oxycodone (Rx)

Brand and Other Names:OxyContin, Xtampza ER, more...Roxicodone, Oxaydo, RoxyBond
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule, immediate-release: Schedule II

  • 5mg

tablet, immediate-release: Schedule II

  • 5mg
  • 10mg
  • 15mg
  • 20mg
  • 30mg

abuse deterrent tablet, immediate-release (Oxaydo): Schedule II

  • 5mg
  • 7.5mg
  • Discourages intranasal abuse

abuse deterrent tablet, immediate-release (RoxyBond): Schedule II

  • 5mg
  • 7.5mg
  • Creates viscous material if mixed with liquid that does not pass through a needle

abuse deterrent tablet, controlled-release (OxyContin): Schedule II

  • 10mg
  • 15mg
  • 20mg
  • 30mg
  • 40mg
  • 60mg
  • 80mg

abuse deterrent capsule, controlled-release (Xtampza ER): Schedule II

  • 9mg (equivalent to 10 mg oxycodone HCl)
  • 13.5mg (equivalent to 15 mg oxycodone HCl)
  • 18mg (equivalent to 20 mg oxycodone HCl)
  • 27mg (equivalent to 30 mg oxycodone HCl)
  • 36mg (equivalent to 40 mg oxycodone HCl)
  • Abuse-deterrent capsule utilizing DETERx technology platform to maintain its extended-release profile after being subjected to common methods of tampering

oral concentrate: Schedule II

  • 20mg/mL

oral solution: Schedule II

  • 5mg/5mL
more...

Moderate-to-Severe Pain

Immediate-release

  • Opioid-tolerant:: 10-30 mg PO q4-6hr
  • Opioid-naïve (initial dose): 5-15 mg PO q4-6hr

Chronic Severe Pain

Controlled-release products (eg, OxyContin, Xtampza ER) are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

Also see Administration

Initial dosing

  • OxyContin
    • Opioid-naïve patients: 10 mg PO q12hr initially; titrate gradually every 1-2 days, increasing by 25-50% increments, with q12hr dosing interval maintained
    • A single dose >40 mg ER or total dose >80 mg ER are for use only in opioid-tolerant patients
  • Xtampza ER
    • Opioid-naïve patients: 9 mg PO q12hr with food

Dosage Modifications

Coadministration with other CNS depressants: Initiate long-acting oxycodone with one-third to one-half the recommended starting dose; monitor for signs of respiratory depression, sedation, and hypotension

Conversion from other opioids to OxyContin

  • Provide immediate-release opioids for breakthrough pain
  • Monitor patient closely for adverse effects or breakthrough pain during conversion and for several days following
  • Also see Medscape reference topic - Opioid Equivalents
  • Conversion from other oral oxycodone formulations
    • Conversion from other oral oxycodone formulations: Administer one-half of the patient's total daily PO oxycodone dose as q12hr
    • Conversion from fentanyl transdermal: Wait 18 hr after patch removed, then initiate conservative dose of ~10 mg q12hr oxycodone controlled-release for each 25 mcg/hr fentanyl transdermal patch
  • Conversion from fentanyl transdermal
    • Wait 18 hr after patch removed, then initiate conservative dose of ~10 mg q12hr oxycodone controlled-release for each 25 mcg/hr fentanyl transdermal patch

Conversion from other opioids to Xtampza ER

  • Conversion from other oral oxycodone formulations
    • Administer one-half of the patient's total daily PO oxycodone dose as q12hr with food
    • Because Xtampza ER is not bioequivalent to other oxycodone extended-release products
    • Monitor patients for possible dosage adjustment
  • Conversion from other opioids
    • Discontinue all other around-the clock opioid drugs
    • There are no established conversion ratios for conversion from other opioids to Xtampza ER defined by clinical trials
    • Initiate dosing using 9 mg PO q12hr with food and provide immediate-release rescue medication while stabilizing patient on Xtampza ER
  • Conversion from methadone
    • Close monitoring is of particular importance when converting from methadone to other opioid agonists; the ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure and methadone has a long half-life and can accumulate in the plasma
  • Conversion from fentanyl transdermal
    • 18 hr following the removal of the transdermal fentanyl patch, initiate Xtampza ER; there has been no systematic assessment of such conversion, a conservative oxycodone dose, ~9 mg (equivalent to 10 mg oxycodone HCl) q12hr should be initially substituted for each 25 mcg/hr fentanyl transdermal patch

Renal impairment

  • CrCl <60 mL/min: Serum concentration may increase by 50%; adjust dosage to response

Hepatic impairment

  • Reduce dosage in liver disease; decrease dosage of extended-release form to 1/3 or 1/2 of usual starting dosage; titrate to response
  • Alternative analgesics are recommended for patients who require a dose of Xtampza ER <9 mg

Dosing Considerations

Discontinuation

  • Use a gradual downward titration of the dosage to avoid signs and symptoms of withdrawal in the physically-dependent patient
  • Do not abruptly discontinue Xtampza ER

Opioid-tolerant definition

  • Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression
  • Patients who are opioid tolerant are those receiving, for 1 week or longer, at least 60 mg/day PO morphine, 25 mcg/hr transdermal fentanyl, 30 mg/day PO oxycodone, 8 mg/day PO hydromorphone, 25 mg/day PO oxymorphone, or an equianalgesic dose of another opioid

Limitations of use

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve for patients whom alternative treatment options (eg, nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain
  • Long-acting opioids are not indicated as a PRN analgesic

Dosage Forms & Strengths

tablet, immediate release: Schedule II

  • 5mg
  • 10mg
  • 15mg
  • 20mg
  • 30mg

capsule, immediate-release: Schedule II

  • 5mg

oral concentrate: Schedule II

  • 20mg/mL

oral solution: Schedule II

  • 5mg/5mL

abuse deterrent tablet, controlled-release (OxyContin): Schedule II

  • 10mg
  • 15mg
  • 20mg
  • 30mg
  • 40mg
  • 60mg
  • 80mg
more...

Moderate-to-Severe Pain

Immediate-release: 0.05-0.15 mg/kg PO q4-6hr PRN 

Chronic Severe Pain

Controlled-release (ie, OxyContin) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in opioid-tolerant pediatric patients aged ≥11 yr who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent

Note: Xtampza ER is not approved for children or adolescents younger than 18 yr

Initial dose

  • Dosing information is only for children ≥11 yr who are already receiving and tolerating opioids for at least 5 consecutive days, and for the 2 days immediately preceding dosing with OxyContin, patients must be taking a minimum of 20 mg/day of oxycodone or its equivalent
  • Not appropriate for use in pediatric patients requiring <20 mg/day
  • Discontinue all other around-the-clock opioid drugs when OxyContin is initiated
  • Also see Administration

Converting to OxyContin in children ≥11 yr

  • Although tables of oral and parenteral equivalents are readily available, there is substantial interpatient variability in the relative potency of different opioid drugs and formulations
  • As such, it is preferable to underestimate a patient’s 24-hr oral oxycodone requirements and provide rescue medication (eg, immediate-release opioid) than to overestimate the 24-hr oral oxycodone requirements and manage adverse effects
  • Conversion factors of prior opioid
    • Oxycodone PO: 1
    • Hydrocodone PO: 0.9
    • Hydromorphone PO: 4
    • Hydromorphone parenteral: 20
    • Morphine PO: 0.5
    • Morphine parenteral: 3
    • Tramadol PO 0.17
    • Tramadol parenteral: 0.2
    • NOTE: 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

Conversion steps to OxyContin

  • Use the conversions listed above
  • Step 1 – calculate daily opioid dose(s)
    • Pediatric patients taking a single opioid: Add the current total daily dosage of the opioid and then multiply the total daily dosage by the approximate conversion factor to calculate the estimated OxyContin daily dose
    • Pediatric patients on a regimen of >1 opioid: Calculate the approximate oxycodone daily dose for each opioid and add the daily totals to obtain the approximate OxyContin dose/day
    • Pediatric patients on a regimen of fixed-ratio opioid/nonopioid analgesic products: Use only the opioid component of these products in the conversion
  • Step 2 – round dose down
    • If rounding is necessary, always round the dosage down to the nearest tablet strength available and initiate OxyContin therapy with that dose
    • If the calculated oxycodone daily dosage is <20 mg, there is no safe strength for conversion and do not initiate
    • Example: Conversion from a single opioid (eg, hydrocodone) to OxyContin; using the conversion factor of 0.9 for oral hydrocodone, a total daily hydrocodone dosage of 50 mg is converted to 45 mg/day of oxycodone or 22.5 mg q12hr of OxyContin
    • After rounding down to the nearest strength available, the recommended OxyContin starting dosage is 20 mg q12hr
  • Step 3 – closely observe and titrate
    • Following conversion, observation and titration are warranted until pain management is stable
    • Monitor for signs and symptoms of opioid withdrawal or for signs of oversedation/toxicity

OxyContin titration and maintenance

  • Individually titrate to a dosage that provides adequate analgesia and minimizes adverse reactions
  • Continually re-evaluate pain control, signs and symptoms of opioid withdrawal, and adverse reactions, as well as monitoring for the development of addiction, abuse and misuse
  • If breakthrough pain occurs, may require a dosage increase of OxyContin or a short-acting rescue analgesic
  • If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the OxyContin
  • Because steady-state plasma concentrations are approximated in 1 day, may adjust OxyContin dose every 1-2 days
  • As a guideline for children ≥11 yr, the total daily oxycodone dosage usually can be increased by 25% of the current total daily dosage

Dosage Modifications

Coadministration with other CNS depressants: Initiate OxyContin with one-third to one-half the recommended starting dose; monitor for signs of respiratory depression, sedation, and hypotension

Dosing Considerations

Long-acting or controlled-release oxycodone is not indicated for PRN analgesic dosing

Reduce starting dose to one-third to one-half of usual starting dosage; titrate cautiously

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Interactions

Interaction Checker

and oxycodone

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            Adverse Effects

            Frequency Not Defined

            Agitation 

            Angina pectoris

            Anticholinergic effects (dry mouth, palpitation, tachycardia) 

            Bradycardia 

            Cardiac arrest 

            Coma 

            Constipation 

            Dizziness 

            Dysphoria 

            Euphoria

            Faintness 

            Mental clouding/depression 

            Myocardial infarction

            Nausea 

            Nervousness 

            Pruritus, urticaria 

            QT-interval prolongation

            Respiratory arrest

            Respiratory/circulatory depression 

            Restlessness 

            Sedation 

            Seizures 

            Severe cardiac arrhythmias

            Shock

            ST-segment elevation

            Sweating, flushing, warmness of face/neck/upper thorax 

            Syncope 

            Urinary retention, oliguria 

            Ventricular tachycardia 

            Visual disturbances 

            Vomiting 

            Weakness 

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            Warnings

            Black Box Warnings

            Addiction, abuse, and misuse

            • Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death
            • Assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions

            Life-threatening respiratory depression

            • Serious, life-threatening, or fatal respiratory depression may occur
            • Monitor for respiratory depression, especially during initiation or following a dose increase
            • Instruct patients to swallow tablet/capsule whole; crushing, chewing, or dissolving can cause rapid release and absorption of a potentially fatal dose

            Accidental exposure

            • Accidental of even 1 dose, especially by children, can result in a fatal overdose

            Neonatal opioid withdrawal syndrome

            • Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts
            • Syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight
            • Onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn
            • If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available

            Cytochrome P450 3A4 interaction

            • Concomitant use of oxycodone ER with all cytochrome P450 (CYP-450) 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression

            Interaction with central nervous system (CNS) depressants

            • Coadministration with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
            • Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation
            • Instruct patients not to consume alcoholic beverages or use alcohol-containing drug products while taking morphine due to risk of additive sedation and respiratory depression

            Oral solutions

            • Concentrated oral solution is available as a 20 mg/mL concentration is indicated for use in opioid-tolerant patients only
            • Take care when prescribing and administering oxycodone oral solution to avoid dosing errors due to confusion between milligrams and milliliter, and other oxycodone solutions with different concentrations

            Contraindications

            Known or suspected GI obstruction, including paralytic ileus

            Hypersensitivity (eg, anaphylaxis) to oxycodone

            Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment

            Cautions

            Use caution in patients with anemia, cardiac arrhythmias, drug abuse or dependence, emotional lability, gallbladder disease, gout, head injury, renal/hepatic disease or impairment, hypoprothrombinemia, toxic psychosis, hypothyroidism, increased intracranial pressure, prostatic hypertrophy, renal impairment, seizures with epilepsy, thyrotoxicosis, urethral stricture, urinary tract surgery, vitamin K deficiency, anoxia, central nervous system (CNS) depression, hypercapmia, respiratory depression or disease, hypersensitivity to phenantrene-derivative opioid agonists, morbid obesity, untreated myxedema, adrenocrotical insufficiency including Addison disease

            If crushed, extended-release preparation (OxyContin) can deliver large opiate dose with potential for abuse or overdose; OxyContin reformulated in April 2010 to prevent tablet from being cut, broken, crushed, or dissolved to release more medication; inability to tamper with product reduces potential for abuse

            Caution with OxyContin in patients who have difficulty swallowing or have underlying GI disorders that may predispose to obstruction

            May obscure diagnosis of acute abdominal conditions

            Avoid use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic; mixed agonist/antagonist and partial agonist analgesics may reduce analgesic effect and/or precipitate withdrawal symptoms; when discontinuing therapy in physically-dependent patient, gradually taper dosage; do not abruptly discontinue therapy in these patients

            Therapy may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients; there is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics); monitor patients for signs of hypotension after initiating or titrating dosage; in patients with circulatory shock, therapy may cause vasodilation that can further reduce cardiac output and blood pressure; avoid therapy in patients with circulatory shock A single dose >40 mg or total dose >80 mg are for use only in opioid-tolerant patients

            May cause constipation, which may be problematic in patients with unstable angina and patients post-myocardial infarction; reduce potential for constipation by administering stool softener or increasing fiber in diet in patients following myocaridal infarction and unstable angina

            Use with caution in patients with biliary tract dysfunction, including acute pancreatitis; may cause constriction of sphincter of Oddi

            Use caution in patients who re morbidly obese

            Use caution in patients with thyroid dysfunction

            Dose adjustment required when initiating extended release therapy in patients taking other CNS depressants

            Use with caution in perioperative setting; individualize treatment when transitioning from parenteral to oral analgesics

            Some dosage forms may contain sodium benzoic acid (benzoate), a metabolite of benzyl alcohol; large amounts of benzyl alcohol have been associated with potentially fatal toxicity (gasping syndrome) in neonates

            Extended release tablets may be difficult to swallow and could become lodged in throat; patients with swallowing difficulties may be at risk; intestinal obstruction or diverticulitis exacerbation also reported

            Cases of serotonin syndrome, a potentially life-threatening condition, reported with concomitant use of serotonergic drugs; this may occur within the recommended dosage range; the onset of symptoms generally occur within several hours to a few days of concomitant use, but may occur later than that; discontinue therapy immediately if serotonin syndrome is suspected

            In patients who may be susceptible to intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), therapy may reduce respiratory drive, and resultant CO2 retention can further increase intracranial pressure; monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy; opioids may obscure clinical course in a patient with a head injury; avoid the use in patients with impaired consciousness or coma

            Contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus; may cause spasm of sphincter of Oddi; opioids may cause increases in serum amylase; monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms

            Therapy may increase frequency of seizures in patients with seizure disorders and in other clinical settings associated with seizures; monitor patients for worsened seizure control during therapy

            Warn patients not to drive or operate dangerous machinery unless they are tolerant to effects of drug and know how they will react to medication

            While serious, life-threatening, or fatal respiratory depression can occur at any time during therapy, risk is greatest during initiation of therapy or following dosage increase; monitor patients closely for respiratory depression, especially within first 24 to 72 hr of initiating therapy with and following dosage increases; accidental ingestion of even one dose, especially by children, can result in respiratory depression and death due to overdose of opioid

            Profound sedation, respiratory depression, coma, and death may result from concomitant administration with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol); because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate

            Use in patients with acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment is contraindicated; patients with significant chronic obstructive pulmonary disease or cor pulmonale, and with substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages

            Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients; monitor closely

            Monoamine oxidase inhibitors (MAOIs) may potentiate effects of opioid, opioid’s active metabolite, including respiratory depression, coma, and confusion; therapy should not be administered within 14 days of initiating or stopping MAOIs

            Cases of adrenal insufficiency reported with opioid use, more often following greater than one month of use; symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure; if adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids; wean patient off of opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers; other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency

            Use caution when selecting dosage for an elderly patient, usually starting at low end of dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy; because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and may be useful to monitor renal function

            Opioid pharmacokinetics may be altered in patients with renal failure; clearance may be decreased and metabolites may accumulate much higher plasma levels in patients with renal failure as compared to patients with normal renal function; start with a lower than normal dosage or with longer dosing intervals and titrate slowly while monitoring for signs of respiratory depression, sedation, and hypotension

            Schedule II opioid analgesics expose users to the risks of addiction, abuse, and misuse; there is a greater risk for overdose and death with extended-release opioids due to the larger amount of active opioid present (see Black Box Warnings)

            Addiction, abuse, and misuse risks are increased in patients with a personal or family history of substance abuse or mental illness (eg, major depression); the potential for these risks should not, however, prevent the prescribing of proper pain management in any given patient; intensive monitoring is necessary (see Black Box Warnings)

            Concomitant use with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of oxycodone and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of oxycodone is achieved; similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in oxycodone-treated patients may increase oxycodone plasma concentrations and prolong opioid adverse reactions; when using drug with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in oxycodone treated patients, monitor patients closely at frequent intervals and consider dosage reduction of oxycodone until stable drug effects are achieved

            Concomitant use of oxycodone with CYP3A4 inducers or discontinuation of a CYP3A4 inhibitor could decrease oxycodone plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to oxycodone; when using oxycodone with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, monitor patients closely at frequent intervals and consider increasing opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur

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            Pregnancy & Lactation

            Pregnancy

            Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome; there are no available data in pregnant women to inform a drug associated risk for major birth defects and miscarriage; published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects

            Labor or delivery

            • Opioids cross placenta and may produce respiratory depression and psycho-physiologic effects in neonates; an opioid antagonist, such as naloxone, must be available for reversal of opioid induced respiratory depression in neonate; drug is not recommended for use in women during and immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate; opioid analgesics can prolong labor through actions that temporarily reduce strength, duration, and frequency of uterine contractions; however, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor; monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression

            Infertility

            • Due to effects of androgen deficiency, chronic use of opioids may cause reduced fertility in females and males of reproductive potential; it is not known whether effects on fertility are reversible

            Lactation

            Drug is present in breast milk; published lactation studies report variable concentrations of drug in breast milk with administration of immediate-release formulation to nursing mothers in early postpartum period

            The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy; capsules and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

            Monitor infants exposed to drug through breast milk for excess sedation and respiratory depression; withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast- feeding is stopped

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Narcotic agonist-analgesic of opiate receptors; inhibits ascending pain pathways, thus altering response to pain; produces analgesia, respiratory depression, and sedation

            Absorption

            Bioavailability: 60-87%

            Increases in peak plasma concentration by 100-150% and AUC by 50-60% following a high-fat and high-calorie meal

            Onset:10-15 min (immediate-release)

            Duration: 3-6 hr (immediate release); ≤12 hr (controlled release)

            Peak plasma time: 1.5-1.9 hr (immediate-release); 4-5 hr (OxyContin 10-80 mg); 4.5 hr (Xtampza ER)

            Steady state: 24-36 hr (Xtampza ER)

            Distribution

            Once absorbed, oxycodone is distributed to skeletal muscle, liver, intestinal tract, lungs, spleen, and brain

            Protein bound: 45%

            Vd: 2.6 L/kg

            Metabolism

            Metabolized in liver by CYP3A mediated N-demethylation to noroxycodone is the primary metabolic pathway of oxycodone with a lower contribution from CYP2D6 mediated O-demethylation to oxymorphone

            Metabolites: Noroxycodone, oxymorphone (and glucuronide conjugates)

            CYP2D6 poor metabolizers may not achieve adequate analgesia; ultra-rapid metabolizers (≤7% of Caucasians and ≤30% of Asian and African populations) may have increased toxicity as consequence of rapid conversion

            Elimination

            Half-life: 2-4 hr; 4.5 hr (OxyContin)

            Excreted, urine: Free and conjugated oxycodone (8.9%), free noroxycodone (23%), free oxymorphone less than (1%), conjugated oxymorphone (10%), free and conjugated noroxymorphone (14%), reduced free and conjugated metabolites (up to 18%)

            Clearance: 1.4 L/min

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            Administration

            Oral Administration, Controlled-release

            Do not discontinue abruptly, use gradually downward titration

            OxyContin

            • May take with or without food
            • Swallow whole, do not chew, crush, dissolve, or break
            • OxyContin is manufactured with abuse deterrence ingredients
            • The abuse-deterrent formulation is an immediate-release preparation with "abuse aversion" technology (if crushed, crumbles into chunks instead of powder and foams if mixed with liquid)

            Xtampza ER

            • Must be taken with food in order to ensure consistent plasma levels are achieved
            • Xtampza ER utilizing DETERx technology platform to maintain its extended-release profile after being subjected to common methods of tampering
            • Difficulty swallowing
              • Open the capsule
              • Sprinkle the capsule contents (microspheres) onto soft food (eg, applesauce, pudding, yogurt, ice cream, or jam) or into a cup and then administer directly into the mouth and swallow immediately
              • Rinse mouth to ensure all capsule contents (microspheres) have been swallowed
              • Discard Xtampza ER capsule shells
            • Nasogastric or gastrostomy tube
              • Flush the tube with water
              • Open an Xtampza ER capsule and carefully pour the microspheres directly into the tube
              • Do not premix the capsule contents with the liquid that you will be using to flush them through the tube
              • Draw up 15 mL of water into a syringe, insert the syringe into the tube, and flush microspheres through tube
              • Repeat the flushing two more times, each with 10 mL of water, to ensure no microspheres remain in the tube

            Storage

            Tablets and capsules: Store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F); dispense in tight, light-resistant container, with child-resistant closure

            Abuse deterrent tablet, immediate-release and controlled-release: Store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F); dispense in tight, light-resistant container

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
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