Generic name: OXYCODONE HYDROCHLORIDE 5mg
Dosage form: tablet
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Important Dosage and Administration Instructions
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].
Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)].
Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with OXAYDO and adjust the dosage accordingly [see Warnings and Precautions (5.2)].
OXAYDO must be swallowed whole. Take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17)]. OXAYDO is not amenable to crushing and dissolution. Do not administer OXAYDO via nasogastric, gastric or other feeding tubes as it may cause obstruction of feeding tubes.
Although it is not possible to list every condition that is important to the selection of the initial dose of OXAYDO, attention must be given to:
- the daily dose, potency and characteristics of a full 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, including the patient’s weight and age
- 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
Selection of patients for treatment with OXAYDO 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 OXAYDO 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.
Use of OXAYDO as the First Opioid Analgesic
Initiate treatment with OXAYDO in a dosing range of 5 mg to 15 mg every 4 to 6 hours as needed for pain.
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.
Conversion from Other Opioids to OXAYDO
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of OXAYDO. It is safer to underestimate a patient’s 24-hour OXAYDO dosage than to overestimate the 24-hour OXAYDO dosage and manage an adverse reaction due to overdose.
Conversion from Fixed-Ratio Oral Opioid/Non-Opioid Combinations
When converting patients from fixed-ratio opioid/non-opioid drug regimens to OXAYDO, determine whether or not to continue the non-opioid analgesic. Titrate the dose of OXAYDO 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 OXAYDO
If a patient has been receiving opioid-containing medications prior to taking OXAYDO, 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 OXAYDO, close observation and adjustment of dosage based upon the patient's response to OXAYDO is imperative.
Conversion from OXAYDO to Extended-Release Oxycodone
The relative bioavailability of OXAYDO compared to extended-release oxycodone is unknown, so conversion to extended-release tablets must be accompanied by close observation for signs of excessive sedation and respiratory depression.
Titration and Maintenance of Therapy
Individually titrate OXAYDO to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OXAYDO to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the dosage of OXAYDO. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Discontinuation of OXAYDO
When a patient who has been taking OXAYDO regularly and may be physically dependent no longer requires therapy with OXAYDO, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue OXAYDO in a physically-dependent patient [see Warnings and Precautions (5.12), Drug Abuse and Dependence (9.3)].
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