Adult Dosing
Moderate-severe pain
Immediate release
Notes:- Individualize dose based upon the individual patients response to their initial dose
- Adjust the dose to an acceptable degree of analgesia taking into account the improvement in pain intensity and the tolerability of the oxycodone by the patient
- Gradually taper dose to discontinue
Conversion from other non-oxycodone opioids to oral oxycodone hydrochloride
- Closely monitor and adjust dosage based upon the patients response to oxycodone hydrochloride
- Refer published relative potency information, keeping in mind that conversion ratios are only approximate
Conversion from controlled-release oral oxycodone to oral oxycodone hydrochloride
- Excessive sedation may occur at peak serum levels during conversion from controlled-release tablets; adjust doses with close observation
Patients currently on opioid therapy
- Consider the potency of the prior opioid relative to oxycodone into the selection of the total daily dose of oxycodone
- Closely observe and adjust dosage based upon the patient's response
Conversion from fixed-ratio opioid/acetaminophen, opioid/aspirin, or opioid/nonsteroidal combination drugs
- Make a decision whether or not to continue the non-opioid analgesic
- Titrate the dose in response to the level of analgesia if a decision is made to discontinue the use of non-opioid analgesic
- On continuation of non-opioid regimen as a separate single entity agent, the initial dose should be based upon the most recent dose of opioid as a baseline for further titration of oxycodone
Extended release
Notes:- Use doses of 60 mg and 80 mg only in opioid-tolerant patients
- Avoid cutting/crushing/chewing/dissolving extended release dosage form
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- <60 mL/min: Decrease dose; dose adjustments not defined
- Hemodialysis: No supplement
Hepatic Dose Adjustment
- Hepatic impairment: Decrease start dose; dose adjustments not defined
See Supplemental Patient Information
- ETABS must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved as this may lead to rapid release and absorption of a potentially fatal dose [US Black Box Warning]
- ETABS 60, 80 mg, a single dose >40 mg, or a total daily dose >80 mg are only for use in opioid-tolerant patients as usage of these doses in patients who are not opioid tolerant may lead to fatal respiratory depression [US Black Box Warning]
- Severe medical consequences, including death, may occur on inappropriate use of this drug; instruct patients against usage by individuals other than the patient for whom this drug is prescribed
- Reserve this drug in cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension, as opioid analgesics exhibit a narrow therapeutic index in certain patient populations especially when combined with CNS depressant drugs
- This drug may induce somnolence, dizziness, alterations in judgment and alterations in levels of consciousness, including coma
- Hypotension, profound sedation, coma or respiratory depression may occur on adding this drug to a regimen that includes other CNS depressants; exercise caution when deciding to initiate therapy in patients who are taking other CNS depressants. Consider types of other medications being taken, the duration of therapy with them, and the patients response to those medicines, including the degree of tolerance that has developed to CNS depression while deciding initiation of therapy. Also consider the patients use, if any, of alcohol and/or illicit drugs that cause CNS depression. Start therapy with a lower dose than usual on considering initiation of therapy
- Risk of decreased respiratory drive resulting in respiratory depression exists; geriatrics or debilitated patients are more susceptible. Profound sedation, unresponsiveness, infrequent deep (sighing) breaths or atypical snoring frequently accompany opioid-induced respiratory depression. Eventually it may lead to hypoxia. In addition to further decrease of consciousness, hypoxia, along with hypercapnia may predispose to life-threatening cardiac arrhythmias
- Aggravation of convulsions may occur in patients with convulsive disorders
- Elevation of cerebrospinal fluid pressure may occur. Presence of head injury, intracranial lesions, or other sources of pre-existing increased intracranial pressure may aggravate this condition. Miosis independent of ambient light and altered consciousness may occur. It may obscure neurologic signs associated with increased intracranial pressure in persons with head injuries
- Severe hypotension may occur, especially in blood volume depleted patients or after concomitant administration with drugs which compromise vasomotor tone. Orthostatic hypotension may occur in ambulatory patients. Administration of this drug in patients with circulatory shock may further reduce cardiac output and blood pressure
- Increase in oxycodone plasma concentrations and potentially fatal respiratory depression may occur on concurrent use of this drug with CYPP450 3A4 inhibitors such as macrolide antibiotics and protease inhibitors. Patients receiving this drug and a CYP3A4 inhibitor should be monitored for an extended period and if necessary dosage adjustments should be made [US Black Box Warning]
- Avoid administration of mixed agonist/antagonist analgesics to a patient receiving this drug as this may reduce the analgesic effect and may precipitate withdrawal symptoms in these patients
- Therapy is associated with obscuring the diagnosis or clinical course in patients with acute abdominal conditions
- Possibility of developing tolerance to this drug exists. A gradual increase in dose may be essential on developing tolerance or increase in severity of pain. Tolerance may develop to varying degrees and at varying rates in a given individual
- This drug has no approved use in the treatment of addiction
- Sensitivity and specificity of the assay for determining urinary concentration of the drugs must be appropriate. Exercise caution in interpreting results
Cautions: Use cautiously in
- Severe renal impairment
- Severe hepatic impairment
- Severe pulmonary dysfunction
- Significant COPD or cor pulmonale
- Risk of substantially decreased respiratory reserve
- Hypoxia
- Hypercapnia
- Pre-existing respiratory depression
- CNS depression
- Use of CNS depressant
- Volume depletion
- Toxic psychosis
- History of seizure disorders
- Circulatory shock
- Increased intracranial pressure
- Biliary tract disease including acute pancreatitis
- Prostatic hypertrophy
- Urethral stricture
- Patients having risk of developing ileus
- GI motility disorder
- Acute abdomen
- Alcoholism
- Delirium tremens
- Adrenocortical insufficiency
- Debilitation
- Kyphoscoliosis associated with respiratory compromise
- Myxedema
- Hypothyroidism
- History of abuse
- Geriatrics
Supplemental Patient Information
- Caution patients against driving a car or operating machinery as impairment of mental and physical abilities may occur
Pregnancy Category:B
Breastfeeding: Probably safe; Drowsiness can occur in infants due to maternal doses of oxycodone. Newborn infants are sensitive to the effects of even small dosages of narcotic analgesics particularly in the first week of life. It is best to limit maternal intake of oral oxycodone (and combinations) and to supplement analgesia with a nonnarcotic analgesic if necessary. Oxycodone elimination decreases in young infants and inter-individual variability exists. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants. Immediately contact a physician if the baby shows signs of increased sleepiness, difficulty breastfeeding, breathing difficulties, or limpness. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 9 June 2011). According to manufacturer's data, a decision should be made to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- OxyCONTIN 20 MG TB12 [Bottle] (PURDUE PHARMA L.P.)
20 mg = $86.99
30 mg = $129.96 - OxyCONTIN 60 MG TB12 [Bottle] (PURDUE PHARMA L.P.)
20 mg = $215
30 mg = $320.96 - OxyCONTIN 30 MG TB12 [Bottle] (PURDUE PHARMA L.P.)
20 mg = $125.99
30 mg = $188.96 - Roxicodone 15 MG TABS [Bottle] (XANODYNE PHARMACEUTICALS)
INC mg = $20
mg = $30 - OxyCONTIN 15 MG TB12 [Bottle] (PURDUE PHARMA L.P.)
20 mg = $72.99
30 mg = $109.49 - OxyCONTIN 10 MG TB12 [Bottle] (PURDUE PHARMA L.P.)
20 mg = $49.99
30 mg = $74.99 - OxyCODONE HCl 10 MG TABS [Bottle] (KVK TECH)
10 mg = $12.99
20 mg = $15.99 - OxyCODONE HCl 15 MG TABS [Bottle] (ACTAVIS ELIZABETH)
20 mg = $20.78
30 mg = $31.16 - OxyCONTIN 80 MG TB12 [Bottle] (PURDUE PHARMA L.P.)
20 mg = $290.99
30 mg = $436.49 - OxyCONTIN 40 MG TB12 [Bottle] (PURDUE PHARMA L.P.)
20 mg = $154.99
30 mg = $231.97 - Roxicodone 30 MG TABS [Bottle] (XANODYNE PHARMACEUTICALS)
INC mg = $20
mg = $30
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.