use the medication during pregnancy. Tell your doctor if you are pregnant.

It is not known whether rectal hydromorphone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I use rectal hydromorphone?

Hydromorphone may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away hydromorphone is against the law.

Follow all directions on your prescription label. Hydromorphone can slow or stop your breathing. Never use rectal hydromorphone in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not take a hydromorphone rectal suppository by mouth. It is for use only in your rectum.

Wash your hands before and after inserting the rectal suppository.

Try to empty your bowel and bladder just before using the hydromorphone suppository.

Remove the wrapper before inserting the suppository. Avoid handling the suppository too long or it will melt in your hands.

Lie on your back with your knees up toward your chest. Gently insert the suppository into your rectum about 1 inch, pointed tip first.

For best results, stay lying down for a few minutes. The suppository will melt quickly and you should feel little or no discomfort while holding it in. Avoid using the bathroom for at least an hour after using the suppository.

If you need surgery, tell the surgeon ahead of time that you are using rectal hydromorphone. You may need to stop using the medicine for a short time.

Do not stop using rectal hydromorphone suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using hydromorphone.

Store in the refrigerator, do not freeze. Protect from light. Keep the medication in a place where others cannot get to it.

Keep track of the number of suppositories used from each new supply. Hydromorphone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since hydromorphone is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A hydromorphone overdose can be fatal, especially in a child who accidentally sucks on or swallows a hydromorphone suppository, or in any other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, and fainting.

What should I avoid while using rectal hydromorphone?

Do not drink alcohol. Dangerous side effects or death can occur when you drink alcohol while using rectal hydromorphone.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how hydromorphone will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Rectal 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:

  • slow heart rate, weak or shallow breathing;

  • severe drowsiness;

  • confusion, mood changes, severe anxiety, feeling of fear;

  • a light-headed feeling, like you might pass out; or

  • little or no urinating.

Common side effects may include:

  • constipation;

  • dizziness, drowsiness;

  • sweating;

  • weakness, muscle stiffness; or

  • joint or muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Hydromorphone dosing information

Usual Adult Dose for Pain:

The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time; each patient should be managed individually.

ORAL:
Immediate-release tablets: Initial dose: 2 to 4 mg orally every 4 to 6 hours
Immediate-release oral liquid: Initial dose: 2.5 to 10 mg orally every 3 to 6 hours
Maintenance dose: Gradually increase dose if analgesia is inadequate, as tolerance develops, or if pain severity increases.

PARENTERAL: Multiple concentrations are available: Standard: 1 mg/mL, 2 mg/mL, 4 mg/mL
-High Potency (HP): for opioid tolerant patients only and should be used only if the amount of hydromorphone can be delivered accurately: 10 mg/mL
IM or Subcutaneous: Initial dose: 1 mg to 2 mg IM or subcutaneously ever 2 to 3 hours as needed
-Adjust dose according to the severity of pain, the severity of adverse events, and the patients underlying disease and age.
IV: Initial dose: 0.2 mg to 1 mg IV; administer slowly over at least 2 to 3 minutes.
-Dose should be titrated to achieve acceptable analgesia and tolerable adverse events.

CONVERSION FROM PRIOR OPIOIDS:
Initial daily dose should be 50% of the 24-hour calculated hydromorphone requirement divided by the number of doses permitted based on dosing interval.
-Dose should be titrated to achieve acceptable analgesia and tolerable adverse events.

-The following may be used as a guide to determine conversion to hydromorphone. A hydromorphone IM or subcutaneous dose of 1.3 to 2 mg is approximately equianalgesic to a hydromorphone oral dose of 6.5 to 7.5 mg.
-Hydromorphone IM or subcutaneous doses of 1.3 to 2 mg are approximately equianalgesic to the following parenteral doses: Morphine 10 mg; Oxymorphone 1 to 1.1 mg; Levorphanol 2 to 2.3 mg; Meperidine 75 to 100 mg; Methadone 10 mg; Nalbuphine 10 to 12 mg; Butorphanol 1.5 to 2.5 mg
-Hydromorphone oral doses of 6.5 to 7.5 mg are approximately equianalgesic to the following oral doses: Morphine 40 to 60 mg; Oxymorphone 6.6 mg; Levorphanol 4 mg; Meperidine 300 to 400 mg; Methadone 10 to 20 mg

Comments:
-Dose titration should be guided by need for analgesia rather than by dose.
-Due to risk of respiratory depression, Hydromorphone-HP injection is reserved for use in opioid tolerant patients only; opioid tolerant patients are those patients taking for one week or longer, at least: oral morphine 60 mg/day, fentanyl transdermal 25 mcg/hour, oral oxycodone 30 mg/day, oral hydromorphone 8 mg/day, oral oxymorphone 25 mg/day, or an equianalgesic dose of another opioid.

Use: Management of pain in patients where an opioid analgesic is appropriate.

SUPPOSITORY: Insert 3 mg suppository rectally every 6 to 8 hours

Comments: The labeling for this product has not been approved by FDA

Use: For the relief of moderate to severe pain such as that due to surgery, trauma, burns, cancer, biliary colic, myocardial infarction, or renal colic.

Usual Adult Dose for Chronic Pain:

The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time; each patient should be managed individually. Discontinue all other around-the-clock opioid drugs when initiating therapy with extended-release hydromorphone.

-Due to risk of respiratory depression, EXTENDED-RELEASE tablets are reserved for use in opioid tolerant patients only; opioid tolerant patients are those patients taking for one week or longer, at least: oral morphine 60 mg/day, fentanyl transdermal 25 mcg/hour, oral oxycodone 30 mg/day, oral hydromorphone 8 mg/day, oral oxymorphone 25 mg/day, or an equianalgesic dose of another opioid.

Initial doses:
Conversion from Immediate-Release Oral Hydromorphone to Extended-Release tablets: Starting dose should be equivalent to the total daily oral immediate-release dose taken as extended-release tablet orally once a day.

Conversion from Other Oral Opioids to Extended-Release tablets: Starting dose should be equivalent to 50% of the calculated daily hydromorphone requirement taken as extended-release tablet orally once a day.
-Published potency tables can be used to estimate a patient's 24-hour oral hydromorphone requirement, however, if used it is best to underestimate the 24-hour requirement due to substantial inter-patient variability; rescue medication can be provided as the dose is titrated
-Alternatively, the following conversion factors (CFs) may be used to convert selected oral opioids to hydromorphone extended-release tablets: Hydromorphone, CF=1; Codeine, CF=0.06; Hydrocodone, CF=0.4; Oxycodone, CF=0.4; Methadone, CF= 0.6, Morphine, CF=0.2, Oxymorphone, CF=0.6.
-Example: Sum the total daily dose of prior oral opioid; multiply that sum by the CF to obtain 24-hour oral requirement; the starting dose should be 50% of this 24-hour oral requirement, round down if necessary.
-These CFs cannot be used to convert from hydromorphone extended-release tablets to oral opioids as doing so will result in overestimation of the opioid dose and may result in fatal respiratory depression.

Conversion from Transdermal Fentanyl to Oral Hydromorphone Extended-Release: Initiate therapy 18 hours following removal of the transdermal fentanyl patch, starting dose should be determined using the conversion: 25 mcg fentanyl patch=12 mg oral extended-release hydromorphone; this 24-hour requirement should then be reduced by 50%, round down if necessary; calculated initial dose taken orally once a day.

TITRATION AND MAINTENANCE:
Maintenance dose: Individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions; dose adjustments may be made in 4 to 8 mg increments every 24 hours, every 3 to 4 days.
Breakthrough Pain: If the level of pain increases after dose stabilization, attempt to identify the source before increasing dose; rescue medication with appropriate immediate-release analgesia may be helpful.

Comments:
-When converting from methadone, close monitoring is of particular importance due to methadone's long half-life.
-Dose conversion should be done carefully and with close monitoring due to large patient variability in regards to opioid analgesic response.
-Extended-release tablets are not indicated as an as-needed analgesic.
-Upon cessation of therapy, gradually taper dose in physically dependent patient.

Use: For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

What other drugs will affect rectal hydromorphone?

Using this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before using a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

You should not use rectal hydromorphone if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Other drugs may interact with hydromorphone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about hydromorphone rectal.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2013-12-12, 2:48:52 PM.

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