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OXYCODONE HCl CONTROLLED-RELEASE TABLETS CII10 mg, 20 mg, 40 mg and * 80 mg | oxycodone hydrochloride

17:41 EDT 24th July 2014 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Oxycodone HCl Controlled-Release Tablets are an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine.

Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Oxycodone HCl Controlled-Release Tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Oxycodone HCl Controlled-Release Tablets are a controlled-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 HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic.

OXYCODONE HCl CONTROLLED-RELEASE 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. A single dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids.

OXYCODONE HCl CONTROLLED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OXYCODONE HCl CONTROLLED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

Oxycodone HCl Controlled-Release Tablets are an opioid analgesic supplied in 10 mg, 20 mg, 40 mg, and 80 mg tablet strengths for oral administration.  The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt.  The structural formula for oxycodone hydrochloride is as follows:

The chemical formula is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride.

Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine.  Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL).  It is slightly soluble in alcohol (octanol water partition coefficient 0.7).  The tablets contain the following inactive ingredients: ammonio methacrylate copolymer, hypromellose, lactose, magnesium stearate, polyethylene glycol 400, povidone, sodium hydroxide, sorbic acid, stearyl alcohol, talc, titanium dioxide, and triacetin.

The 10 mg tablets also contain: hydroxypropyl cellulose. 

The 20 mg tablets also contain: polysorbate 80 and red iron oxide. 

The 40 mg tablets also contain: polysorbate 80 and yellow iron oxide. 

The 80 mg tablets also contain:  FD&C blue No. 2, hydroxypropyl cellulose, and yellow iron oxide.

Oxycodone HCl controlled-release 10 mg, 20 mg, 40 mg, and 80 mg tablets are tested using USP Dissolution Test 2 and meet the associated tolerances provided in Acceptance Table 2 of the Oxycodone Hydrochloride Extended-Release Tablets USP Monograph.

IMAGE oxycontin_struct.jpg

Oxycodone is a pure agonist opioid whose principal therapeutic action is analgesia.  Other members of the class known as opioid agonists include substances such as morphine, hydromorphone, fentanyl, codeine, and hydrocodone.  Pharmacological effects of opioid agonists include anxiolysis, euphoria, feelings of relaxation, respiratory depression, constipation, miosis, and cough suppression, as well as analgesia.  Like all pure opioid agonist analgesics, with increasing doses there is increasing analgesia, unlike with mixed agonist/antagonists or non-opioid analgesics, where there is a limit to the analgesic effect with increasing doses.  With pure opioid agonist analgesics, there is no defined maximum dose; the ceiling to analgesic effectiveness is imposed only by side effects, the more serious of which may include somnolence and respiratory depression.

The precise mechanism of the analgesic action is unknown.  However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of this drug. 

Oxycodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves both a reduction in the responsiveness of the brain stem respiratory centers to increases in carbon dioxide tension and to electrical stimulation. 

Oxycodone depresses the cough reflex by direct effect on the cough center in the medulla.  Antitussive effects may occur with doses lower than those usually required for analgesia. 

Oxycodone causes miosis, even in total darkness.  Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings).  Marked mydriasis rather than miosis may be seen with hypoxia in the setting of Oxycodone HCl Controlled-Release Tablets overdose (See OVERDOSAGE).

Oxycodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.  Digestion of food in the small intestine is delayed and propulsive contractions are decreased.  Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation.  Other opioid-induced effects may include a reduction in gastric, biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.

Oxycodone may produce release of histamine with or without associated peripheral vasodilation.  Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.

Studies in normal volunteers and patients reveal predictable relationships between oxycodone dosage and plasma oxycodone concentrations, as well as between concentration and certain expected opioid effects, such as pupillary constriction, sedation, overall “drug effect”, analgesia and feelings of “relaxation”.

As with all opioids, the minimum effective plasma concentration for analgesia will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids.  As a result, patients must be treated with individualized titration of dosage to the desired effect.  The minimum effective analgesic concentration of oxycodone for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome and/or the development of analgesic tolerance.

Oxycodone HCl Controlled-Release Tablets are associated with typical opioid-related adverse experiences. There is a general relationship between increasing oxycodone plasma concentration and increasing frequency of dose-related opioid adverse experiences such as nausea, vomiting, CNS effects, and respiratory depression. In opioid-tolerant patients, the situation is altered by the development of tolerance to opioid-related side effects, and the relationship is not clinically relevant. 

As with all opioids, the dose must be individualized (see DOSAGE AND ADMINISTRATION ), because the effective analgesic dose for some patients will be too high to be tolerated by other patients.

The activity of Oxycodone HCl Controlled-Release Tablets is primarily due to the parent drug oxycodone.  Oxycodone HCl Controlled-Release Tablets are designed to provide controlled delivery of oxycodone over 12 hours.   

Breaking, chewing or crushing Oxycodone HCl Controlled-Release Tablets eliminates the controlled delivery mechanism and results in the rapid release and absorption of a potentially fatal dose of oxycodone. 

Oxycodone release from Oxycodone HCl Controlled-Release Tablets is pH independent.  Oxycodone is well absorbed from Oxycodone HCl Controlled-Release Tablets with an oral bioavailability of 60% to 87%.  The relative oral bioavailability of Oxycodone HCl Controlled-Release Tablets to immediate-release oral dosage forms is 100%.  Upon repeated dosing in normal volunteers in pharmacokinetic studies, steady-state levels were achieved within 24-36 hours.  Dose proportionality and/or bioavailability has been established for the 10 mg, 20 mg, 40 mg, 80 mg, and 160 mg tablet strengths for both peak plasma levels (C) and extent of absorption (AUC).  Oxycodone is extensively metabolized and eliminated primarily in the urine as both conjugated and unconjugated metabolites.  The apparent elimination half-life of oxycodone following the administration of Oxycodone HCl Controlled-Release Tablets was 4.5 hours compared to 3.2 hours for immediate-release oxycodone..

About 60% to 87% of an oral dose of oxycodone reaches the central compartment in comparison to a parenteral dose.  This high oral bioavailability is due to low pre-systemic and/or first-pass metabolism.  In normal volunteers, the t½ of absorption is 0.4 hours for immediate-release oral oxycodone.  In contrast, Oxycodone HCl Controlled-Release Tablets exhibit a biphasic absorption pattern with two apparent absorption half-lives of 0.6 and 6.9 hours, which describes the initial release of oxycodone from the tablet followed by a prolonged release.

Dose proportionality has been established for the 10 mg, 20 mg, 40 mg, and 80 mg tablet strengths for both peak plasma concentrations (C) and extent of absorption (AUC) (see Table 1 below). Another study established that the 160 mg tablet is bioequivalent to 2 x 80 mg tablets as well as to 4 x 40 mg for both peak plasma concentrations (C) and extent of absorption (AUC) (see Table 2 below). Given the short half-life of elimination of oxycodone from Oxycodone HCl Controlled-Release Tablets, steady-state plasma concentrations of oxycodone are achieved within 24-36 hours of initiation of dosing with Oxycodone HCl Controlled-Release Tablets.  In a study comparing 10 mg of Oxycodone HCl Controlled-Release Tablets every 12 hours to 5 mg of immediate-release oxycodone every 6 hours, the two treatments were found to be equivalent for AUC and C, and similar for C (trough) concentrations. 

Oxycodone HCl Controlled-Release Tablets are NOT INDICATED FOR RECTAL ADMINISTRATION.  Data from a study involving 21 normal volunteers show that Oxycodone HCl Controlled-Release Tablets administered per rectum resulted in an AUC 39% greater and a C9% higher than tablets administered by mouth.  Therefore, there is an increased risk of adverse events with rectal administration.

IMAGE oxycontin_fig.jpg
TABLE 1 Mean [% coefficient variation]
Regimen/ Dosage Form AUC
(ng•hr/mL)†
Cmax
(ng/mL)
Tmax
(hrs)
Trough Conc.
(ng/mL)
 
Single
Dose
10 mg Oxycodone HCl Controlled-Release Tablets 100.7 [26.6] 10.6 [20.1] 2.7 [44.1] n.a.
20 mg Oxycodone HCl Controlled-Release Tablets 207.5 [35.9] 21.4 [36.6] 3.2 [57.9] n.a.
40 mg Oxycodone HCl Controlled-Release Tablets 423.1 [33.3] 39.3 [34.0] 3.1 [77.4] n.a.
80 mg Oxycodone HCl Controlled-Release Tablets* 1085.5 [32.3] 98.5 [32.1] 2.1 [52.3] n.a.
 
Multiple
Dose
10 mg Oxycodone HCl Controlled-Release Tablets q12h 103.6 [38.6] 15.1 [31.0] 3.2 [69.5] 7.2 [48.1]
5 mg immediate-
   release q6h
99.0 [36.2] 15.5 [28.8] 1.6 [49.7] 7.4 [50.9]
TABLE 2 Mean [% coefficient variation]
Regimen/ Dosage Form AUC
(ng•hr/mL)†
Cmax
(ng/mL)
Tmax
(hrs)
Trough Conc.
(ng/mL)
† for single-dose AUC = AUC0-inf; for multiple-dose AUC = AUC0-T
* data obtained while volunteers received naltrexone which can enhance absorption
Single
Dose
4 x 40 mg
Oxycodone HCl Controlled-Release Tablets*
1935.3 [34.7] 152.0 [28.9] 2.56 [42.3] n.a.
2 x 80 mg
Oxycodone HCl Controlled-Release Tablets*
1859.3 [30.1] 153.4 [25.1] 2.78 [69.3] n.a.
1 x 160 mg
Oxycodone HCl Controlled-Release Tablets*
1856.4 [30.5] 156.4 [24.8] 2.54 [36.4] n.a.

Food has no significant effect on the extent of absorption of oxycodone from Oxycodone HCl Controlled-Release Tablets.  However, the peak plasma concentration of oxycodone increased by 25% when an Oxycodone HCl Controlled-Release Tablets 160 mg Tablet was administered with a high-fat meal.

Following intravenous administration, the volume of distribution (Vss) for oxycodone was 2.6 L/kg.  Oxycodone binding to plasma protein at 37°C and a pH of 7.4 was about 45%.  Once absorbed, oxycodone is distributed to skeletal muscle, liver, intestinal tract, lungs, spleen, and brain.  Oxycodone has been found in breast milk (see PRECAUTIONS ).

Oxycodone hydrochloride is extensively metabolized to noroxycodone, oxymorphone, noroxymorphone, and their glucuronides.  The major circulating metabolite is noroxycodone.  Noroxycodone is reported to be a considerably weaker analgesic than oxycodone.  Oxymorphone, although possessing analgesic activity, is present in the plasma only in low concentrations.  The correlation between oxymorphone concentrations and opioid effects was much less than that seen with oxycodone plasma concentrations.  The analgesic activity profile of other metabolites is not known.  

CYP3A mediated N-demethylation (to noroxycodone) is the primary metabolic pathway of oxycodone with a lower contribution from CYP2D6 mediated O-demethylation (to oxymorphone).  Therefore, the formation of these and related metabolites can, in theory, be affected by other drugs (see Drug-Drug Interactions) .

Oxycodone and its metabolites are excreted primarily via the kidney.  The amounts measured in the urine have been reported as follows: free oxycodone up to 19%; conjugated oxycodone up to 50%; free oxymorphone 0%; conjugated oxymorphone ≤ 14%; both free and conjugated noroxycodone have been found in the urine but not quantified.  The total plasma clearance was 0.8 L/min for adults.

The plasma concentrations of oxycodone are only nominally affected by age, being 15% greater in elderly as compared to young subjects.

Female subjects have, on average, plasma oxycodone concentrations up to 25% higher than males on a body weight adjusted basis. The reason for this difference is unknown.

Data from a pharmacokinetic study involving 13 patients with mild to severe renal dysfunction (creatinine clearance <60 mL/min) show peak plasma oxycodone and noroxycodone concentrations 50% and 20% higher, respectively, and AUC values for oxycodone, noroxycodone, and oxymorphone 60%, 50%, and 40% higher than normal subjects, respectively. This is accompanied by an increase in sedation but not by differences in respiratory rate, pupillary constriction, or several other measures of drug effect. There was an increase in t½ of elimination for oxycodone of only 1 hour (see PRECAUTIONS ).

Data from a study involving 24 patients with mild to moderate hepatic dysfunction show peak plasma oxycodone and noroxycodone concentrations 50% and 20% higher, respectively, than normal subjects. AUC values are 95% and 65% higher, respectively. Oxymorphone peak plasma concentrations and AUC values are lower by 30% and 40%. These differences are accompanied by increases in some, but not other, drug effects. The t½ elimination for oxycodone increased by 2.3 hours (see PRECAUTIONS ).

Drug-Drug Interactions (see PRECAUTIONS)

CYP3A mediated N-demethylation is the principal metabolic pathway of oxycodone with a lower contribution from CYP2D6 mediated O-demethylation and in theory can be affected by drugs affecting cytochrome P450 enzymes. 

Oxycodone is metabolized in part by cytochrome P450 2D6 to oxymorphone which represents less than 15% of the total administered dose.  This route of elimination may be blocked by a variety of drugs (e.g., certain cardiovascular drugs including amiodarone and quinidine as well as polycyclic anti-depressants).  However, in a study involving 10 subjects using quinidine, a known inhibitor of cytochrome P450 2D6, the pharmacodynamic effects of oxycodone were unchanged.

A single-dose, double-blind, placebo- and dose-controlled study was conducted using Oxycodone HCl Controlled-Release Tablets (10, 20, and 30 mg) in an analgesic pain model involving 182 patients with moderate to severe pain.  Twenty and 30 mg of Oxycodone HCl Controlled-Release Tablets were superior in reducing pain compared with placebo, and this difference was statistically significant.  The onset of analgesic action with Oxycodone HCl Controlled-Release Tablets occurred within 1 hour in most patients following oral administration.

A double-blind placebo-controlled, fixed-dose, parallel group, two-week study was conducted in 133 patients with chronic, moderate to severe pain, who were judged as having inadequate pain control with their current therapy.  In this study, 20 mg Oxycodone HCl Controlled-Release Tablets q12h but not 10 mg Oxycodone HCl Controlled-Release Tablets q12h decreased pain compared with placebo, and this difference was statistically significant.

Oxycodone HCl Controlled-Release Tablets are a controlled-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 HCl Controlled-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 Healthcare 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 HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative 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 HCl Controlled-Release Tablets are only indicated for postoperative 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.)

Oxycodone HCl Controlled-Release Tablets are contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated.  This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment), and patients with acute or severe bronchial asthma or hypercarbia.  Oxycodone HCl Controlled-Release Tablets are contraindicated in any patient who has or is suspected of having paralytic ileus.

OXYCODONE HCl CONTROLLED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED.  TAKING BROKEN, CHEWED, OR CRUSHED OXYCODONE HCl CONTROLLED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

Oxycodone HCl Controlled-Release 80 mg Tablets, or a single dose greater than 40 mg, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY.  A single dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids.

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.

Oxycodone is an opioid agonist of the morphine-type.  Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. 

Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit.  This should be considered when prescribing or dispensing Oxycodone HCl Controlled-Release Tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Oxycodone HCl Controlled-Release Tablets have been reported as being abused by crushing, chewing, snorting, or injecting the dissolved product.  These practices will result in the uncontrolled delivery of the opioid and pose a significant risk to the abuser that could result in overdose and death (see WARNINGS and DRUG ABUSE AND ADDICTION ).

Concerns about abuse, addiction, and diversion should not prevent the proper management of pain.   

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.

Oxycodone may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.

Oxycodone HCl Controlled-Release Tablets contain oxycodone which is a full mu-agonist opioid with an abuse liability similar to morphine and is a Schedule II controlled substance.  Oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion.

Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm.  There is a potential for drug addiction to develop following exposure to opioids, including oxycodone.  Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common. 

“Drug-seeking” behavior is very common in addicts and drug abusers.  Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s).  “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. 

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts.  In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Oxycodone HCl Controlled-Release Tablets, like other opioids, have been diverted for non-medical use.  Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised. 

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. 

Oxycodone HCl Controlled-Release Tablets consist of a dual-polymer matrix, intended for oral use only.  Abuse of the crushed tablet poses a hazard of overdose and death.  This risk is increased with concurrent abuse of alcohol and other substances.  With parenteral abuse, the tablet excipients, especially talc, can be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury.  Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

Respiratory depression is the chief hazard from oxycodone, the active ingredient in Oxycodone HCl Controlled-Release Tablets, as with all opioid agonists.  Respiratory depression is a particular problem in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration. 

Oxycodone should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression.  In such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea.  In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.

The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in the presence of head injury, intracranial lesions, or other sources of pre-existing increased intracranial pressure.  Oxycodone produces effects on pupillary response and consciousness which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries.

Oxycodone HCl Controlled-Release Tablets may cause severe hypotension.  There is an added risk to individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone.  Oxycodone may produce orthostatic hypotension in ambulatory patients. Oxycodone, like all opioid analgesics of the morphine-type, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Opioid analgesics have a narrow therapeutic index in certain patient populations, especially when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension. 

Use of Oxycodone HCl Controlled-Release Tablets is associated with increased potential risks and should be used only with caution in the following conditions: acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease); CNS depression or coma; delirium tremens; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary or renal function; and toxic psychosis. 

The administration of oxycodone may obscure the diagnosis or clinical course in patients with acute abdominal conditions.  Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

Oxycodone HCl Controlled-Release Tablets should be used with caution and started in a reduced dosage (1/3 to 1/2 of the usual dosage) in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, other tranquilizers, and alcohol.  Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with the usual doses of Oxycodone HCl Controlled-Release Tablets.

Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as oxycodone. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms in these patients.

Oxycodone HCl Controlled-Release Tablets are not indicated for pre-emptive analgesia (administration pre-operatively for the management of postoperative pain).

Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established.

Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the postoperative period if the pain is mild or not expected to persist for an extended period of time.  

Oxycodone HCl Controlled-Release Tablets are only indicated for postoperative 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).  

Patients who are already receiving Oxycodone HCl Controlled-Release Tablets as part of ongoing analgesic therapy may be safely continued on the drug if appropriate dosage adjustments are made considering the procedure, other drugs given, and the temporary changes in physiology caused by the surgical intervention (see DOSAGE AND ADMINISTRATION ). 

Oxycodone HCl Controlled-Release Tablets and other morphine-like opioids have been shown to decrease bowel motility.  Ileus is a common postoperative complication, especially after intra-abdominal surgery with opioid analgesia.  Caution should be taken to monitor for decreased bowel motility in postoperative patients receiving opioids.  Standard supportive therapy should be implemented.

Oxycodone may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like oxycodone may cause increases in the serum amylase level.

Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.

The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

In general, opioids should not be abruptly discontinued (see DOSAGE AND ADMINISTRATION: Cessation of Therapy ).

If clinically advisable, patients receiving Oxycodone HCl Controlled-Release Tablets or their caregivers should be given the following information by the physician, nurse, pharmacist, or caregiver:

Oxycodone HCl Controlled-Release Tablets are an opioid with no approved use in the management of addictive disorders.  Its proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the management of pain requiring opioid analgesia.

Opioid analgesics, including Oxycodone HCl Controlled-Release Tablets, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Inhibitors of CYP3A4:

Since the CYP3A4 isoenzyme plays a major role in the metabolism of oxycodone, co-administration of drugs that inhibit CYP3A4 activity, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations.  Although clinical studies have not been conducted, the expected clinical results would be increased or prolonged opioid effects.  If co-administration with Oxycodone HCl Controlled-Release Tablets is necessary, caution is advised when initiating therapy with, currently taking, or discontinuing CYP450 inhibitors.  These patients should be evaluated at frequent intervals and dose adjustments considered until stable drug effects are achieved.

Inducers of CYP3A4:

Although clinical studies have not been conducted, CYP450 inducers, such as rifampin, carbamazepine, and phenytoin, may induce the metabolism of oxycodone and, therefore, may cause increased clearance of the drug, which could lead to a decrease in oxycodone plasma concentrations, lack of efficacy, or, possibly, development of abstinence syndrome in a patient who had developed physical dependence to oxycodone.  If co-administration with Oxycodone HCl Controlled-Release Tablets is necessary, caution is advised when initiating therapy with, currently taking, or discontinuing CYP450 inducers.  These patients should be evaluated at frequent intervals and dose adjustments considered until stable drug effects are achieved.

Inhibitors of CYP2D6:

Oxycodone is metabolized in part to oxymorphone via cytochrome P450 2D6.  While this pathway may be blocked by a variety of drugs (e.g., certain cardiovascular drugs including amiodarone and quinidine as well as polycyclic antidepressants), such blockade has not yet been shown to be of clinical significance with this agent.  Clinicians should be aware of this possible interaction, however.

Oxycodone HCl Controlled-Release Tablets, like all opioid analgesics, should be started at 1/3 to 1/2 of the usual dosage in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, centrally acting anti-emetics, tranquilizers, and alcohol because respiratory depression, hypotension, and profound sedation or coma may result.  No specific interaction between oxycodone and monoamine oxidase inhibitors has been observed, but caution in the use of any opioid in patients taking this class of drugs is appropriate.

Studies of oxycodone to evaluate its carcinogenic potential have not been conducted.

Oxycodone was not mutagenic in the following assays: Ames Salmonella and E. coli test with and without metabolic activation at doses of up to 5000 µg, chromosomal aberration test in human lymphocytes in the absence of metabolic activation at doses of up to 1500 µg/mL and with activation 48 hours after exposure at doses of up to 5000 µg/mL, and in the in vivo bone marrow micronucleus test in mice (at plasma levels of up to 48 µg/mL).  Oxycodone was clastogenic in the human lymphocyte chromosomal assay in the presence of metabolic activation in the human chromosomal aberration test (at greater than or equal to 1250 µg/mL) at 24 but not 48 hours of exposure and in the mouse lymphoma assay at doses of 50 µg/mL or greater with metabolic activation and at 400 µg/mL or greater without metabolic activation.

Teratogenic Effects - Category B: Reproduction studies have been performed in rats and rabbits by oral administration at doses up to 8 mg/kg and 125 mg/kg, respectively.  These doses are 3 and 46 times a human dose of 160 mg/day, based on mg/kg basis.  The results did not reveal evidence of harm to the fetus due to oxycodone.  There are, however, no adequate and well-controlled studies in pregnant women.  Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Oxycodone HCl Controlled-Release Tablets are not recommended for use in women during and immediately prior to labor and delivery because oral opioids may cause respiratory depression in the newborn.  Neonates whose mothers have been taking oxycodone chronically may exhibit respiratory depression and/or withdrawal symptoms, either at birth and/or in the nursery.

Low concentrations of oxycodone have been detected in breast milk.  Withdrawal symptoms can occur in breast-feeding infants when maternal administration of an opioid analgesic is stopped.  Ordinarily, nursing should not be undertaken while a patient is receiving Oxycodone HCl Controlled-Release Tablets because of the possibility of sedation and/or respiratory depression in the infant.

Safety and effectiveness of Oxycodone HCl Controlled-Release Tablets have not been established in pediatric patients below the age of 18.  It must be remembered that Oxycodone HCl Controlled-Release Tablets cannot be crushed or divided for administration.

In controlled pharmacokinetic studies in elderly subjects (greater than 65 years) the clearance of oxycodone appeared to be slightly reduced.  Compared to young adults, the plasma concentrations of oxycodone were increased approximately 15% (see PHARMACOKINETICS AND METABOLISM ). Of the total number of subjects (445) in clinical studies of Oxycodone HCl Controlled-Release Tablets, 148 (33.3%) were age 65 and older (including those age 75 and older) while 40 (9.0%) were age 75 and older.  In clinical trials with appropriate initiation of therapy and dose titration, no untoward or unexpected side effects were seen in the elderly patients who received Oxycodone HCl Controlled-Release Tablets.  Thus, the usual doses and dosing intervals are appropriate for these patients.  As with all opioids, the starting dose should be reduced to 1/3 to 1/2 of the usual dosage in debilitated, non-tolerant patients.  Respiratory depression is the chief hazard in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration.

Due to the broad range of plasma concentrations seen in clinical populations, the varying degrees of pain, and the development of tolerance, plasma oxycodone measurements are usually not helpful in clinical management. Plasma concentrations of the active drug substance may be of value in selected, unusual or complex cases.

A study of Oxycodone HCl Controlled-Release Tablets in patients with hepatic impairment indicates greater plasma concentrations than those with normal function.  The initiation of therapy at 1/3 to 1/2 the usual doses and careful dose titration is warranted.

In patients with renal impairment, as evidenced by decreased creatinine clearance (<60 mL/min), the concentrations of oxycodone in the plasma are approximately 50% higher than in subjects with normal renal function. Dose initiation should follow a conservative approach. Dosages should be adjusted according to the clinical situation.

In pharmacokinetic studies, opioid-naive females demonstrate up to 25% higher average plasma concentrations and greater frequency of typical opioid adverse events than males, even after adjustment for body weight. The clinical relevance of a difference of this magnitude is low for a drug intended for chronic usage at individualized dosages, and there was no male/female difference detected for efficacy or adverse events in clinical trials.

The safety of Oxycodone HCl Controlled-Release Tablets was evaluated in double-blind clinical trials involving 713 patients with moderate to severe pain of various etiologies.  In open-label studies of cancer pain, 187 patients received Oxycodone HCl Controlled-Release Tablets in total daily doses ranging from 20 mg to 640 mg per day.  The average total daily dose was approximately 105 mg per day.

Serious adverse reactions which may be associated with Oxycodone HCl Controlled-Release Tablet therapy in clinical use are those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, and (to an even lesser degree) circulatory depression, hypotension, or shock (see OVERDOSAGE ).

The non-serious adverse events seen on initiation of therapy with Oxycodone HCl Controlled-Release Tablets are typical opioid side effects.  These events are dose-dependent, and their frequency depends upon the dose, the clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual.  They should be expected and managed as a part of opioid analgesia.  The most frequent (>5%) include: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, sweating, and asthenia.

In many cases the frequency of these events during initiation of therapy may be minimized by careful individualization of starting dosage, slow titration, and the avoidance of large swings in the plasma concentrations of the opioid.  Many of these adverse events will cease or decrease in intensity as Oxycodone HCl Controlled-Release Tablet therapy is continued and some degree of tolerance is developed.

Clinical trials comparing Oxycodone HCl Controlled-Release Tablets with immediate-release oxycodone and placebo revealed a similar adverse event profile between Oxycodone HCl Controlled-Release Tablets and immediate-release oxycodone.  The most common adverse events (>5%) reported by patients at least once during therapy were:

The following adverse experiences were reported in Oxycodone HCl Controlled-Release Tablets-treated patients with an incidence between 1% and 5%.  In descending order of frequency they were anorexia, nervousness, insomnia, fever, confusion, diarrhea, abdominal pain, dyspepsia, rash, anxiety, euphoria, dyspnea, postural hypotension, chills, twitching, gastritis, abnormal dreams, thought abnormalities, and hiccups.

The following adverse reactions occurred in less than 1% of patients involved in clinical trials or were reported in postmarketing experience.

Blood and lymphatic system disorders:  lymphadenopathy 

Cardiac disorders:  palpitations (in the context of withdrawal)   

Ear and labyrinth disorders:  tinnitus  

Endocrine disorders:  syndrome of inappropriate antidiuretic hormone secretion (SIADH) 

Eye disorders:   abnormal vision 

Gastrointestinal disorders:  dysphagia, eructation, flatulence, gastrointestinal disorder, ileus, increased appetite, stomatitis  

General disorders and administration site conditions:  chest pain, edema, facial edema, malaise, pain, peripheral edema, thirst, withdrawal syndrome (with and without seizures) 

Immune system disorders:  anaphylactic or anaphylactoid reaction (symptoms of)

Infections and infestations:  pharyngitis  

Injury, poisoning and procedural complications:  accidental injury 

Investigations:  hyponatremia, increased hepatic enzymes, ST depression  

Metabolism and nutrition disorders:  dehydration  

Musculoskeletal and connective tissue disorders:  neck pain 

Nervous system disorders: abnormal gait, amnesia, hyperkinesia, hypertonia (muscular), hypesthesia, hypotonia, migraine, paresthesia, seizures, speech disorder, stupor, syncope, taste perversion, tremor, vertigo 

Psychiatric disorders:  agitation, depersonalization, depression, emotional lability, hallucination 

Renal and urinary disorders:  dysuria, hematuria,  polyuria, urinary retention, urination impaired 

Reproductive system and breast disorders:  amenorrhea,decreased libido, impotence 

Respiratory, thoracic and mediastinal disorders:  cough increased, voice alteration 

Skin and subcutaneous tissue disorders:  dry skin, exfoliative dermatitis, urticaria 

Vascular disorders:  vasodilation 

TABLE 3
Oxycodone HCl Controlled-Release Tablets
(n=227)
Immediate-Release
(n=225)
Placebo
(n=45)
(%) (%) (%)
Constipation (23) (26) (7)
Nausea (23) (27) (11)
Somnolence (23) (24) (4)
Dizziness (13) (16) (9)
Pruritus (13) (12) (2)
Vomiting (12) (14) (7)
Headache (7) (8) (7)
Dry Mouth (6) (7) (2)
Asthenia (6) (7) -
Sweating (5) (6) (2)

Acute overdosage with oxycodone can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, bradycardia, hypotension, and death.

Deaths due to overdose have been reported with abuse and misuse of Oxycodone HCl Controlled-Release Tablets, by ingesting, inhaling, or injecting the crushed tablets.  Review of case reports has indicated that the risk of fatal overdose is further increased when Oxycodone HCl Controlled-Release Tablets are abused concurrently with alcohol or other CNS depressants, including other opioids.

In the treatment of oxycodone overdosage, primary attention should be given to the re-establishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated.  Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.

The pure opioid antagonists such as naloxone or nalmefene are specific antidotes against respiratory depression from opioid overdose.  Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose.  In patients who are physically dependent on any opioid agonist including Oxycodone HCl Controlled-Release Tablets, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome.  The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered.  Please see the prescribing information for the specific opioid antagonist for details of their proper use.

OXYCODONE HCl CONTROLLED-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 HCl CONTROLLED-RELEASETABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED.  TAKING BROKEN, CHEWED, OR CRUSHED OXYCODONE HCl CONTROLLED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

One Oxycodone HCl controlled-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).

Patients should be started on the lowest appropriate dose (see DOSAGE AND ADMINISTRATION: Initiation of Therapy ).

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 HCl Controlled-Release Tablets are a controlled-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.  The controlled-release nature of the formulation allows Oxycodone HCl Controlled-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. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING ).

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 HCl Controlled-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 HCl Controlled-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.

Experience indicates a reasonable starting dose of Oxycodone HCl Controlled-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 HCl Controlled-Release Tablets should be individually titrated to a dose that provides adequate analgesia and minimizes side effects.

In all cases, supplemental analgesia should be made available in the form of a suitable short-acting analgesic.

Oxycodone HCl Controlled-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 ).

TABLE 4. Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Daily Dose of Oral Oxycodone*
* 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.
(Mg/Day Prior Opioid x Factor = Mg/Day Oral
Oxycodone)
Oral Prior Opioid Parenteral Prior Opioid
Oxycodone 1 --
Codeine 0.15 --
Hydrocodone 0.9 --
Hydromorphone 4 20
Levorphanol 7.5 15
Meperidine 0.1 0.4
Methadone 1.5 3
Morphine 0.5 3

Eighteen hours following the removal of the transdermal fentanyl patch, Oxycodone HCl Controlled-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 HCl Controlled-Release T

Manufacturer

Apotex Corp.

Active Ingredients

Source

Drugs and Medications [730 Associated Drugs and Medications listed on BioPortfolio]

Oxycodone hydrochloride [Mallinckrodt Inc.]

OXYCODONE HYDROCHLORIDE ORAL SOLUTION USP, 5 mg per 5 mL OXYCODONE HYDROCHLORIDE ORAL CONCENTRATE SOLUTION, 20 mg per mL OXYCODONE HYDROCHLORIDE ORAL CONCENTRATE SOLUTION (Raspberry Flavored), 20 mg p...

Oxycodone and acetaminophen [Physicians Total Care, Inc.]

Oxycodone hcl controlled-release [Ranbaxy Pharmaceuticals Inc]

OXYCODONE HCl CONTROLLED-RELEASE TABLETS10 mg and 20 mg CII302389-0A

Oxycodone and acetaminophen tablets, usp cii [MIKART, INC.]

OXYCODONE AND ACETAMINOPHEN TABLETS, USP CII

Oxycodone hydrochloride [Actavis Totowa LLC]

OXYCODONE HCl                                        CII CONTROLLED-RELEASE TABLETS 10 mg, 20 mg, 40 mg, 80 mg* *80 mg and 160 mg is for use in opioid-tolerant p...

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Fed Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets

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A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion

Assessing the safety and tolerability of Oxycodone Hydrochloride 50mg/mL in subjects with severe cancer pain.

Fasting Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets

The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an equivale...

Fasting Study of Oxycodone Hydrochloride 15 mg Tablets and Roxicodone™ 15 mg Tablets

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Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer

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Pharmacokinetics of oxycodone hydrochloride and three of its metabolites after intravenous administration in Chinese patients with pain.

The aim of this study is to evaluate the pharmacokinetic profile of oxycodone and three of its metabolites, noroxycodone, oxymorphone and noroxymorphone after intravenous administration in Chinese pat...

A randomized trial to compare pain control using oral analgesia with epidural analgesia after cesarean section following combined spinal-epidural anesthesia.

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Oxycodone vs. Fentanyl Patient-Controlled Analgesia after Laparoscopic Cholecystectomy.

Objectives Oxycodone is semi-synthetic opioid, oral and parenteral preparations have been widely used for acute and chronic pain. The aim of this study was to assess the efficacy and side effects of o...

Observations of Urinary Oxycodone and Metabolite Distributions in Pain Patients.

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Effects of an Oxycodone Conjugate Vaccine on Oxycodone Self-Administration and Oxycodone-Induced Brain Gene Expression in Rats.

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