Description
Hydromorphone injection is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. It belongs to the group of medicines called narcotic analgesics (pain medicines) and acts on the central nervous system (CNS) to relieve pain. Do not use this medicine for mild pain or pain that you only have once in a while or "as needed."
When hydromorphone 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 the 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. Severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- 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 injection 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 injection in the elderly. However, elderly patients are more likely to have age-related lung, kidney, liver, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving hydromorphone injection in order to avoid potentially serious side effects.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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.
- Isocarboxazid
- Naltrexone
- Safinamide
- Samidorphan
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.
- Acepromazine
- Aclidinium
- Alfentanil
- Almotriptan
- Alprazolam
- Amantadine
- Amifampridine
- Amiloride
- Amineptine
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Anileridine
- Aripiprazole
- Aripiprazole Lauroxil
- Asenapine
- Atropine
- Baclofen
- Belladonna
- Bemetizide
- Bendroflumethiazide
- Benperidol
- Bentazepam
- Benzhydrocodone
- Benzphetamine
- Benzthiazide
- Benztropine
- Biperiden
- Bromazepam
- Bromopride
- Brompheniramine
- Bumetanide
- Buprenorphine
- Bupropion
- Buspirone
- Butabarbital
- Butalbital
- Butorphanol
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.
- Desflurane
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 disease (adrenal gland problem) or
- Alcohol use disorder, history of or
- Breathing or lung problems, severe (eg, asthma, apnea, low oxygen levels) or
- Chronic obstructive pulmonary disease (COPD) or
- Cor pulmonale (serious 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 problems) or
- Mental health problems, history of or
- Problems with passing urine or
- Prostatic hypertrophy (enlarged prostate, BPH)—Use with caution. May increase risk for more serious side effects.
- Allergy to sulfites or
- Asthma, acute or severe or
- Respiratory depression (serious breathing problem) 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 because of slower removal of the medicine from the body.
- Patients who are not opioid-tolerant—Dilaudid-HP® should not be given in these patients.
Proper Use
This medicine is available in 2 forms: vial and prefilled syringe.
Vial: A doctor or other trained health professional will give you this medicine. It is given through a needle that is placed in one of your veins or as a shot into one of your muscles. The medicine must be given slowly, so the needle will have to remain in place for at least 2 to 3 minutes.
Prefilled syringe: You may also be taught how to give your medicine at home. It is usually given as a shot under the skin. Make sure you understand all instructions before you give yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
This medicine should come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
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.
Each package of Dilaudid® contains instructions for use. Read this sheet carefully and make sure you understand:
- How to prepare the medicine.
- How to inject the medicine.
- How to dispose of syringes, needles, and injection devices.
Use a new needle and syringe each time you inject the medicine.
Check the liquid in the syringe or vial. Do not use it if it is discolored or has particles in it. Do not use it if it has been damaged.
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.
- For patients who are not taking opioid medicines (not opioid-tolerant):
- For moderate to severe pain:
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.
Precautions
It is very important that your doctor check your progress while you are receiving 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. 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) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.
This medicine will add to 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 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. 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 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 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 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 cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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 receiving this medicine.
If you have been using this medicine regularly for several weeks or longer, do not suddenly stop using it 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 possibility of withdrawal symptoms, including stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.
Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.
Call your doctor right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.
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.
This medicine may cause adrenal gland problems. 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.
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.
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 or nurse immediately if any of the following side effects occur:
Incidence not known
- Blurred vision
- change in consciousness
- change in the ability to see colors, especially blue or yellow
- chest pain, discomfort, or tightness
- cold, clammy skin
- confusion
- cough
- difficulty or trouble breathing
- dizziness
- fast, pounding, or irregular heartbeat or pulse
- headache
- increased sensitivity to pain
- 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
- stomach pain
- sweating
- trouble with sleeping
- unusual tiredness
- very slow heartbeat or pulse
- vomiting
- worsening of pain
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Change in consciousness
- cold and clammy skin
- 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
- seizures
- sleepiness or unusual drowsiness
- slow heartbeat
- unable to speak
- very slow or troubled breathing
- weak muscle tone
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:
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 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.
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