Patient Medication Information: uses, side effects, how to take - Hydromorphone Hydrochloride Injection USP (Jamp Pharma)

Serious Warnings and Precautions

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. To understand your risk of opioid addiction, abuse, and misuse you should speak to your prescriber (e.g., doctor).
Life-threatening breathing problems can happen while taking HYDROmorphone Hydrochloride Injection USP, especially if not take 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 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:
o has changes in their breathing (such as weak, difficult or fast breathing)
o is unusually difficult to comfort
o has tremors (shakiness)
o 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.

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: sterile solution for injection: Citric acid, hydrochloric acid, sodium citrate, sodium chloride, water for injection.

HYDROmorphone Hydrochloride Injection USP comes in the following dosage forms:

Sterile solution for injection: 2 mg / mL.

Do not use HYDROmorphone Hydrochloride Injection USP if:

your doctor 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 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 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 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 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 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 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.

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 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 (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 USP with monoamine oxidase (MAO) inhibitors or if you have taken MAO inhibitors in the last 14 days before treatment with HYDROmorphone Hydrochloride Injection USP.
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 USP:

Take HYDROmorphone Hydrochloride Injection USP:

usually every 4 to 6 hours, or as directed by your doctor.

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 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 USP for up to 7 days. If you need to take HYDROmorphone Hydrochloride Injection USP 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 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 doctor 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 doctor 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 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	Stop taking drug and get immediate medical help
Only if severe	In all case s
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			√

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:

Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

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 USP in a secure place to prevent theft, misuse or accidental exposure.
Store HYDROmorphone Hydrochloride Injection USP at room temperature (15⁰- 30⁰C). 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 (www.jamppharma.com), or by calling the manufacturer, JAMP Pharma Corporation, at: 1-866-399-9091.
or by written request at:
1310 rue Nobel
Boucherville, Quebec
J4B 5H3
or by e-mail at : www.jamppharma.com

Rx or OTC	Prescription (Rx)?
DIN	02529645
Schedule(s)	NARCOTICS (CDSA I)
Risk Management Plans	A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.
Active ingredient(s)	Hydromorphone hydrochloride 2 MG
Dosage form(s)	Solution
Route(s) of administration	Subcutaneous, Intravenous, Intramuscular
Drug class (WHO ATC)	N Nervous system drugs N02 Analgesics N02A Opioid analgesics N02AA Natural opium alkaloid analgesics N02AA03 Hydromorphone
Company	JAMP PHARMA CORPORATION
Current status	Dormant
Current status date	August 3, 2026

Hydromorphone Hydrochloride Injection USP (Jamp Pharma): Uses, Side Effects and Dosage