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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.
Unknown. Thought to interact with opioid receptor sites primarily in limbic system, thalamus, and spinal cord, blocking transmission of pain impulses.
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.
• Hepatic disease
• Renal impairment
• Debilitated or opioid-naive patients
• Postherpetic neuralgia (controlled release form)
• Hypersensitivity to drug
• Paralytic ileus
• When opioids are contraindicated (as in respiratory depression, severe bronchial asthma, hypercarbia)
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.
• 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.
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
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
☞ 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.
☞ 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.