Roxicodone


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oxycodone hydrochloride

Oxecta, OxyContin, Oxynorm (UK), Roxicodone, Supeudol (CA)

Pharmacologic class: Opioid agonist

Therapeutic class: Narcotic analgesic

Controlled substance schedule II

Pregnancy risk category B

FDA Box Warning

• Drug is opioid agonist and Schedule II controlled substance, with abuse potential similar to morphine. This potential must be considered when prescribing or dispensing drug.

• Extended-release tablets are indicated for managing moderate to severe pain when continuous, around-the-clock analgesia is needed for extended period of time. Extended-release tablets aren't intended for as-needed analgesia.

• Extended-release 80-mg tablets are for use only in opioid-tolerant patients. This strength may cause fatal respiratory depression when given to patients without previous opioid exposure.

• Instruct patients to swallow extended-release tablets whole. Caution them not to break, chew, or crush them, as this causes rapid release and absorption of potentially fatal dose.

Action

Unknown. Thought to interact with opioid receptor sites primarily in limbic system, thalamus, and spinal cord, blocking transmission of pain impulses.

Availability

Capsules (immediate-release): 5 mg

Solution (oral): 5 mg/5 ml

Tablets: 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg

Tablets (controlled-release): 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg

Indications and dosages

Moderate to severe pain

Adults: 5 mg P.O. q 6 hours p.r.n., increased gradually to 10 to 30 mg q 6 hours p.r.n.

Moderate or severe pain when continuous around-the-clock analgesia is needed

Adults: 10 mg P.O. (controlled-release) q 12 hours. For patients already taking opioids, use total oral oxycodone daily equianalgesic dosage and then round down to closest tablet strength. For breakthrough pain, give supplemental immediate-release doses.

Dosage adjustment

• Hepatic disease
• Renal impairment
• Debilitated or opioid-naive patients

Off-label uses

• Postherpetic neuralgia (controlled release form)

Contraindications

• Hypersensitivity to drug
• Paralytic ileus
• When opioids are contraindicated (as in respiratory depression, severe bronchial asthma, hypercarbia)

Precautions

Use cautiously in:
• head trauma; increased intracranial pressure (ICP); severe renal, hepatic, or pulmonary disease; hypothyroidism; adrenal insufficiency; urethral stricture; undiagnosed abdominal pain or prostatic hyperplasia; extensive burns; alcoholism
• history of substance abuse
• prolonged or high-dose therapy
• elderly or debilitated patients
• labor and delivery
• pregnant or breastfeeding patients
• children younger than age 18.

Administration

• Be aware that drug has high abuse potential.
• Know that controlled-release Oxy-Contin isn't indicated for p.r.n. pain control but is reserved for patients who need continuous, around-the-clock analgesia.
• Be aware that 80-mg controlled-release tablets are for opioid-tolerant patients only.

Never break, crush, or let patient chew controlled-release forms. Otherwise, rapid release and absorption of potentially fatal dose may occur.
• Give Oxecta tablets whole. Don't crush or dissolve tablets or administer by nasogastric, gastric, or other feeding tubes, because this may cause obstruction of feeding tubes.
• When discontinuing, taper dosage gradually to prevent withdrawal symptoms.

Adverse reactions

CNS: dizziness, asthenia, drowsiness, euphoria, light-headedness, insomnia, confusion, anxiety, twitching, abnormal dreams and thoughts

CV: orthostatic hypotension, circulatory depression, bradycardia, shock

GI: nausea, vomiting, constipation, diarrhea, ileus, abdominal pain, dyspepsia, gastritis, anorexia

GU: urinary retention

Respiratory: apnea, respiratory depression, respiratory arrest

Skin: pruritus, sweating

Other: chills, fever, hiccups, physical and psychological drug dependence

Interactions

Drug-drug.Antihistamines, sedative-hypnotics: additive CNS depression

Barbiturates, protease inhibitors: increased respiratory and CNS depression

Opioid agonist-antagonists: precipitation of opioid withdrawal in physically dependent patients

Drug-diagnostic tests.Amylase, lipase: increased levels

Drug-behaviors.Alcohol use: additive CNS depression

Patient monitoring

Monitor vital signs and respiratory status. Withhold drug in significant respiratory or CNS depression.
• Assess patient's pain level frequently.
• Monitor bowel and bladder function.
• Assess patient for anxiety, twitching, and other CNS symptoms.
• Closely monitor head-trauma patient. Drug may increase ICP while masking signs and symptoms.
• Carefully assess patient with acute abdominal pain. Drug may obscure diagnosis.
• Stay alert for drug hoarding, tolerance, and dependence.

Patient teaching

Caution patient not to break, crush, chew, or dissolve controlled-release tablets. Warn him that doing so may cause rapid drug release and absorption (possibly fatal).
• Tell patient taking controlled-release form not to drive for 3 to 4 days after dosage increase, after consuming even a single alcoholic beverage, or if also taking antihistamines or other drugs that cause drowsiness.
• Tell patient to take Oxecta tablets whole.

Instruct patient to promptly report adverse reactions, especially difficulty breathing or slow pulse.
• Advise patient not to drink alcohol.
• Tell patient not to be alarmed if controlled-release tablets appear in stools; drug has already been absorbed.
• Advise ambulatory patient to change position slowly, to avoid dizziness from orthostatic hypotension.
• Instruct patient to consult prescriber before taking other drugs.
• Caution patient to avoid driving and other hazardous activities, because drug may cause drowsiness or dizziness.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.

oxyCODONE

(ox-i-koe-done) ,

Oxecta

(trade name),

OxyCONTIN

(trade name),

Oxy IR

(trade name),

Oxyneo

(trade name),

Roxicodone

(trade name),

Supeudol

(trade name)

Classification

Therapeutic: opioid analgesics
Pharmacologic: opioid agonists
Pregnancy Category: B

Indications

Moderate to severe pain; extended release product should be used for patients requiring around-the-clock management of chronic pain.

Action

Binds to opiate receptors in the CNS.
Alters the perception of and response to painful stimuli, while producing generalized CNS depression.

Therapeutic effects

Decreased pain.

Pharmacokinetics

Absorption: Well absorbed from the GI tract.
Distribution: Widely distributed. Crosses the placenta; enters breast milk.
Protein Binding: 38–45%
Metabolism and Excretion: Mostly metabolized by the liver by the CYP3A4 isoenzyme.
Half-life: 2–3 hr.

Time/action profile (analgesic effects)

ROUTEONSETPEAKDURATION
PO10–15 min60–90 min3–6 hr
PO-CR†10–15 min3 hr12 hr
†Controlled release

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Some products contain alcohol or bisulfites and should be avoided in patients with known intolerance or hypersensitivity;Significant respiratory depression;Paralytic ileus;Acute or severe bronchial asthma.Acute, mild, intermittent, or postoperative pain (extended-release);
Use Cautiously in: Head trauma;↑ intracranial pressure;Severe renal or hepatic disease;Hypothyroidism;Adrenal insufficiency;Alcoholism;Seizure disorders;Undiagnosed abdominal pain;Prostatic hyperplasia;Difficulty swallowing or GI disorders that may predispose patient to obstruction (↑ risk for GI obstruction); Obstetric: Avoid chronic use; weigh maternal benefit against fetal risks; Lactation: Lactation; Geriatric: Elderly or debilitated patients (initial dose ↓ recommended).

Adverse Reactions/Side Effects

Central nervous system

  • confusion (most frequent)
  • sedation (most frequent)
  • dizziness
  • dysphoria
  • euphoria
  • floating feeling
  • hallucinations
  • headache
  • unusual dreams

Ear, Eye, Nose, Throat

  • blurred vision
  • diplopia
  • miosis

Respiratory

  • respiratory depression (life-threatening)

Cardiovascular

  • orthostatic hypotension

Gastrointestinal

  • constipation (most frequent)
  • dry mouth
  • choking
  • GI obstruction
  • nausea
  • vomiting

Genitourinary

  • urinary retention

Dermatologic

  • flushing
  • sweating

Miscellaneous

  • physical dependence
  • psychological dependence
  • tolerance

Interactions

Drug-Drug interaction

Use with caution in patients receiving MAO inhibitors (may result in unpredictable reactions—↓ initial dose of oxycodone to 25% of usual dose).Additive CNS depression with alcohol, antihistamines, and sedative/hypnotics.Administration of partial-antagonistopioid analgesics may precipitate withdrawal in physically dependent patients.Nalbuphine, buprenorphine, or pentazocine may ↓ analgesia.Potent CYP3A4 inhibitors including erythromycin, ketoconazole, itraconazole, voriconazole, or ritonavir may ↑ levels.Potent CYP3A4 inducers including rifampin, carbamazepine, and phenytoin may ↓ levels.

Route/Dosage

Larger doses may be required during chronic therapy
Oral (Adults ≥50 kg) 5–10 mg q 3–4 hr initially, as needed. Controlled-release tablets (Oxycontin) may be given q 12 hr.
Oral (Adults <50 kg ) 0.2 mg/kg q 3–4 hr initially, as needed.
Oral (Children) 0.05–0.15 mg/kg q 4–6 hr as needed, as immediate-release product
Rectal (Adults) 10–40 mg 3–4 times daily initially, as needed.

Availability (generic available)

Tablets (Oxecta, Roxicodone): 5 mg, 10 mg, 15 mg, 20 mg, 30 mg Cost: Generic — 5 mg $47.99 / 100, 10 mg $62.50 / 100, 15 mg $75.90 / 100, 20 mg $110.30 / 100, 30 mg $145.47 / 100
Immediate-release capsules: 5 mg Cost: Generic — $79.59 / 100
Controlled-release tablets (Oxycontin): 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg Cost: 10 mg $52.54 / 20, 15 mg $78.60 / 20, 20 mg $100.42 / 20, 30 mg $142.16 / 20, 40 mg $178.10 / 20, 60 mg $259.32 / 20, 80 mg $335.08 / 20
Oral solution: 1 mg/mL Cost: Generic — $142.50 / 500 mL
Concentrated oral solution: 20 mg/mL Cost: Generic — $218.75 / 30 mL
Suppositories: 10 mg, 20 mg
In combination with: aspirin (Endodan, Percodan), acetaminophen (Endocet, Magnacet, Oxycet, Percocet, Roxicet, Tylox); see combination drugs.

Nursing implications

Nursing assessment

  • Assess type, location, and intensity of pain prior to and 1 hr (peak) after administration. When titrating opioid doses, increases of 25–50% should be administered until there is either a 50% reduction in the patient's pain rating on a numerical or visual analog scale or the patient reports satisfactory pain relief. A repeat dose can be safely administered at the time of the peak if previous dose is ineffective and side effects are minimal.
  • Patients taking controlled-release tablets may also be given supplemental short-acting opioid doses for breakthrough pain.
  • An equianalgesic chart (see ) should be used when changing routes or when changing from one opioid to another.
  • Assess BP, pulse, and respirations before and periodically during administration. If respiratory rate is <10/min, assess level of sedation. Physical stimulation may be sufficient to prevent significant hypoventilation. Dose may need to be decreased by 25–50%. Initial drowsiness will diminish with continued use.
  • Prolonged use may lead to physical and psychological dependence and tolerance. This should not prevent patient from receiving adequate analgesia. Most patients who receive oxycodone for pain do not develop psychological dependence. Progressively higher doses may be required to relieve pain with long-term therapy.
  • Assess bowel function routinely. Prevention of constipation should be instituted with increased intake of fluids and bulk, and laxatives to minimize constipating effects. Stimulant laxatives should be administered routinely if opioid use exceeds 2–3 days, unless contraindicated.
  • Lab Test Considerations: May ↑ plasma amylase and lipase levels.
  • If an opioid antagonist is required to reverse respiratory depression or coma, naloxone is the antidote. Dilute the 0.4-mg ampule of naloxone in 10 mL of 0.9% NaCl and administer 0.5 mL (0.02 mg) by direct IV push every 2 min. For children and patients weighing <40 kg, dilute 0.1 mg of naloxone in 10 mL of 0.9% NaCl for a concentration of 10 mcg/mL and administer 0.5 mcg/kg every 2 min. Titrate dose to avoid withdrawal, seizures, and severe pain.

Potential Nursing Diagnoses

Acute pain (Indications)
Chronic pain (Indications)
Risk for injury (Side Effects)

Implementation

  • high alert: Accidental overdose of opioid analgesics has resulted in fatalities. Before administering, clarify all ambiguous orders; have second practitioner independently check original order and dose calculations.
  • Do not confuse short-acting oxycodone with long-acting Oxycontin. Do not confuse oxycodone with hydrocodone. Do not confuse Oxycontin with MS Contin.
  • Explain therapeutic value of medication prior to administration to enhance the analgesic effect.
    • Regularly administered doses may be more effective than prn administration. Analgesic is more effective if given before pain becomes severe.
    • Coadministration with nonopioid analgesics may have additive analgesic effects and may permit lower doses.
    • Oxycodone should be discontinued gradually after long-term use to prevent withdrawal symptoms.
  • Oral: May be administered with food or milk to minimize GI irritation.
    • Administer solution with properly calibrated measuring device.
  • Controlled Release: Take 1 tablet at a time. Swallow controlled-release tablet whole; do not crush, break, or chew. Taking broken, chewed, crushed or dissolved controlled-release tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone. Advise patients not to pre-soak, lick, or wet controlled-release tablets prior to placing in the mouth. Take each tablet with enough water to ensure complete swallowing immediately after placing in mouth. Dose should be based on 24-hr opioid requirement determined with short-acting opioids then converted to controlled-release form.
    • Do not use Oxceta for administration via nasogastric, gastric or other feeding tubes as it may cause obstruction of feeding tubes.

Patient/Family Teaching

  • Instruct patient on how and when to ask for and take pain medication.
  • Advise patient that oxycodone is a drug with known abuse potential. Protect it from theft, and never give to anyone other than the individual for whom it was prescribed.
  • Medication may cause drowsiness or dizziness. Advise patient to call for assistance when ambulating or smoking. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
  • Advise patients taking Oxycontin tablets that empty matrix tablets may appear in stool.
  • Advise patient to make position changes slowly to minimize orthostatic hypotension.
  • Advise patient to avoid concurrent use of alcohol or other CNS depressants with this medication.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • Encourage patient to turn, cough, and breathe deeply every 2 hr to prevent atelectasis.
  • Advise patient to notify health care professional if pregnancy is planned or suspected, or if breast feeding.

Evaluation/Desired Outcomes

  • Decrease in severity of pain without a significant alteration in level of consciousness or respiratory status.

Roxicodone

Oxycodone Pain management A formulation of oxycodone, an opioid analgesic indicated for severe pain. See Oxycodone.
References in periodicals archive ?
Oxycodone: Oxycontin, Percolone, Roxicodone, various; also in Percocet
This product is the generic version of Xanodyne's Roxicodone, a treatment for moderate to severe pain.
Wipf was able to obtain prescriptions for more than 14,000 units of Roxicodone during single visits to the doctor.
9 28% Prescription Trends ('000) Q2 2001A Q2 2002A Q2 Change '01 - '02 Zanaflex 512 878 71% Skelaxin 1,006 1,209 20% Roxicodone 145 142 (2%) Zonegran 38 93 145% Sonata 444 439 (1%) Maxipime(c) 813 1,238 52% Abelcet(c) 187 195 4% Azactam(c) 51 54 6% (c) Represents audited sales volumes for 3 months ended May 2002
Over Painkiller Patent Judge halts proposed marketing of Roxicodone SR by U.