(oxycodone hydrochloride) extended-release tablets, CII
- A strong prescription pain medicine that contains an opioid
(narcotic) that is used to manage pain severe enough to require daily
around-the-clock, long-term treatment with an opioid, when other pain
treatments such as non-opioid pain medicines or immediate-release
opioid medicines do not treat your pain well enough or you cannot
- A long-acting (extended-release) opioid pain medicine that
can put you at risk for overdose and death. Even if you take your
dose correctly as prescribed you are at risk for opioid addiction,
abuse, and misuse that can lead to death.
- Not for use to treat pain that is not around-the-clock.
- Not for use in children less than 11 years of age and who
are not already using opioid pain medicines regularly to manage pain
severe enough to require daily around-the-clock long-term treatment
of pain with an opioid.
Important information about OXYCONTIN:
Get emergency help or call 911 right away if you take
too much OXYCONTIN (overdose). When you first start taking
OXYCONTIN, when your dose is changed, or if you take too much (overdose),
serious or life-threatening breathing problems that can lead to death
may occur. Talk to your healthcare provider about naloxone, a medicine
for the emergency treatment of an opioid overdose.
- Taking OXYCONTIN 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.
- Never give anyone else your OXYCONTIN. They could die from
taking it. Selling or giving away OXYCONTIN is against the law.
- Store OXYCONTIN securely, out of sight and reach of children,
and in a location not accessible by others, including visitors to
Do not take OXYCONTIN if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
Before taking OXYCONTIN, tell your healthcare provider if
you have a history of:
- head injury, seizures
- liver, kidney, thyroid problems
- problems urinating
- pancreas or gallbladder problems
- abuse of street or prescription drugs, alcohol addiction,
opioid overdose, or mental health problems.
Tell your healthcare provider if you are:
pregnant or planning to become pregnant. Prolonged
use of OXYCONTIN during pregnancy can cause withdrawal symptoms in
your newborn baby that could be life-threatening if not recognized
breastfeeding. Not recommended during treatment
with OXYCONTIN. It may harm your baby.
- living in a household where there are small children or
someone who has abused street or prescription drugs
- taking prescription or over-the-counter medicines, vitamins,
or herbal supplements. Taking OXYCONTIN with certain other medicines
can cause serious side effects that could lead to death.
When taking OXYCONTIN:
- Do not change your dose. Take OXYCONTIN exactly as prescribed
by your healthcare provider. Use the lowest dose possible for the
shortest time needed.
- Take your prescribed dose every 12 hours at the same time
every day. Do not take more than your prescribed dose in 12 hours.
If you miss a dose, take your next dose at your usual time.
- Swallow OXYCONTIN whole. Do not cut, break, chew, crush,
dissolve, snort, or inject OXYCONTIN because this may cause you to
overdose and die.
- OXYCONTIN should be taken 1 tablet at a time. Do not pre-soak,
lick, or wet the tablet before placing in your mouth to avoid choking
on the tablet.
Call your healthcare provider if the dose you are
taking does not control your pain.
Do not stop taking OXYCONTIN without talking to your
Dispose of expired, unwanted, or unused OXYCONTIN
by promptly flushing down the toilet, if a drug take-back option is
not readily available. Visit www.fda.gov/drugdisposal for additional
information on disposal of unused medicines.
While taking OXYCONTIN DO NOT:
- Drive or operate heavy machinery until you know how OXYCONTIN
affects you. OXYCONTIN can make you sleepy, dizzy, or lightheaded.
- Drink alcohol, or use prescription or over-the-counter medicines
that contain alcohol. Using products containing alcohol during treatment
with OXYCONTIN may cause you to overdose and die.
The possible side effects of OXYCONTIN are:
- constipation, nausea, sleepiness, vomiting, tiredness, headache,
dizziness, abdominal pain. Call your healthcare provider if you have
any of these symptoms and they are severe.
Get emergency medical help or call 911 right away if you
- trouble breathing, shortness of breath, fast heartbeat,
chest pain, swelling of your face, tongue, or throat, extreme drowsiness,
light-headedness when changing positions, feeling faint, agitation,
high body temperature, trouble walking, stiff muscles, or mental
changes such as confusion.
|These are not all the
possible side effects of OXYCONTIN. Call your doctor for medical advice
about side effects.
You may report side effects to FDA
at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov
Manufactured by: Purdue Pharma L.P., Stamford,
CT 06901-3431, www.purduepharma.com or call 1-888-726-7535