Patient Medication Information: uses, side effects, how to take - Oxycontin 10mg
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT OXYCONTIN?
Do not cut, break chew, dissolve or crush OxyContin
tablets before swallowing. If OxyContin is taken this way, oxycodone could be released too fast. This can lead to serious and life-threatening breathing problems. Life-threatening breathing problems can also happen because of an overdose or if the dose you are using is too high for you. Get emergency medical help immediately if you:
have trouble breathing, or have slow or shallow
breathing
- have a slow heartbeat
- have severe sleepiness
- have cold, clammy skin
feel faint, dizzy, confused, or cannot think, walk or
talk normally
- have a seizure
- have hallucinations
OxyContin is not for use to treat pain that you only have
once in a while (“as needed”)
Take OxyContin exactly as described by your physician.
Do not take the 60 or 80 mg strength or a single dose of 40 mg or more of OxyContin unless you are “opioid tolerant”. Your doctor will tell you when you are “opioid tolerant” to a certain dose of OxyContin.
Never give OxyContin to anyone else, even if they have
the same symptoms as you have. It may harm them or even cause death.
Tell your doctor if you (or a family member) have ever
abused or been dependent on alcohol, prescription medicines or street drugs.
- Prevent theft, misuse or abuse. Keep OxyContin in a safe place to protect it from being stolen.
- After you stop taking OxyContin, you should take the unused tablets to your pharmacist to be destroyed.
ABOUT THIS MEDICATION
What the medication is used for:
OxyContin is an oral controlled release tablet that slowly releases oxycodone (an opioid analgesic) over a 12 hour period, and requires a dose every 12 hours to control your pain.
What it does:
Oxycodone is a medicine used to treat moderate to severe pain requiring the continuous use of an opioid analgesic preparation for several days or more.
Oxycodone belongs to a class of drugs which is commonly referred to as opiates, opioids or narcotics and also includes codeine, fentanyl, hydromorphone and morphine.
Your pain may increase or decrease occasionally and your doctor may need to change the amount of oxycodone you take daily (daily dosage).
When it should not be used:
OxyContin should not be used if:
- Your doctor did not prescribe it for you;
- You are allergic to oxycodone, opioids or any other ingredient in the tablets; (see What the nonmedicinal ingredients are:)
- Your pain is mild;
- Your pain can be controlled by occasional use of any painkillers;
- You have severe asthma or severe lung problems;
- You suffer from alcoholism;
- You have a head injury;
- You suffer from seizures;
- You had surgery less than 12-24 hours ago and you were not taking OxyContin just before surgery;
- You have a condition where the small bowel does not work properly (paralytic ileus) or you have severe pain in your abdomen;
- You are taking, or have taken within the past 2 weeks, a monoamine oxidase inhibitor medications (e.g., phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline);
You are pregnant, in labour or breast-feeding.
Individuals under 18 years of age should not take OxyContin tablets.
What the medicinal ingredient is:
Oxycodone Hydrochloride
What the nonmedicinal ingredients are:
OxyContin Controlled Release Tablets: hydroxypropyl methylcellulose (hypromellose), lactose, magnesium stearate, polyethylene glycol (Macrogol 400), polymethyl acrylate, povidone, stearyl alcohol, talc, titanium dioxide triacetin. In addition, the tablet coatings contain the following: 5 mg – FD&C Blue No. 1 [brilliant blue]
10 mg – hydroxypropylcellulose
15 mg – iron oxide
20 mg, 30 mg, 40 mg and 120 mg – polysorbate 80 and iron oxide 60 mg – polysorbate 80 FD&C Red No. 40 Aluminum Lake and iron oxide
80 mg – hydroxypropylcellulose, iron oxide and FD&C Blue No. 2 Aluminum Lake [indigo carmine]
160 mg – polysorbate 80 and FD&C Blue No. 2 Aluminum Lake [indigo carmine].
What dosage forms it comes in:
OxyContin Controlled Release Tablets: 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 120 mg and 160 mg.
WARNINGS AND PRECAUTIONS
OxyContin tablets are designed to work properly over 12 hours when swallowed whole. If a tablet is cut, broken, crushed, dissolved or chewed, the entire 12-hour dose will be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose, which can be fatal.
Keep OxyContin out of the reach of children. You should not give OxyContin to anyone as inappropriate use may have severe medical consequences, including death.
BEFORE you use OxyContin, talk to your doctor or pharmacist if you have, or had in the past any other medical conditions, especially the following ones: trouble breathing or lung problems, head injury, liver or kidney problems, adrenal gland problems, such as Addison’s disease, convulsions or seizures, alcoholism, hallucinations or other severe mental problems, past or present substance abuse or drug addiction.
Tell your doctor or pharmacist if you are pregnant, plan to become pregnant, or are breastfeeding. OxyContin will pass through the milk and may harm the baby. OxyContin should not be used in patients who are pregnant or lactating.
If you are planning surgery, or about to undergo surgery, tell your doctor that you are taking OxyContin.
You should take the following precautions while taking OxyContin tablets:
- You must not consume alcohol while taking OxyContin, as it may increase the chance of experiencing dangerous side effects;
- Driving or other tasks requiring full alertness should not be attempted until you are sure that taking OxyContin does not make you drowsy;
- You must tell your doctor and pharmacist if you are taking any other over-the-counter or prescription medications - they will tell you what you should do.
Abuse, Addiction and Physical Dependence
There is a risk of abuse or addiction with all opioids. Some patients, particularly those who have abused drugs in the past, may have a higher risk of abusing or developing an addiction while taking opioids such as OxyContin. Patients who have taken OxyContin for a period of time may develop physical dependence, and should not abruptly stop taking it. See ‘Discontinuation:’ section of this leaflet.
While there are important differences between physical dependence and addiction, each is a reason for close medical supervision and honest discussions with your doctor. If you have questions or concerns about abuse, addiction or physical dependence, please tell your doctor.
INTERACTIONS WITH THIS MEDICATION
You should not take OxyContin if you are currently taking
(or recently stopped taking) one of the medicines known as monoamine oxidase inhibitor medications (e.g., phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline).
Drugs that may interact with OxyContin include:
- Alcohol or other sedative drugs may enhance the drowsiness caused by oxycodone;
- Other opioids, anaesthetics, sedatives, hypnotics, antidepressants, sleeping aids, phenothiazines, neuroleptics, some heart medications (e.g., beta-blockers), chloral hydrate and glutethimide;
- Antihistamines or sleep aids (these medicines could make you drowsy and depress your breathing);
- Any nonprescription, (over-the-counter) medications;
- Any herbal remedies.
PROPER USE OF THIS MEDICATION
OxyContin tablets must be swallowed whole and should not be broken, chewed, dissolved or crushed since this can lead to the release and absorption of an excessive dose of oxycodone which can seriously harm you.
OxyContin is not recommended for rectal administration.
Usual dose:
Take the dose prescribed by your doctor. OxyContin tablets should be taken every 12 hours with a glass of water.
OxyContin can be taken with or without food.
Your dose of OxyContin will be clearly labelled on the medication bottle. Be sure to follow the directions on the label exactly; this is very important. Do not increase or decrease your dose without consulting your doctor. If your dosage is changed by your doctor, be sure to write it down at the time your doctor calls or sees you, and follow the new directions exactly. Review your pain regularly with your doctor to determine if you still need OxyContin. Be sure to use OxyContin only for the condition for which it was prescribed.
You may see tablets in your stools (bowel movements) when using OxyContin. Do not be concerned, your body has absorbed the medicine.
Discontinuation:
After you stop taking OxyContin you should take the unused tablets to your pharmacist to be destroyed.
Consult your doctor for instructions on how to stop this medicine slowly to avoid uncomfortable symptoms such as body aches, diarrhea, gooseflesh, loss of appetite, nausea, nervousness or restlessness, runny nose, sneezing, tremors or shivering, stomach cramps, tachycardia, trouble with sleeping, unusual increase in sweating, unexplained fever, weakness and yawning.
You should not stop taking OxyContin all at once if you have been taking it for more than a few days.
Reordering OxyContin:
A new written prescription is required from your doctor each time you need more OxyContin. Therefore, it is important that you contact your doctor at least three working days before your current supply runs out.
Overdose:
The most important sign of overdose is decreased breathing (abnormally slow or weak breathing), dizziness, confusion or extreme drowsiness. If you accidentally take an overdose of OxyContin, call your doctor and/or your local emergency number and/or a Regional Poison Control Centre immediately, or go to a hospital emergency and take any remaining tablets and the container with you, even though you may not feel sick.
Missed Dose:
It is very important that you do not miss any doses. 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, unless your doctor tells you to. If you miss several
doses in succession, talk to your doctor before restarting your medication.
Do not seek additional prescriptions for this medicine from any other doctor - unless responsibility for your pain management has been transferred to another doctor.
Should your pain increase or any other complaint develop as a result of taking OxyContin, tell your doctor immediately.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The most common side effects you may experience are constipation, nausea, drowsiness, dizziness, vomiting, itching, headache, dry mouth, weakness and sweating. Tell your doctor about these problems if they arise. Your doctor may order a laxative and stool softener to help relieve your constipation while you are taking OxyContin.
If you experience any symptoms related to difficulty in breathing, such as tight chest or wheezing, fainting, or rapid heartbeat, seek immediate emergency medical assistance.
Physical dependence, abuse and withdrawal reactions have been reported. See withdrawal reactions listed within the ‘Discontinuation:” section of this leaflet.
This is not a complete list of side effects. For any unexpected effects while taking OxyContin, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15E-30˚C). Keep in a dry place.
Keep OxyContin in a secure place to prevent theft and misuse.
Do not give OxyContin to anyone other than the person for whom it was prescribed, since it may seriously harm them, including death
Keep OxyContin under lock and out of sight and out of reach of children. Accidental ingestion by a child is dangerous and may result in death.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Report online at:
www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789
Mail to:
Canada Vigilance Program
Marketed Health Products Directorate Health Canada
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available in the MedEffect™ Canada Web site at
www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of the side effects, please contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This leaflet summarized important information about OxyContin. If you would like more information, talk with your doctor and/or pharmacist.
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.purdue.ca/products
or by contacting the manufacturer, Purdue Pharma, at: 1-800-387-5349.
Last revised: November 8, 2011
®Purdue Pharma, owner of the registered trademark OxyContin.