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Details for: HYDROMORPH CONTIN

Company: PURDUE PHARMA

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02125323HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 3MGHYDROMORPHONE HYDROCHLORIDE3 MGCAPSULE (SUSTAINED-RELEASE)ORAL
02359502HYDROMORPH CONTINHYDROMORPHONE HYDROCHLORIDE4.5 MGCAPSULE (SUSTAINED-RELEASE)ORAL
02125331HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 6MGHYDROMORPHONE HYDROCHLORIDE6 MGCAPSULE (SUSTAINED-RELEASE)ORAL
02359510HYDROMORPH CONTINHYDROMORPHONE HYDROCHLORIDE9 MGCAPSULE (SUSTAINED-RELEASE)ORAL
02125366HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 12MGHYDROMORPHONE HYDROCHLORIDE12 MGCAPSULE (SUSTAINED-RELEASE)ORAL
02243562HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 18MGHYDROMORPHONE HYDROCHLORIDE18 MGCAPSULE (SUSTAINED-RELEASE)ORAL
02125382HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 24MGHYDROMORPHONE HYDROCHLORIDE24 MGCAPSULE (SUSTAINED-RELEASE)ORAL
02125390HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 30MGHYDROMORPHONE HYDROCHLORIDE30 MGCAPSULE (SUSTAINED-RELEASE)ORAL
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Summary Reports

Summary Safety Review - Hydromorphone Controlled Release Capsules - Assessing the Increased Risk of Serious Infections Linked to the Injection of the Content of the Capsules into Veins

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

HYDROMORPH CONTIN is used for the long-term management of pain, when:

  • the pain is severe enough to require daily, around-the-clock pain medication
  • the doctor determines that other treatment options are not able to effectively manage your pain

HYDROMORPH CONTIN is NOT used (“as needed”) to treat pain that you only have once in a while.

What it does

HYDROMORPH CONTIN is an oral controlled release capsule that slowly releases HYDROmorphone over a 12 hour period.

HYDROMORPH CONTIN contains HYDROmorphone which is a pain medication belonging to the class of medicines 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.

When it should not be used

Do not use HYDROMORPH CONTIN if:

  • your doctor did not prescribe it for you
  • you are allergic to HYDROmorphone, other opioids, or any of the other ingredients of HYDROMORPH CONTIN (see What are the ingredients in HYDROMORPH CONTIN?)
  • you have mild or short term pain that can be controlled by the occasional use of pain medications, including those available without a prescription
  • you have severe asthma, trouble breathing, or other breathing problems
  • you have any heart problems
  • you have a bowel blockage or narrowing of the stomach or intestines
  • you have severe pain in your abdomen
  • you have a head injury
  • if 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 (MAO inhibitor) medication (e.g., phenelzine sulfate, tranylcypromine sulfate, moclobemide or selegiline)
  • you are pregnant or plan to become pregnant or you are in labour
  • you are breastfeeding
  • you are under 18 years of age
  • you are going to have, or recently had, a planned surgery
What the medicinal ingredient is

Medicinal ingredient: HYDROmorphone hydrochloride

What the non-medicinal ingredients are

Non-medicinal ingredients: Colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, hydroxypropyl methylcellulose, and microcrystalline cellulose.

In addition, the capsule shells contain the following ingredients:
All capsules: gelatin, titanium dioxide
3 mg: D&C Yellow No.10, FD&C Green No.3
4.5 mg: FD&C Blue No.1, FD&C Red No.3
6 mg: D&C Red No.28, FD&C Blue No.1, FD&C Red No.40
9 mg: FD&C Blue No.1
10 mg: none
12 mg: D&C Red No.28, D&C Yellow No.10, FD&C Blue No.1, FD&C Red No.40
18 mg: yellow iron oxide
20 mg: FD&C Blue No.1
24 mg: black iron oxide
30 mg: FD&C Red No.3, red iron oxide, yellow iron oxide

What dosage form it comes in

HYDROMORPH CONTIN comes in the following dosage forms:

Controlled Release Capsules: 3 mg, 4.5 mg, 6 mg, 9 mg, 10 mg, 12 mg, 18 mg, 20 mg, 24 mg and 30 mg

Warnings and precautions

Serious Warnings and Precautions

  • Even if you take HYDROMORPH CONTIN as prescribed you are at risk for opioid addiction, abuse, and misuse that 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 HYDROMORPH CONTIN, 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 HYDROMORPH CONTIN. They could die from taking it. If a person has not been prescribed HYDROMORPH CONTIN, taking even one dose can cause a fatal overdose. This is especially true for children.
  • If you took HYDROMORPH CONTIN 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 HYDROMORPH CONTIN 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.

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 HYDROMORPH CONTIN while pregnant, nursing, during labour or delivery.
Opioids can be transferred to your baby through breast milk, or while still in the womb.
HYDROMORPH CONTIN can then cause life-threatening breathing problems in your unborn baby or nursing infant.

Driving and using machines
Before you do tasks which may require special attention, you should wait until you know howyou react to HYDROMORPH CONTIN. HYDROMORPH CONTIN can cause:

  • drowsiness
  • dizziness
  • 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 HYDROMORPH CONTIN.

Serotonin Syndrome

HYDROMORPH CONTIN 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 HYDROMORPH CONTIN with certain antidepressants 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.

Interactions with this medication
  • alcohol, including prescription and non-prescription medications containing alcohol. Do not drink alcohol while taking HYDROMORPH CONTIN. 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 HYDROMORPH CONTIN
  • other opioid analgesics (for pain)
  • general anesthetics (used during surgery)
  • drugs used to help you sleep or to reduce anxiety (benzodiazepines)
  • antidepressants (for depression and mood disorders). Do not take HYDROMORPH CONTIN with monoamine oxidase (MAO) inhibitors or if you have taken MAO inhibitors in the last 14 days before treatment with HYDROMORPH CONTIN
  • 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
  • anticoagulants (blood thinners)
  • some heart medication (such as beta blockers)
  • drugs used to treat migraines (e.g. triptans)
  • St. John’s Wort
Proper use of this medication

How to take HYDROMORPH CONTIN:

Take HYDROMORPH CONTIN:

  • exactly as prescribed
  • every 12 hours

HYDROMORPH CONTIN can be swallowed whole or sprinkled on applesauce or custard.

Swallowed:

  • swallow the capsule whole
  • take the capsule with a full glass of water
  • do not cut, break, chew, dissolve or crush the capsule - this can be dangerous and life threatening

Sprinkled:

  • measure a tablespoon of warm or cold (4° - 40°C) applesauce or room temperature custard
  • open the capsule
  • sprinkle contents onto the tablespoon
  • ensure the capsule is emptied of all contents
  • take the entire tablespoon as soon as possible
  • do not chew the contents (beads)
  • rinse your mouth and swallow the water
  • do not keep any of the food/medicine mixture for another dose

If you do not remember when you sprinkled the medicine on the applesauce or custard, or which food you sprinkled the medicine on, throw out the food/medicine mixture. Do not take a single dose greater than 12 mg of HYDROMORPH CONTIN every 12 hours unless you are “opioid tolerant”. Your doctor will tell you when you are “opioid tolerant” to a certain dose of HYDROMORPH CONTIN.

Usual Adult Starting Dose:

Dosage is individualized. Be sure to follow your doctor’s dosing instructions exactly. Do not increase or decrease your dose without consulting your doctor. Taking higher doses can lead to more side effects and greater chance of overdose.

Review your pain regularly with your doctor to determine if you still need HYDROMORPH CONTIN. Be sure to use HYDROMORPH CONTIN only for the condition for which it was prescribed.

Should your pain increase or any other complaint develop as a result of taking HYDROMORPH CONTIN, tell your doctor immediately.

Stopping your Medication:
You should not stop taking HYDROMORPH CONTIN all at once if you have been taking it for more than a few days. Your doctor will monitor and guide you on how to slowly stop taking HYDROMORPH CONTIN. 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 with 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 HYDROMORPH CONTIN.

Refilling your Prescription for HYDROMORPH CONTIN:
A new written prescription is required from your doctor each time you need more HYDROMORPH CONTIN. 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.

Overdose:

If you think you have taken too much HYDROMORPH CONTIN, 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:

It is important that you do not miss any doses.If you miss a dose, take your next dose at your usual time.You should always try to get back on track with your regular dosing schedule (e.g., 8o’clock in the morning and 8 o’clock in the evening). If you miss several doses in a row, talk to your doctor before restarting your medication.

What are possible side effects from using HYDROMORPH CONTIN?
These are not all the possible side effects you may feel when taking HYDROMORPH CONTIN. If you experience any side effects not listed here, contact your healthcare professional.

Side effects and what to do about them

Side effects may include:

  • confusion
  • constipation
  • dizziness
  • drowsiness
  • light-headedness
  • nausea, vomiting, or poor appetite
  • lack of muscle strength
  • sleepiness
  • sweating
  • low sex drive, impotence (erectile dysfunction), infertility
  • itching
  • dry mouth
  • insomnia
  • abdominal pain
  • headache
  • anxiety
  • problems with vision
  • weakness, uncoordinated muscle movement

Talk with your doctor or pharmacist about ways to prevent constipation when you start using HYDROMORPH CONTIN.

If nausea and vomiting become troublesome during prolonged therapy with HYDROMORPH CONTIN, talk to your doctor or pharmacist.

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, 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.

How to store

Storage:

  • Keep unused or expired HYDROMORPH CONTIN in a secure place to prevent theft, misuse or accidental exposure.
  • Store at room temperature (15° - 25°C). Keep in a dry place.
  • Keep HYDROMORPH CONTIN 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 HYDROMORPH CONTIN, get emergency help right away.

Disposal:

HYDROMORPH CONTIN 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:

More information

If you want more information about HYDROMORPH CONTIN:

This leaflet was prepared by Purdue Pharma.

Last Revised: July 30, 2020

HYDROMORPH CONTIN® is a registered trademark of Purdue Pharma

Date modified: