OXYCONTIN - oxycodone hydrochloride tablet, film
coated, extended release
Purdue Pharma LP
----------
MEDICATION
GUIDE
OXYCONTIN
(ox-e-KON-tin) CII
(oxycodone hydrochloride controlled-release)
Tablets
Read this Medication Guide before you start taking OxyContin and each time
you get a refill. There may be new information. This Medication Guide does not
take the place of talking to your healthcare provider about your medical
condition or your treatment.
What is the most important information
I should know about OxyContin?
-
OxyContin can cause serious side
effects, including addiction or death.
-
Do not cut, break, chew, crush, or
dissolve OxyContin before swallowing. If OxyContin is taken in this way, the
medicine in the tablets will be released too fast. This is dangerous. It may
cause you to stop breathing, and may lead to death.
- OxyContin is not for use to treat pain that you only have once in a while
("as needed").
-
Do not take OxyContin 60 mg or 80 mg
tablets unless you are "opioid tolerant." Opioid tolerant means
that you regularly use OxyContin or another opioid medicine for your constant
(around-the-clock) pain and your body is used to it.
-
Do not take more than 40 mg of
OxyContin in one dose or more than 80 mg of OxyContin in one day unless you are
"opioid tolerant." This may cause you to stop breathing and may
lead to death.
-
OxyContin is a federally controlled
substance (CII) because it is a strong opioid pain medicine that
can be abused by people who abuse prescription medicines or street drugs.
-
Prevent theft, misuse and
abuse. Keep OxyContin in a safe place, to keep it from being
stolen. OxyContin can be a target for people who misuse or abuse prescription
medicines or street drugs.
-
Never give OxyContin to anyone else,
even if they have the same symptoms you have. It may harm them and even cause
death.
- Before taking OxyContin, tell your doctor if you or a family member have
been addicted to or abused other medicines, street drugs, or alcohol, or if you
have a history of mental illness.
|
-
Do not drink alcohol while using
OxyContin. Using alcohol with OxyContin may increase your risk of dangerous side
effects, including death.
-
Certain medicines can interact with
OxyContin and cause you to have high levels of oxycodone in your blood. This may
cause you to stop breathing and lead to death. Before taking OxyContin, tell
your healthcare provider if you take an antibiotic, an antifungal medicine, or
an anti-HIV medicine.
What is OxyContin?
- OxyContin is a prescription medicine used when an opioid medicine is needed
to manage moderate to severe pain that continues around-the-clock and is
expected to last for a long period of time.
- It is not known if OxyContin is safe and effective in children younger than
18 years.
- OxyContin is not for use:
- to manage pain "as needed"
- before surgery to manage any pain from your surgery
- to manage pain after surgery if the pain is mild and is not expected to last
for a long period of time
- If you already take OxyContin, it may be used to manage your pain after
surgery if:
- it has been at least 12 to 24 hours after your surgery, and
- your pain from surgery is expected to be moderate to severe, and last for a
long period of time.
Who should not take
OxyContin?
Do not take OxyContin if
you:
- are allergic to any of its ingredients. See the end of this Medication Guide
for a list of the ingredients in OxyContin.
- have had a severe allergic reaction to a medicine that contains oxycodone.
Ask your healthcare provider if you are not sure.
- are having an asthma attack or have severe asthma, trouble breathing, or
lung problems
- have a bowel blockage called paralytic ileus
What should I tell my healthcare
provider before taking OxyContin?
OxyContin may not be right for you.
Before taking OxyContin, tell your doctor if you:
Tell your healthcare provider about all
the medicines you take, including prescription and
non-prescription medicines, vitamins, and herbal supplements. Sometimes the
doses of medicines that you take with OxyContin may need to be changed if used
together.
-
See "What is the most important
information I should know about OxyContin?"
- Be especially careful about taking other medicines that make you sleepy such
as:
- pain medicines
- sleeping pills
- anxiety medicines
- antihistamines
- anti-depressants
- tranquilizers
- anti-nausea medicine
Do not take other medicines without talking to your healthcare provider. Your
healthcare provider will tell you if it is safe to take other medicines while
you take OxyContin.
Know the medicines you take. Keep a list of your medicines to show your
healthcare provider and pharmacist.
How should I take
OxyContin?
- See "What is the most important information I should know about OxyContin?"
-
Take OxyContin exactly as prescribed.
Do not change your dose unless your healthcare provider tells you
to.
-
Swallow OxyContin tablets whole. Do
not cut, break, chew, crush, or dissolve before swallowing.
- Take OxyContin every 12 hours.
- You can take OxyContin with or without food.
- If you miss a dose, take it as soon as possible. Take your next dose 12
hours later. Do not take more than your prescribed dose of OxyContin. Call your
healthcare provider if you are not sure about your dose of OxyContin or when to
take it.
-
If you take more OxyContin than
prescribed, or overdose, call your local emergency number (such as
911) or your local Poison Control Center right away, or get emergency help.
-
Talk with your healthcare provider
regularly about your pain to see if you still need to take
OxyContin.
What should I avoid while taking
OxyContin?
-
Do not drink alcohol while using
OxyContin. See "What is the
most important information I should know about OxyContin?" Do not drive, operate
heavy machinery, or do other dangerous activities, especially when you start
taking OxyContin and when your dose is changed, until you know how you react to
this medicine. OxyContin can make you sleepy, and also cause you to feel dizzy.
Ask your healthcare provider to tell you when it is okay to do these
activities.
What are the possible side effects of
OxyContin?
OxyContin can cause serious side
effects, including:
The most common side effects of
OxyContin include:
- constipation
- nausea
- drowsiness
- dizziness
- itching
- vomiting
- headache
- dry mouth
- weakness
- sweating
Some of these side effects may decrease with continued use. Talk with your
healthcare provider if you continue to have these side effects. These are not
all the possible side effects of OxyContin. For a complete list, ask your
healthcare provider or pharmacist.
Constipation (not often enough or hard bowel movements) is a very common side
effect of pain medicines (opioids) including OxyContin, and is unlikely to go
away without treatment. Talk to your healthcare provider about dietary changes,
and the use of laxatives (medicines to treat constipation) and stool softeners
to prevent or treat constipation while taking OxyContin.
Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1–800–FDA–1088.
How should I store
OxyContin?
-
Keep OxyContin out of the reach of
children. Accidental overdose by a child is dangerous and can lead
to death.
- Store OxyContin at 59 F to 86F (15 C to 30 C)
- Keep OxyContin in the container it comes in.
- Keep the container tightly closed and away from light.
- After you stop taking OxyContin, flush the unused tablets down the toilet.
General information about
OxyContin
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use OxyContin for a condition
for which it was not prescribed. Never give your OxyContin to other people even
if they have the same symptoms you have.
Selling or giving away OxyContin may
harm others, even causing death, and is against the law.
This Medication Guide summarizes the most important information about
OxyContin. If you would like more information, talk with your healthcare
provider. You can ask your healthcare provider or pharmacist for information
about OxyContin that is written for health professionals. For more information
about OxyContin, go to www.purduepharma.com or call 1-888-726-7535.