Oxycodone: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Even if you take OXYCODONE as prescribed you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.
• When you take OXYCODONE it must be swallowed whole. Do not cut, break, crush, chew, dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.
• You may get life-threatening breathing problems while taking OXYCODONE. This is less likely to happen if you take it as prescribed by your doctor. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing.

• You should never give anyone your OXYCODONE. They could die from taking it.

  If a person has not been prescribed OXYCODONE, taking even one dose can cause a fatal overdose. This is especially true for children.

• If you took OXYCODONE 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 OXYCODONE 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 OXYCODONE used for?

OXYCODONE is a medicine used to control pain.

How does OXYCODONE work?

OXYCODONE contains oxycodone which is a pain medication belonging to the class of drugs known as opioid which includes codeine, fentanyl, hydromorphone and morphine. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

What are the ingredients in OXYCODONE?

Medicinal ingredients: Oxycodone Hydrochloride

Non-medicinal ingredients: Croscarmellose Sodium, Dibasic Calcium Phosphate, Magnesium Stearate, and Microcrystalline Cellulose. The 5 mg tablets also contain FD&C Blue No. 1.

OXYCODONE comes in the following dosage forms:

OXYCODONE Tablets: 5 mg, 10 mg and 20 mg.

Do not use OXYCODONE if:

• your doctor did not prescribe it for you
• you are allergic to oxycodone, opioids, or any of the other ingredients in OXYCODONE
• 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 suffer from alcoholism

• you are taking or have taken within the past 2 weeks a Monoamine Oxidase inhibitor

  (MAOi) such as phenelzine sulphate, tranylcypromine sulphate, 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 OXYCODONE. 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 heart disease
• have low blood pressure
• have past or current depression
• suffer from chronic or severe constipation
• have problems with your thyroid, 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 OXYCODONE while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb OXYCODONE can then cause life-threatening breathing problems in your unborn baby or nursing infant.

If you are pregnant and are taking OXYCODONE, 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 OXYCODONE. 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 OXYCODONE. OXYCODONE 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 OXYCODONE.

Serotonin Syndrome: OXYCODONE 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 OXYCODONE 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.

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 OXYCODONE:

• Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking OXYCODONE. 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 OXYCODONE
• other opioid analgesics (drugs used to treat pain)
• general anesthetics (drugs used during surgery)
• benzodiazepines (drugs used to help you sleep or that help reduce anxiety)

• antidepressants (for depression and mood disorders). Do not take OXYCODONE with

  MAO inhibitors (MAOi) or if you have taken MAOi’s in the last 14 days.

• drugs used to treat serious mental or emotional disorders (such as schizophrenia)
• antihistamines (drugs used to treat allergies)
• anti-emetics (drugs used for the prevention of vomiting)
• drugs used to treat muscle spasms and back pain
• anti-retroviral drugs (used to treat viral infections)
• anti-fungal drugs (used to treat fungal infections)
• antibiotic drugs (used to treat bacterial infections)
• anticonvulsants (used to treat seizures)
• some heart medication (such as beta blockers)
• grapefruit juice
• drugs used to treat migraines (e.g., triptans)
• St. John’s Wort

How to take OXYCODONE:

OXYCODONE is usually taken every 6 hours with water. OXYCODONE is for oral use. Your doctor may prescribe a different dose, if this is necessary for you. The dose of OXYCODONE varies based on each patient’s weight, age, severity and cause of pain, as well as medical and pain medication history.

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 Adult Starting 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 OXYCODONE for up to 7 days. If you need to take OXYCODONE 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 OXYCODONE. Be sure to use OXYCODONE only for the condition for which it was prescribed.

If your pain increases or you develop any side effect as a result of taking OXYCODONE, tell your doctor immediately.

Stopping your Medication:

If you have been taking OXYCODONE 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 OXYCODONE. 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 OXYCODONE.

Refilling your Prescription for OXYCODONE:

A new written prescription is required from your doctor each time you need more OXYCODONE. 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 OXYCODONE, 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:

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 doctor before restarting your medication.

What are possible side effects from using OXYCODONE?

These are not all the possible side effects you may feel when taking OXYCODONE. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• Drowsiness
• Insomnia
• Dizziness
• Nausea, vomiting, or a poor appetite
• Dry mouth
• Headache
• Weakness, uncoordinated muscle movement
• Itching
• Sweating
• Constipation
• Abdominal pain
• Fever
• Diarrhea
• Indigestion
• Tremor
• Abnormal dreams or thoughts
• Anxiety
• Confusion
• Depression
• Nervousness
• Rash
• Difficulty breathing
• Low sex drive, impotence (erectile dysfunction), infertility

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

Serious side effects and what to do about them

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:

Store between 15°C and 30°C.

• Keep unused or expired OXYCODONE in a secure place to prevent theft, misuse or accidental exposure.
• Keep OXYCODONE 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 OXYCODONE, get emergency help right away.

Disposal:

OXYCODONE 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 OXYCODONE:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and

  Pro Doc Ltée

  Laval, Quebec

  H7L 3W9

Last revised: December 21, 2018