Generic Name: hydromorphone (Oral route)

hye-droe-MOR-fone

Oral route(Tablet;Liquid)

HYDROmorphone is a potent Schedule II opioid agonist, which has the highest potential for abuse and risk of producing respiratory depression. Alcohol, other opioids and central nervous system depressants (sedative-hypnotics) potentiate the respiratory depressant effects of HYDROmorphone, increasing the risk of respiratory depression that might result in death .

Oral route(Tablet, Extended Release;Capsule, Extended Release)

HYDROmorphone hydrochloride exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor regularly for development of these behaviors or conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow HYDROmorphone hydrochloride capsules or tablets whole to avoid exposure to a potentially fatal dose of HYDROmorphone. Accidental consumption of HYDROmorphone hydrochloride, especially in children, can result in fatal overdose of HYDROmorphone. Prolonged use of HYDROmorphone hydrochloride during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available . Instruct patients not to consume alcohol or any products containing alcohol while during treatment because co-ingestion can result in fatal overdose .

Commonly used brand name(s)

In the U.S.

  • Dilaudid
  • Dilaudid-5
  • Exalgo
  • Palladone

Available Dosage Forms:

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

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Exalgo

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".

Slideshow: Prescription Drug Addiction - Top 18 Facts for You and Your Family

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.

Before Using Exalgo

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

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.

Breast Feeding

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.

Interactions with Medicines

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
  • 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

Interactions with Food/Tobacco/Alcohol

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 of hydromorphone

This section provides information on the proper use of a number of products that contain hydromorphone. It may not be specific to Exalgo. Please read with care.

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 While Using Exalgo

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.

Exalgo 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
  • Agitation
  • bloody, black, or tarry stools
  • blurred vision
  • changes in behavior
  • chest pain or discomfort
  • convulsions
  • decreased urination
  • dry mouth
  • fast, pounding, or irregular heartbeat or pulse
  • lightheadedness, dizziness, or fainting
  • mood or mental changes
  • rapid breathing
  • severe stomach pain, cramping, or burning
  • severe vomiting
  • slow or irregular heartbeat
  • stiff neck
  • sunken eyes
  • thoughts of killing oneself
  • trouble breathing
  • unusual tiredness
  • vomiting of material that looks like coffee grounds, severe and continuing
  • wrinkled skin
Incidence not known
  • Bluish lips or skin
  • change in the ability to see colors, especially blue or yellow
  • cold, clammy skin
  • confusion
  • cough
  • decrease in the frequency of urination
  • decrease in urine volume
  • difficulty in passing urine (dribbling)
  • dizziness
  • fast, weak pulse
  • headache
  • heart stops
  • irregular, fast or slow, or shallow breathing
  • loss of appetite
  • no pulse or blood pressure
  • noisy breathing
  • not breathing
  • painful urination
  • pale or blue lips, fingernails, or skin
  • sweating
  • tightness in the chest
  • trouble sleeping
  • unconscious

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

Symptoms of overdose
  • Decreased awareness or responsiveness
  • increased sensitivity of the eyes to light
  • no muscle tone or movement
  • 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
  • Difficulty having a bowel movement (stool)
  • difficulty with moving
  • muscle pain or stiffness
  • nausea
  • pain in the joints
Less common
  • Acid or sour stomach
  • back pain
  • belching
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • diarrhea
  • discouragement
  • feeling sad or empty
  • heartburn
  • indigestion
  • irritability
  • loss of interest or pleasure
  • muscle spasms
  • pain in the arms or legs
  • stomach discomfort, upset, or pain
  • tingling of the hands or feet
  • trouble concentrating
  • unusual weight gain or loss
Less common or rare
  • Being forgetful
  • bleeding after defecation
  • change in taste
  • changes in the patterns and rhythms of speech
  • clumsiness
  • continuing ringing or buzzing or other unexplained noise in the ears
  • crying
  • decreased interest in sexual intercourse
  • delusions of persecution, mistrust, suspiciousness, or combativeness
  • difficulty with swallowing
  • difficulty with walking
  • double vision
  • excess air or gas in the stomach or intestines
  • extra heartbeats
  • feeling of constant movement of self or surroundings
  • full feeling
  • hearing loss
  • inability to have or keep an erection
  • increased appetite
  • joint pain, stiffness, or swelling
  • loss in sexual ability, desire, drive, or performance
  • loss of balance
  • loss of taste
  • low body temperature
  • muscle aches
  • muscle twitching or jerking
  • overactive reflexes
  • passing gas
  • rhythmic movement of muscles
  • runny nose
  • seeing double
  • seeing, hearing, or feeling things that are not there
  • sensation of spinning
  • shivering
  • slurred speech
  • sneezing
  • swelling of the feet or lower legs
  • trouble with speaking
  • uncomfortable swelling around the anus
  • weak or feeble pulse
Incidence not known
  • Bad, unusual or unpleasant (after) taste
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chills
  • constricted, pinpoint, or small pupils (black part of the eye)
  • deep or fast breathing with dizziness
  • drowsiness
  • dry mouth
  • false or unusual sense of well-being
  • fear or nervousness
  • feeling of warmth
  • hives or welts
  • muscle stiffness or tightness
  • numbness of the feet, hands, and around the mouth
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • relaxed and calm
  • shaking
  • skin itching
  • uncontrolled eye movements
  • 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.

See also: Side effects (in more detail)

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