Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/725
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Oxycodone Hydrochloride (Tablet)
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General Principles: OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS ARE AN OPIOID AGONIST AND A
SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY
SIMILAR TO MORPHINE. OXYCODONE, LIKE MORPHINE AND OTHER
OPIOIDS USED IN ANALGESIA, CAN BE ABUSED AND IS SUBJECT TO
CRIMINAL DIVERSION. OXYCODONE HYDROCHLORIDE
EXTENDED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE, AND ARE
NOT TO BE BROKEN, CHEWED OR CRUSHED. TAKING BROKEN, CHEWED
OR CRUSHED OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS LEADS TO THE RAPID RELEASE AND
ABSORPTION OF A POTENTIALLY FATAL DOSE OF
OXYCODONE. One oxycodone hydrochloride extended-release 160 mg tablet is comparable to two 80 mg
tablets when taken on an empty stomach. With a high fat
meal, however, there is a 25% greater peak plasma
concentration following one 160 mg tablet. Dietary caution
should be taken when patients are initially titrated to 160
mg tablets (see DOSAGE AND
ADMINISTRATION). In treating pain it is vital to assess the patient
regularly and systematically. Therapy should also be regularly
reviewed and adjusted based upon the patient's own
reports of pain and side effects and the health
professional's clinical judgment. Oxycodone hydrochloride extended-release tablets are an
extended-release oral formulation of oxycodone hydrochloride
indicated for the management of moderate to severe pain
requiring treatment with a strong opioid for continuous,
around-the-clock analgesia for an extended period of time. The
extended-release nature of the formulation allows oxycodone
hydrochloride extended-release tablets to be effectively
administered every 12 hours While
symmetric (same dose AM and PM), around-the-clock, q12h dosing
is appropriate for the majority of patients, some patients may
benefit from asymmetric (different dose given in AM than in PM)
dosing, tailored to their pain pattern. It is usually
appropriate to treat a patient with only one opioid for
around-the-clock therapy. Physicians should individualize treatment using a
progressive plan of pain management such as outlined by the
World Health Organization, the American Pain Society and the
Federation of State Medical Boards Model Guidelines. Health care
professionals should follow appropriate pain management
principles of careful assessment and ongoing monitoring [SeeBOXED
WARNINGS].<br/>Initiation of Therapy: It is critical to initiate the dosing regimen for each
patient individually, taking into account the
patient's prior opioid and non-opioid analgesic
treatment. Attention should be given to: Care should be taken to use low initial doses of
oxycodone hydrochloride extended-release tablets in patients who
are not already opioid-tolerant, especially those who are
receiving concurrent treatment with muscle relaxants, sedatives,
or other CNS active medications (see PRECAUTIONS:
Drug-Drug Interactions). For initiation of oxycodone hydrochloride
extended-release tablet therapy for patients previously taking
opioids, the conversion ratios from Foley, KM. [NEJM, 1985;
313:84-95], found below, are a reasonable starting point,
although not verified in well-controlled, multiple-dose trials. Experience indicates a reasonable starting dose of
oxycodone hydrochloride extended-release tablets for patients
who are taking non-opioid analgesics and require continuous
around-the-clock therapy for an extended period of time is 10 mg
q12h. If a non-opioid analgesic is being provided, it may be
continued. Oxycodone hydrochloride extended-release tablets
should be individually titrated to a dose that provides adequate
analgesia and minimizes side effects. In all cases, supplemental analgesia (see below) should
be made available in the form of a suitable short-acting
analgesic. Oxycodone hydrochloride extended-release tablets can be
safely used concomitantly with usual doses of non-opioid
analgesics and analgesic adjuvants, provided care is taken to
select a proper initial dose .<br/>Conversion from Transdermal Fentanyl to Oxycodone Hydrochloride
Extended-Release Tablets: Eighteen hours following the removal of the transdermal
fentanyl patch, oxycodone hydrochloride extended-release tablet
treatment can be initiated. Although there has been no
systematic assessment of such conversion, a conservative
oxycodone dose, approximately 10 mg q12h of oxycodone
hydrochloride extended-release tablets, should be initially
substituted for each 25 mcg/hr fentanyl transdermal patch. The
patient should be followed closely for early titration, as there
is very limited clinical experience with this
conversion.<br/>Managing Expected Opioid Adverse Experiences: Most patients receiving opioids, especially those who are
opioid- naive, will experience side effects. Frequently the side
effects from oxycodone hydrochloride extended-release tablets
are transient, but may require evaluation and management. Adverse events such as constipation should be anticipated and
treated aggressively and prophylactically with a stimulant
laxative and/or stool softener. Patients do not usually become
tolerant to the constipating effects of opioids. Other opioid-related side effects such as sedation and
nausea are usually self-limited and often do not persist beyond
the first few days. If nausea persists and is unacceptable to
the patient, treatment with anti-emetics or other modalities may
relieve these symptoms and should be considered.<br/>Individualization of Dosage: Once therapy is initiated, pain relief and other opioid
effects should be frequently assessed. Patients should be
titrated to adequate effect (generally mild or no pain with the
regular use of no more than two doses of supplemental analgesia
per 24 hours). Patients who experience breakthrough pain may
require dosage adjustment or rescue medication. Because
steady-state plasma concentrations are approximated within 24 to
36 hours, dosage adjustment may be carried out every 1 to 2
days. It is most appropriate to increase the q12h dose, not the
dosing frequency. There is no clinical information on dosing
intervals shorter than q12h. As a guideline, except for the
increase from 10 mg to 20 mg q12h, the totaldaily oxycodone
dose usually can be increased by 25% to 50% of
the current dose at each increase. If signs of excessive opioid-related adverse experiences
are observed, the next dose may be reduced. If this adjustment
leads to inadequate analgesia, a supplemental dose of
immediate-release oxycodone may be given. Alternatively,
non-opioid analgesic adjuvants may be employed. Dose adjustments
should be made to obtain an appropriate balance between pain
relief and opioid-related adverse experiences. If significant adverse events occur before the
therapeutic goal of mild or no pain is achieved, the events
should be treated aggressively. Once adverse events are under
control, upward titration should continue to an acceptable level
of pain control. During periods of changing analgesic requirements,
including initial titration, frequent contact is recommended
between physician, other members of the health-care team, the
patient and the caregiver/family.<br/>Special Instructions for Oxycodone Hydrochloride Extended-Release
80 mg Tablets: (for use in opioid-tolerant patients
only) Oxycodone hydrochloride
extended-release 80 mg tablets are for use only in
opioid-tolerant patients requiring daily oxycodone
equivalent dosages of 160 mg or more for the 80 mg tablets.
Care should be taken in the prescribing of this tablet
strength. Patients should be instructed against use by
individuals other than the patient for whom it was
prescribed, as such inappropriate use may have severe
medical consequences, including death. One oxycodone hydrochloride
extended-release 160 mg tablet is comparable to two 80 mg
tablets when taken on an empty stomach. With a high fat
meal, however, there is a 25% greater peak plasma
concentration following one 160 mg tablet. Dietary caution
should be taken when patients are initially titrated to 160 mg tablets.<br/>Supplemental Analgesia: Most patients given around-the-clock therapy with
controlled-release opioids may need to have immediate-release
medication available for exacerbations of pain or to prevent
pain that occurs predictably during certain patient activities
(incident pain).<br/>Maintenance of Therapy: The intent of the titration period is to establish a
patient-specific q12h dose that will maintain adequate analgesia
with acceptable side effects for as long as pain relief is
necessary. Should pain recur then the dose can be incrementally
increased to re-establish pain control. The method of therapy
adjustment outlined above should be employed to re-establish
pain control. During chronic therapy, especially for non-cancer pain
syndromes, the continued need for around-the-clock opioid
therapy should be reassessed periodically (e.g., every 6 to 12
months) as appropriate.<br/>Cessation of Therapy: When the patient no longer requires therapy with
oxycodone hydrochloride extended-release tablets, doses should
be tapered gradually to prevent signs and symptoms of withdrawal
in the physically dependent patient.<br/>Conversion from Oxycodone Hydrochloride Extended-Release Tablets
to Parenteral Opioids: To avoid overdose, conservative dose conversion ratios should be followed.
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Oxycodone Hydrochloride
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dailymed-instance:fullName |
Oxycodone Hydrochloride (Tablet)
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dailymed-instance:indicatio... |
Oxycodone hydrochloride extended-release tablets are an extended-release oral formulation of oxycodone hydrochloride indicated
for the management of moderate to severe pain when a continuous,
around-the-clock analgesic is needed for an extended period of time. Oxycodone hydrochloride extended-release tablets are NOT intended for use as a prn analgesic. Physicians should individualize treatment in every case,
initiating therapy at the appropriate point along a progression from
non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and
acetaminophen to opioids in a plan of pain management such as outlined
by the World Health Organization, the Agency for Health Research and
Quality (formerly known as the Agency for Health Care Policy and
Research), the Federation of State Medical Boards Model Guidelines, or
the American Pain Society. Oxycodone hydrochloride extended-release tablets are not
indicated for pain in the immediate post-operative period (the first
12-24 hours following surgery), or if the pain is mild, or not expected
to persist for an extended period of time. Oxycodone hydrochloride
extended-release tablets are only indicated for post-operative use if
the patient is already receiving the drug prior to surgery or if the
postoperative pain is expected to be moderate to 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.)
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Oxycodone Hydrochloride
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