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Roxicodone™ (oxycodone hydrochloride tablets USP) is an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.
IMPORTANT RISK INFORMATION
Roxicodone is contraindicated:
In patients with known hypersensitivities to oxycodone.
In patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment).
In patients with acute or severe bronchial asthma or hypercarbia.
In patients who have or are suspected of having paralytic ileus.
WARNINGS AND PRECAUTIONS
Respiratory depression is the chief hazard from all opioid agonist preparations. In some patients, usual therapeutic doses of Roxicodone may cause respiratory depression. Patients with pulmonary conditions and pre-existing respiratory depression are at the highest risk.
Roxicodone should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression.
Roxicodone is a Schedule II controlled substance, and like other opioids used in analgesia, can be abused and is subject to criminal diversion. Oxycodone hydrochloride tablets are intended for oral use only. Abuse of oxycodone hydrochloride tablets poses a risk of overdose and death. The risk is increased with concurrent abuse of alcohol and other substances. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.
Psychic dependence, physical dependence and tolerance may develop upon repeated administration of this drug.
Roxicodone may cause severe hypotension in individuals whose ability to maintain blood pressure has been compromised.
Roxicodone may produce orthostatic hypotension in ambulatory patients.
The adverse effects of narcotics may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may obscure the clinical course of patients with head injuries or acute abdominal conditions.
Use of Roxicodone is associated with increased potential risks and should be used only with caution in the following conditions: acute alcoholism; adrenocortical insufficiency (e.g., Addison’s disease); convulsive disorders; CNS depression or coma; delirium tremens; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary or renal function; and toxic psychosis.
Oxycodone may cause severe hypotension in individuals whose ability to maintain blood pressure has been compromised.
Opioid analgesics should be used with caution when combined with CNS depressant drugs.
Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.
Some patients will develop tolerance and require progressively higher dosages of Roxicodoneto maintain pain control. If Roxicodone is abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur.
Roxicodone may cause spasm of the sphincter of Oddi. and increases in the serum amylase level.
Serious adverse reactions may includerespiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and shock.
Common adverse reactions include: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
USE IN SPECIFIC POPULATIONS
Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms.
Breast feeding: Oxycodone has been detected in breast milk. Withdrawal symptoms can occur in breast-feeding infants when maternal administration of an opioid analgesic is stopped.
Pediatrics: The safety and efficacy of oxycodone in pediatric patients have not been evaluated.
Dose initiation should be conservative in patients with renal or hepatic impairment.