Naloxone / Oxycodone Dosage
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Pain
Opioid naive patients:
Initial dose: 1 tablet (naloxone-oxycodone 5 mg-10 mg) orally every 12 hours.
Maintenance dose: The dose may be titrated every 1 to 2 days until adequate pain relief is achieved
Opioid experienced patients:
Initial dose: The dose, given every 12 hours, should be titrated to the needs of the patient based on previous opioid exposure
Maximum dose: 1 tablet (naloxone-oxycodone 20 mg-40 mg) orally every 12 hours
-Patients requiring higher than the maximum recommended dose should be given supplemental, single entity controlled release oxycodone at the same time intervals. However, with the use of supplemental oxycodone, the beneficial effect of naloxone on bowel function may be lost.
-Patients receiving other oral oxycodone formulations may be switched to naloxone-oxycodone at the same total daily dosage, equally divided into two 12 hourly doses.
Renal Dose Adjustments
The initial dose should be reduced to 1/2 the usual starting dose followed by careful dose titration.
Liver Dose Adjustments
Mild hepatic impairment: The dose should be reduced by 1/3 to 1/2 the usual starting dose followed by careful dose titration
Moderate or severe hepatic impairment: Contraindicated
The dosage for each patient should be adjusted according to the pain severity, functional status, sensitivity, and the patient's previous history of analgesic requirements, including opiates. The lowest dose that controls the pain, provides functional improvement, and is well tolerated for 12 hours is recommended. Naloxone-oxycodone should be used for the shortest possible duration. Patients requiring long-term treatment with naloxone-oxycodone should receive regular assessments and monitoring in order to determine the need for continued treatment. For patients no longer requiring treatment with naloxone-oxycodone, gradual withdrawal is recommended following prolonged therapy in order to minimize withdrawal symptoms.
For infirm or debilitated elderly patients, the initial dose should be reduced to 1/3 to 1/2 of the usual dose. Dose reduction may be required in patients with hypothyroidism.
Controlled-release naloxone-oxycodone oral tablets are not indicated for use as "rescue" medication for breakthrough pain: immediate release analgesics (e.g., immediate release oxycodone) may be used for this purpose. A single dose of rescue medication should be approximately 1/6 to 1/12 of the equivalent daily dose of oxycodone hydrochloride. If more than two doses of rescue medication is required per day, the patient should be reassessed and the dosage of naloxone-oxycodone may require upward adjustment.
Patients requiring higher dosages than the daily recommended maximum dose of naloxone-oxycodone may be administered single entity controlled release oxycodone at the same time intervals. The beneficial effects of naloxone on bowel function may be impaired in patients receiving supplemental oxycodone.
Most patients are well managed by administration of the identical dose every 12 hours (symmetrical dosing). However, some patients may benefit from an asymmetric dosing schedule for naloxone-oxycodone, (higher dose in the morning or evening) tailored to the individual patient's analgesic requirements. In these patients, the lowest total daily dose required to achieve adequate pain relief is still recommended.
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioid analgesics. The REMS consists of a medication guide and elements to assure safe use. Additional information is available at www.fda.gov/Drugs/DrugSafety/postmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.
US BLACK BOX WARNINGS:
-ABUSE AND ADDICTION: Naloxone-oxycodone exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Each patient should be assessed for risk before prescribing and monitored regularly for development of addiction.
-RESPIRATORY: Serious, life-threatening, or fatal respiratory depression may occur. Patients should be monitored closely, especially upon initiation or following a dose increase. Patients should be instructed to swallow tablets whole to avoid exposure to a potentially fatal dose of oxycodone.
-OVERDOSE: Accidental ingestion, especially in children, can result in a fatal overdose of oxycodone.
-NEONATE WITHDRAWAL SYNDROME: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, the patient should be advised of the risk of neonatal opioid withdrawal syndrome.
-DRUG INTERACTIONS: Initiation of CYP450 3A4 inhibitors (or discontinuation of CYP450 3A4 inducers) can result in a fatal overdose of oxycodone.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
US Controlled Substance: Schedule II
Data not available
-May be taken with or without food with a sufficient amount of liquid.
-Tablets should be swallowed whole, not crushed, chewed, or dissolved.
-This drug may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving or operating machinery.
-When discontinuing therapy, the dose should be gradually tapered, not abruptly discontinued.
-Symptoms of opioid withdrawal have occurred in some people. Symptoms included but were not limited to hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning. Patients should be monitored for symptoms of opioid withdrawal. In opioid tolerant patients, if symptoms of opioid withdrawal occur following conversion to naloxone-oxycodone or following dose escalation, lowering the dose to should be considered.
-Parenteral use of naloxone has been associated with abrupt and complete reversal of opioid effects leading to withdrawal symptoms (e.g., abdominal cramping, muscle aches, sweating, anxiety, nausea, vomiting, diarrhea). Several instances of hypotension, hypertension, ventricular tachycardia, fibrillation, and pulmonary edema have been associated with parenteral naloxone used postoperatively.
-Naloxone-oxycodone tablets should be swallowed whole and not broken, chewed, or crushed. If the integrity of the tablet is compromised, the rapid release and absorption of oxycodone may result in a fatal overdose. Following oral administration, the empty tablet matrix may be visible in the stool.