Patient Medication Information: uses, side effects, how to take - Hydromorphone Hydrochloride Injection USP (Sandoz Canada)
Serious Warnings and Precautions
Seek immediate medical help for your baby. |
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What is HYDROmorphone Hydrochloride Injection USP used for?
HYDROmorphone Hydrochloride Injection USP is a pain medication used to control pain.
How does HYDROmorphone Hydrochloride Injection USP work?
HYDROmorphone Hydrochloride Injection USP 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 USP 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 USP?
Medicinal ingredient: HYDROmorphone hydrochloride
Non-medicinal ingredients in sterile solution for injection: Citric acid, hydrochloric acid, sodium citrate, sodium chloride, sodium hydroxide, water for injection .
HYDROmorphone Hydrochloride Injection USP comes in the following dosage forms:
Sterile solution for injection: 1 mg/mL and 2 mg/mL.
Do not use HYDROmorphone Hydrochloride Injection USP if:
- your health care professional did not prescribe it for you
- you are allergic to HYDROmorphone, or any of the other ingredients in HYDROmorphone Hydrochloride Injection USP (see What are the ingredients in HYDROmorphone Hydrochloride Injection USP?)
- 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 lung problems
- you have any heart problems
- you have bowel blockage or narrowing of the stomach or intestines
- you have a condition where the bowel does not work properly (ileus) or have severe pain in your abdomen
- you have increased pressure in your skull or have a head injury
- you have epilepsy (seizures) or a history with epilepsy
- you have a brain tumor
you suffer from alcoholism or alcohol withdrawal
- 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 a surgery or operation or have had a surgery in the last 24 hours
- 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 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, liver or lung disease
- have been told you are at risk of having heart problems or seizures
- have heart disease
- have low blood pressure
- have a history of sleep apnea
- have had problems with your mood (such as depression or anxiety), hallucinations, or other mental health problems
- suffer from chronic or severe constipation
- have problems with your adrenal or prostate gland
- suffer from migraines
- are pregnant or planning to become pregnant or are in labour
- are breastfeeding or planning to breastfeed
- have a sleep disorder which causes pauses in breathing or shallow breathing while sleeping (sleep apnea)
- are planning on drinking alcohol. Drinking alcohol while taking HYDROmorphone Hydrochloride Injection USP may cause dangerous side effects, including death. Do NOT drink alcohol while taking HYDROmorphone Hydrochloride Injection USP.
- have a condition that causes weakness or frailty.
Other warnings you should know about:
Opioid dependence and addiction: Like any opioid, HYDROmorphone Hydrochloride Injection USP may cause mental and physical dependence. Hydromorphone hydrochloride also has the potential to cause addiction. There are important differences between physical dependence and addiction. Tolerance means that, over time, a higher dose may be needed to get the same level of pain relief. It is important that you talk to your healthcare professional if you have questions or concerns about addiction, physical dependence, or tolerance. Your healthcare professional should prescribe and administer HYDROmorphone Hydrochloride Injection USP with the same degree of caution appropriate to the use of other opioid medications. It is not recommended to use these products for a long period of time.
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. Your healthcare professional will determine if the benefits of using HYDROmorphone Hydrochloride Injection USP outweigh the risks to your unborn baby or breastfeeding 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 healthcare professional will monitor and guide you on how to slowly stop taking HYDROmorphone 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. HYDROmorphone Hydrochloride Injection USP 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 health care professional may do tests, give you another medication, and slowly take you off HYDROmorphone Hydrochloride Injection USP.
Serotonin toxicity (also known as serotonin syndrome): HYDROmorphone Hydrochloride Injection USP can cause serotonin toxicity, 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 toxicity if you take HYDROmorphone Hydrochloride Injection USP with certain anti-depressants, or migraine medications or muscle relaxants medications.
Serotonin toxicity 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 health care professional if you have a history of sleep apnea or if anyone notices that you stop breathing from time to time while sleeping.
Worsened pain: Taking opioids for pain can sometimes have the unintended effect of making your pain feel worse (opioid-induced hyperalgesia) even though your opioid dose has been unchanged or increased. This can also include feeling pain in new places in your body, or feeling pain from something that would not normally hurt, for example, feeling pain from clothing touching your skin. Tell your healthcare professional if you notice a change like this in your pain while you are taking HYDROmorphone Hydrochloride Injection USP.
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 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
- general anesthetics (medicines used during surgery)
- drugs used to treat serious mental or emotional disorders such as schizophrenia
- antihistamines, medicines used to treat allergies
- anti-emetics (for the prevention of vomiting)
- muscle relaxants drugs used to treat muscle spasms and back pain (e.g., baclofen)
- anticoagulants (blood thinners)
- some heart medications (such as beta blockers)
drugs used to treat migraines (e.g. triptans)
Serious Drug Interactions
Taking HYDROmorphone Hydrochloride Injection USP with the following medicines can cause serious side effects, including breathing problems that can lead to death:
alcohol, including 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.
- Monoamine Oxidase Inhibitors (MAOi), used to treat depression. Do NOT take DILAUDID with MAOi’s or if you have taken an MAOi in the last 14 days.
- benzodiazepines, medicines used to help you sleep or that help reduce anxiety (e.g., diazepam, lorazepam, alprazolam).
- antiepileptics, used to treat and prevent seizures (e.g., gabapentin, carbamazepine, phenytoin, oxcarbazepine, phenobarbital).
- drugs used to treat nerve pain (e.g., pregabalin)
- drugs used to prevent and control seizures in the treatment of epilepsy (e.g., gapapentin)
- other sedative drugs which may enhance the drowsiness caused by HYDROmorphone Hydrochloride Injection USP.
- St. John’s Wort
How to take HYDROmorphone Hydrochloride Injection USP:
Take HYDROmorphone Hydrochloride Injection USP:
- usually every 4 to 6 hours, or as directed by your health care professional.
HYDROmorphone Hydrochloride Injection USP 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 health care professional’s dosing instructions exactly. Do not increase or decrease your dose without consulting your healthcare professional.
Your healthcare professional will prescribe the lowest dose that works to control your pain. It is recommended that you only take HYDROmorphone Hydrochloride Injection USP for up to 7 days. If you need to take HYDROmorphone Hydrochloride Injection USP for longer, your healthcare professional 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 healthcare professional to determine if you still need HYDROmorphone Hydrochloride Injection USP. Be sure to use HYDROmorphone Hydrochloride Injection USP 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 USP, tell your healthcare professional immediately.
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 healthcare professional will monitor and guide you on how to slowly stop taking HYDROmorphone Hydrochloride Injection USP. 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 USP.
Overdose:
If you think you, or a person you are caring for, have taken too much HYDROmorphone Hydrochloride Injection USP, contact a 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 USP?
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
- Light-headedness
- Sweating
- Constipation
- Confusion
- Anxiety
- Abdominal pain
- Injection site reaction
- Low sex drive, impotence (erectile dysfunction), infertility
Talk with your healthcare professional 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 | 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 toxicity (also known as 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.
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. |
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Storage:
- Keep unused or expired HYDROmorphone Hydrochloride Injection USP in a secure place to prevent theft, misuse, or accidental exposure.
- Store HYDROmorphone Hydrochloride Injection USP at 15oC to 30oC. Protect from light. Discard unused portion.
- 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.
If you want more information about HYDROmorphone Hydrochloride Injection USP:
- 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 Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (https://www.sandoz.ca), or by calling the manufacturer, Sandoz Canada Inc., at: 1-800- 361-3062.