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- Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl
per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or
an equianalgesic dose of another opioid.
- Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
- Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse.
- Instruct patients to swallow tablets intact and not to cut, break, chew, crush, or dissolve tablets (risk of potentially fatal dose).
- Instruct patients to take tablets one at a time, with enough water to ensurecomplete swallowing immediately after placing in mouth.
- Do not abruptly discontinue OXYCONTIN in a physically dependent patient.
Adults: For opioid-naïve and opioid non-tolerant patients, initiate with 10 mg tablets orally every 12 hours. See full prescribing information for instructions on conversion from opioids to OXYCONTIN, titration and maintenance of therapy.
Pediatric Patients 11 Years of Age and Older
- For use only in pediatric patients 11 years and older already receiving and tolerating opioids for at least 5 consecutive days with a minimum of 20 mg per day of oxycodone or its equivalent for at least two days immediately preceding dosing with OXYCONTIN.
- Low blood pressure including from having low blood volume
- Increased prostate size or difficulty passing urine
- Chronic lung, liver or kidney disease
- Problems with or recent surgery on your gall bladder or bile duct
- Inflammation of the pancreas
- Adrenal glands not working properly
- Underactive thyroid gland
- Inflammatory bowel disease or recent abdominal surgery
- Severe mental condition involving losing contact with reality, hearing voices or aninability to think clearly
- An addiction or history of abuse of alcohol, opioids or other drugs. Or history of abuse of alcohol, opioids or other drugs.
-ROXICODONE® is contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated.
-Significant respiratory depression.
-Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment.
-Known or suspected gastrointestinal obstruction, including paralytic ileus.
-Suffer from shallow breathing or have any breathing problems such as acute asthma,chronic bronchitis or impaired lung function
The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore,narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.
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.
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 . WIKI
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