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PubMed1991

The pharmacokinetics of oxycodone after intravenous injection in adults.

Oxycodone chloride (0.07 mg kg-1) was given by intravenous bolus to nine young adult surgical patients on the first postoperative day. Plasma was sampled for up to 12 h. Mean values of t1/2z, CL and Vss were 222 min, 0.78 l min-1 and 2.60 l kg-1, respectively. The concentrations of the metabolite noroxycodone was also measured. The mean AUC(0,12) ratio of noroxycodone to oxycodone was 0.33. Oxymorphone was not detected.

Adult↗

PubMed1981

The effect of buprenorphine and oxycodone on the intracholedochal passage pressure.

The effect of i.v. buprenorphine (0.3 mg) and oxycodone (10mg) on intracholedochal passage pressure were studied in 20 patients who had undergone surgery of the common biliary tract, prior to the extraction of an indwelling T tube. Informed consent was obtained from all patients, each of who was given buprenorphine or oxycodone in random order. The intracholedochal passage pressure was measured from the T tube perfused with continuous saline infusion (55 ml/h). Both analgesics significantly (P less than 0.01) increased the intracholedochal passage pressure after 5 min, with an equal peak increase of about 1.5 kPa at about 7 min. The pressure decline was rapid and similar in both groups: 20 min after administration of the test drug only about 40% of the maximum elevation caused by either drug remained. Thereafter, a slower fall towards the baseline was recorded after both drugs during the remaining 45 min of the study period. The results indicate that buprenorphine can be used with the same indications and precautions as other narcotics for postoperative pain relief in patients who have undergone surgery of the biliary tract.

Adult↗

PubMed1980

Self-association of analgesics in aqueous solution: association models for codeine, oxycodone, ethylmorphine and pethidine.

Light scattering, vapour pressure osmometry, conductivity and surface tension techniques have been used to examine aqueous solutions of several narcotic analgesics for evidence of association. Contrary to a previous report, no significant association could be detected in solutions of morphine sulphate and codeine phosphate. Other drugs which showed no evidence of aggregation in water included morphine hydrochloride, ethylmorphine hydrochloride, oxycodone hydrochloride and dihydrocodeine tartrate. Self-association of ethylmorphine hydrochloride, oxycodone hydrochloride and codeine phosphate was observed in the presence of 0.5 mol dm-3 electrolyte, the pattern of association conforming to that of a stepwise association process with all association constants of equal value. The association of pethidine hydrochloride in 0.5 mol dm-3 sodium chloride could be represented by an association scheme in which association constant KN increased sequentially with aggregation number N according to the relation KN = K(N - 1)/N.

Codeine↗

PubMed2004

Clinical efficacy of controlled-release oxycodone 20 mg administered on a 12-h dosing schedule on the management of postoperative pain after breast surgery for cancer.

OBJECTIVE: To assess clinical efficacy of controlled-release oxycodone (CRO) 20 mg on a 12-h dosing schedule in this prospective, randomised, placebo-controlled, double-blinded study of 40 ASA physical status I-III women undergoing breast surgery for cancer. RESEARCH DESIGN AND METHODS: General anaesthesia using remifentanil and propofol was performed for surgery. Both groups received premedication with oral midazolam 7.5 mg 1 h before surgery. In the controlled-release oxycodone group, one tablet of 20 mg CRO was administered with the premedication, and 12 h after the premedication another 20 mg CRO. In the placebo (PL) group, a placebo tablet was administered with the premedication, and 12 h later another placebo tablet. All patients had access to opioid rescue medication via an IV patient-controlled analgesia (PCA) device. MAIN OUTCOME MEASURES: Area under the curve (AUC), based on IV opioid rescue consumption over 24 h postoperatively. RESULTS: The AUC for IV PCA opioid consumption was significantly lower in the CRO group than in the PL group (p = 0.01). The CRO group required less IV opioid loading dose (p < 0.001), and consumed less opioid rescue medication 4 h (p = 0.036), 16 h (p = 0.01), and 24 h (p = 0.005) postoperatively. AUC for VAS scores at rest was significantly lower in the CRO group than in the PL group (p = 0.05). VAS scores at rest were lower in the CRO group 16 h (p = 0.04) and 24 h (p = 0.03) postoperatively. There was no difference in AUC for pain scores on movement (p = 0.103) and for quality of analgesia (p = 0.139). There was no difference in nausea between groups (p = 0.34). Pruritus, arterial hypotension or hypertension, bradycardia, and tachycardia were not observed in either treatment group. None of the patients showed signs of confusion, agitation, or respiratory depression. CONCLUSIONS: The administration of CRO 20 mg on a 12-h dosing schedule halves postoperative IV PCA opioid consumption. CRO 20mg is effective in preventing pain after breast surgery for cancer with only mild side-effects.

Adolescent↗

PubMed2005

Measurements of plasma oxycodone, noroxycodone and oxymorphone levels in a patient with bilateral nephrectomy who is undergoing haemodialysis.

The use of opioid analgesics in renal dysfunction is potentially problematic and many patients with end stage renal disease are unable to tolerate these medications. A greater understanding of the pharmacokinetics of opioid analgesics is vital in informing safe and effective practice. Using pharmacokinetic analysis, this case study demonstrates for the first time that oxycodone and its metabolites are removed by haemodialysis. As such, care should be taken when using oxycodone in patients undergoing haemodialysis.

Analgesics, Opioid↗

PubMed1963

The addiction potential of oxycodone (Percodan).

Dihydrohydroxycodeinone (oxycodone, Percodan(R)) is a useful analgesic. Its addiction potential, however, is comparable to that of morphine. This fact should be considered when it is prescribed. Because of increasing numbers of addicts to this drug in the State of California, the California Medical Association Committee on Dangerous Drugs and the House of Delegates has recommended that oxycodone-containing drugs be returned to the triplicate prescription list as they were originally in 1949. This recommendation was incorporated in Senate Bill 385, which failed to pass the legislature.

Analgesics↗

PubMed2003

[Controlled-release oxycodone--a therapeutic option for severe neuropathic pain. Two multicenter observational studies].

Two postmarketing studies (PMS) involving 603 patients with neuropathic pain treated with controlled-release oxycodone were performed. Pain intensity and impairment of performance were evaluated using a numeric rating scale (NRS) ranging from 0 to 10 (0 = no pain/impairment, 10 = most severe pain/impairment) measured at the start of the study, and at one week and some three weeks into the study. Mean pain intensity decreased from more than 6 at the start of the PMS to about 4 after one week, and under 3 after three weeks, of treatment. The mean dose of oxycodone after three weeks was slightly more than 40 mg per day. Impairment, quality of life and performance (daily activities, mood, sleep quality and joie de vivre) improved substantially.

Adult↗

PubMed1992

[Oxycodone versus paracetamol in oral premedication in cholecystectomy].

This double-blind study was carried out at random on 2 groups of 10 women, comparable by age and weight, all having to undergo a cholecystectomy as a result of gall-bladder stones. Group A received 10 mg os of oxycodone, while group B received 1000 mg os of paracetamol. The level of sedation before the operation, post-operative pain, canalization and the side effect were recorded. The results showed that the group treated with oxycodone presented a greater degree of pre-operative sedation. As far as the post-operative pain is concerned, no significant differences were seen between the two groups based on both what was expressed by the patients and what was reported by a visual analog. Furthermore, no significant differences were noted as far as the side effects and canalization are concerned.

Acetaminophen↗

PubMed2006

[Efficacy of controlled-release oxycodone for dyspnea in cancer patients--three case series].

Dyspnea is a common symptom in patients with advanced cancer. Systemic morphine administration has been reported as an effective pharmacological treatment to control dyspnea. However, there have been few reports on similar effects of alternative opioids except for morphine. To evaluate the effect of controlled-release oxycodone on the relief of dyspnea, we investigated three cases with opioid substitution from subcutaneous morphine to oral oxycodone. In all cases, both opioids provided equivalent effects for the palliation of cancer dyspnea with no significant adverse effects. Future studies in the appropriate clinical designs will be needed to confirm our findings.

Administration, Oral↗

PubMedDate not supplied

GC-MS quantitation of codeine, morphine, 6-acetylmorphine, hydrocodone, hydromorphone, oxycodone, and oxymorphone in blood.

A method is described for the simultaneous analysis of seven opiates, codeine, morphine, 6-acetylmorphine, hydrocodone, hydromorphone, oxycodone, and oxymorphone, in blood samples by gas chromatography-mass spectrometry (GC-MS). One milliliter of blood is combined with an internal standard mixture containing 200 ng of each of the seven deuterated opiates. Two milliliters of acetonitrile is added to precipitate the proteins and cellular material. After centrifugation, the clear supernatant is removed, and the acetonitrile is evaporated. The remaining aqueous portion is adjusted to pH 9 with sodium bicarbonate buffer, and the drugs are extracted into chloroform/ trifluoroethanol (10:1). The organic extractant is transferred and dried under nitrogen. The residue is reconstituted in dilute hydrochloric acid and washed consecutively with hexane and chloroform. The purified aqueous portion is adjusted to pH 9 with bicarbonate buffer, and the drugs are again extracted into chloroform/trifluoroethanol (10:1). The organic portion is removed from the aqueous fraction and dried under nitrogen. The residue is consecutively derivatized with methoxyamine and propionic anhydride using pyridine as a catalyst. The ketone groups on hydrocodone, hydromorphone, oxycodone, and oxymorphone are converted to methoximes. Hydroxyl groups present at the O(3) and O(6) positions of codeine, morphine, 6-acetylmorphine, hydromorphone, and oxymorphone are converted to their respective propionyl esters. After a post-derivatization purification step, the extracts are analyzed by full scan GC-MS using electron impact ionization. The method is linear to at least 2000 ng/mL. Day-to-day precision (N = 15) at 500 ng/mL and 75 ng/mL were less than 10% for all seven targeted opiates. Extraction efficiencies at these two concentrations ranged from 50% to 68%. For each opiate, the limit of quantitation was 10 ng/mL, and the limit of detection was 2 ng/mL.

Analgesics, Opioid↗

PubMed1986

Tourette syndrome: successful treatment with clonidine and oxycodone.

A 15-year-old boy with Tourette's syndrome exhibited severe involuntary self-mutilatory behavior. While clonidine effectively controlled the motor and phonic tics, it failed to ameliorate the self-mutilatory behavior. Administration of oxycodone (50 mg/day) combined with clonidine produced a dramatic reduction in the frequency and severity of the self-mutilatory acts within 12 h. This report indicates that disturbances in the functional interplay between the noradrenergic and opiatergic systems may be important in the pathophysiology of Tourette's syndrome.

Adolescent↗

PubMed1994

The antinociceptive potencies of oxycodone, noroxycodone and morphine after intracerebroventricular administration to rats.

The antinociceptive activity of noroxycodone (NOR) was determined and its potency compared with that of oxycodone (OXY) and morphine (MOR) after intracerebroventricular (icv) administration to Sprague-Dawley rats. The antinociceptive potencies of OXY and NOR relative to MOR were 0.44 and 0.17, respectively. Administration of naloxone (55 nmol icv) abolished the antinociceptive response produced by the subsequent administration of OXY (227 nmol icv), indicating that the antinociceptive effects of OXY are mediated by opioid receptors. In addition, the same dose of naloxone (55 nmol icv) markedly reduced the antinociceptive effects of NOR (332 nmol icv) and MOR (93 nmol icv) indicating the involvement of opioid receptors in the antinociceptive activities of NOR and MOR. NOR, administered by the icv route, also produced excitatory effects throughout the antinociceptive dose range, the severity of which was reduced but not abolished by prior administration of naloxone (55 nmol icv). As excitatory effects have not been observed in patients receiving OXY, it is unlikely that NOR contributes to the analgesic activity of OXY administered systemically to humans.

Animals↗

PubMed1998

Granulomatous glomerulonephritis in intravenous drug users: a report of three cases in oxycodone addicts.

Various well-documented renal lesions are associated with intravenous drug use; however, intraglomerular mesangial granulomas have not been previously described. We report three patients who developed an unusual granulomatous glomerulonephritis and interstitial nephritis after intravenous injection of oxycodone, derived from suppositories. Granulomas were seen in an intraglomerular mesangial and also interstitial location. In both sites, the granulomas were associated with filamentous material, presumably derived from a component of the suppositories. This material was periodic acid-Schiff-positive, but negative with Congo red and silver stains. Ultrastructurally, the filamentous material was seen within the mesangial granulomas and also in a subendothelial location, suggesting derivation from the circulation with subsequent transport across the basement membrane and accumulation in the mesangium, where a granulomatous reaction was elicited. All patients developed a degree of renal failure; two of the patients require hemodialysis 20 and 30 months after presentation.

Adult↗

PubMed2002

Combination hydrocodone and ibuprofen versus combination oxycodone and acetaminophen in the treatment of moderate or severe acute low back pain.

BACKGROUND: Introduced in 1997, the combination of hydrocodone and ibuprofen is the only fixed-dose combination analgesic containing an opioid and ibuprofen that has been approved by the US Food and Drug Administration. OBJECTIVE: This study compared the efficacy and tolerability of combination hydrocodone 7.5 mg and ibuprofen 200 mg (HC/IB) with those of combination oxycodone 5 mg and acetaminophen 325 mg (OX/AC) in the treatment of moderate or severe acute low back pain. METHODS: This was a multicenter, randomized, double-blind, parallel-group, repeat-dose study lasting up to 8 days. The recommended dosing of the study medications was 1 tablet every 4 to 6 hours, not to exceed 5 tablets per day. If adequate pain relief was not obtained, patients were permitted to take up to 4 doses per day of supplemental analgesic medication-the nonopioid component of the assigned study medication (ibuprofen 200 mg or acetaminophen 325 mg). Measures of efficacy included mean daily pain relief scores (0 = no relief, 1 = slight relief, 2 = moderate relief, 3 = good relief, and 4 = complete relief), mean daily number of tablets and doses of study medication, mean daily number of tablets and doses of supplemental analgesic medication, global evaluation (poor, fair, good, very good, or excellent), and results on the modified 36-item Short-Form Health Survey (SF-36). All efficacy measures were analyzed on an intent-to-treat basis. Tolerability was evaluated based on adverse events reported spontaneously or elicited by the in vestigators using nonsuggestive questioning, as well as on the number of patients discontinuing treatment because of adverse events. RESULTS: The study enrolled 147 patients (75 HC/IB, 72 OX/AC). The most common cause of low back pain was muscular/ligamentous injury (97/147; 66.0%), followed by degenerative disk disease (27/147; 18.4%). At baseline, 80 patients (54.4%) reported experiencing moderate pain, and 67 patients (45.6%) reported experiencing severe pain. There were no significant differences between HC/IB and OX/AC with regard to mean ( +/- SD) daily pain relief scores (2.40 +/- 1.06 vs 2.50 +/- 1.01, respectively), mean daily number of tablets of study medication (1.80 +/- 1.70 vs 2.20 +/- 1.60), mean daily number of doses of study medication (1.80 +/- 1.65 vs 2.10 +/- 1.58), mean daily number of tablets of supplemental analgesic medication (0.60 +/- 1.13 vs 0.50 +/- 0.99), mean daily number of doses of supplemental analgesic medication (0.60 +/- 1.07 vs 0.50 +/- 0.90), global evaluations, or mean scores on the modified SF-36. In addition, there were no significant differences in the proportion of patients experiencing adverse events with HC/IB (47; 62.7%) and OX/AC (45; 62.5%). Adverse events were consistent with those generally associated with the component analgesics and predominantly involved the central nervous system and gastrointestinal system. CONCLUSIONS: The results of this study suggest that HC/IB and OX/AC are similarly effective and tolerable in relieving moderate or severe acute low back pain. Additional controlled longitudinal trials are necessary to evaluate the clinical utility of HC/IB in treating acute low back pain.

Acetaminophen↗

PubMed2002

Capillary electrophoresis and capillary electrophoresis-ion trap multiple-stage mass spectrometry for the differentiation and identification of oxycodone and its major metabolites in human urine.

Oxycodone (OCOD) and its metabolites, including oxymorphone (OMOR), noroxycodone (NOCOD) and noroxymorphone (NOMOR), are opioids that carry an OH group at position 14. Using capillary electrophoresis (CE) with a binary phosphate buffer containing 60% ethylene glycol (pH 7.9), the migration order of OCOD and OMOR with respect to their N-demethylated analogs was found to be reversed compared to that observed for codeine, dihydrocodeine, morphine and dihydromorphine, compounds that do not have an OH group at position 14. OCOD and structurally related compounds can also be distinguished from these opioids by their absorbance spectra at low wavelengths and via a characteristic neutral H2O loss at the MS2 level. Using the binary phosphate buffer, CE with UV detection is shown to be capable of monitoring OCOD, NOCOD, OMOR (after hydrolysis only) and NOMOR (after hydrolysis and in patient urine only) in alkaline liquid-liquid extracts of urines that were collected after ingestion of 10 mg OCOD hydrochloride and in a patient urine collected at steady state (80 mg OCOD hydrochloride daily). Using an aqueous pH 9 ammonium acetate buffer, these results were confirmed by CE-MS3. Based on CE-MS, MS2 and MS3 data, the absorbance spectra measured across the CE peaks and the relative position within the electropherogram, two peaks monitored in the UV absorbance electropherograms could be assigned to the two keto-reduced metabolites 6oxycodol (60COL) and nor6oxycodol, for which no standards were available. Comparison of data obtained with urines pretreated with two different enzyme products (beta-glucuronidase and beta-glucuronidase/arylsulfatase) suggest that OCOD, NOCOD and 6OCOL are mainly glucuronidated, whereas OMOR mainly forms other conjugates. Furthermore, in a first attempt to directly measure conjugates of the compounds of interest, solid-phase extracts were analyzed by CE-MS4, which revealed the presence of the acyl glucuronides of 6OCOL and OMOR and an unidentified OMOR conjugate. The quantitation of free OCOD and NOCOD by CE-MS using deuterated internal standards is also discussed briefly.

Analgesics, Opioid↗

PubMed2001

Advancement of opioid analgesia with controlled-release oxycodone.

Optimal pharmacologic management of pain requires selection of the appropriate analgesic drug, prescription of the appropriate dose, administration of the analgesic by the appropriate route, scheduling of the appropriate dosing interval, prevention of persistent pain and relief of breakthrough pain, aggressive titration of the dose of the analgesic, prevention, anticipation, and management of analgesic side-effects, use of appropriate co-analgesic drugs, and consideration of sequential trials of opioid analgesics. Controlled-release oxycodone (CRO) has the characteristics of an 'ideal' opioid analgesic drug: short half-life, long duration of action, predictable pharmacokinetics, absence of clinically active metabolites, rapid onset of action, easy titration, no ceiling dose, minimal adverse effects, and minimal associated stigma. CRO has been shown to be effective in the control of pain caused by cancer, osteoarthritis, post-herpetic neuralgia, major surgery, and degenerative spine disease.

Analgesics, Opioid↗

PubMed2002

The simultaneous determination of codeine, morphine, hydrocodone, hydromorphone, 6-acetylmorphine, and oxycodone in hair and oral fluid.

Recently, the abuse of prescription opiates as alternatives to heroin has become a national concern. The determination of a six-drug opiate panel, codeine, morphine, 6-acetylmorphine, hydrocodone, hydromorphone, and oxycodone, in hair and oral fluid using solid-phase extraction and capillary gas chromatography-mass spectrometry (GC-MS) is described. Oral fluid was obtained from the donor by insertion of absorptive collectors into the mouth. Hair was collected from the patient and powdered using stainless steel ball bearings in a mini bead-beater apparatus. Opiates present in the samples were extracted from a buffered, aqueous matrix using a solid-phase cartridge. The extracts were concentrated and the methoxime/BSTFA derivatives prepared in order to eliminate interference from the keto-opiates. The extracts were separated by GC-MS in electron impact mode. By utilizing methoxyamine, we were able to produce the methoxime derivatives required for single derivative production and chromatographically separate all six opiates. The routine analysis of these opiates in hair and oral fluid using GC-MS is described for the first time.

Codeine↗

PubMed2006

Assessing cognition and psychomotor function under long-term treatment with controlled release oxycodone in non-cancer pain patients.

BACKGROUND: The therapeutic use of opioids can be associated with altered cognition and impaired psychomotor function. Several studies have demonstrated the impact of opioid therapy on psychomotor performance and cognition, but no data exist about the effect of long-term treatment with controlled release oxycodone (CRO) on driving ability. METHODS: Thirty patients suffering from chronic non-cancer pain who had been treated with stable doses of CRO where included in a prospective trial and compared with 90 healthy volunteers (matched pairs). A computerized test battery that was developed to assess the driving ability of traffic delinquents in Germany was employed. Attention reaction, visual orientation, motor coordination and vigilance were evaluated. The data from a total of 11 parameters were assessed and for each test a relevant score was defined. As the primary endpoint the sum score of the three relevant scores was determined. A weaker statistical means to assess the patients' performance is to compare the test results with an age-independent control group. Individuals performing worse than the 16th percentile of this control group are considered to be unable to drive according to German legislation. RESULTS: Significant non-inferiority could not be demonstrated for the primary endpoint. However, driving ability as defined as a result above the 16th percentile did not differ significantly between the patients receiving CRO and the age-independent control group. CONCLUSION: The use of CRO does not prohibit driving, but individual assessment is necessary.

Adult↗