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Generic Name: hydromorphone (oral) (HYE droe MOR fone)
Brand Names: Dilaudid, Exalgo, Hydrostat IR
Dilaudid (hydromorphone) is an opioid pain medication. An opioid is sometimes called a narcotic.
Dilaudid is used to treat moderate to severe pain.
Dilaudid may also be used for purposes not listed in this medication guide.
You should not take Dilaudid if you have severe breathing problems, or a blockage in your stomach or intestines.
Dilaudid can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use Dilaudid 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.
Dilaudid may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION 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. Dilaudid may cause life-threatening addiction and withdrawal symptoms in a newborn if the mother has taken this medicine during pregnancy.
Do not drink alcohol. Dangerous side effects or death could occur when alcohol is combined with hydromorphone.
You should not take Dilaudid if you have ever had an allergic reaction to hydromorphone or other narcotic medicines, or if you have:
breathing problems, sleep apnea;
a blockage in your stomach or intestines; or
a bowel obstruction called paralytic ileus.
Do not use Dilaudid if you have used a 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 Dilaudid 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.
Dilaudid may be habit-forming. 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. Selling or giving away hydromorphone to any other person is against the law.
To make sure hydromorphone is safe for you, tell your doctor if you have:
noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
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;
problems with your gallbladder, pancreas, or thyroid; or
if you use a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
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 Dilaudid.
Take Dilaudid exactly as prescribed. Follow all directions on your prescription label. Dilaudid can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use Dilaudid in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Dilaudid may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.
Measure the 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 Dilaudid suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
Never crush or break a tablet 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 Dilaudid tablets or liquid. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused tablets or liquid down the toilet. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety.
Since Dilaudid 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.
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.
Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with hydromorphone.
This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Dilaudid will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Get emergency medical help if you have any signs of an allergic reaction to Dilaudid: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Like other narcotic medicines, hydromorphone can slow your breathing. Death may occur if breathing becomes too weak.
Call your doctor at once if you have:
noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
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 Dilaudid 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.
Hydromorphone can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
other narcotic medications - opioid pain medicine or prescription cough medicine;
a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.
This list is not complete. Other drugs may affect hydromorphone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Dilaudid only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Dilaudid (www.drugs.com/dilaudid.html).
Note: This document contains side effect information about hydromorphone. Some of the dosage forms listed on this page may not apply to the brand name Dilaudid.
For the ConsumerApplies to hydromorphone: oral solution, oral tablet, oral tablet extended release
Other dosage forms:
Oral route (Solution; Tablet)
Risk of Medication ErrorsEnsure accuracy when prescribing, dispensing, and administering HYDROmorphone oral solution. Dosing errors due to confusion between mg and mL can result in accidental overdose and death.Addiction, Abuse, and MisuseHYDROmorphone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing HYDROmorphone, and monitor all patients regularly for the development of these behaviors and conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of HYDROmorphone. Monitor for respiratory depression, especially during initiation of HYDROmorphone or following a dose increase.Accidental IngestionAccidental ingestion of even one dose of HYDROmorphone, especially by children, can result in a fatal overdose of HYDROmorphone.Neonatal Opioid Withdrawal SyndromeProlonged use of HYDROmorphone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. 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.Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of HYDROmorphone and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Oral route (Tablet, Extended Release)
Addiction, Abuse, and MisuseHYDROmorphone hydrochloride exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing HYDROmorphone hydrochloride, and monitor all patients regularly for the development of these behaviors and conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of HYDROmorphone hydrochloride. Monitor for respiratory depression, especially during initiation of HYDROmorphone hydrochloride or following a dose increase. Instruct patients to swallow HYDROmorphone hydrochloride extended-release tablets whole; crushing, chewing, or dissolving HYDROmorphone hydrochloride can cause rapid release and absorption of a potentially fatal dose of HYDROmorphone.Accidental IngestionAccidental ingestion of even one dose of HYDROmorphone hydrochloride, especially by children, can result in a fatal overdose of HYDROmorphone.Neonatal Opioid Withdrawal SyndromeProlonged use of HYDROmorphone hydrochloride during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. 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.Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of HYDROmorphone and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Along with its needed effects, hydromorphone (the active ingredient contained in Dilaudid) 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 while taking hydromorphone:
Less common
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking hydromorphone:
Symptoms of overdose
Some side effects of hydromorphone 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
Less common
Less common
Incidence not known
For Healthcare Professionals
Applies to hydromorphone: compounding powder, injectable powder for injection, injectable solution, intravenous solution, oral capsule extended release, oral liquid, oral tablet, oral tablet extended release, rectal suppository
GeneralThe most common adverse effects are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus.
GastrointestinalVery common (10% or more): Constipation (up to 31%), nausea (up to 28%), vomiting (up to 14%),
Common (1% to 10%): Dry mouth, dry mouth, abdominal pain, diarrhea, dyspepsia
Uncommon (0.1% to 1%): Ileus, cramps, taste alteration, gastritis, diverticulitis
Rare (less than 0.1%): Anal fissure, bezoar, duodenitis, impaired gastric emptying, painful defecation
Frequency not reported: Flatulence, dysphagia, hematochezia, abdominal distension, hemorrhoids, abnormal feces, intestinal obstruction, eructation, diverticulum, gastrointestinal motility disorder, large intestine perforation
Postmarketing reports: Oropharyngeal swelling
Nervous systemVery common (10% or more): Somnolence (up to 15%), headache (up to 12%), dizziness (up to 11%)
Common (1% to 10%): Lightheadedness, sedation, memory impairment, hypoesthesia, paresthesia
Uncommon (0.1% to 1%): Tremor, nystagmus, increased intracranial pressure, taste alteration, involuntary muscle contractions
Rare (less than 0.1%): Hyperreflexia
Frequency not reported: Balance disorder, encephalopathy
Postmarketing reports: Convulsions, drowsiness, dyskinesia, hyperalgesia, myoclonus, serotonin syndrome (with concomitant serotonergic drugs)
PsychiatricCommon (1% to 10%): Dysphoria, euphoria, insomnia, anxiety, depression, nervousness, nightmares, mood swings
Uncommon (0.1% to 1%): Agitation, altered mood, hallucination, disorientation, abnormal dreams
Frequency not reported: Floating feelings, dreams, apprehension, panic attack, suicide ideation, aggression
Postmarketing reports: Confusional state
HypersensitivityPostmarketing reports: Anaphylactic reactions, hypersensitivity reactions
RespiratoryCommon (1% to 10%): Dyspnea
Uncommon (0.1% to 1%): Bronchospasm, laryngospasm
Frequency not reported: Respiratory depression, apnea, respiratory arrest, rhinorrhea, respiratory distress, hypoxia, sneezing, hyperventilation
Postmarketing reports: Dyspnea
CardiovascularCommon (1% to 10%): Flushing, hypotension, peripheral edema, chest pain
Uncommon (0.1% to 1%): Tachycardia, bradycardia, palpitations, syncope, presyncope, hypertension
Frequency not reported: Circulatory depression, cardiac arrest, shock, extrasystoles
Postmarketing reports: Peripheral edema
DermatologicCommon (1% to 10%): Sweating, pruritus, hyperhidrosis, rash
Uncommon (0.1% to 1%): Urticaria, diaphoresis
Frequency not reported: Erythema
Postmarketing reports: Angioedema
LocalUncommon (0.1% to 1%): Injection site urticaria
Postmarketing reports: Injection site reactions
GenitourinaryCommon (1% to 10%): Urinary retention, urinary hesitancy
Postmarketing reports: Erectile dysfunction
HepaticUncommon (0.1% to 1%): Biliary tract spasm
Rare (less than 0.1%): Biliary colic
Postmarketing reports: Hepatic enzyme increased
OtherCommon (1% to 10%): Asthenia (up to 11%), pain, pyrexia, fall
Uncommon (0.1% to 1%): Weakness, abnormal feeling, chills
Rare (less than 0.1%): Feeling drunk
Frequency not reported: Neonatal withdrawal syndrome, addiction, abuse, misuse, overdose, drug withdrawal syndrome, vertigo, tinnitus, malaise
Postmarketing reports: Fatigue, lethargy
MetabolicCommon (1% to 10%): Anorexia/decreased appetite, decreased weight, dehydration
Uncommon (0.1% to 1%): Fluid retention, increased appetite, hyperuricemia
MusculoskeletalCommon (1% to 10%): Arthralgia, muscle spasms, back pain, extremity pain
Uncommon (0.1% to 1%): Muscle rigidity
Frequency not reported: Myalgia
OcularUncommon (0.1% to 1%): Blurred vision, diplopia, miosis, visual impairment
Frequency not reported: Dry eye
RenalUncommon (0.1% to 1%): Antidiuretic effects
EndocrineHydromorphone (the active ingredient contained in Dilaudid)
Uncommon (0.1% to 1%): Decreased libido, sexual dysfunction
Rare (less than 0.1%): Hypogonadism
Opioids:
Postmarketing reports: Adrenal insufficiency, androgen deficiency
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Dilaudid (www.drugs.com/dilaudid.html).
February 18, 2021
August 17, 2020
July 15, 2020
July 2, 2020
April 25, 2020
August 2, 2021
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