Palladone (Oral)

Hydromorphone oral liquid and tablets are used to relieve pain. The hydromorphone extended-release capsules and extended-release tablets are used to relieve pain in patients who are already tolerant to opioids and need continuous pain relief for a long time.

Hydromorphone extended-release capsules and extended-release tablets should not be used for short-term pain relief, such as after surgery. Do not use this medicine for mild pain. This medicine should not be used for pain that occurs only occasionally or "as needed."

Hydromorphone is part of a group of medicines called narcotic analgesics (pain medicines). It works on the central nervous system (CNS) to relieve pain.

Using a narcotic medicine for a long time may lead to habit formation, causing mental or physical dependence. However, people with ongoing pain should not let the fear of dependence prevent them from using narcotics to relieve their pain. Mental dependence (addiction) is unlikely when narcotics are used for this purpose. Physical dependence may cause withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be avoided by gradually lowering the dose over time before stopping treatment completely.

This medicine is available only through a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

It is very important for your doctor to check your progress while you are using this medicine. This will help your doctor see if the medicine is working properly and decide if you should continue taking it. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) including isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®] within the past 14 days.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. 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.

This medicine may cause problems with your adrenal glands. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Dizziness, lightheadedness, or fainting may happen 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 lead to severe constipation. To prevent this, your doctor may tell you to take laxatives, drink a lot of fluids, or eat more fiber. Be sure to follow the directions carefully, because ongoing constipation can lead to more serious problems.

This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause serious allergic reactions, including anaphylaxis, which 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 told 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 (e.g., anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble sleeping).

Using too much hydromorphone may lead to an overdose, which can be life-threatening. Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. In case of an overdose, call your doctor right away. Your doctor may also give naloxone to treat an overdose.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

For nursing mothers taking this medicine:

• Talk to your doctor if you have any questions about taking hydromorphone or how this medicine may affect your baby.
• Call your doctor if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every 2 to 3 hours and should not sleep more than 4 hours at a time.
• Check with your doctor, hospital emergency room, or local emergency services (e.g., "call 9-1-1") immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

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.

In deciding to use a medicine, the chances of using the medication must be weighed against the beneficial it will do. This is a decision you and your clinician will make. For this medicine, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this drug or any other medications. As well 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 issues that would limit the usefulness of hydromorphone in the elderly. Nevertheless, 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 issues, which may require caution and an adjustment in the dose for patients receiving hydromorphone.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this drug during breastfeeding. Weigh the potential benefits against the potential chances prior to taking this medication while breastfeeding.

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 clinician may want to change the dose, or other precautions may be necessary. When you are using this medication, it is especially essential that your healthcare professional know if you are using 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 medication with any of the following drugs is not recommended. Your physician may decide not to treat you with this medication or change some of the other medicines you take.

• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

Using this drug with any of the following medications is usually not advised, but may be required in some cases. If both drugs are prescribed together, your physician may change the dose or how frequently you use one or both of the medications.

• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Amifampridine
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Anileridine
• Aripiprazole
• Asenapine
• Baclofen
• Benperidol
• Benzhydrocodone
• Benzphetamine
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Citalopram
• Clobazam
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clozapine
• Cocaine
• Codeine
• Cyclobenzaprine
• Daridorexant
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Duloxetine
• Eletriptan
• Enflurane
• Escitalopram
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Fenfluramine
• Fentanyl
• Flibanserin
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fospropofol
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydroxytryptophan
• Hydroxyzine
• Imipramine
• Iproniazid
• Isocarboxazid
• Isoflurane
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Lasmiditan
• Lemborexant
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lorazepam
• Lorcaserin
• Loxapine
• Magnesium Oxybate
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Midazolam
• Milnacipran
• Mirtazapine
• Moclobemide
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nialamide
• Nicomorphine
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Ozanimod
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

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 drugs may additionally 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 advised, but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Issues

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

• Addison disease (adrenal gland issue) or
• Alcohol abuse, or history of or
• Brain tumor or
• Breathing or lung problems (eg, apnea, low oxygen levels) or
• Chronic obstructive pulmonary disease (COPD) or
• Cor pulmonale (severe heart condition) or
• Depression, history of or
• Drug dependence, especially narcotic abuse or dependence, history of or
• Gallbladder disease or
• Head injury, history of or
• Hypothyroidism (an underactive thyroid) or
• Mental health issues, or history of or
• Obesity, serious or
• Prostatic hypertrophy (enlarged prostate, BPH) or
• Weakened physical condition—Use with caution. May increase risk for more severe side effects.

• Allergy to sulfites or
• Lung or breathing issues (eg, asthma, respiratory depression), serious or
• Narrowing of the stomach or bowels ("blind loops") or
• Stomach or bowel blockage (eg, paralytic ileus), known or suspected—Should not be used in patients with these conditions.

• Hypotension (low blood pressure) or
• Pancreatitis (swelling 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 medication from the body.

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

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

Less common

• Agitation
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody, black, or tarry stools
• blurred vision
• changes in behavior
• chest pain or discomfort
• decreased urination
• dry mouth
• fast, pounding, slow, or irregular heartbeat
• lightheadedness, dizziness, or fainting
• mood or mental changes
• rapid breathing
• severe stomach pain, cramping, or burning
• stiff neck
• sunken eyes
• thoughts of killing oneself
• trouble breathing
• unusual tiredness or weakness
• 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
• constricted, pinpoint, or small pupils (black part of the eye)
• cough
• darkening of the skin
• decrease in frequency of urination or urine amount
• deep or fast breathing with dizziness
• difficulty in passing urine (dribbling)
• fast or weak pulse
• headache
• hives or welts, itching, skin rash
• irregular, fast or slow, or shallow breathing
• loss of appetite
• mental depression
• nausea
• noisy breathing
• overactive reflexes
• painful urination
• pale or blue lips, fingernails, or skin
• poor coordination
• restlessness
• sweating
• talking or acting with excitement you cannot control
• tightness in the chest
• trouble sleeping
• vomiting

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

Symptoms of overdose

• Cold, clammy skin
• drowsiness that is so severe you are not able to answer when spoken to or, if asleep, cannot be awakened
• pinpoint (small) pupils in the eyes
• seizures
• slow heartbeat
• very slow or trouble breathing

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
• difficulty with moving
• joint pain
• muscle pain or stiffness

Less common

• Back pain
• belching
• 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

• Being forgetful
• bleeding after defecation
• clumsiness
• continuing ringing or buzzing or other unexplained noise in the ears
• crying
• delusions of persecution, mistrust, suspiciousness, or combativeness
• difficulty with swallowing
• difficulty with walking
• double vision
• excess air or gas in the stomach or bowels
• feeling of constant movement of self or surroundings
• full feeling
• increased appetite
• joint pain, stiffness, or swelling
• loss in sexual ability, desire, drive, or performance
• loss of balance
• low body temperature
• muscle aches
• muscle twitching or jerking
• rhythmic movement of muscles
• runny nose
• seeing, hearing, or feeling things that are not there
• sensation of spinning
• shivering
• slurred speech
• sneezing
• trouble with speaking

Incidence not known

• Bad, unusual or unpleasant (after) taste
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• drowsiness
• dry mouth
• false or unusual sense of well-being
• fear or nervousness
• feeling of warmth
• muscle stiffness or tightness
• numbness of the feet, hands, and around the mouth
• redness of the face, neck, arms, and occasionally, upper chest
• relaxed and calm feeling
• shaking
• uncontrolled eye movements
• upper 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.

In the U.S.

• Dilaudid
• Dilaudid-5
• Exalgo
• Palladone

Available Dosage Forms:

• Tablet, Extended Release
• Tablet
• Solution

Therapeutic Class: Analgesic

Chemical Class: Opioid

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).

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of hydromorphone. This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

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 extended-release tablets:

• Hydromorphone extended-release capsules or extended-release 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.
• Take this medicine at the same time each day, with or without food.
• Swallow the extended-release tablet whole. Do not crush, break, chew, dissolve, snort, or inject it.
• While taking this medicine, part of the extended-release tablet may pass into your stools. This is normal and is nothing to worry about.

Exalgo® extended-release 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 the other narcotic you have been taking. Your doctor will determine your dose and adjust the dose as needed. 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 the other narcotic you have been taking. Your doctor will determine your dose and adjust the dose as needed. Children—Use and dose must be determined by your doctor.
• For oral dosage form (solution):For pain: Adults—At first, 2.5 to 10 milliliters (mL) or one-half to two teaspoons every 3 to 6 hours as needed. Your doctor may adjust 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 adjust your dose as needed. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

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