Consumer Information for: HYDROMORPHONE HYDROCHLORIDE INJECTION, USP

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

HYDROmorphone Hydrochloride Injection, USP is used in adults (18 years of age and older) for the:

  • Relief of severe pain. It is used only in patients who need an injectable opioid in doses or concentrations higher than usually needed.
  • Treatment of severe opioid use disorder. It is used for patients who are using injectable opioids who have not been helped by other medication. Patients take HYDROmorphone Hydrochloride Injection, USP:
    • under the care of a doctor
    • in a safe, supervised place for injection treatment
    • as part of a complete treatment program that includes medical, social and psychological
    support
What it does

HYDROmorphone Hydrochloride Injection, USP belongs to the class of drugs known as opioids. This class of drugs also include heroin, codeine, fentanyl, morphine and oxycodone. Opioids relieve pain by acting on specific nerve cells of the spinal cord and brain. They may also be used to help people who are dependent on injected opioids who have not been helped by other medication, such as methadone

When it should not be used

Do not use HYDROmorphone Hydrochloride Injection, USP if:

  • your doctor did not prescribe it for you
  • you are not already taking high doses or high concentrations of opioids
  • you are allergic to hydromorphone, other opioids, or to any of the other ingredients in HYDROmorphone Hydrochloride Injection, USP (see What the non-medicinal ingredients list above);
  • you are taking this medication for pain, and you can control your pain by the occasional use of other pain medications. This includes those available without a prescription
  • you have severe asthma, trouble breathing, or other breathing problems
  • you have any heart problems
  • you have bowel blockage or narrowing of the stomach or intestines or you have severe pain in your abdomen
  • you have a head injury
  • you are at risk for seizures
  • you suffer from alcoholism
  • you are taking or have taken within the past 2 weeks a monoamine oxidase (MAO) inhibitor (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
  • you are going to have, or recently had, a planned surgery
  • you are pregnant or planning to become pregnant or you are in labour
  • you are breastfeeding
  • you are taking this medication for the supervised treatment of opioid use disorder and you also had alcohol, benzodiazepines (also known as “downers”), stimulants (also known as “uppers”) or other street drugs
What the medicinal ingredient is

Medicinal ingredient: hydromorphone hydrochloride

What the non-medicinal ingredients are

Non-medicinal ingredients: citric acid, sodium citrate, and water.

What dosage form it comes in

Solution; 10 mg / mL: 1 mL, 5 mL and 50 mL single-use vials

Warnings and precautions

Serious Warnings and Precautions

  • HYDROmorphone Hydrochloride Injection, USP is a highly concentrated solution of hydromorphone hydrochloride. You should only be taking this medication if you are already taking high doses or high concentrations of opioids.
  • Even if you take HYDROmorphone Hydrochloride Injection, USP as prescribed you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.
  • You may get life-threatening breathing problems while taking HYDROmorphone Hydrochloride Injection, USP. This is less likely to happen if you take it as prescribed by your doctor. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing.
  • You should never give anyone your HYDROmorphone Hydrochloride Injection, USP. They could die from taking it. If a person has not been prescribed HYDROmorphone Hydrochloride Injection, USP, taking even one dose can cause a fatal overdose. This is especially true for children.
  • If you took HYDROmorphone Hydrochloride Injection, USP while you were pregnant, whether for short or long periods of time or in small or large doses, your baby can suffer life-threatening withdrawal symptoms after birth. This can occur in the days after birth and for up to 4 weeks after delivery. If your baby has any of the following symptoms:
    • has changes in their breathing (such as weak, difficult or fast breathing)
    • is unusually difficult to comfort
    • has tremors (shakiness)
    • has increased stools, sneezing, yawning, vomiting, or fever
    Seek immediate medical help for your baby.
  • Taking HYDROmorphone Hydrochloride Injection, USP with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • If you are taking HYDROmorphone Hydrochloride Injection, USP for treatment for opioid use disorder, do not inject it into your neck or groin.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take HYDROmorphone Hydrochloride Injection, USP. Talk about any health conditions or problems you may have, including if you:

  • have a history of illicit or prescription drug or alcohol abuse
  • have severe kidney disease, liver or lung disease
  • have heart disease
  • have low blood pressure
  • have past or current depression
  • suffer from chronic or severe constipation
  • have problems with your thyroid, adrenal or prostate gland
  • have, or had in the past hallucinations or other severe mental problems
  • suffer from migraines
  • have suffered a head injury
  • take any other medicines, especially tranquilizers, sedatives, medicine for depression, or mania (manic depression) or for other mental health conditions or pain, or if you take any street drugs
  • are taking this medicine for supervised treatment of opioid use disorder and:
    • you have missed a dose or doses. Your doctor may need to change your dose before you can restart your medication to help prevent serious side effects and overdose
    • you don’t feel well and have a fever (in case you have an infection)
    • you are taking methadone
    • you are taking blood thinners

Other warnings you should know about:

Opioid dependence and addiction: There are important differences between physical dependence and addiction. It is important that you talk to your doctor if you have questions or concerns about abuse, addiction or physical dependence.

Pregnancy, nursing, labour and delivery: Do not use HYDROmorphone Hydrochloride Injection, USP while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. HYDROmorphone Hydrochloride Injection, USP can then cause life-threatening breathing problems in your unborn baby or nursing infant.

If you are pregnant and are taking HYDROmorphone Hydrochloride Injection, USP, it is important that you don’t stop taking your medication all of a sudden. If you do, it can cause a miscarriage or a still-birth. Your doctor will monitor and guide you on how to slowly stop taking Hydrochloride Injection, USP. This may help avoid serious harm to your unborn baby.

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to HYDROmorphone Hydrochloride Injection, USP. It can cause:

  • drowsiness
  • dizziness or
  • light headedness
This can usually occur after you take your first dose and when your dose is increased.

Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal insufficiency. This means that your adrenal gland is not making enough of certain hormones. You may experience symptoms such as:
  • nausea, vomiting
  • feeling tired, weak or dizzy
  • decreased appetite
You may be more likely to have problems with your adrenal gland if you have been taking opioids for longer than one month. Your doctor may do tests, give you another medication, and slowly take you off HYDROmorphone Hydrochloride Injection, USP.

Serotonin Syndrome: HYDROmorphone Hydrochloride Injection, USP can cause Serotonin Syndrome, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin Syndrome if you take HYDROmorphone Hydrochloride Injection, USP with certain anti-depressants or migraine medications.

Serotonin Syndrome symptoms include:
  • fever, sweating, shivering, diarrhea, nausea, vomiting;
  • muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
  • fast heartbeat, changes in blood pressure;
  • confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.
Sexual Function/Reproduction: Long term use of opioids may lead to a decrease in sex hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication

The following may interact with HYDROmorphone Hydrochloride Injection, USP:

  • Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do NOT drink alcohol while you are taking HYDROmorphone Hydrochloride Injection, USP. It can lead to:
    • drowsiness
    • unusually slow or weak breathing
    • serious side effects or
    • a fatal overdose
  • other sedative drugs which may enhance the drowsiness caused by HYDROmorphone Hydrochloride Injection, USP
  • other opioid analgesics (drugs used to treat pain)
  • general anesthetics (drugs used during surgery)
  • benzodiazepines (drugs used to help you sleep or that help reduce anxiety)
  • antidepressants (for depression and mood disorders). Do NOT use HYDROmorphone Hydrochloride Injection, USP with MAO inhibitors (MAOi) or if you have taken MAOi’s in the last 14 days.
  • drugs used to treat serious mental or emotional disorders, such as mania (manic depression) or schizophrenia
  • antihistamines (drugs used to treat allergies)
  • anti-emetics (drugs used for the prevention of vomiting)
  • drugs used to treat muscle spasms and back pain
  • some heart medication (such as beta blockers)
  • drugs used to treat migraines (e.g. triptans)
  • St. John’s Wort
Proper use of this medication
HYDROmorphone Hydrochloride Injection, USP is a highly concentrated solution of hydromorphone hydrochloride. You should only be taking this medication if you are already taking high doses or high concentrations of opioids.

Before you take HYDROmorphone Hydrochloride Injection, USP check the vial. Only clear solutions free from particles should be used.

The injection should be taken right away after opening the vial. Once opened, any unused portion should be thrown away. HYDROmorphone Hydrochloride Injection, USP is taken as an injection:

  • under the skin (subcutaneously) or
  • into the muscle (intramuscularly) or
  • into the vein (intravenously)


If you are taking this medication for the relief of severe pain:
  • Your doctor will prescribe this medication at the lowest dose that works to control your pain.
  • Take your medication exactly as your doctor has told you.
  • You should only take this medication for a maximum of 7 days. If you need to take it for longer, your doctor will determine the best dose for you to lower the risk of side effects. Taking higher doses can lead to more side effects and a greater chance of overdose.
  • You should review your pain regularly with your doctor to determine if you still need to take HYDROmorphone Hydrochloride Injection, USP.
  • Tell your doctor right away if your pain gets worse while taking HYDROmorphone Hydrochloride Injection, USP
  • Tell your doctor if you have missed a dose or several doses in a row. Your doctor may need to change your dose before you can restart your medication.
Refilling your Prescription:
  • A new written prescription is required from your doctor each time you need more HYDROmorphone Hydrochloride Injection, USP. Therefore, it is important that you contact your doctor before your current supply runs out.
  • Only obtain prescriptions for this medicine from the doctor in charge of your treatment. Do NOT seek prescriptions from other doctors unless you switch to another doctor for your pain management.
If you are taking this medication for the supervised treatment of opioid use disorder:
  • You should only be given this medication under the supervision of a doctor who has experience in the treatment of opioid use disorder and in a medically supervised place where there is equipment available to the doctor in case you experience any serious side effects.
  • To lower your risk of feeling side effects or having an overdose and to ensure you take your dose on time, it is important you take this medication exactly as your doctor tells you.
  • Tell your doctor if you have missed a dose or several doses in a row. Your doctor may need to change your dose before you can restart your medication.
  • Your doctor may also prescribe methadone to help you with cravings.
  • Tell your doctor right away if you have:
    • body aches,
    • diarrhea,
    • goosebumps,
    • loss of appetite,
    • nausea,
    • feeling nervous or restless,
    • runny nose,
    • sneezing,
    • tremors or shivering,
    • stomach cramps,
    • rapid heart rate,
    • have trouble sleeping,
    • an unusual increase in sweating,
    • heart palpitations,
    • an unexplained fever,
    • weakness
    • yawning
    Your doctor may need to change your medication or your dose.
If you develop any side effects (see What are possible side effects from using HYDROmorphone Hydrochloride Injection, USP) tell your doctor right away.

Usual Adult Dose: Your doctor will decide your dose based on your health and age. Your dose is tailored/personalized just for you. Be sure to follow your doctor’s dosing instructions exactly. Do NOT increase or decrease your dose without first talking to your doctor.

Stopping your Medication: If you have been taking HYDROmorphone Hydrochloride Injection, USP for more than a few days you should not stop taking it all of a sudden. Your doctor will monitor and guide you on how to slowly stop taking it. You should stop slowly to avoid withdrawal symptoms such as:
  • body aches
  • diarrhea
  • goosebumps
  • loss of appetite
  • nausea
  • feeling nervous or restless
  • runny nose
  • sneezing
  • tremors or shivering
  • stomach cramps
  • rapid heart rate (tachycardia)
  • having trouble sleeping
  • an unusual increase in sweating
  • heart palpitations
  • an unexplained fever
  • weakness
  • yawning
By reducing or stopping your opioid treatment, your body will become less used to opioids. If you start treatment again, you will need to start at the lowest dose. You may overdose if you restart at the last dose you took before you slowly stopped taking HYDROmorphone Hydrochloride Injection, USP.

Overdose

If you think you have taken too much HYDROmorphone Hydrochloride Injection, USP, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Signs of overdose may include:

  • unusually slow or weak breathing
  • dizziness
  • confusion
  • extreme drowsiness

Missed Dose

Your doctor will tell you what to do if you miss the dose. Do NOT take two doses at once. If you miss a dose or several doses in a row, talk to your doctor before restarting your medication.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking HYDROmorphone Hydrochloride Injection, USP. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

  • Drowsiness
  • Insomnia
  • Dizziness
  • Fainting
  • Nausea, vomiting, or a poor appetite
  • Dry mouth
  • Headache
  • Problems with vision
  • Weakness, uncoordinated muscle movement
  • Lack of muscle strength
  • Itching at the site of injection
  • Light headedness
  • Sweating
  • Constipation
  • Confusion
  • Anxiety
  • Feeling agitated
  • Abdominal pain
  • Injection site reaction
  • Low sex drive, impotence (erectile dysfunction), infertility
Talk with your doctor or pharmacist about ways to prevent constipation when you start using HYDROmorphone Hydrochloride Injection, USP.
Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Rare
Overdose: hallucinations, confusion, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, or dizziness, floppy muscles/low muscle tone, cold and clammy skin     ✔
Respiratory Depression: slow, shallow or weak breathing.     ✔
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing     ✔
Bowel Blockage (impaction): abdominal pain, severe constipation, nausea     ✔
Withdrawal: nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite.   ✔  
Fast, Slow or Irregular Heartbeat: heart palpitations.   ✔  
Low Blood Pressure: dizziness, fainting, light- headedness. ✔    
Serotonin Syndrome: agitation or restlessness, loss of muscle control or muscle twitching, tremor, diarrhea     ✔

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

  • Keep unused or expired HYDROmorphone Hydrochloride Injection, USP in a secure place to prevent theft, misuse or accidental exposure.
  • Keep HYDROmorphone Hydrochloride Injection, USP under lock, out of sight and reach of children and pets.
  • Never take medicine in front of small children as they will want to copy you. Accidental ingestion by a child is dangerous and may result in death. If a child accidentally takes HYDROmorphone Hydrochloride Injection, USP, get emergency help right away.
  • Store at 15 °C to 30 °C. Protect from light. Do not use beyond the expiry date indicated on the label.

Disposal:

HYDROmorphone Hydrochloride Injection, USP should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.

Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by: NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information

This Information is current up to the time of the date of preparation shown below, but more current information may be available from Fresenius Kabi.
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