Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Dilaudid
  2. Dilaudid-5
  3. Exalgo
  4. Palladone

Descriptions


Hydromorphone oral liquid and tablets are used to relieve pain. The hydromorphone extended-release capsules and extended-release tablets are used to relieve moderate to severe pain in opioid-tolerant patients who require around-the-clock pain relief for a long period of time.

Hydromorphone extended-release capsules and extended-release tablets should not be used if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine to relieve mild pain. This medicine should not be used to treat pain that you only have once in a while or "as needed".

Hydromorphone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Liquid
  • Tablet, Extended Release
  • Capsule, Extended Release
  • Tablet
  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of hydromorphone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydromorphone in the elderly. However, elderly patients may be more sensitive to the effects of hydromorphone than younger adults, and are more likely to have age-related lung, liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving hydromorphone.

Pregnancy

Information about this hydromorphone-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Naltrexone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfentanil
  • Alprazolam
  • Anileridine
  • Aripiprazole
  • Baclofen
  • Brofaromine
  • Bromazepam
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carbinoxamine
  • Carisoprodol
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpromazine
  • Chlorzoxazone
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Clorgyline
  • Clozapine
  • Codeine
  • Dantrolene
  • Desflurane
  • Dexmedetomidine
  • Dezocine
  • Diazepam
  • Diphenhydramine
  • Doxylamine
  • Enflurane
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Fentanyl
  • Flunitrazepam
  • Fluphenazine
  • Flurazepam
  • Fospropofol
  • Furazolidone
  • Halazepam
  • Haloperidol
  • Halothane
  • Hydrocodone
  • Hydromorphone
  • Hydroxyzine
  • Iproniazid
  • Isocarboxazid
  • Isoflurane
  • Ketamine
  • Ketazolam
  • Lazabemide
  • Levorphanol
  • Linezolid
  • Lorazepam
  • Lormetazepam
  • Loxapine
  • Meclizine
  • Medazepam
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methocarbamol
  • Methohexital
  • Midazolam
  • Moclobemide
  • Molindone
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Nialamide
  • Nitrazepam
  • Nitrous Oxide
  • Olanzapine
  • Opium
  • Orphenadrine
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Paliperidone
  • Pargyline
  • Pentazocine
  • Pentobarbital
  • Perphenazine
  • Phenelzine
  • Phenobarbital
  • Pimozide
  • Prazepam
  • Procarbazine
  • Promazine
  • Promethazine
  • Propofol
  • Propoxyphene
  • Quazepam
  • Quetiapine
  • Ramelteon
  • Rasagiline
  • Remifentanil
  • Risperidone
  • Secobarbital
  • Selegiline
  • Sevoflurane
  • Sodium Oxybate
  • Sufentanil
  • Suvorexant
  • Tapentadol
  • Temazepam
  • Thiopental
  • Thioridazine
  • Thiothixene
  • Tizanidine
  • Toloxatone
  • Tranylcypromine
  • Triazolam
  • Trifluoperazine
  • Zaleplon
  • Ziprasidone
  • Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Perampanel

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Addison's disease (adrenal gland problem) or
  • Alcohol abuse, or history of or
  • Brain tumor or
  • Breathing or lung problems (eg, chronic obstructive pulmonary disease [COPD], cor pulmonale, hypercapnia, hypoxia, sleep apnea) or
  • CNS depression, history of or
  • Drug dependence, especially narcotic abuse or dependence, history of or
  • Enlarged prostate (BPH, prostatic hypertrophy) or
  • Gallbladder disease or
  • Head injuries, history of or
  • Hypothyroidism (an underactive thyroid) or
  • Increased pressure in your head or
  • Mental illness, or history of or
  • Obesity, severe or
  • Problems with passing urine or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Allergy to sulfites or
  • Not opioid-tolerant (if you are not already taking a certain amount of morphine, oxycodone, or other opioid medicine) or
  • Paralytic ileus (intestinal blockage) or
  • Stomach or bowel problems (eg, narrowing of the intestines, Meckel's diverticulum, peritonitis, "short gut" syndrome), history of or
  • Surgery involving the stomach or intestinal, history of or
  • Trouble swallowing—Exalgo® and Palladone® should not be given in patients with these conditions.
  • Breathing problems (eg, asthma, hypercapnia), severe or
  • Respiratory depression (hypoventilation or slow breathing)—Should not be used in patients with these conditions.
  • Hypotension (low blood pressure) or
  • Pancreatitis (inflammation of the pancreas) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Stomach or digestion problems—This medicine may mask the diagnosis of these conditions.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

If you are using the extended-release capsules or tablets:

  • Hydromorphone extended-release capsules or tablets are for use in opioid-tolerant patients only. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.
  • This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
  • Take this medicine at the same time each day, with or without food.
  • Swallow the tablet whole. Do not crush, break, or chew it.
  • While taking this medicine, part of the tablet may pass into your stools. This is normal and is nothing to worry about.

Exalgo® tablets works differently than hydromorphone tablets, even at the same dose (number of milligrams). Do not switch from the extended-release tablets to the immediate-release tablets unless your doctor tells you to.

Be careful not to handle crushed or broken tablets. If you have contact with broken or crushed tablets or spilled oral liquid, wash your skin or the affected areas with soap and water right away.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release capsules):
    • For moderate to severe pain:
      • For patients switching from other narcotic medicines:
        • Adults—The capsule is given once a day. Your first dose will depend on the amount of other narcotics you have been taking every day. Your doctor will determine your dose and may increase the dose as needed. For patients switching from fentanyl transdermal, this medicine should be started at least 18 hours after the removal of the fentanyl patch.
        • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release tablets):
    • For moderate to severe pain:
      • For patients switching from regular hydromorphone forms:
        • Adults—The tablet is given once a day. The total amount of milligrams (mg) per day is the same as the total amount of regular hydromorphone that is taken per day.
        • Children—Use and dose must be determined by your doctor.
      • For patients switching from other narcotic medicines:
        • Adults—The tablet is given once a day. Your first dose will depend on the amount of other narcotics you have been taking every day. Your doctor will determine your dose and may increase the dose as needed. For patients switching from fentanyl transdermal, this medicine should be started at least 18 hours after the removal of the fentanyl patch.
        • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (liquid):
    • For pain:
      • Adults—At first, 2.5 to 10 milliliters (mL) or one-half to two teaspoonfuls every 3 to 6 hours as needed. Your doctor may increase your dose as needed.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • For pain:
      • Adults—At first, 2 to 4 milligrams (mg) every 4 to 6 hours. Your doctor may increase your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Hydromorphone can cause serious unwanted effects or fatal overdose if taken by children, pets, or adults who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Flush the unused medicine down the toilet or take it to a community take-back program when available.

Precautions

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

If you have been using this medicine regularly for several weeks or more, do not change your dose or suddenly stop using it without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely, or to take another narcotic for a while, to lessen the chance of withdrawal side effects (eg, abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping).

Do not take too much of this medicine. This can be life-threatening. Symptoms of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare

  1. Agitation
  2. bloody, black, or tarry stools
  3. blurred vision
  4. changes in behavior
  5. chest pain or discomfort
  6. convulsions
  7. decreased urination
  8. dry mouth
  9. fast, pounding, or irregular heartbeat or pulse
  10. lightheadedness, dizziness, or fainting
  11. mood or mental changes
  12. rapid breathing
  13. severe stomach pain, cramping, or burning
  14. severe vomiting
  15. slow or irregular heartbeat
  16. stiff neck
  17. sunken eyes
  18. thoughts of killing oneself
  19. trouble breathing
  20. unusual tiredness
  21. vomiting of material that looks like coffee grounds, severe and continuing
  22. wrinkled skin

Incidence not known

  1. Bluish lips or skin
  2. change in the ability to see colors, especially blue or yellow
  3. cold, clammy skin
  4. confusion
  5. cough
  6. decrease in the frequency of urination
  7. decrease in urine volume
  8. difficulty in passing urine (dribbling)
  9. dizziness
  10. fast, weak pulse
  11. headache
  12. heart stops
  13. irregular, fast or slow, or shallow breathing
  14. loss of appetite
  15. no pulse or blood pressure
  16. noisy breathing
  17. not breathing
  18. painful urination
  19. pale or blue lips, fingernails, or skin
  20. sweating
  21. tightness in the chest
  22. trouble sleeping
  23. unconscious

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Decreased awareness or responsiveness
  2. increased sensitivity of the eyes to light
  3. no muscle tone or movement
  4. sleepiness or unusual drowsiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Difficulty having a bowel movement (stool)
  2. difficulty with moving
  3. muscle pain or stiffness
  4. nausea
  5. pain in the joints

Less common

  1. Acid or sour stomach
  2. back pain
  3. belching
  4. bloating or swelling of the face, arms, hands, lower legs, or feet
  5. diarrhea
  6. discouragement
  7. feeling sad or empty
  8. heartburn
  9. indigestion
  10. irritability
  11. loss of interest or pleasure
  12. muscle spasms
  13. pain in the arms or legs
  14. stomach discomfort, upset, or pain
  15. tingling of the hands or feet
  16. trouble concentrating
  17. unusual weight gain or loss

Less common or rare

  1. Being forgetful
  2. bleeding after defecation
  3. change in taste
  4. changes in the patterns and rhythms of speech
  5. clumsiness
  6. continuing ringing or buzzing or other unexplained noise in the ears
  7. crying
  8. decreased interest in sexual intercourse
  9. delusions of persecution, mistrust, suspiciousness, or combativeness
  10. difficulty with swallowing
  11. difficulty with walking
  12. double vision
  13. excess air or gas in the stomach or intestines
  14. extra heartbeats
  15. feeling of constant movement of self or surroundings
  16. full feeling
  17. hearing loss
  18. inability to have or keep an erection
  19. increased appetite
  20. joint pain, stiffness, or swelling
  21. loss in sexual ability, desire, drive, or performance
  22. loss of balance
  23. loss of taste
  24. low body temperature
  25. muscle aches
  26. muscle twitching or jerking
  27. overactive reflexes
  28. passing gas
  29. rhythmic movement of muscles
  30. runny nose
  31. seeing double
  32. seeing, hearing, or feeling things that are not there
  33. sensation of spinning
  34. shivering
  35. slurred speech
  36. sneezing
  37. swelling of the feet or lower legs
  38. trouble with speaking
  39. uncomfortable swelling around the anus
  40. weak or feeble pulse

Incidence not known

  1. Bad, unusual or unpleasant (after) taste
  2. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  3. chills
  4. constricted, pinpoint, or small pupils (black part of the eye)
  5. deep or fast breathing with dizziness
  6. drowsiness
  7. dry mouth
  8. false or unusual sense of well-being
  9. fear or nervousness
  10. feeling of warmth
  11. hives or welts
  12. muscle stiffness or tightness
  13. numbness of the feet, hands, and around the mouth
  14. redness of the face, neck, arms, and occasionally, upper chest
  15. redness of the skin
  16. relaxed and calm
  17. shaking
  18. skin itching
  19. uncontrolled eye movements
  20. upper abdominal or stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.