Apo-Hydromorphone: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Even if you take APO-HYDROmorphone 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., health care professional).
• When you take APO-HYDROmorphone tablets they must be swallowed whole. Do not cut, break, crush, chew, or dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.
• Life-threatening breathing problems can happen while taking APO-HYDROmorphone, especially if not take as directed. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing.
• You should never give anyone your APO-HYDROmorphone. They could die from taking it. If a person has not been prescribed APO-HYDROmorphone, taking even one dose can cause a fatal overdose. This is especially true for children and for an adult who is not already taking opioids continuously.

• If you took APO-HYDROmorphone 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 APO-HYDROmorphone 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 APO-HYDROmorphone used for?

APO-HYDROmorphone is a pain medication used to control pain.

How does APO-HYDROmorphone work?

APO-HYDROmorphone 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.

What are the ingredients in APO-HYDROmorphone?

Medicinal ingredient: HYDROmorphone hydrochloride

Non-medicinal ingredients in tablet: lactose anhydrous, magnesium stearate.

In addition, the tablet strengths listed below contain the following dyes:

1 mg: DC Yellow #10 Lake and FD&C Blue # 1

2 mg: DC Yellow #10 Lake and FD&C Yellow #6 Lake 35-42%

4 mg: DC Yellow #10 Lake

APO-HYDROmorphone comes in the following dosage forms:

Immediate Release Tablets: 1 mg, 2 mg, 4 mg and 8 mg.

Do not use APO-HYDROmorphone if:

• your health care professional did not prescribe it for you.
• you are allergic to HYDROmorphone, or any of the other ingredients in APO-HYDROmorphone tablets (see What are the ingredients in APO-HYDROmorphone?).
• 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 APO-HYDROmorphone. 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 APO-HYDROmorphone may cause dangerous side effects, including death. Do NOT drink alcohol while taking APO-HYDROmorphone.
• have a condition that causes weakness or frailty.

Other warnings you should know about:

Opioid dependence and addiction: Like any opioid, APO-HYDROmorphone 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 APO-HYDROmorphone with the same degree of caution appropriate to the use of other oral opioid medications. It is not recommended to use these products for a long period of time.

Pregnancy, nursing, labour, and delivery: Do not use APO-HYDROmorphone while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. APO-HYDROmorphone can then cause life-threatening breathing problems in your unborn baby or nursing infant. Your healthcare professional will determine if the benefits of using APO-HYDROmorphone outweigh the risks to your unborn baby or breastfeeding infant.

If you are pregnant and are taking APO-HYDROmorphone, 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 health care professional will monitor and guide you on how to slowly stop taking APO-HYDROmorphone. 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 APO-HYDROmorphone. APO-HYDROmorphone 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 APO-HYDROmorphone.

Serotonin toxicity (also known as serotonin syndrome): APO-HYDROmorphone 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 APO-HYDROmorphone with certain anti-depressants, 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 APO-HYDROmorphone.

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 APO-HYDROmorphone:

• alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking APO-HYDROmorphone. 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 APO-HYDROmorphone
• 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)
• St. John’s Wort

How to take APO-HYDROmorphone:

Take APO-HYDROmorphone tablets:

• usually every 4 to 6 hours, or as directed by your health care professional
• with a full glass of water

APO-HYDROmorphone tablets:

Swallow whole. Do not cut, break, crush, chew or dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.

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 health care professional.

Your health care professional will prescribe the lowest dose that works to control your pain. It is recommended that you only take APO-HYDROmorphone for up to 7 days. If you need to take APO-HYDROmorphone for longer, your health care 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 health care professional to determine if you still need APO-HYDROmorphone. Be sure to use APO-HYDROmorphone only for the condition for which it was prescribed.

If your pain increases or you develop any side effect as a result of taking APO-HYDROmorphone, tell your health care professional immediately.

Stopping your Medication:

If you have been taking APO-HYDROmorphone for more than a few days, you should not stop taking it all of a sudden. Your health care professional will monitor and guide you on how to slowly stop taking APO-HYDROmorphone. 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 APO-HYDROmorphone.

Refilling your Prescription for APO-HYDROmorphone:

A new written prescription is required from your health care professional each time you need more APO-HYDROmorphone. Therefore, it is important that you contact your health care professional before your current supply runs out.

Only obtain prescriptions for this medication from the health care professional in charge of your treatment. Do not seek prescriptions from other health care professionals unless you switch to another health care professional for your pain management.

Overdose:

Signs of overdose may include:

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

Missed Dose:

If you miss one dose, take it as soon as possible. However, if it is almost time for your next dose, then skip the missed dose. Do not take two doses at once. If you miss several doses in a row, talk to your health care professional before restarting your medication.

What are possible side effects from using APO-HYDROmorphone?

These are not all the possible side effects you may feel when taking APO-HYDROmorphone. 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
• low sex drive, impotence (erectile dysfunction), infertility

Talk with your health care professional or pharmacist about ways to prevent constipation when you start using APO-HYDROmorphone.

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

Reporting Side Effects

Storage:

• Keep unused or expired APO-HYDROmorphone in a secure place to prevent theft, misuse, or accidental exposure.
• Store tablets at room temperature (15° to 30°C). Protect from light.
• Keep APO-HYDROmorphone 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 APO-HYDROmorphone, get emergency help right away.

Disposal:

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

If you want more information about APO-HYDROmorphone:

• 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 (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Revised: APR 04, 2024