"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
OXECTA is an immediate-release oral formulation of oxycodone HCl indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.
DOSAGE AND ADMINISTRATION
Selection of patients for treatment with OXECTA should be governed by the same principles that apply to the use of other potent opioid analgesics. Opioid analgesics given on a fixed-dosage schedule have a narrow therapeutic index in certain patient populations, especially when combined with other drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension. Healthcare providers should individualize treatment in every case, using non-opioid analgesics, opioids and/or combination products when necessary, and chronic opioid therapy with drugs such as OXECTA in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Health Care Policy and Research, and the American Pain Society.
OXECTA must be swallowed whole. Take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth [see PATIENT INFORMATION]. OXECTA is not amenable to crushing and dissolution. Do not administer OXECTA via nasogastric, gastric or other feeding tubes as it may cause obstruction of feeding tubes.
Individualization Of Dose
The dose of OXECTA should be individually adjusted according to severity of pain, and the patient's response, weight, age, and prior analgesic treatment experience. Although it is not possible to list every condition that is important to the selection of the initial dose of OXECTA, attention must be given to:
- the daily dose, potency and characteristics of a pure agonist or mixed agonist/antagonist the patient has been taking previously
- the reliability of the relative potency estimate to calculate the dose of oxycodone HCl needed
- the degree of opioid tolerance
- the general condition and medical status of the patient
- the balance between pain management and adverse reactions
- the type and severity of the patient's pain
- risk factors for abuse or addiction, including a prior history of abuse or addiction
Initiation Of Therapy
Patients who have not been receiving opioid analgesics should be started on OXECTA 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 OXECTA.
Patients with chronic pain may need to be dosed at the lowest dosage level that will achieve acceptable analgesia and tolerable adverse reactions, on an around-the-clock basis rather than on an as needed basis.
Since oxycodone is extensively metabolized in the liver, its clearance may decrease in patients with hepatic impairment. Dose initiation in such patients should follow a conservative approach. Dosages should be adjusted according to the clinical situation [see Use In Specific Populations].
Published data reported that elimination of oxycodone was impaired in patients with end-stage renal failure. The mean elimination half-life was prolonged in uremic patients due to increased volume of distribution and reduced clearance. Dose initiation in such patients should follow a conservative approach. Dosages should be adjusted according to the clinical situation [see Use In Specific Populations].
Conversion To OXECTA
Conversion from Fixed-Ratio Oral Opioid/Non-Opioid Combinations
When converting patients from fixed-ratio opioid/non-opioid drug regimens to OXECTA, determine whether or not to continue the non-opioid analgesic. Titrate the dose of OXECTA in response to the level of analgesia and adverse reactions afforded by the dosing regimen regardless of whether the non-opioid is continued.
Conversion from Other Oral Opioid Therapy to OXECTA
If a patient has been receiving opioid-containing medications prior to taking OXECTA, factor the potency of the prior opioid relative to oxycodone into the selection of the total daily dose of oxycodone.
In converting patients from other opioids to OXECTA, close observation and adjustment of dosage based upon the patient's response to OXECTA is imperative.
Maintenance Of Therapy
Continual re-evaluation of the patient receiving OXECTA is important, with special attention to the maintenance of pain management and the relative incidence of adverse reactions associated with therapy. If the level of pain increases, effort should be made to identify the source of the increased pain, while adjusting the dose as described above to decrease the level of pain.
During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), the continued need for the use of opioid analgesics must be re-assessed as appropriate.
Cessation Of Therapy
When a patient no longer requires therapy with OXECTA after chronic use, it is important that therapy be gradually tapered over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal [see Drug Abuse And Dependence for a description of the signs and symptoms of withdrawal]. If the patient develops these signs or symptoms, the dose should be raised to the previous level and tapered more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. It is not known at what dose of OXECTA that treatment may be discontinued without risk of the opioid abstinence syndrome occurring.
Dosage Forms And Strengths
OXECTA is supplied as white, debossed tablets in two strengths, 5 mg and 7.5 mg of oxycodone HCl, USP, as noted below.
|5 mg||Round, convex, white tablet, debossed “5” on one side, King Logo on other side.|
|7.5 mg||Round, convex, white tablet, debossed “7.5” on one side, King Logo on other side.|
Storage And Handling
OXECTA (oxycodone HCl, USP) is supplied as round, convex, white tablets as follows:
5 mg tablets debossed with the strength “5” on one side and the King Logo on the other side.
NDC 60793-525-01 Bottles of 100 tablets
7.5 mg tablets debossed with the strength “7.5” on one side and the King Logo on the other side.
NDC 60793-526-01 Bottles of 100 tablets
Dispense in tight container as defined in the USP, with a child-resistant closure.
Store at 25°C (77°F); with excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].
Protect from moisture.
All opioids, including OXECTA, are liable to diversion and misuse both by the general public and healthcare workers and must be handled accordingly.
DEA Schedule II Order Form Required
Distributed by: Pfizer Inc, New York, NY 10017. Prescribing Information as of January 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/28/2016
Additional Oxecta Information
- Oxecta Drug Interactions Center: oxycodone oral
- Oxecta Side Effects Center
- Oxecta FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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