About Opioids
Opioids are a type of medicine that is generally prescribed to
manage pain, either by itself or in combination with other
treatments. The information contained in this website does not
replace talking with your healthcare provider about your pain
treatment options, including medication.
What is a long-acting opioid?
Long-acting opioids are a type of
pain medicine used to treat moderate to severe chronic pain. They
are sometimes called "controlled-release" or "extended-release"
because the medicine is gradually released into the body over an 8-
to 24-hour period or longer. Long-acting opioids are usually taken
at regularly scheduled times, such as every 12 hours.
Opana® ER is an example of a long-acting opioid.
How do long-acting opioids differ from short-acting
opioids?
While short-acting opioids are
designed to release the drug into your body immediately,
long-acting opioids are designed to release the drug over an
extended period of time.
Are long-acting opioids addictive?
Yes, they can be. Addiction is
defined as compulsive drug seeking that is beyond a person's
voluntary control, even if it may cause harm. Most doctors who
treat patients with pain agree that patients treated with prolonged
opioid medicines usually do not become addicted.
Physical dependence, which is different from addiction, may
develop when taking opioids for pain relief for a long time. This
means that your body adapts to the drug and you will have
withdrawal symptoms if the medicine is stopped or decreased
suddenly. Taking opioids for pain relief is NOT addiction.
How should I take my long-acting pain relief medicine to get
the best pain relief?
People should take their pain
medicine at regularly scheduled times as directed by their
healthcare provider.
What should I do if I miss a dose?
If you miss a dose, take that
dose as soon as you remember. However, if you remember that you
missed a dose at about the time for the next dose, only take the
next dose - DO NOT take two doses. Then, take future
doses at the time prescribed by your healthcare provider.
What happens if I take too much medicine?
Seek emergency medical
attention if you think you have used too much (overdose) of
your opioid medicine.
What are the common symptoms seen following an overdose?
Seek emergency room care if you
have any of the following side effects:
- Slow breathing
- Shallow breathing (little chest movement with breathing)
- Sleepiness
- Slow heart beat
- Extremely small pupils
- Low blood pressure
- Confusion
- Dizziness
- Feeling faint
- Other unusual symptoms
Can I drink wine or other alcoholic beverages while taking
long-acting opioids?
All opioids have warning labels
not to drink alcohol while taking the opioid. This is because of
the potential for serious and even fatal reactions.
What side effects will I have during treatment with a
long-acting opioid?
The most common side effects are
constipation, nausea and/or vomiting, sleepiness, and slowed
breathing.
- Constipation
- Constipation from opioids is common. Your healthcare provider
may prescribe a laxative or combination laxative-stool softener to
treat constipation before it begins. You can help ease constipation
by drinking plenty of water each day and adding more fiber
too.
- Nausea and/or vomiting
- Nausea and/or vomiting are common as you begin treatment, or
just after your dose is increased. Your healthcare provider can
also provide medication to relieve the nausea and vomiting. Once
your body adjusts to the opioid, that uneasy, uncomfortable feeling
that you need to vomit may disappear.
- Sleepiness
- Some degree of sleepiness is normal when you start taking an
opioid analgesic or when the dose is increased, but after a few
days the drowsiness usually goes away. You may notice sleepiness
because the pain you had been feeling has left you tired. However,
keep in mind that taking opioids may affect your ability to perform
some tasks like driving or operating heavy machinery. Be careful if
you are drowsy, and steady yourself when you walk.
- Slowed breathing
- Seek emergency medical attention immediately.
Slowed breathing is very rare when oral opioids are used
appropriately for pain relief. However, taking too much of an
opioid pain medicine or taking doses when you are not experiencing
any pain may cause slowed breathing - also known as "respiratory
depression." If you have a history of troubled breathing, be sure
to tell your healthcare provider and be especially careful to
follow the instructions on the prescription. If you become so
sleepy that you cannot make yourself stay awake, you may be in
danger of slowed breathing.
Will I be able to drive?
It is possible to drive if you
have normal mental acuity (clear thinking and alertness) and take
stable doses of long-acting opioids. You should ask your healthcare
provider if the medication you have been prescribed might impair
your driving ability. Additionally, state laws regarding driving
while taking a medication that may impair your ability to drive
vary greatly.
I take several other medicines to treat other conditions. Is
there a risk of an
interaction between my pain medicine and these other drugs?
It's always possible that two
medicines will interact. Therefore, it is important to make your
healthcare provider aware of all other medicines you are taking to
treat your pain or other medical problems. These include medicines
prescribed by other healthcare providers, non-prescription
medicines, and herbal supplements. Your healthcare provider can
select medication combinations that will give the greatest benefit
while minimizing the risk of a drug interaction or toxicity.
IMPORTANT SAFETY INFORMATION
Opana® ER has a boxed warning as follows:
WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE.
Potential for Abuse
OPANA® ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.
Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OPANA® ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
Proper Patient Selection
OPANA® ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Limitations of Use
OPANA® ER is NOT intended for use as an as needed analgesic.
OPANA® ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA® ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone.
Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA® ER therapy. The co-ingestion of alcohol with OPANA® ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.
CONTRAINDICATIONS
- OPANA® ER is contraindicated in patients with a known hypersensitivity to oxymorphone hydrochloride, morphine analogs such as codeine, or any of the other ingredients of OPANA ER; in patients with moderate or severe hepatic impairment or in any situation where opioids are contraindicated such as: patients with respiratory depression (in the absence of resuscitative equipment or in unmonitored settings), acute or severe bronchial asthma, hypercarbia, and in any patient who has or is suspected of having paralytic ileus.
- OPANA ER is not indicated for pain in the immediate post-operative period or if the pain is mild, or not expected to persist for an extended period of time. OPANA ER is only indicated for post-operative use if the patient is already receiving the drug prior to surgery or if the post-operative pain is expected to be moderate or severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines). OPANA ER is not indicated for pre-emptive analgesia (administration pre-operatively for the management of post-operative pain).
WARNINGS
- Respiratory depression is the chief hazard of OPANA ER, particularly in elderly or debilitated patients.
- OPANA ER should be administered with extreme caution to patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve.
- Patients receiving other opioid analgesics, general anesthetics, phenothiazines or other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) may experience additive effects resulting in respiratory depression, hypotension, profound sedation, coma or death.
- In the presence of head injury, the respiratory depressant effects of OPANA ER and the potential to elevate cerebrospinal fluid pressure may be markedly exaggerated.
- OPANA ER may cause severe hypotension in patients with compromised ability to maintain blood pressure. Administer with caution to patients in circulatory shock.
- Prolonged gastric obstruction may occur in patients with gastrointestinal obstruction, especially paralytic ileus.
- Use with caution in patients with biliary tract disease, as it may cause spasm of the sphincter of oddi.
- Opioid analgesics impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
- OPANA ER is not recommended during labor and delivery, pregnancy, or nursing.
- OPANA ER should be used with caution in elderly and debilitated patients and in patients who are known to be sensitive to CNS depressants, such as those with cardiovascular, pulmonary, renal, or hepatic disease. OPANA ER should be used with caution in patients with mild hepatic impairment and in patients with moderate to severe renal impairment. These patients should be started cautiously with lower doses of OPANA ER while carefully monitoring for side effects.
- Patients and their families should be instructed to flush any OPANA ER tablets that are no longer needed.
ADVERSE REACTIONS
- Adverse reactions reported at (≥2%) in placebo-controlled trials were: nausea, constipation, dizziness, somnolence, vomiting, pruritus, headache, sweating increased, dry mouth, sedation, diarrhea, insomnia, fatigue, appetite decreased, and abdominal pain.
- In clinical trials there were several adverse events that were more frequently observed in subjects 65 and over compared to younger subjects. These adverse events included dizziness, somnolence, confusion, and nausea.
DRUG INTERACTIONS
- CNS depressants: Increased risk of respiratory depression, hypotension, profound sedation, coma or death. When combined therapy with CNS depressant is contemplated, the dose of one or both agents should be reduced. Mixed agonist/antagonist opioids (i.e., pentazocine, nalbuphine, and butorphanol): May reduce analgesic effect and/or precipitate withdrawal symptoms. Cimetidine: Combination use may precipitate confusion, disorientation, respiratory depression, apnea, seizures. Anticholinergics: May result in urinary retention and/or severe constipation, which may lead to paralytic ileus. Monoamine oxidase inhibitors (MAOIs): Potentiate the action of opioids. OPANA ER should not be used in patients taking MAOIs or within 14 days of stopping such treatment.
Please see full Prescribing Information, including boxed WARNING for Opana® ER.
Oxymorphone is also available in immediate release tablets and injectable form. For more information, please see full Prescribing Information for Opana® Tablets and Opana® Injection.
Vermont prescribers, please see additional information for Opana® ER.
