Severe pain which requires long-term opioid treatment

Active Ingredient: Oxycodone

Indication for Oxycodone

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Curative procedure

Oxycodone is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

Limitations of Use:

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxycodone for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • Oxycodone is not indicated as an as-needed (prn) analgesic.

For this indication, competent medicine agencies globally authorize below treatments:

10 mg every 12 hours and thereafter 10-80 mg every 12 hours

For:

Dosage regimens

Tablet, extended release oral, 10 milligrams oxycodone, once every 12 hours. Afterwards, tablet, extended release oral, between 10 milligrams oxycodone and 80 milligrams oxycodone, once every 12 hours.

Detailed description

Oxycodone should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

Oxycodone 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Adult patients who are opioid tolerant are those receiving, 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.
  • 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
  • Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with oxycodone and adjust the dosage accordingly.

Oxycodone is administered orally every 12 hours.

Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with oxycodone.

Initial dosage in adults who are not opioid-tolerant

The starting dosage for patients who are not opioid tolerant is oxycodone 10 mg orally every 12 hours.

Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

Conversion from opioids to oxycodone

Conversion from other oral oxycodone formulations to oxycodone

If switching from other oral oxycodone formulations to oxycodone, administer one half of the patient’s total daily oral oxycodone dose as oxycodone every 12 hours.

Conversion from other opioids to oxycodone

Discontinue all other around-the-clock opioid drugs when oxycodone therapy is initiated.

There are no established conversion ratios for conversion from other opioids to oxycodone defined by clinical trials. Initiate dosing using oxycodone 10 mg orally every 12 hours.

It is safer to underestimate a patient’s 24-hour oral oxycodone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral oxycodone dosage and manage an adverse reaction due to an overdose. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioids.

Close observation and frequent titration are warranted until pain management is stable on the new opioid. Monitor patients for signs and symptoms of opioid withdrawal and for signs of oversedation/toxicity after converting patients to oxycodone.

Conversion from methadone to oxycodone

Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

Conversion from transdermal fentanyl to oxycodone

Treatment with oxycodone can be initiated after the transdermal fentanyl patch has been removed for at least 18 hours. Although there has been no systematic assessment of such conversion, start with a conservative conversion: substitute 10 mg of oxycodone every 12 hours for each 25 mcg per hour fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to oxycodone, as there is limited documented experience with this conversion.

Dosage considerations

Instruct patients to swallow oxycodone tablets whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth. Instruct patients not to pre-soak, lick, or otherwise wet the tablet prior to placing in the mouth. Cutting, breaking, crushing, chewing, or dissolving oxycodone tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death.

5-15 mg every 4-6 hours as needed for pain

For:

Dosage regimens

Capsule oral, between 5 milligrams oxycodone and 15 milligrams oxycodone, once every 4 to 6 hours.

Detailed description

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

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.

Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with oxycodone hydrochloride capsules and adjust the dosage accordingly.

Use of oxycodone hydrochloride capsules as the first opioid analgesic

Initiate treatment with oxycodone hydrochloride capsules in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain.

Conversion from other opioids to oxycodone hydrochloride capsules

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 oxycodone hydrochloride capsules. It is safer to underestimate a patient’s 24-hour oxycodone hydrochloride capsules dosage than to overestimate the 24-hour oxycodone hydrochloride capsules dosage and manage an adverse reaction due to overdose.

Conversion from oxycodone hydrochloride capsules to extended-release oxycodone hydrochloride

The relative bioavailability of oxycodone hydrochloride capsules 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 oxycodone hydrochloride capsules to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving oxycodone hydrochloride capsules 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. 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 oxycodone hydrochloride capsules dosage. 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 oxycodone hydrochloride capsules

When a patient who has been taking oxycodone hydrochloride capsules regularly and may be physically dependent no longer requires therapy with oxycodone hydrochloride capsules, 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 oxycodone hydrochloride capsules in a physically-dependent patient.

20 mg daily for patients already receiving and tolerating opioids for at least 5 consecutive days, with the possibility of a 25% increase of the current total daily dosage

For:

Dosage regimens

In case that patient age in years is ≥ 11, tablet, extended release oral, 10 milligrams oxycodone, once every 12 hours.

Detailed description

Oxycodone should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

Oxycodone is administered orally every 12 hours.

Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with oxycodone.

Initial dosage in pediatric patients 11 years and older

The following dosing information is for use only in pediatric patients 11 years and older already receiving and tolerating opioids for at least five consecutive days. For the two days immediately preceding dosing with oxycodone, patients must be taking a minimum of 20 mg per day of oxycodone or its equivalent. Oxycodone is not appropriate for use in pediatric patients requiring less than a 20 mg total daily dose. Table 1, based on clinical trial experience, displays the conversion factor when switching pediatric patients 11 years and older (under the conditions described above) from opioids to oxycodone.

Discontinue all other around-the-clock opioid drugs when oxycodone therapy is initiated.

There is substantial inter-patient variability in the relative potency of different opioid drugs and formulations. Therefore, a conservative approach is advised when determining the total daily dosage of oxycodone. It is safer to underestimate a patient’s 24-hour oral oxycodone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral oxycodone requirements and manage an adverse reaction due to an overdose.

Consider the following when using the information in Table 1.

  • This is not a table of equianalgesic doses.
  • The conversion factors in this table are only for the conversion from one of the listed oral opioid analgesics to oxycodone.
  • The table cannot be used to convert from oxycodone to another opioid. Doing so will result in an over-estimation of the dose of the new opioid and may result in fatal overdose.
  • The formula for conversion from prior opioids, including oral oxycodone, to the daily dose of oxycodone is mg per day of prior opioid x factor = mg per day of oxycodone. Divide the calculated total daily dose by 2 to get the every-12-hour oxycodone dose. If rounding is necessary, always round the dose down to the nearest oxycodone tablet strength available.

Table 1. Conversion Factors When Switching Pediatric Patients 11 Years and Older to oxycodone:

Prior OpioidConversion Factor
Oral Parenteral*
Oxycodone 1 --
Hydrocodone 0.9 --
Hydromorphone 4 20
Morphine 0.5 3
Tramadol 0.17 0.2

* For patients receiving high-dose parenteral opioids, a more conservative conversion is warranted. For example, for high-dose parenteral morphine, use 1.5 instead of 3 as a multiplication factor.

Step #1: To calculate the estimated total oxycodone daily dosage using Table 1:

  • For pediatric patients taking a single opioid, sum the current total daily dosage of the opioid and then multiply the total daily dosage by the approximate conversion factor to calculate the approximate oxycodone daily dosage.
  • For pediatric patients on a regimen of more than one opioid, calculate the approximate oxycodone dose for each opioid and sum the totals to obtain the approximate oxycodone daily dosage.
  • For pediatric patients on a regimen of fixed-ratio opioid/non-opioid analgesic products, use only the opioid component of these products in the conversion.

Step #2: If rounding is necessary, always round the dosage down to the nearest oxycodone tablet strength available and initiate oxycodone therapy with that dose. If the calculated oxycodone total daily dosage is less than 20 mg, there is no safe strength for conversion and do not initiate oxycodone.

Example conversion from a single opioid (e.g., hydrocodone) to oxycodone: Using the conversion factor of 0.9 for oral hydrocodone in Table 1, a total daily hydrocodone dosage of 50 mg is converted to 45 mg of oxycodone per day or 22.5 mg of oxycodone every 12 hours. After rounding down to the nearest strength available, the recommended oxycodone starting dosage is 20 mg every 12 hours.

Step #3: Close observation and titration are warranted until pain management is stable on the new opioid. Monitor patients for signs and symptoms of opioid withdrawal or for signs of over-sedation/toxicity after converting patients to oxycodone.

There is limited experience with conversion from transdermal fentanyl to oxycodone in pediatric patients 11 years and older. If switching from transdermal fentanyl patch to oxycodone, ensure that the patch has been removed for at least 18 hours prior to starting oxycodone. Although there has been no systematic assessment of such conversion, start with a conservative conversion: substitute 10 mg of oxycodone every 12 hours for each 25 mcg per hour fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to oxycodone.

If using asymmetric dosing, instruct patients to take the higher dose in the morning and the lower dose in the evening.

Titration and maintenance of therapy in pediatric patients 11 years and older

Individually titrate oxycodone to a dosage that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving oxycodone to assess the maintenance of pain control, signs and symptoms of opioid withdrawal, and adverse reactions, as well as monitoring for the development of addiction, abuse and misuse. 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. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics.

Patients who experience breakthrough pain may require a dosage adjustment of oxycodone or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the oxycodone dosage. Because steady-state plasma concentrations are approximated in 1 day, oxycodone dosage may be adjusted every 1 to 2 days.

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.

There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours. As a guideline for pediatric patients 11 years and older, the total daily oxycodone dosage usually can be increased by 25% of the current total daily dosage.

Dosage considerations

Instruct patients to swallow oxycodone tablets whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth. Instruct patients not to pre-soak, lick, or otherwise wet the tablet prior to placing in the mouth. Cutting, breaking, crushing, chewing, or dissolving oxycodone tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death.

5-15 mg every 4-6 hours as needed for pain

For:

Dosage regimens

Solution oral, between 5 milligrams oxycodone and 15 milligrams oxycodone, once every 4 to 6 hours.

Detailed description

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

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.

Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with oxycodone hydrochloride solution and adjust the dosage accordingly.

Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with oxycodone hydrochloride oral solution.

Use of oxycodone hydrochloride oral solution as the first opioid analgesic

Initiate treatment with oxycodone hydrochloride oral solution: 5 to 15 mg every 4 to 6 hours as needed for pain.

Titrate the dose based upon the individual patient’s response to their initial dose of oxycodone hydrochloride oral solution. 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, oxycodone hydrochloride oral solution should be administered on a regularly scheduled basis, every 4 to 6 hours, at the lowest dosage level that will achieve adequate analgesia.

Conversion from other opioids to oxycodone hydrochloride oral solution

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 oxycodone hydrochloride oral solution. It is safer to underestimate a patient’s 24-hour oxycodone hydrochloride oral solution than to overestimate the 24-hour oxycodone hydrochloride oral solution dosage and manage an adverse reaction due to overdose. If a patient has been receiving opioid-containing medications prior to taking oxycodone hydrochloride oral solution, the potency of the prior opioid relative to oxycodone should be factored into the selection of the total daily dose (TDD) of oxycodone.

In converting patients from other opioids to oxycodone hydrochloride oral solution, close observation and adjustment of dosage based upon the patient’s response to oxycodone hydrochloride oral solution is imperative. Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of oxycodone hydrochloride oral solution may be necessary, especially in patients who have disease states that are changing rapidly.

Conversion from oxycodone hydrochloride oral solution to extended-release oxycodone

The relative bioavailability of oxycodone hydrochloride oral solution compared to extended-release oxycodone is unknown, so conversion to extended-release tablets/capsules must be accompanied by close observation for signs of excessive sedation and respiratory depression.

Titration and maintenance of therapy

Individually titrate oxycodone hydrochloride oral solution to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving oxycodone hydrochloride oral solution 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. 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 oxycodone hydrochloride oral solution dosage. 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.

Safe reduction or discontinuation of oxycodone hydrochloride oral solution

Do not abruptly discontinue oxycodone hydrochloride oral solution in patients who may be physically dependent on opioids. Rapid discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.

When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking oxycodone hydrochloride oral solution, there are a variety of factors that should be considered, including the dose of oxycodone hydrochloride oral solution the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic. When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder. Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder. Complex patients with co-morbid pain and substance use disorders may benefit from referral to a specialist.

There are no standard opioid tapering schedules that are suitable for all patients. Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually. For patients on oxycodone hydrochloride oral solution who are physically opioid-dependent, initiate the taper by a small enough increment (e.g., no greater than 10% to 25% of the total daily dose) to avoid withdrawal symptoms, and proceed with dose-lowering at an interval of every 2 to 4 weeks. Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper.

It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper. Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge. Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper. In addition, monitor patients for any changes in mood, emergence of suicidal thoughts, or use of other substances.

When managing patients taking opioid analgesics, particularly those who have been treated for a long duration and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper. A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic.

5 mg every 6 hours and thereafter 5 mg every 4-6 hours

For:

Dosage regimens

Solution oral, 5 milligrams oxycodone, once every 6 hours. Afterwards, solution oral, 5 milligrams oxycodone, once every 4 to 6 hours.

Detailed description

Opioids must only be used for appropriate indications and prescribed by a specialist experienced in managing severe pain in children, with careful assessments of the benefits and risks.

Dose initiation:

The usual starting dose for opioid-naive patients, patients presenting with severe pain uncontrolled by weak opioids is 5 mg oxycodone hydrochloride at 6-hour intervals. The dose should be carefully titrated, if necessary on a daily basis, until sufficient pain control is achieved.

During this process, the dosing interval of oxycodone concentrate may be reduced to 4 hours if required.

However, oxycodone concentrate should not be taken more than 6 times a day.

Patients already receiving opioids may be initiated on higher doses depending on their previous opioid experience.

1-10 mg over 1-2 min by intravenous bolus injection, 2 mg/hour by intravenous infusion and 0.03 mg/kg with a minimum lock–out time of 5 min in PCA

For:

Dosage regimens

Regimen A: Intravenous, between 1 milligrams oxycodone and 10 milligrams oxycodone, once every 4 hours.

Regimen B: Intravenous, 2 milligrams oxycodone, once hourly.

Regimen C: Intravenous, 0.03 milligrams oxycodone per kilogram of body weight, once every 5 minutes.

Detailed description

The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication. The correct dosage per individual patient is the lowest dose which sufficiently controls the pain with no or tolerable side effects. The patient’s previous history of analgesic requirements, their body weight, and sex (higher plasma concentration are produced in females), should be taken into account when determining the dose.

Generally, the lowest effective dose for analgesia should be selected. If higher doses are necessary, increases should be made in 25% - 50% increments where possible.

The correct dosage per individual patients is that which controls the pain with no or tolerable side effects.

If an immediate release opioid formulation is used as rescue medication in addition to prolonged-release, the need for more than two “rescues” per day could be an indication that the prolonged-release dosage requires upward titration.

The following starting doses are recommended. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases.

Intravenous bolus: Slow administration of a bolus dose of 1 to 10 mg slowly over 1-2 minutes is recommended. With acute pain the dose should be titrated gradually until optimum analgesic effect is achieved. Bolus doses can be repeated, usually every 4 hours. In adolescents, a maximum bolus dose of 5 mg oxycodone hydrochloride is recommended.

Intravenous Infusion: A starting dose of 2 mg/hour is recommended.

Intravenous patient-controlled analgesia: Administration of a bolus doses of 0.03 mg/kg should be administered with a minimum lock–out time of 5 minutes.

Cancer patients transferring from oral oxycodone may require much higher doses (see below).

Treatment goals and discontinuation

Before initiating treatment with OxyNorm injection, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered.

Duration of treatment

Oxycodone should not be used for longer than necessary.

Conversion from morphine

It must be emphasized that this is a guide to the dose of oxycodone required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose. Initially, a lower-than-equivalent dose may be advisable.

Transferring patients between oral and parenteral oxycodone

The dose should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be emphasized that this is a guide to the dose required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

Parenteral

Patients switching from parenteral morphine to parenteral oxycodone therapy should do so on the basis of a one to one dose ratio.

Elderly

Elderly patients should be treated with caution. The lowest dose should be administered with careful titration to pain control.

5 mg every 4 hours by subcutaneous bolus or 7.5 mg/day followed by titration according to symptom control

For:

Dosage regimens

Regimen A: Subcutaneous, 5 milligrams oxycodone, once every 4 hours.

Regimen B: Subcutaneous, 7.5 milligrams oxycodone, once daily.

Detailed description

The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication. The correct dosage per individual patient is the lowest dose which sufficiently controls the pain with no or tolerable side effects. The patient’s previous history of analgesic requirements, their body weight, and sex (higher plasma concentration are produced in females), should be taken into account when determining the dose.

Generally, the lowest effective dose for analgesia should be selected. If higher doses are necessary, increases should be made in 25% - 50% increments where possible.

The correct dosage per individual patients is that which controls the pain with no or tolerable side effects.

If an immediate release opioid formulation is used as rescue medication in addition to prolonged-release, the need for more than two “rescues” per day could be an indication that the prolonged-release dosage requires upward titration.

The following starting dose is recommended. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases.

Subcutaneous bolus: Use as 10 mg/ml strength. A strong dose of 5 mg is recommended. With acute pain the dose should be titrated gradually until optimum analgesic effect is achieved. Bolus doses can be repeated, usually every 4 hours, if pain relief decreases.

Subcutaneous infusion: A starting dose of 7.5 mg/day is recommended in opioid naïve patients, titrating gradually according to symptom control.

Cancer patients transferring from oral oxycodone may require much higher doses (see below).

Treatment goals and discontinuation

Before initiating treatment with OxyNorm injection, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered.

Duration of treatment

Oxycodone should not be used for longer than necessary.

Conversion from morphine

It must be emphasized that this is a guide to the dose of oxycodone required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose. Initially, a lower-than-equivalent dose may be advisable.

Transferring patients between oral and parenteral oxycodone

The dose should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be emphasized that this is a guide to the dose required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

Parenteral

Patients switching from parenteral morphine to parenteral oxycodone therapy should do so on the basis of a one to one dose ratio.

Elderly

Elderly patients should be treated with caution. The lowest dose should be administered with careful titration to pain control.

5 mg every 4 hours by subcutaneous bolus or 5 mg per day by subcutaneous infusion followed by titration according to symptom control

For:

Dosage regimens

Regimen A: Subcutaneous, 5 milligrams oxycodone, once every 4 hours.

Regimen B: Subcutaneous, 5 milligrams oxycodone, once daily.

Detailed description

The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication. The correct dosage per individual patient is the lowest dose which sufficiently controls the pain with no or tolerable side effects. The patient’s previous history of analgesic requirements, their body weight, and sex (higher plasma concentration are produced in females), should be taken into account when determining the dose.

Generally, the lowest effective dose for analgesia should be selected. If higher doses are necessary, increases should be made in 25% - 50% increments where possible.

The correct dosage per individual patients is that which controls the pain with no or tolerable side effects.

If an immediate release opioid formulation is used as rescue medication in addition to prolonged-release, the need for more than two “rescues” per day could be an indication that the prolonged-release dosage requires upward titration.

The following starting dose is recommended. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases.

Subcutaneous bolus: Use as 10 mg/ml strength. A strong dose of 5 mg is recommended. With acute pain the dose should be titrated gradually until optimum analgesic effect is achieved. Bolus doses can be repeated, usually every 4 hours, if pain relief decreases.

Subcutaneous infusion: In adolescents, a starting dose of 5 mg oxycodone hydrochloride per day is recommended.

Cancer patients transferring from oral oxycodone may require much higher doses (see below).

Treatment goals and discontinuation

Before initiating treatment with OxyNorm injection, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered.

Duration of treatment

Oxycodone should not be used for longer than necessary.

Conversion from morphine

It must be emphasized that this is a guide to the dose of oxycodone required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose. Initially, a lower-than-equivalent dose may be advisable.

Transferring patients between oral and parenteral oxycodone

The dose should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be emphasized that this is a guide to the dose required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

Parenteral

Patients switching from parenteral morphine to parenteral oxycodone therapy should do so on the basis of a one to one dose ratio.

Active ingredient

Oxycodone

Oxycodone is a full opioid agonist with no antagonist properties. It has an affinity for kappa, mu and delta opioid receptors in the brain and spinal cord. Oxycodone is similar to morphine in its action. The therapeutic effect is mainly analgesic, anxiolytic, antitussive and sedative.

Read more about Oxycodone

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