oxycodone hydrochloride

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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 hydrochloride

[ok′sikōdōn]
an opioid analgesic.
indication It is used to treat moderate to severe pain, often in combination with nonopioid analgesics. OxyContin is a formulation that should be used only when severe persistent pain is anticipated.
contraindications It is used with caution in many conditions, including head injuries, asthma, impaired renal or hepatic function, or unstable cardiovascular status. Known hypersensitivity to this drug prohibits its use.
adverse effects Among the most serious adverse effects are drowsiness, dizziness, nausea, constipation, respiratory and circulatory depression, and drug addiction.