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Oxycodone (Oxycodone Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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 to 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 post-operative 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.)

DOSAGE AND ADMINISTRATION

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.

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 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 the oxycodone hydrochloride extended-release tablets to be effectively administered every 12 hours (see CLINICAL PHARMACOLOGY; PHARMACOKINETICS AND METABOLISM). 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 [See BOXED WARNINGS ].

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:

  1. the general condition and medical status of the patient;
  2. the daily dose, potency and kind of the analgesic(s) the patient has been taking;
  3. the reliability of the conversion estimate used to calculate the dose of oxycodone;
  4. the patient's opioid exposure and opioid tolerance (if any);
  5. special safety issues associated with conversion to oxycodone hydrochloride extended-release tablets doses at or exceeding 160 mg q12h (see Special instructions for Oxycodone Hydrochloride Extended-Release Tablets, 80 mg); and
  6. the balance between pain control and adverse experiences.

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 tablets 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.

Oxycodone hydrochloride extended-release tablets should be individually titrated to a dose that provides adequate analgesia and minimizes side effects.

  1. Using standard conversion ratio estimates (see Table 4 below), multiply the mg/day of the previous opioids by the appropriate multiplication factors to obtain the equivalent total daily dose of oral oxycodone.
  2. When converting from oxycodone, divide this 24-hour oxycodone dose in half to obtain the twice a day (q12h) dose of oxycodone hydrochloride extended-release tablets.
  3. Round down to a dose which is appropriate for the tablet strength available (80 mg tablets).
  4. Discontinue all other around-the-clock opioid drugs when oxycodone hydrochloride extended-release tablets therapy is initiated.
  5. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses. The recommended doses shown in Table 4 are only a starting point, and close observation and frequent titration are indicated until patients are stable on the new therapy.
Table 4: Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Daily Dose of Oral Oxycodone* (Mg/Day Prior Opioid × Factor = Mg/Day Oral Oxycodone)
Oral Prior OpioidParenteral Prior Opioid
Oxycodone1--
Codeine0.15--
Hydrocodone0.9--
Hydromorphone420
Levorphanol7.515
Meperidine0.10.4
Methadone1.53
Morphine0.53

* To be used only for conversion to oral oxycodone . For patients receiving high-dose parenteral opioids, a more conservative conversion is warranted. For example, for high-dose parenteral morphine, use 1.5 instead of 3 as a multiplication factor.

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 (see PRECAUTIONS).

Conversion from Transdermal Fentanyl to Oxycodone Hydrochloride Extended-Release Tablets

Eighteen hours following the removal of the transdermal fentanyl patch, oxycodone hydrochloride extended-release tablets 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.

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.

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 total daily 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.

Special instructions for Oxycodone Hydrochloride Extended-Release Tablets, 80 mg (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. 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.

Supplemental Analgesia

Most patients given around-the-clock therapy with extended-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).

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.

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.

Conversion from Oxycodone Hydrochloride Extended-Release Tablets to Parenteral Opioids

To avoid overdose, conservative dose conversion ratios should be followed.

SAFETY AND HANDLING

Oxycodone hydrochloride extended-release tablets are solid dosage forms that contain oxycodone which is a controlled substance. Like morphine, oxycodone is controlled under Schedule II of the Controlled Substances Act.

Oxycodone hydrochloride extended-release tablets have been targeted for theft and diversion by criminals. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

HOW SUPPLIED

Oxycodone Hydrochloride Extended-Release Tablets, 80 mg are green, film-coated, oval, convex tablets debossed with “93” on one side and “33” on the other side. They are available in bottles of 100.

Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

CAUTION

DEA Order Form Required.

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