Patient Medication Information: uses, side effects, how to take - Hydromorphone Hydrochloride Injection
Serious Warnings and Precautions
- Even if you take HYDROmorphone Hydrochloride Injection as prescribed you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death. To understand your risk of opioid addiction abuse, and misuse you should speak to your prescriber (e.g., doctor).
- Life-threatening breathing problems while taking HYDROmorphone Hydrochloride Injection, especially if not taken as directed. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing.
- Never give anyone your HYDROmorphone Hydrochloride Injection. They could die from taking it. If a person has not been prescribed HYDROmorphone Hydrochloride Injection, taking even one dose can cause a fatal overdose. This is especially true for children.
If you took HYDROmorphone Hydrochloride Injection 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 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.
What is HYDROmorphone Hydrochloride Injection used for?
HYDROmorphone Hydrochloride Injection is a pain medication used to control pain.
How does HYDROmorphone Hydrochloride Injection work?
HYDROmorphone Hydrochloride Injection contains HYDROmorphone which is a pain medication belonging to the class of drugs known as opioids which includes codeine, fentanyl, morphine and oxycodone. It relieves pain by acting on specific nerve cells of the spinal cord and brain.
HYDROmorphone Hydrochloride Injection is used to treat severe pain in patients who need an opioid administered by injection. This is given under the skin, into the muscle or vein in doses or concentrations that are higher than those usually needed.
What are the ingredients in HYDROmorphone Hydrochloride Injection?
Medicinal ingredient: HYDROmorphone hydrochloride
Non-medicinal ingredients: citric acid, sodium chloride, sodium citrate, hydrochloric acid and/or sodium hydroxide, water for injection.
HYDROmorphone Hydrochloride Injection comes in the following dosage forms:
Sterile solution for injection: 1 mg/mL is available in 2 mL amber vials and 2 mg/mL is available in 1 mL amber ampoules - boxes of 10.
Do not use HYDROmorphone Hydrochloride Injection if:
- your doctor did not prescribe it for you
- you are allergic to HYDROmorphone, or any of the other ingredients in HYDROmorphone Hydrochloride Injection (see What are the ingredients in HYDROmorphone Hydrochloride Injection?)
- 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
- you have severe pain in your abdomen
- you have a head injury
- you are at risk for seizures
- you have a brain tumor
- you suffer from alcoholism
- you are taking or have taken within the past 2 weeks a Monoamine Oxidase inhibitor (MOI) (such as phenelzine sulfate, tranylcypromine sulfate, 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
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take HYDROmorphone Hydrochloride Injection. 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 a history of sleep apnea
- have past or current depression
- suffer from chronic or severe constipation
- have problems with your adrenal or prostate gland
- have, or had in the past hallucinations or other severe mental problems
- suffer from migraines
- are pregnant or planning to become pregnant
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 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 can then cause life-threatening breathing problems in your unborn baby or nursing infant.
If you are pregnant and are taking HYDROmorphone Hydrochloride Injection, 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 HYDROmorphone Hydrochloride Injection. 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. HYDROmorphone Hydrochloride Injection 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.
Serotonin Syndrome
HYDROmorphone Hydrochloride Injection 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 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.
Sleep Apnea
Opioids can cause a problem called sleep apnea (stopping breathing from time to time while sleeping). Tell your doctor if you have a history of sleep apnea or if anyone notices that you stop breathing from time to time while sleeping.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with HYDROmorphone Hydrochloride Injection:
Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking HYDROmorphone Hydrochloride Injection. 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
- other opioid analgesics (for pain)
- general anesthetics (used during surgery)
- drugs used to help you sleep or that help reduce anxiety benzodiazepines
- antidepressants (for depression and mood disorders). Do not take HYDROmorphone Hydrochloride Injection with monoamine oxidase (MAO) inhibitors or if you have taken MAO inhibitors in the last 14 days before treatment with HYDROmorphone Hydrochloride Injection.
- drugs used to treat serious mental or emotional disorders such as schizophrenia
- antihistamines (for allergies)
- anti-emetics (for the prevention of vomiting)
- drugs used to treat muscle spasms and back pain
- some heart medications (such as beta blockers)
- drugs used to treat migraines (e.g. triptans)
- St. John’s Wort
How to take HYDROmorphone Hydrochloride Injection:
Take HYDROmorphone Hydrochloride Injection:
- usually every 4 to 6 hours, or as directed by your doctor.
HYDROmorphone Hydrochloride Injection should be visually inspected prior to use. Only clear solutions free from particles should be used. The injection should be given immediately after opening the ampoule. Once opened, any unused portion should be discarded.
Usual Dose:
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 consulting your doctor.
Your doctor will prescribe the lowest dose that works to control your pain. It is recommended that you only take HYDROmorphone Hydrochloride Injection for up to 7 days. If you need to take HYDROmorphone Hydrochloride Injection for longer, your doctor will determine the best dose for you to lower the risk of side effects and overdose. Higher doses can lead to more side effects and a greater chance of overdose.
Review your pain regularly with your doctor to determine if you still need HYDROmorphone Hydrochloride Injection. Be sure to use HYDROmorphone Hydrochloride Injection only for the condition for which it was prescribed.
If your pain increases or you develop any side effect as a result of taking HYDROmorphone Hydrochloride Injection, tell your doctor immediately.
Stopping your Medication
If you have been taking HYDROmorphone Hydrochloride Injection 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 HYDROmorphone Hydrochloride Injection. You should do it slowly to avoid uncomfortable symptoms such as having:
- 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.
Overdose:
| If you think you, or a person you are caring for, have taken too much HYDROmorphone Hydrochloride Injection, 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
What are possible side effects from using HYDROmorphone Hydrochloride Injection?
These are not all the possible side effects you may feel when taking HYDROmorphone Hydrochloride Injection. 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
- Light headedness
- Sweating
- Constipation
- Confusion
- Anxiety
- 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.
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.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| 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, sweating. | √ | ||
| 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. | √ | ||
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. |
|---|
Storage:
- Keep unused or expired HYDROmorphone Hydrochloride Injection in a secure place to prevent theft, misuse or accidental exposure.
- Store HYDROmorphone Hydrochloride Injection between 15° and 30°C. Protect from light. Discard unused portion.
- Keep HYDROmorphone Hydrochloride Injection 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, get emergency help right away.
If you want more information about HYDROmorphone Hydrochloride Injection:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Drug Product Database (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.sterimaxinc.com, or by calling 1-800-881-3550.