Dilaudid-HP (Injection)

Hydromorphone injection is used to treat moderate to severe pain. It is part of a group of medicines called narcotic analgesics (pain medicines) and works on the central nervous system (CNS) to relieve pain. Do not use this medicine for mild pain or pain that occurs only occasionally or "as needed."

When hydromorphone is used for a long time, it may become habit-forming, leading to mental or physical dependence. However, people with ongoing pain should not let the fear of dependence stop them from using narcotics to relieve their pain. Mental dependence (addiction) is unlikely to happen when narcotics are used for this purpose. Physical dependence may cause withdrawal side effects if treatment is stopped suddenly. Severe withdrawal side effects can usually be avoided by gradually lowering the dose over time.

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

It is very important that your doctor checks your progress while you are taking this medicine. This will help your doctor see if the medicine is working correctly and decide if you should keep taking it.

This medicine will increase the effects of alcohol and other central nervous system (CNS) depressants. 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 allergies or colds, sedatives, tranquilizers, or sleeping medicines, other prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before drinking alcohol or taking any of the medicines listed above while using this medicine.

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

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

This medicine may make you dizzy, drowsy, confused, or disoriented. 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.

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

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and needs 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 using this medicine.

If you have been using this medicine regularly for several weeks or longer, do not stop using it suddenly without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the risk of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Some babies born to mothers who are physically dependent on this medicine may also be physically dependent and may have breathing problems and withdrawal symptoms. This could be life-threatening and requires immediate medical attention. Check with your doctor right away if your baby has difficulty breathing, shortness of breath, excessive crying, irritability, fever, vomiting, or tremors.

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 are also taking certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause reduced 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 medication, the chances of using the medicine must be weighed against the good it will do. This is a decision you and your physician will make. For this medicine, the following should be considered:

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Additionally inform 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 injection 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 injection in the elderly. Nevertheless, elderly patients are more likely to have age-related lung, kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving hydromorphone injection in order to avoid serious side effects.

Breast Feeding

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

Interactions with Drugs

Although certain drugs should not be used together at all, in other cases two different medications 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 receiving this drug, it is especially critical that your healthcare professional know if you are using any of the medications 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 advised. Your clinician may decide not to treat you with this drug or change some of the other medicines you take.

• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

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

• 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 medications 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 drug with any of the following is usually not advised, but may be unavoidable in some cases. If used together, your physician may change the dose or how frequently 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 issues may affect the use of this medicine. Make sure you tell your clinician if you have any other medical problems, especially:

• Addison disease (adrenal gland issue) or
• Alcohol abuse, acute or
• Breathing or lung problems, severe (eg, asthma, 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, or history of or
• Gallbladder disease or gallstones or
• Head injury, history of or
• Hypothyroidism (an underactive thyroid) or
• Kyphoscoliosis (curvature of the spine with breathing issues) or
• Mental health issues, history of or
• Problems with passing urine or
• Prostatic hypertrophy (enlarged prostate, BPH)—Use with caution. May raise chance for more severe adverse effects.

• Allergy to sulfites or
• Stomach or bowel blockage (eg, paralytic ileus)—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 since of slower removal of the drug from the body.

• Patients who are not opioid-tolerant—Dilaudid-HP® should not be given in these patients.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you might need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

Incidence not known

• Abdominal or stomach pain
• blurred vision
• change in consciousness
• change in the ability to see colors, especially blue or yellow
• chest pain or discomfort
• cold, clammy skin
• confusion
• cough
• difficult or troubled breathing
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• headache
• irregular, fast, slow, or shallow breathing
• lightheadedness, dizziness, or fainting
• loss of appetite
• noisy breathing
• pale or blue lips, fingernails, or skin
• severe constipation
• severe vomiting
• slow or irregular heartbeat
• sweating
• tightness in the chest
• trouble with sleeping
• unusual tiredness
• very slow heartbeat or pulse
• vomiting

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

Symptoms of overdose

• Change in consciousness
• cold and clammy skin
• convulsions (seizures)
• drowsiness that is so severe you are not able to answer when spoken to or, if asleep, cannot be awakened
• pale or blue lips, fingernails, or skin
• pinpoint (small) pupils in the eyes
• sleepiness or unusual drowsiness
• slow heartbeat
• unable to speak
• very slow or troubled breathing
• weak muscle tone

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

Incidence not known

• Anxiety
• bad, unusual, or unpleasant (after) taste
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• chills
• constricted, pinpoint, or small pupils (black part of the eye)
• decrease in the frequency or amount of urination
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty in passing urine (dribbling)
• double vision
• dry mouth
• false or unusual sense of well-being
• fast or rapid breathing
• feeling of warmth
• hives or welts
• irritability
• itching
• loss of appetite
• muscle stiffness or tightness
• nausea
• painful urination
• redness, pain, or swelling at the injection site
• redness of the face, neck, arms, and occasionally, upper chest
• relaxed or calm feeling
• seeing, hearing, or feeling things that are not there
• seeing double
• shaking
• sleepiness
• uncontrolled eye movements
• upper stomach pain
• weight loss

Other side effects not listed may also happen 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-HP

Available Dosage Forms:

• Solution

Therapeutic Class: Analgesic

Chemical Class: Hydromorphone

A nurse or other trained health professional will give you this medicine in a hospital. This medicine may be given as a shot under the skin, as a shot into one of your muscles, or through a needle placed in one of your veins.

Hydromorphone injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure you understand the instructions before giving yourself an injection.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.

Use a new needle and syringe each time you inject the medicine.

If the medicine in the vial has changed color, or if you see particles in it, do not use it.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

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 injection (intramuscular or subcutaneous) dosage forms:For moderate to severe pain:For patients who are not taking opioid medicines (not opioid-tolerant): Adults—At first, 1 to 2 milligrams (mg) injected under the skin or into one of your muscles every 2 to 3 hours as needed. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor. For patients who are already taking opioid medicines (opioid-tolerant): Adults—Your dose is based on the narcotic pain medicine you are already receiving. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

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

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.

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