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Dosage and Administration
All doses of opioids carry an inherent risk of fatal or non-fatal adverse events. This risk is increased with higher doses. For the management of chronic non-cancer, non-palliative pain, it is recommended that 60 mg (90 morphine milligram equivalent) of OxyNEO®
(oxycodone hydrochloride controlled release tablets) not be exceeded. Each patient should be assessed for their risk prior to prescribing OxyNEO, as the likelihood of experiencing serious adverse events can depend upon the type of opioid, duration of treatment, level of pain as well as the patient’s own level of tolerance. In addition, the level of pain should be assessed routinely to confirm the most appropriate dose and the need for further use of OxyNEO, at the lowest dosage level that will achieve adequate analgesia.Patients who have not been receiving opioid analgesics should be started on ROXICODONE® in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain. The dose should be titrated based upon the individual patient’s response to their initial dose of ROXICODONE®. Patients with chronic pain should have their dosage given on an around-the-clock basis to prevent the reoccurrence of pain rather than treating the pain after it has occurred. This dose can then be adjusted to an acceptable level of analgesia taking into account side effects experienced by the patient.
For control of severe chronic pain, ROXICODONE® should be administered on a regularly scheduled basis, every
4 to 6 hours
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ROXICODONE® is contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia.In patients with known or suspected mechanical gastrointestinal obstruction (e.g., bowel obstruction, strictures) or any diseases/conditions that affect bowel transit (e.g., ileus of anytype).
- Patients with suspected surgical abdomen (e.g., acute appendicitis or pancreatitis).
- Patients with mild, intermittent or short duration pain that can be managed with other pain medications.
- The management of acute pain.
- Patients with acute or severe bronchial asthma, chronic obstructive airway or status asthmaticus.
- Patients with acute respiratory depression, elevated carbon dioxide levels in the blood, and cor pulmonale.
- Patients with acute alcoholism, delirium tremens, and convulsive disorders.
- Patients with severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury.
- Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy).
- Women who are breastfeeding, pregnant, or during labour and delivery
Respiratory depression is the chief hazard from all opioid agonist preparations.
Respiratory depression occurs most frequently in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration.
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. In such patients, even usual therapeutic doses of ROXICODONE® may decrease respiratory drive to the point of apnea. In these patients alternative nonopioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.
ROXICODONE®, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. ROXICODONE® may produce orthostatic hypotension in ambulatory patients. ROXICODONE®, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilatation produced by the drug may further reduce cardiac output and blood pressure. WIKI