hydromorphone

Generic Name: hydromorphone (oral) (HYE droe MOR fone)
Brand Name: Dilaudid, Dilaudid-5, Exalgo

What is hydromorphone?

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

Hydromorphone is used to treat moderate to severe pain.

The extended-release form of this medicine is for around-the-clock treatment of moderate to severe pain. This form of hydromorphone is not for use on an as-needed basis for pain.

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

What is the most important information I should know about 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 MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

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

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with hydromorphone.

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

You should not take this medicine if you have ever had an allergic reaction to hydromorphone or other narcotic medicines, or if you have:

• severe asthma or breathing problems;

• a blockage in your stomach or intestines; or

• a bowel obstruction called paralytic ileus.

Do not use 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.

Some medicines can interact with hydromorphone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

You may not be able to take hydromorphone if you are NOT already being treated with a similar opioid (narcotic) pain medicine and are tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

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

• any type of breathing problem or lung disease;

• a history of head injury, brain tumor, or seizures;

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

• urination problems;

• liver or kidney disease;

• sulfite allergy;

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

• problems with your gallbladder, pancreas, or thyroid.

It is not known whether this medicine will harm an unborn baby. If you use hydromorphone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Hydromorphone can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using hydromorphone.

How should I use hydromorphone?

Follow all directions on your prescription label. Hydromorphone can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use 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.

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 MEDICINE 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.

Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

Stop taking all other around-the-clock narcotic pain medications when you start taking hydromorphone.

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.

Do not stop using hydromorphone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using hydromorphone.

Never crush or break a hydromorphone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of hydromorphone and similar prescription drugs.

Store at room temperature away from moisture, heat, and light. Throw away any unused liquid after 90 days.

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.

Do not keep leftover hydromorphone pills or liquid. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused pills or liquid medicine down the toilet.

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 or 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, pinpoint pupils, and fainting.

What should I avoid while using hydromorphone?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with hydromorphone. Check your food and medicine labels to be sure these products do not contain alcohol.

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.

Hydromorphone side effects

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

Call your doctor at once if you have:

• weak or shallow breathing;

• confusion, feelings of extreme happiness or sadness;

• severe weakness or drowsiness;

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

• infertility, missed menstrual periods;

• impotence, sexual problems, loss of interest in sex; or

• low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

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

Common side effects may include:

• constipation, nausea, vomiting, stomach pain;

• dizziness, drowsiness;

• headache, tired feeling;

• feelings of extreme happiness or sadness;

• sweating, mild itching;

• dry mouth; or

• flushing (warmth, redness, or tingly feeling).

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 hydromorphone?

Some medicines can cause unwanted or dangerous effects when used with hydromorphone. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Taking 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 taking hydromorphone with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with hydromorphone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

• Your pharmacist can provide more information about hydromorphone.