Oxycontin

Oxycontin Manufacturers

• Blenheim Pharmacal, Inc.
  

  ×

  Oxycontin | Blenheim Pharmacal, Inc.

  

  ---

  General Principles

  OXYCONTIN IS AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE. OXYCODONE, LIKE MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA, CAN BE ABUSED AND IS SUBJECT TO CRIMINAL DIVERSION.

  OXYCONTIN TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OXYCONTIN® TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

  One OxyContin 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets (see DOSAGE AND ADMINISTRATION).

  Patients should be started on the lowest appropriate dose (see DOSAGE AND ADMINISTRATION: Initiation of Therapy). In treating pain it is vital to assess the patient regularly and systematically. Therapy should also be regularly reviewed and adjusted based upon the patient's own reports of pain and side effects and the health professional's clinical judgment.

  OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The controlled-release nature of the formulation allows OxyContin to be effectively administered every 12 hours (see CLINICAL PHARMACOLOGY; PHARMACOKINETICS AND METABOLISM). While symmetric (same dose AM and PM), around-the-clock, q12h dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern. It is usually appropriate to treat a patient with only one opioid for around-the-clock therapy.

  Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).

  Initiation of Therapy

  It is critical to initiate the dosing regimen for each patient individually, taking into account the patient's prior opioid and non-opioid analgesic treatment. Attention should be given to:

  (1) the general condition and medical status of the patient; (2) the daily dose, potency, and kind of the analgesic(s) the patient has been taking; (3) the reliability of the conversion estimate used to calculate the dose of oxycodone; (4) the patient's opioid exposure and opioid tolerance (if any); (5) the Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg; and (6) the balance between pain control and adverse experiences.

  Care should be taken to use low initial doses of OxyContin in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications (see PRECAUTIONS: Drug-Drug Interactions).

  For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios from Foley, KM. [NEJM, 1985; 313:84-95], found below, are a reasonable starting point, although not verified in well-controlled, multiple-dose trials.

  Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg q12h. If a non-opioid analgesic is being provided, it may be continued. OxyContin should be individually titrated to a dose that provides adequate analgesia and minimizes side effects.

  Using standard conversion ratio estimates (see Table 4 below), multiply the mg/day of the previous opioids by the appropriate multiplication factors to obtain the equivalent total daily dose of oral oxycodone. When converting from oxycodone, divide the 24-hour oxycodone dose in half to obtain the twice a day (q12h) dose of OxyContin. Round down to a dose which is appropriate for the tablet strengths available. Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses. The recommended doses shown in Table 4 are only a starting point, and close observation and frequent titration are indicated until patients are stable on the new therapy. TABLE 4. Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Daily Dose of Oral Oxycodone* * To be used only for conversion to oral oxycodone. 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. (Mg/Day Prior Opioid x Factor = Mg/Day Oral
  Oxycodone) Oral Prior Opioid Parenteral Prior Opioid Oxycodone 1 -- Codeine 0.15 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Levorphanol 7.5 15 Meperidine 0.1 0.4 Methadone 1.5 3 Morphine 0.5 3

  In all cases, supplemental analgesia should be made available in the form of a suitable short-acting analgesic.

  OxyContin® can be safely used concomitantly with usual doses of non-opioid analgesics and analgesic adjuvants, provided care is taken to select a proper initial dose (see PRECAUTIONS).

  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg q12h of OxyContin, should be initially substituted for each 25 µg/hr fentanyl transdermal patch. The patient should be followed closely for early titration, as there is very limited clinical experience with this conversion.

  Managing Expected Opioid Adverse Experiences

  Most patients receiving opioids, especially those who are opioid-naive, will experience side effects. Frequently the side effects from OxyContin are transient, but may require evaluation and management. Adverse events such as constipation should be anticipated and treated aggressively and prophylactically with a stimulant laxative and/or stool softener. Patients do not usually become tolerant to the constipating effects of opioids.

  Other opioid-related side effects such as sedation and nausea are usually self-limited and often do not persist beyond the first few days. If nausea persists and is unacceptable to the patient, treatment with antiemetics or other modalities may relieve these symptoms and should be considered.

  Patients receiving OxyContin® may pass an intact matrix "ghost" in the stool or via colostomy. These ghosts contain little or no residual oxycodone and are of no clinical consequence.

  Individualization of Dosage

  Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. Patients should be titrated to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours). Patients who experience breakthrough pain may require dosage adjustment or rescue medication. Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. It is most appropriate to increase the q12h dose, not the dosing frequency. There is no clinical information on dosing intervals shorter than q12h. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose at each increase.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given. Alternatively, non-opioid analgesic adjuvants may be employed. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences.

  If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are under control, upward titration should continue to an acceptable level of pain control.

  During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family.

  Special Instructions for OxyContin 60 mg, 80 mg and 160 mg Tablets or a Single Dose Greater Than 40 mg (for use in opioid-tolerant patients only)

  OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, are for use in opioid-tolerant patients only. A single daily dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

  One OxyContin® 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (incident pain).

  Maintenance of Therapy

  The intent of the titration period is to establish a patient-specific q12h dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary. Should pain recur then the dose can be incrementally increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to re-establish pain control.

  During chronic therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with OxyContin Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from OxyContin to Parenteral Opioids

  To avoid overdose, conservative dose conversion ratios should be followed.

  Close
  No Recall

  More Info
• Stat Rx Usa Llc
  

  ×

  Oxycontin | Stat Rx Usa Llc

  

  ---

  General Principles

  OXYCONTIN IS AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE. OXYCODONE, LIKE MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA, CAN BE ABUSED AND IS SUBJECT TO CRIMINAL DIVERSION.

  OXYCONTIN TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OXYCONTIN® TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

  One OxyContin 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets (see DOSAGE AND ADMINISTRATION).

  Patients should be started on the lowest appropriate dose (see DOSAGE AND ADMINISTRATION: Initiation of Therapy). In treating pain it is vital to assess the patient regularly and systematically. Therapy should also be regularly reviewed and adjusted based upon the patient's own reports of pain and side effects and the health professional's clinical judgment.

  OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The controlled-release nature of the formulation allows OxyContin to be effectively administered every 12 hours (see CLINICAL PHARMACOLOGY; PHARMACOKINETICS AND METABOLISM). While symmetric (same dose AM and PM), around-the-clock, q12h dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern. It is usually appropriate to treat a patient with only one opioid for around-the-clock therapy.

  Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).

  Initiation of Therapy

  It is critical to initiate the dosing regimen for each patient individually, taking into account the patient's prior opioid and non-opioid analgesic treatment. Attention should be given to:

  (1) the general condition and medical status of the patient; (2) the daily dose, potency, and kind of the analgesic(s) the patient has been taking; (3) the reliability of the conversion estimate used to calculate the dose of oxycodone; (4) the patient's opioid exposure and opioid tolerance (if any); (5) the Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg; and (6) the balance between pain control and adverse experiences.

  Care should be taken to use low initial doses of OxyContin in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications (see PRECAUTIONS: Drug-Drug Interactions).

  For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios from Foley, KM. [NEJM, 1985; 313:84-95], found below, are a reasonable starting point, although not verified in well-controlled, multiple-dose trials.

  Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg q12h. If a non-opioid analgesic is being provided, it may be continued. OxyContin should be individually titrated to a dose that provides adequate analgesia and minimizes side effects.

  Using standard conversion ratio estimates (see Table 4 below), multiply the mg/day of the previous opioids by the appropriate multiplication factors to obtain the equivalent total daily dose of oral oxycodone. When converting from oxycodone, divide the 24-hour oxycodone dose in half to obtain the twice a day (q12h) dose of OxyContin. Round down to a dose which is appropriate for the tablet strengths available. Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses. The recommended doses shown in Table 4 are only a starting point, and close observation and frequent titration are indicated until patients are stable on the new therapy. TABLE 4. Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Daily Dose of Oral Oxycodone* * To be used only for conversion to oral oxycodone. 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. (Mg/Day Prior Opioid x Factor = Mg/Day Oral
  Oxycodone) Oral Prior Opioid Parenteral Prior Opioid Oxycodone 1 -- Codeine 0.15 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Levorphanol 7.5 15 Meperidine 0.1 0.4 Methadone 1.5 3 Morphine 0.5 3

  In all cases, supplemental analgesia should be made available in the form of a suitable short-acting analgesic.

  OxyContin® can be safely used concomitantly with usual doses of non-opioid analgesics and analgesic adjuvants, provided care is taken to select a proper initial dose (see PRECAUTIONS).

  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg q12h of OxyContin, should be initially substituted for each 25 µg/hr fentanyl transdermal patch. The patient should be followed closely for early titration, as there is very limited clinical experience with this conversion.

  Managing Expected Opioid Adverse Experiences

  Most patients receiving opioids, especially those who are opioid-naive, will experience side effects. Frequently the side effects from OxyContin are transient, but may require evaluation and management. Adverse events such as constipation should be anticipated and treated aggressively and prophylactically with a stimulant laxative and/or stool softener. Patients do not usually become tolerant to the constipating effects of opioids.

  Other opioid-related side effects such as sedation and nausea are usually self-limited and often do not persist beyond the first few days. If nausea persists and is unacceptable to the patient, treatment with antiemetics or other modalities may relieve these symptoms and should be considered.

  Patients receiving OxyContin® may pass an intact matrix "ghost" in the stool or via colostomy. These ghosts contain little or no residual oxycodone and are of no clinical consequence.

  Individualization of Dosage

  Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. Patients should be titrated to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours). Patients who experience breakthrough pain may require dosage adjustment or rescue medication. Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. It is most appropriate to increase the q12h dose, not the dosing frequency. There is no clinical information on dosing intervals shorter than q12h. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose at each increase.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given. Alternatively, non-opioid analgesic adjuvants may be employed. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences.

  If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are under control, upward titration should continue to an acceptable level of pain control.

  During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family.

  Special Instructions for OxyContin 60 mg, 80 mg and 160 mg Tablets or a Single Dose Greater Than 40 mg (for use in opioid-tolerant patients only)

  OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, are for use in opioid-tolerant patients only. A single daily dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

  One OxyContin® 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (incident pain).

  Maintenance of Therapy

  The intent of the titration period is to establish a patient-specific q12h dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary. Should pain recur then the dose can be incrementally increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to re-establish pain control.

  During chronic therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with OxyContin Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from OxyContin to Parenteral Opioids

  To avoid overdose, conservative dose conversion ratios should be followed.

  Close
  No Recall

  More Info
• Pd-rx Pharmaceuticals, Inc.
  

  ×

  Oxycontin | Pd-rx Pharmaceuticals, Inc.

  

  ---

  General Principles

  OXYCONTIN IS AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE. OXYCODONE, LIKE MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA, CAN BE ABUSED AND IS SUBJECT TO CRIMINAL DIVERSION.

  OXYCONTIN TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OXYCONTIN® TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

  One OxyContin 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets (see DOSAGE AND ADMINISTRATION).

  Patients should be started on the lowest appropriate dose (see DOSAGE AND ADMINISTRATION: Initiation of Therapy). In treating pain it is vital to assess the patient regularly and systematically. Therapy should also be regularly reviewed and adjusted based upon the patient's own reports of pain and side effects and the health professional's clinical judgment.

  OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The controlled-release nature of the formulation allows OxyContin to be effectively administered every 12 hours (see CLINICAL PHARMACOLOGY; PHARMACOKINETICS AND METABOLISM). While symmetric (same dose AM and PM), around-the-clock, q12h dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern. It is usually appropriate to treat a patient with only one opioid for around-the-clock therapy.

  Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).

  Initiation of Therapy

  It is critical to initiate the dosing regimen for each patient individually, taking into account the patient's prior opioid and non-opioid analgesic treatment. Attention should be given to:

  (1) the general condition and medical status of the patient; (2) the daily dose, potency, and kind of the analgesic(s) the patient has been taking; (3) the reliability of the conversion estimate used to calculate the dose of oxycodone; (4) the patient's opioid exposure and opioid tolerance (if any); (5) the Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg; and (6) the balance between pain control and adverse experiences.

  Care should be taken to use low initial doses of OxyContin in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications (see PRECAUTIONS: Drug-Drug Interactions).

  For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios from Foley, KM. [NEJM, 1985; 313:84-95], found below, are a reasonable starting point, although not verified in well-controlled, multiple-dose trials.

  Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg q12h. If a non-opioid analgesic is being provided, it may be continued. OxyContin should be individually titrated to a dose that provides adequate analgesia and minimizes side effects.

  Using standard conversion ratio estimates (see Table 4 below), multiply the mg/day of the previous opioids by the appropriate multiplication factors to obtain the equivalent total daily dose of oral oxycodone. When converting from oxycodone, divide the 24-hour oxycodone dose in half to obtain the twice a day (q12h) dose of OxyContin. Round down to a dose which is appropriate for the tablet strengths available. Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses. The recommended doses shown in Table 4 are only a starting point, and close observation and frequent titration are indicated until patients are stable on the new therapy. TABLE 4. Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Daily Dose of Oral Oxycodone* * To be used only for conversion to oral oxycodone. 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. (Mg/Day Prior Opioid x Factor = Mg/Day Oral
  Oxycodone) Oral Prior Opioid Parenteral Prior Opioid Oxycodone 1 -- Codeine 0.15 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Levorphanol 7.5 15 Meperidine 0.1 0.4 Methadone 1.5 3 Morphine 0.5 3

  In all cases, supplemental analgesia should be made available in the form of a suitable short-acting analgesic.

  OxyContin® can be safely used concomitantly with usual doses of non-opioid analgesics and analgesic adjuvants, provided care is taken to select a proper initial dose (see PRECAUTIONS).

  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg q12h of OxyContin, should be initially substituted for each 25 µg/hr fentanyl transdermal patch. The patient should be followed closely for early titration, as there is very limited clinical experience with this conversion.

  Managing Expected Opioid Adverse Experiences

  Most patients receiving opioids, especially those who are opioid-naive, will experience side effects. Frequently the side effects from OxyContin are transient, but may require evaluation and management. Adverse events such as constipation should be anticipated and treated aggressively and prophylactically with a stimulant laxative and/or stool softener. Patients do not usually become tolerant to the constipating effects of opioids.

  Other opioid-related side effects such as sedation and nausea are usually self-limited and often do not persist beyond the first few days. If nausea persists and is unacceptable to the patient, treatment with antiemetics or other modalities may relieve these symptoms and should be considered.

  Patients receiving OxyContin® may pass an intact matrix "ghost" in the stool or via colostomy. These ghosts contain little or no residual oxycodone and are of no clinical consequence.

  Individualization of Dosage

  Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. Patients should be titrated to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours). Patients who experience breakthrough pain may require dosage adjustment or rescue medication. Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. It is most appropriate to increase the q12h dose, not the dosing frequency. There is no clinical information on dosing intervals shorter than q12h. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose at each increase.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given. Alternatively, non-opioid analgesic adjuvants may be employed. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences.

  If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are under control, upward titration should continue to an acceptable level of pain control.

  During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family.

  Special Instructions for OxyContin 60 mg, 80 mg and 160 mg Tablets or a Single Dose Greater Than 40 mg (for use in opioid-tolerant patients only)

  OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, are for use in opioid-tolerant patients only. A single daily dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

  One OxyContin® 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (incident pain).

  Maintenance of Therapy

  The intent of the titration period is to establish a patient-specific q12h dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary. Should pain recur then the dose can be incrementally increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to re-establish pain control.

  During chronic therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with OxyContin Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from OxyContin to Parenteral Opioids

  To avoid overdose, conservative dose conversion ratios should be followed.

  Close
  No Recall

  More Info
• Pd-rx Pharmaceuticals, Inc.
  

  ×

  Oxycontin | Pd-rx Pharmaceuticals, Inc.

  

  ---

  General Principles

  OXYCONTIN IS AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE. OXYCODONE, LIKE MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA, CAN BE ABUSED AND IS SUBJECT TO CRIMINAL DIVERSION.

  OXYCONTIN TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OXYCONTIN® TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

  One OxyContin 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets (see DOSAGE AND ADMINISTRATION).

  Patients should be started on the lowest appropriate dose (see DOSAGE AND ADMINISTRATION: Initiation of Therapy). In treating pain it is vital to assess the patient regularly and systematically. Therapy should also be regularly reviewed and adjusted based upon the patient's own reports of pain and side effects and the health professional's clinical judgment.

  OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The controlled-release nature of the formulation allows OxyContin to be effectively administered every 12 hours (see CLINICAL PHARMACOLOGY; PHARMACOKINETICS AND METABOLISM). While symmetric (same dose AM and PM), around-the-clock, q12h dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern. It is usually appropriate to treat a patient with only one opioid for around-the-clock therapy.

  Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).

  Initiation of Therapy

  It is critical to initiate the dosing regimen for each patient individually, taking into account the patient's prior opioid and non-opioid analgesic treatment. Attention should be given to:

  (1) the general condition and medical status of the patient; (2) the daily dose, potency, and kind of the analgesic(s) the patient has been taking; (3) the reliability of the conversion estimate used to calculate the dose of oxycodone; (4) the patient's opioid exposure and opioid tolerance (if any); (5) the Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg; and (6) the balance between pain control and adverse experiences.

  Care should be taken to use low initial doses of OxyContin in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications (see PRECAUTIONS: Drug-Drug Interactions).

  For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios from Foley, KM. [NEJM, 1985; 313:84-95], found below, are a reasonable starting point, although not verified in well-controlled, multiple-dose trials.

  Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg q12h. If a non-opioid analgesic is being provided, it may be continued. OxyContin should be individually titrated to a dose that provides adequate analgesia and minimizes side effects.

  Using standard conversion ratio estimates (see Table 4 below), multiply the mg/day of the previous opioids by the appropriate multiplication factors to obtain the equivalent total daily dose of oral oxycodone. When converting from oxycodone, divide the 24-hour oxycodone dose in half to obtain the twice a day (q12h) dose of OxyContin. Round down to a dose which is appropriate for the tablet strengths available. Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses. The recommended doses shown in Table 4 are only a starting point, and close observation and frequent titration are indicated until patients are stable on the new therapy. TABLE 4. Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Daily Dose of Oral Oxycodone* * To be used only for conversion to oral oxycodone. 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. (Mg/Day Prior Opioid x Factor = Mg/Day Oral
  Oxycodone) Oral Prior Opioid Parenteral Prior Opioid Oxycodone 1 -- Codeine 0.15 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Levorphanol 7.5 15 Meperidine 0.1 0.4 Methadone 1.5 3 Morphine 0.5 3

  In all cases, supplemental analgesia should be made available in the form of a suitable short-acting analgesic.

  OxyContin® can be safely used concomitantly with usual doses of non-opioid analgesics and analgesic adjuvants, provided care is taken to select a proper initial dose (see PRECAUTIONS).

  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg q12h of OxyContin, should be initially substituted for each 25 µg/hr fentanyl transdermal patch. The patient should be followed closely for early titration, as there is very limited clinical experience with this conversion.

  Managing Expected Opioid Adverse Experiences

  Most patients receiving opioids, especially those who are opioid-naive, will experience side effects. Frequently the side effects from OxyContin are transient, but may require evaluation and management. Adverse events such as constipation should be anticipated and treated aggressively and prophylactically with a stimulant laxative and/or stool softener. Patients do not usually become tolerant to the constipating effects of opioids.

  Other opioid-related side effects such as sedation and nausea are usually self-limited and often do not persist beyond the first few days. If nausea persists and is unacceptable to the patient, treatment with antiemetics or other modalities may relieve these symptoms and should be considered.

  Patients receiving OxyContin® may pass an intact matrix "ghost" in the stool or via colostomy. These ghosts contain little or no residual oxycodone and are of no clinical consequence.

  Individualization of Dosage

  Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. Patients should be titrated to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours). Patients who experience breakthrough pain may require dosage adjustment or rescue medication. Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. It is most appropriate to increase the q12h dose, not the dosing frequency. There is no clinical information on dosing intervals shorter than q12h. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose at each increase.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given. Alternatively, non-opioid analgesic adjuvants may be employed. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences.

  If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are under control, upward titration should continue to an acceptable level of pain control.

  During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family.

  Special Instructions for OxyContin 60 mg, 80 mg and 160 mg Tablets or a Single Dose Greater Than 40 mg (for use in opioid-tolerant patients only)

  OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, are for use in opioid-tolerant patients only. A single daily dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

  One OxyContin® 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (incident pain).

  Maintenance of Therapy

  The intent of the titration period is to establish a patient-specific q12h dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary. Should pain recur then the dose can be incrementally increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to re-establish pain control.

  During chronic therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with OxyContin Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from OxyContin to Parenteral Opioids

  To avoid overdose, conservative dose conversion ratios should be followed.

  Close
  No Recall

  More Info
• Pd-rx Pharmaceuticals, Inc.
  

  ×

  Oxycontin | Pd-rx Pharmaceuticals, Inc.

  

  ---

  General Principles

  OXYCONTIN IS AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE. OXYCODONE, LIKE MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA, CAN BE ABUSED AND IS SUBJECT TO CRIMINAL DIVERSION.

  OXYCONTIN TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OXYCONTIN® TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

  One OxyContin 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets (see DOSAGE AND ADMINISTRATION).

  Patients should be started on the lowest appropriate dose (see DOSAGE AND ADMINISTRATION: Initiation of Therapy). In treating pain it is vital to assess the patient regularly and systematically. Therapy should also be regularly reviewed and adjusted based upon the patient's own reports of pain and side effects and the health professional's clinical judgment.

  OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The controlled-release nature of the formulation allows OxyContin to be effectively administered every 12 hours (see CLINICAL PHARMACOLOGY; PHARMACOKINETICS AND METABOLISM). While symmetric (same dose AM and PM), around-the-clock, q12h dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern. It is usually appropriate to treat a patient with only one opioid for around-the-clock therapy.

  Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).

  Initiation of Therapy

  It is critical to initiate the dosing regimen for each patient individually, taking into account the patient's prior opioid and non-opioid analgesic treatment. Attention should be given to:

  (1) the general condition and medical status of the patient; (2) the daily dose, potency, and kind of the analgesic(s) the patient has been taking; (3) the reliability of the conversion estimate used to calculate the dose of oxycodone; (4) the patient's opioid exposure and opioid tolerance (if any); (5) the Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg; and (6) the balance between pain control and adverse experiences.

  Care should be taken to use low initial doses of OxyContin in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications (see PRECAUTIONS: Drug-Drug Interactions).

  For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios from Foley, KM. [NEJM, 1985; 313:84-95], found below, are a reasonable starting point, although not verified in well-controlled, multiple-dose trials.

  Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg q12h. If a non-opioid analgesic is being provided, it may be continued. OxyContin should be individually titrated to a dose that provides adequate analgesia and minimizes side effects.

  Using standard conversion ratio estimates (see Table 4 below), multiply the mg/day of the previous opioids by the appropriate multiplication factors to obtain the equivalent total daily dose of oral oxycodone. When converting from oxycodone, divide the 24-hour oxycodone dose in half to obtain the twice a day (q12h) dose of OxyContin. Round down to a dose which is appropriate for the tablet strengths available. Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses. The recommended doses shown in Table 4 are only a starting point, and close observation and frequent titration are indicated until patients are stable on the new therapy. TABLE 4. Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Daily Dose of Oral Oxycodone* * To be used only for conversion to oral oxycodone. 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. (Mg/Day Prior Opioid x Factor = Mg/Day Oral
  Oxycodone) Oral Prior Opioid Parenteral Prior Opioid Oxycodone 1 -- Codeine 0.15 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Levorphanol 7.5 15 Meperidine 0.1 0.4 Methadone 1.5 3 Morphine 0.5 3

  In all cases, supplemental analgesia should be made available in the form of a suitable short-acting analgesic.

  OxyContin® can be safely used concomitantly with usual doses of non-opioid analgesics and analgesic adjuvants, provided care is taken to select a proper initial dose (see PRECAUTIONS).

  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg q12h of OxyContin, should be initially substituted for each 25 µg/hr fentanyl transdermal patch. The patient should be followed closely for early titration, as there is very limited clinical experience with this conversion.

  Managing Expected Opioid Adverse Experiences

  Most patients receiving opioids, especially those who are opioid-naive, will experience side effects. Frequently the side effects from OxyContin are transient, but may require evaluation and management. Adverse events such as constipation should be anticipated and treated aggressively and prophylactically with a stimulant laxative and/or stool softener. Patients do not usually become tolerant to the constipating effects of opioids.

  Other opioid-related side effects such as sedation and nausea are usually self-limited and often do not persist beyond the first few days. If nausea persists and is unacceptable to the patient, treatment with antiemetics or other modalities may relieve these symptoms and should be considered.

  Patients receiving OxyContin® may pass an intact matrix "ghost" in the stool or via colostomy. These ghosts contain little or no residual oxycodone and are of no clinical consequence.

  Individualization of Dosage

  Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. Patients should be titrated to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours). Patients who experience breakthrough pain may require dosage adjustment or rescue medication. Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. It is most appropriate to increase the q12h dose, not the dosing frequency. There is no clinical information on dosing intervals shorter than q12h. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose at each increase.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given. Alternatively, non-opioid analgesic adjuvants may be employed. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences.

  If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are under control, upward titration should continue to an acceptable level of pain control.

  During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family.

  Special Instructions for OxyContin 60 mg, 80 mg and 160 mg Tablets or a Single Dose Greater Than 40 mg (for use in opioid-tolerant patients only)

  OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, are for use in opioid-tolerant patients only. A single daily dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

  One OxyContin® 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (incident pain).

  Maintenance of Therapy

  The intent of the titration period is to establish a patient-specific q12h dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary. Should pain recur then the dose can be incrementally increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to re-establish pain control.

  During chronic therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with OxyContin Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from OxyContin to Parenteral Opioids

  To avoid overdose, conservative dose conversion ratios should be followed.

  Close
  No Recall

  More Info
• St Marys Medical Park Pharmacy
  

  ×

  Oxycontin | St Marys Medical Park Pharmacy

  

  ---

  General Principles

  OXYCONTIN IS AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE. OXYCODONE, LIKE MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA, CAN BE ABUSED AND IS SUBJECT TO CRIMINAL DIVERSION.

  OxyContin Tablets must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Taking cut, broken, chewed, crushed or dissloved OxyContin® Tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone.

  One OxyContin 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets (see DOSAGE AND ADMINISTRATION).

  Patients should be started on the lowest appropriate dose (see DOSAGE AND ADMINISTRATION: Initiation of Therapy). In treating pain it is vital to assess the patient regularly and systematically. Therapy should also be regularly reviewed and adjusted based upon the patient's own reports of pain and side effects and the health professional's clinical judgment.

  OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The controlled-release nature of the formulation allows OxyContin to be effectively administered every 12 hours (see CLINICAL PHARMACOLOGY; PHARMACOKINETICS AND METABOLISM). While symmetric (same dose AM and PM), around-the-clock, q12h dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern. It is usually appropriate to treat a patient with only one opioid for around-the-clock therapy.

  Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).

  Initiation of Therapy

  It is critical to initiate the dosing regimen for each patient individually, taking into account the patient's prior opioid and non-opioid analgesic treatment. Attention should be given to:

  (1) risk factors for abuse or addiction; including whether the patient has a previous or current substance abuse problem, a family history of substance abuse, or a history of mental illness or depression; (2) the age, general condition and medical status of the patient; (3) the daily dose, potency, and kind of the analgesic(s) the patient has been taking; (4) the reliability of the conversion estimate used to calculate the dose of oxycodone; (5) the patient's opioid exposure and opioid tolerance (if any); (6) the Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg; and (7) the balance between pain control and adverse experiences.

  Care should be taken to use low initial doses of OxyContin in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications (see PRECAUTIONS: Drug-Drug Interactions).

  For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios from Foley, KM. [NEJM, 1985; 313:84-95], found below, are a reasonable starting point, although not verified in well-controlled, multiple-dose trials.

  Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg q12h. If a non-opioid analgesic is being provided, it may be continued. OxyContin should be individually titrated to a dose that provides adequate analgesia and minimizes side effects.

  Using standard conversion ratio estimates (see Table 4 below), multiply the mg/day of the previous opioids by the appropriate multiplication factors to obtain the equivalent total daily dose of oral oxycodone. When converting from oxycodone, divide the 24-hour oxycodone dose in half to obtain the twice a day (q12h) dose of OxyContin. Round down to a dose which is appropriate for the tablet strengths available. Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses. The recommended doses shown in Table 4 are only a starting point, and close observation and frequent titration are indicated until patients are stable on the new therapy. TABLE 4. Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Daily Dose of Oral Oxycodone* * To be used only for conversion to oral oxycodone. 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. (Mg/Day Prior Opioid x Factor = Mg/Day Oral
  Oxycodone) Oral Prior Opioid Parenteral Prior Opioid Oxycodone 1 -- Codeine 0.15 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Levorphanol 7.5 15 Meperidine 0.1 0.4 Methadone 1.5 3 Morphine 0.5 3

  In all cases, supplemental analgesia should be made available in the form of a suitable short-acting analgesic.

  OxyContin® can be safely used concomitantly with usual doses of non-opioid analgesics and analgesic adjuvants, provided care is taken to select a proper initial dose (see PRECAUTIONS).

  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg q12h of OxyContin, should be initially substituted for each 25 µg/hr fentanyl transdermal patch. The patient should be followed closely for early titration, as there is very limited clinical experience with this conversion.

  Managing Expected Opioid Adverse Experiences

  Most patients receiving opioids, especially those who are opioid-naive, will experience side effects. Frequently the side effects from OxyContin are transient, but may require evaluation and management. Adverse events such as constipation should be anticipated and treated aggressively and prophylactically with a stimulant laxative and/or stool softener. Patients do not usually become tolerant to the constipating effects of opioids.

  Other opioid-related side effects such as sedation and nausea are usually self-limited and often do not persist beyond the first few days. If nausea persists and is unacceptable to the patient, treatment with antiemetics or other modalities may relieve these symptoms and should be considered.

  Patients receiving OxyContin® may pass an intact matrix "ghost" in the stool or via colostomy. These ghosts contain little or no residual oxycodone and are of no clinical consequence.

  Individualization of Dosage

  Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. Patients should be titrated to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours). Patients who experience breakthrough pain may require dosage adjustment or rescue medication. Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. It is most appropriate to increase the q12h dose, not the dosing frequency. There is no clinical information on dosing intervals shorter than q12h. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose at each increase.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given. Alternatively, non-opioid analgesic adjuvants may be employed. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences.

  If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are under control, upward titration should continue to an acceptable level of pain control.

  During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family.

  Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg (for use in opioid-tolerant patients only)

  OxyContin 60 mg, 80 mg, and 160 mg Tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in opioid-tolerant patients, as they may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory-depressant, or sedating effects of opioids. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

  Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

  One OxyContin® 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (incident pain).

  Maintenance of Therapy

  The intent of the titration period is to establish a patient-specific q12h dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary. Should pain recur then the dose can be incrementally increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to re-establish pain control.

  During chronic therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with OxyContin Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from OxyContin to Parenteral Opioids

  To avoid overdose, conservative dose conversion ratios should be followed.

  Close
  No Recall

  More Info
• Rebel Distributors Corp
  

  ×

  Oxycontin | Rebel Distributors Corp

  

  ---

  2.1  Safe Administration Instructions

  OxyContin tablets must be swallowed whole and must not be cut, broken, chewed, crushed or dissolved. Taking cut, broken, chewed, crushed or dissolved OxyContin tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone.

  OxyContin tablets should be taken one tablet at a time. Take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17.1)].

  Selection of patients for treatment with OxyContin should be governed by the same principles that apply to the use of similar opioid analgesics. Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, Federation of State Medical Boards Model Policy, and the American Pain Society.  Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring.

  2.2  Initiating Therapy with OxyContin

  It is critical to initiate the dosing regimen for each patient individually.  Attention should be given to:

  risk factors for abuse or addiction; including whether the patient has a previous or current substance abuse problem, a family history of substance abuse, or a history of mental illness or depression; the age, general condition and medical status of the patient; the patient's opioid exposure and opioid tolerance (if any); the daily dose, potency, and kind of the analgesic(s) the patient has been taking; the reliability of the conversion estimate used to calculate the dose of oxycodone; the special instructions for OxyContin  60 mg and 80 mg tablets, a single dose greater than 40 mg, or total daily doses greater than 80 mg [see Dosage and Administration (2.7)]; and the balance between pain control and adverse reactions.

  Use low initial doses of OxyContin in patients who are not already opioid-tolerant [see Dosage and Administration (2.7)], especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications [see Warnings and Precautions (5.1, 5.3) and   Drug Interactions (7.1, 7.3)].

  Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg every 12 hours.  Individually titrate OxyContin to a dose that provides adequate analgesia and minimizes adverse reactions while maintaining an every-twelve-hour dosing regimen.

  For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios found in Table 1 are a reasonable starting point, although not verified in well-controlled, multiple-dose trials. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses.  A reasonable approach for converting from existing opioid therapy to OxyContin is as follows:

  Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated. Using standard conversion ratio estimates (see Table 1), multiply the mg/day of each of the current opioids to be converted by their appropriate multiplication factor to obtain the equivalent total daily dose of oral oxycodone. Divide the calculated 24-hour oxycodone dose in half to approximate the every 12-hour dose of OxyContin. Round down, if necessary, to the appropriate OxyContin tablet strengths available. Close observation and frequent titration are indicated until patients are stable on the new therapy. TABLE 1 Multiplication Factors for Converting the Daily Dose
  of Current Opioids to the Daily Dose of Oral Oxycodone1* * To be used only for conversion to oral oxycodone. 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.   (mg/Day Opioid x Factor = mg/Day Oral Oxycodone)   Oral Opioid Parenteral Opioid Oxycodone 1 -- Codeine 0.15 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Levorphanol 7.5 15 Meperidine 0.1 0.4 Methadone 1.5 3 Morphine 0.5 3 2.3  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated.  Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg every 12 hours of OxyContin, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch.  Follow the patient closely during conversion from transdermal fentanyl to OxyContin, as there is limited documented experience with this conversion.

  2.4  Hepatic Impairment

  For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the usual starting dose followed by careful dose titration [see Clinical Pharmacology (12.3)].

  2.5  Managing Expected Opioid Adverse Reactions

  Most patients receiving OxyContin, especially those who are opioid-naive, will experience adverse reactions. Patients do not usually become tolerant to the constipating effects of opioids, therefore, anticipate constipation  and treat aggressively and prophylactically with a stimulant laxative with or without a stool softener.

  If nausea persists and is unacceptable to the patient, consider treatment with antiemetics or other modalities to relieve these symptoms.

  2.6  Individualization of Dosage

  Once therapy is initiated, assess pain relief and other opioid effects frequently.  Titrate patients to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours).  Patients who experience breakthrough pain may require dosage adjustment or rescue medication.  Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. 

  There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours.  Increase the OxyContin dose by increasing the total daily dose, not by changing the 12-hour dosing interval. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose, each time an increase is clinically indicated.

  If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced.  If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given.  Alternatively, non-opioid analgesic adjuvants may be employed.  Adjust the dose to obtain an appropriate balance between pain relief and opioid-related adverse reactions.

  During periods of changing analgesic requirements, including initial titration, maintain frequent contact between physician, other members of the healthcare team, the patient and, with proper consent, the caregiver/family.

  2.7  Special Instructions for Patients who are not Opioid Tolerant

  Do not begin treatment with OxyContin 60 mg and 80 mg Tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg in patients who are not already tolerant to the respiratory-depressant and sedating effects of opioids.  Use of these doses in patients who are not opioid tolerant may cause fatal respiratory depression.  These doses are only for use in opioid-tolerant patients. 

  Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

  Instruct patients not to share or permit use by individuals other than the patient for whom OxyContin was prescribed, as such inappropriate use may have severe medical consequences, including death.

  2.8  Continuation of Therapy

  During chronic therapy, especially for non-cancer pain syndromes, reassess the continued need for around-the-clock opioid therapy regularly (e.g., every 6 to 12 months) as appropriate.

  2.9  Cessation of Therapy

  When the patient no longer requires therapy with OxyContin, taper the dose gradually to prevent signs and symptoms of withdrawal in the physically-dependent patient.

  2.10  Conversion from OxyContin to Parenteral Opioids

  To avoid overdose, follow conservative dose conversion ratios. When converting from OxyContin to parenteral opioids, it is advisable to calculate an equivalent parenteral dose and then initiate treatment at half of this calculated value.

  Close
  No Recall

  More Info
• Rebel Distributors Corp
  

  ×

  Oxycontin | Rebel Distributors Corp

  

  ---

  2.1  Safe Administration Instructions

  OxyContin tablets must be swallowed whole and must not be cut, broken, chewed, crushed or dissolved. Taking cut, broken, chewed, crushed or dissolved OxyContin tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone.

  OxyContin tablets should be taken one tablet at a time. Take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17.1)].

  Selection of patients for treatment with OxyContin should be governed by the same principles that apply to the use of similar opioid analgesics. Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, Federation of State Medical Boards Model Policy, and the American Pain Society.  Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring.

  2.2  Initiating Therapy with OxyContin

  It is critical to initiate the dosing regimen for each patient individually.  Attention should be given to:

  risk factors for abuse or addiction; including whether the patient has a previous or current substance abuse problem, a family history of substance abuse, or a history of mental illness or depression; the age, general condition and medical status of the patient; the patient's opioid exposure and opioid tolerance (if any); the daily dose, potency, and kind of the analgesic(s) the patient has been taking; the reliability of the conversion estimate used to calculate the dose of oxycodone; the special instructions for OxyContin  60 mg and 80 mg tablets, a single dose greater than 40 mg, or total daily doses greater than 80 mg [see Dosage and Administration (2.7)]; and the balance between pain control and adverse reactions.

  Use low initial doses of OxyContin in patients who are not already opioid-tolerant [see Dosage and Administration (2.7)], especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications [see Warnings and Precautions (5.1, 5.3) and   Drug Interactions (7.1, 7.3)].

  Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg every 12 hours.  Individually titrate OxyContin to a dose that provides adequate analgesia and minimizes adverse reactions while maintaining an every-twelve-hour dosing regimen.

  For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios found in Table 1 are a reasonable starting point, although not verified in well-controlled, multiple-dose trials. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses.  A reasonable approach for converting from existing opioid therapy to OxyContin is as follows:

  Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated. Using standard conversion ratio estimates (see Table 1), multiply the mg/day of each of the current opioids to be converted by their appropriate multiplication factor to obtain the equivalent total daily dose of oral oxycodone. Divide the calculated 24-hour oxycodone dose in half to approximate the every 12-hour dose of OxyContin. Round down, if necessary, to the appropriate OxyContin tablet strengths available. Close observation and frequent titration are indicated until patients are stable on the new therapy. TABLE 1 Multiplication Factors for Converting the Daily Dose
  of Current Opioids to the Daily Dose of Oral Oxycodone1* * To be used only for conversion to oral oxycodone. 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.   (mg/Day Opioid x Factor = mg/Day Oral Oxycodone)   Oral Opioid Parenteral Opioid Oxycodone 1 -- Codeine 0.15 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Levorphanol 7.5 15 Meperidine 0.1 0.4 Methadone 1.5 3 Morphine 0.5 3 2.3  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated.  Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg every 12 hours of OxyContin, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch.  Follow the patient closely during conversion from transdermal fentanyl to OxyContin, as there is limited documented experience with this conversion.

  2.4  Hepatic Impairment

  For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the usual starting dose followed by careful dose titration [see Clinical Pharmacology (12.3)].

  2.5  Managing Expected Opioid Adverse Reactions

  Most patients receiving OxyContin, especially those who are opioid-naive, will experience adverse reactions. Patients do not usually become tolerant to the constipating effects of opioids, therefore, anticipate constipation  and treat aggressively and prophylactically with a stimulant laxative with or without a stool softener.

  If nausea persists and is unacceptable to the patient, consider treatment with antiemetics or other modalities to relieve these symptoms.

  2.6  Individualization of Dosage

  Once therapy is initiated, assess pain relief and other opioid effects frequently.  Titrate patients to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours).  Patients who experience breakthrough pain may require dosage adjustment or rescue medication.  Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. 

  There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours.  Increase the OxyContin dose by increasing the total daily dose, not by changing the 12-hour dosing interval. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose, each time an increase is clinically indicated.

  If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced.  If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given.  Alternatively, non-opioid analgesic adjuvants may be employed.  Adjust the dose to obtain an appropriate balance between pain relief and opioid-related adverse reactions.

  During periods of changing analgesic requirements, including initial titration, maintain frequent contact between physician, other members of the healthcare team, the patient and, with proper consent, the caregiver/family.

  2.7  Special Instructions for Patients who are not Opioid Tolerant

  Do not begin treatment with OxyContin 60 mg and 80 mg Tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg in patients who are not already tolerant to the respiratory-depressant and sedating effects of opioids.  Use of these doses in patients who are not opioid tolerant may cause fatal respiratory depression.  These doses are only for use in opioid-tolerant patients. 

  Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

  Instruct patients not to share or permit use by individuals other than the patient for whom OxyContin was prescribed, as such inappropriate use may have severe medical consequences, including death.

  2.8  Continuation of Therapy

  During chronic therapy, especially for non-cancer pain syndromes, reassess the continued need for around-the-clock opioid therapy regularly (e.g., every 6 to 12 months) as appropriate.

  2.9  Cessation of Therapy

  When the patient no longer requires therapy with OxyContin, taper the dose gradually to prevent signs and symptoms of withdrawal in the physically-dependent patient.

  2.10  Conversion from OxyContin to Parenteral Opioids

  To avoid overdose, follow conservative dose conversion ratios. When converting from OxyContin to parenteral opioids, it is advisable to calculate an equivalent parenteral dose and then initiate treatment at half of this calculated value.

  Close
  No Recall

  More Info
• Lake Erie Medical Dba Quality Care Products Llc
  

  ×

  Oxycontin | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  General Principles

  OXYCONTIN IS AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE. OXYCODONE, LIKE MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA, CAN BE ABUSED AND IS SUBJECT TO CRIMINAL DIVERSION.

  OxyContin Tablets must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Taking cut, broken, chewed, crushed or dissloved OxyContin® Tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone.

  One OxyContin 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets (see DOSAGE AND ADMINISTRATION).

  Patients should be started on the lowest appropriate dose (see DOSAGE AND ADMINISTRATION: Initiation of Therapy). In treating pain it is vital to assess the patient regularly and systematically. Therapy should also be regularly reviewed and adjusted based upon the patient's own reports of pain and side effects and the health professional's clinical judgment.

  OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The controlled-release nature of the formulation allows OxyContin to be effectively administered every 12 hours (see CLINICAL PHARMACOLOGY; PHARMACOKINETICS AND METABOLISM). While symmetric (same dose AM and PM), around-the-clock, q12h dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern. It is usually appropriate to treat a patient with only one opioid for around-the-clock therapy.

  Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).

  Initiation of Therapy

  It is critical to initiate the dosing regimen for each patient individually, taking into account the patient's prior opioid and non-opioid analgesic treatment. Attention should be given to:

  (1) risk factors for abuse or addiction; including whether the patient has a previous or current substance abuse problem, a family history of substance abuse, or a history of mental illness or depression; (2) the age, general condition and medical status of the patient; (3) the daily dose, potency, and kind of the analgesic(s) the patient has been taking; (4) the reliability of the conversion estimate used to calculate the dose of oxycodone; (5) the patient's opioid exposure and opioid tolerance (if any); (6) the Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg; and (7) the balance between pain control and adverse experiences.

  Care should be taken to use low initial doses of OxyContin in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications (see PRECAUTIONS: Drug-Drug Interactions).

  For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios from Foley, KM. [NEJM, 1985; 313:84-95], found below, are a reasonable starting point, although not verified in well-controlled, multiple-dose trials.

  Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg q12h. If a non-opioid analgesic is being provided, it may be continued. OxyContin should be individually titrated to a dose that provides adequate analgesia and minimizes side effects.

  Using standard conversion ratio estimates (see Table 4 below), multiply the mg/day of the previous opioids by the appropriate multiplication factors to obtain the equivalent total daily dose of oral oxycodone. When converting from oxycodone, divide the 24-hour oxycodone dose in half to obtain the twice a day (q12h) dose of OxyContin. Round down to a dose which is appropriate for the tablet strengths available. Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses. The recommended doses shown in Table 4 are only a starting point, and close observation and frequent titration are indicated until patients are stable on the new therapy. TABLE 4. Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Daily Dose of Oral Oxycodone* * To be used only for conversion to oral oxycodone. 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. (Mg/Day Prior Opioid x Factor = Mg/Day Oral
  Oxycodone) Oral Prior Opioid Parenteral Prior Opioid Oxycodone 1 -- Codeine 0.15 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Levorphanol 7.5 15 Meperidine 0.1 0.4 Methadone 1.5 3 Morphine 0.5 3

  In all cases, supplemental analgesia should be made available in the form of a suitable short-acting analgesic.

  OxyContin® can be safely used concomitantly with usual doses of non-opioid analgesics and analgesic adjuvants, provided care is taken to select a proper initial dose (see PRECAUTIONS).

  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg q12h of OxyContin, should be initially substituted for each 25 µg/hr fentanyl transdermal patch. The patient should be followed closely for early titration, as there is very limited clinical experience with this conversion.

  Managing Expected Opioid Adverse Experiences

  Most patients receiving opioids, especially those who are opioid-naive, will experience side effects. Frequently the side effects from OxyContin are transient, but may require evaluation and management. Adverse events such as constipation should be anticipated and treated aggressively and prophylactically with a stimulant laxative and/or stool softener. Patients do not usually become tolerant to the constipating effects of opioids.

  Other opioid-related side effects such as sedation and nausea are usually self-limited and often do not persist beyond the first few days. If nausea persists and is unacceptable to the patient, treatment with antiemetics or other modalities may relieve these symptoms and should be considered.

  Patients receiving OxyContin® may pass an intact matrix "ghost" in the stool or via colostomy. These ghosts contain little or no residual oxycodone and are of no clinical consequence.

  Individualization of Dosage

  Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. Patients should be titrated to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours). Patients who experience breakthrough pain may require dosage adjustment or rescue medication. Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. It is most appropriate to increase the q12h dose, not the dosing frequency. There is no clinical information on dosing intervals shorter than q12h. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose at each increase.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given. Alternatively, non-opioid analgesic adjuvants may be employed. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences.

  If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are under control, upward titration should continue to an acceptable level of pain control.

  During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family.

  Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg (for use in opioid-tolerant patients only)

  OxyContin 60 mg, 80 mg, and 160 mg Tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in opioid-tolerant patients, as they may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory-depressant, or sedating effects of opioids. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

  Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

  One OxyContin® 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (incident pain).

  Maintenance of Therapy

  The intent of the titration period is to establish a patient-specific q12h dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary. Should pain recur then the dose can be incrementally increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to re-establish pain control.

  During chronic therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with OxyContin Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from OxyContin to Parenteral Opioids

  To avoid overdose, conservative dose conversion ratios should be followed.

  Close
  No Recall

  More Info
• Lake Erie Medical Dba Quality Care Products Llc
  

  ×

  Oxycontin | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  DOSAGE AND ADMINISTRATION General Principles

  OXYCONTIN IS AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE. OXYCODONE, LIKE MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA, CAN BE ABUSED AND IS SUBJECT TO CRIMINAL DIVERSION.

  OXYCONTIN TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OXYCONTIN® TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

  One OxyContin 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets (see DOSAGE AND ADMINISTRATION).

  Patients should be started on the lowest appropriate dose (see DOSAGE AND ADMINISTRATION: Initiation of Therapy). In treating pain it is vital to assess the patient regularly and systematically. Therapy should also be regularly reviewed and adjusted based upon the patient's own reports of pain and side effects and the health professional's clinical judgment.

  OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The controlled-release nature of the formulation allows OxyContin to be effectively administered every 12 hours (see CLINICAL PHARMACOLOGY; PHARMACOKINETICS AND METABOLISM). While symmetric (same dose AM and PM), around-the-clock, q12h dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern. It is usually appropriate to treat a patient with only one opioid for around-the-clock therapy.
  

  Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).
  
  Initiation of Therapy

  It is critical to initiate the dosing regimen for each patient individually, taking into account the patient's prior opioid and non-opioid analgesic treatment. Attention should be given to:

  (1)the general condition and medical status of the patient;(2)the daily dose, potency, and kind of the analgesic(s) the patient has been taking;(3)the reliability of the conversion estimate used to calculate the dose of oxycodone;(4)the patient's opioid exposure and opioid tolerance (if any);(5)the Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg; and (6)the balance between pain control and adverse experiences.
  

  Care should be taken to use low initial doses of OxyContin in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications (see PRECAUTIONS: Drug-Drug Interactions).

  For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios from Foley, KM. [NEJM, 1985; 313:84-95], found below, are a reasonable starting point, although not verified in well-controlled, multiple-dose trials.

  
  

  Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg q12h. If a non-opioid analgesic is being provided, it may be continued. OxyContin should be individually titrated to a dose that provides adequate analgesia and minimizes side effects.

  Using standard conversion ratio estimates (see Table 4 below), multiply the mg/day of the previous opioids by the appropriate multiplication factors to obtain the equivalent total daily dose of oral oxycodone. When converting from oxycodone, divide the 24-hour oxycodone dose in half to obtain the twice a day (q12h) dose of OxyContin. Round down to a dose which is appropriate for the tablet strengths available. Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses. The recommended doses shown in Table 4 are only a starting point, and close observation and frequent titration are indicated until patients are stable on the new therapy.

  In all cases, supplemental analgesia should be made available in the form of a suitable short-acting analgesic.

  OxyContin® can be safely used concomitantly with usual doses of non-opioid analgesics and analgesic adjuvants, provided care is taken to select a proper initial dose (see PRECAUTIONS).

  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg q12h of OxyContin, should be initially substituted for each 25 µg/hr fentanyl transdermal patch. The patient should be followed closely for early titration, as there is very limited clinical experience with this conversion.

  Managing Expected Opioid Adverse Experiences

  Most patients receiving opioids, especially those who are opioid-naive, will experience side effects. Frequently the side effects from OxyContin are transient, but may require evaluation and management. Adverse events such as constipation should be anticipated and treated aggressively and prophylactically with a stimulant laxative and/or stool softener. Patients do not usually become tolerant to the constipating effects of opioids.

  Other opioid-related side effects such as sedation and nausea are usually self-limited and often do not persist beyond the first few days. If nausea persists and is unacceptable to the patient, treatment with antiemetics or other modalities may relieve these symptoms and should be considered.

  Patients receiving OxyContin® may pass an intact matrix "ghost" in the stool or via colostomy. These ghosts contain little or no residual oxycodone and are of no clinical consequence.

  Individualization of Dosage

  Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. Patients should be titrated to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours). Patients who experience breakthrough pain may require dosage adjustment or rescue medication. Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. It is most appropriate to increase the q12h dose, not the dosing frequency. There is no clinical information on dosing intervals shorter than q12h. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose at each increase.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given. Alternatively, non-opioid analgesic adjuvants may be employed. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences.

  If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are under control, upward titration should continue to an acceptable level of pain control.

  During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family.

  Special Instructions for OxyContin 60 mg, 80 mg and 160 mg Tablets or a Single Dose Greater Than 40 mg (for use in opioid-tolerant patients only)

  OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, are for use in opioid-tolerant patients only. A single daily dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

  One OxyContin® 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (incident pain).

  Maintenance of Therapy

  The intent of the titration period is to establish a patient-specific q12h dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary. Should pain recur then the dose can be incrementally increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to re-establish pain control.

  During chronic therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with OxyContin Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from OxyContin to Parenteral Opioids

  To avoid overdose, conservative dose conversion ratios should be followed.

  Close
  No Recall

  More Info
• Stat Rx Usa Llc
  

  ×

  Oxycontin | Stat Rx Usa Llc

  

  ---

  2.1  Safe Administration Instructions

  OxyContin tablets must be swallowed whole and must not be cut, broken, chewed, crushed or dissolved. Taking cut, broken, chewed, crushed or dissolved OxyContin tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone.

  OxyContin tablets should be taken one tablet at a time. Take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17.1)].

  Selection of patients for treatment with OxyContin should be governed by the same principles that apply to the use of similar opioid analgesics. Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, Federation of State Medical Boards Model Policy, and the American Pain Society.  Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring.

  2.2  Initiating Therapy with OxyContin

  It is critical to initiate the dosing regimen for each patient individually.  Attention should be given to:

  risk factors for abuse or addiction; including whether the patient has a previous or current substance abuse problem, a family history of substance abuse, or a history of mental illness or depression; the age, general condition and medical status of the patient; the patient's opioid exposure and opioid tolerance (if any); the daily dose, potency, and kind of the analgesic(s) the patient has been taking; the reliability of the conversion estimate used to calculate the dose of oxycodone; the special instructions for OxyContin  60 mg and 80 mg tablets, a single dose greater than 40 mg, or total daily doses greater than 80 mg [see Dosage and Administration (2.7)]; and the balance between pain control and adverse reactions.

  Use low initial doses of OxyContin in patients who are not already opioid-tolerant [see Dosage and Administration (2.7)], especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications [see Warnings and Precautions (5.1, 5.3) and Drug Interactions (7.1, 7.3)].

  Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg every 12 hours.  Individually titrate OxyContin to a dose that provides adequate analgesia and minimizes adverse reactions while maintaining an every-twelve-hour dosing regimen.

  For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios found in Table 1 are a reasonable starting point, although not verified in well-controlled, multiple-dose trials. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses.  A reasonable approach for converting from existing opioid therapy to OxyContin is as follows:

  Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated. Using standard conversion ratio estimates (see Table 1), multiply the mg/day of each of the current opioids to be converted by their appropriate multiplication factor to obtain the equivalent total daily dose of oral oxycodone. Divide the calculated 24-hour oxycodone dose in half to approximate the every 12-hour dose of OxyContin. Round down, if necessary, to the appropriate OxyContin tablet strengths available. Close observation and frequent titration are indicated until patients are stable on the new therapy. TABLE 1 Multiplication Factors for Converting the Daily Dose
  of Current Opioids to the Daily Dose of Oral Oxycodone1* * To be used only for conversion to oral oxycodone. 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.   (mg/Day Opioid x Factor = mg/Day Oral Oxycodone)   Oral Opioid Parenteral Opioid Oxycodone 1 -- Codeine 0.15 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Levorphanol 7.5 15 Meperidine 0.1 0.4 Methadone 1.5 3 Morphine 0.5 3 2.3  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated.  Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg every 12 hours of OxyContin, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch.  Follow the patient closely during conversion from transdermal fentanyl to OxyContin, as there is limited documented experience with this conversion.

  2.4  Hepatic Impairment

  For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the usual starting dose followed by careful dose titration [see Clinical Pharmacology (12.3)].

  2.5  Managing Expected Opioid Adverse Reactions

  Most patients receiving OxyContin, especially those who are opioid-naive, will experience adverse reactions. Patients do not usually become tolerant to the constipating effects of opioids, therefore, anticipate constipation  and treat aggressively and prophylactically with a stimulant laxative with or without a stool softener. If nausea persists and is unacceptable to the patient, consider treatment with antiemetics or other modalities to relieve these symptoms.

  2.6  Individualization of Dosage

  Once therapy is initiated, assess pain relief and other opioid effects frequently.  Titrate patients to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours).  Patients who experience breakthrough pain may require dosage adjustment or rescue medication.  Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. 

  There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours.  Increase the OxyContin dose by increasing the total daily dose, not by changing the 12-hour dosing interval. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose, each time an increase is clinically indicated.

  If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced.  If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given.  Alternatively, non-opioid analgesic adjuvants may be employed.  Adjust the dose to obtain an appropriate balance between pain relief and opioid-related adverse reactions.

  During periods of changing analgesic requirements, including initial titration, maintain frequent contact between physician, other members of the healthcare team, the patient and, with proper consent, the caregiver/family.

  2.7  Special Instructions for Patients who are not Opioid Tolerant

  Do not begin treatment with OxyContin 60 mg and 80 mg Tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg in patients who are not already tolerant to the respiratory-depressant and sedating effects of opioids.  Use of these doses in patients who are not opioid tolerant may cause fatal respiratory depression.  These doses are only for use in opioid-tolerant patients. 

  Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

  Instruct patients not to share or permit use by individuals other than the patient for whom OxyContin was prescribed, as such inappropriate use may have severe medical consequences, including death.

  2.8  Continuation of Therapy

  During chronic therapy, especially for non-cancer pain syndromes, reassess the continued need for around-the-clock opioid therapy regularly (e.g., every 6 to 12 months) as appropriate.

  2.9  Cessation of Therapy

  When the patient no longer requires therapy with OxyContin, taper the dose gradually to prevent signs and symptoms of withdrawal in the physically-dependent patient.

  2.10  Conversion from OxyContin to Parenteral Opioids

  To avoid overdose, follow conservative dose conversion ratios. When converting from OxyContin to parenteral opioids, it is advisable to calculate an equivalent parenteral dose and then initiate treatment at half of this calculated value.

  Close
  No Recall

  More Info
• Stat Rx Usa Llc
  

  ×

  Oxycontin | Stat Rx Usa Llc

  

  ---

  2.1  Safe Administration Instructions

  OxyContin tablets must be swallowed whole and must not be cut, broken, chewed, crushed or dissolved. Taking cut, broken, chewed, crushed or dissolved OxyContin tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone.

  OxyContin tablets should be taken one tablet at a time. Take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17.1)].

  Selection of patients for treatment with OxyContin should be governed by the same principles that apply to the use of similar opioid analgesics. Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, Federation of State Medical Boards Model Policy, and the American Pain Society.  Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring.

  2.2  Initiating Therapy with OxyContin

  It is critical to initiate the dosing regimen for each patient individually.  Attention should be given to:

  risk factors for abuse or addiction; including whether the patient has a previous or current substance abuse problem, a family history of substance abuse, or a history of mental illness or depression; the age, general condition and medical status of the patient; the patient's opioid exposure and opioid tolerance (if any); the daily dose, potency, and kind of the analgesic(s) the patient has been taking; the reliability of the conversion estimate used to calculate the dose of oxycodone; the special instructions for OxyContin  60 mg and 80 mg tablets, a single dose greater than 40 mg, or total daily doses greater than 80 mg [see Dosage and Administration (2.7)]; and the balance between pain control and adverse reactions.

  Use low initial doses of OxyContin in patients who are not already opioid-tolerant [see Dosage and Administration (2.7)], especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications [see Warnings and Precautions (5.1, 5.3) and Drug Interactions (7.1, 7.3)].

  Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg every 12 hours.  Individually titrate OxyContin to a dose that provides adequate analgesia and minimizes adverse reactions while maintaining an every-twelve-hour dosing regimen.

  For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios found in Table 1 are a reasonable starting point, although not verified in well-controlled, multiple-dose trials. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses.  A reasonable approach for converting from existing opioid therapy to OxyContin is as follows:

  Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated. Using standard conversion ratio estimates (see Table 1), multiply the mg/day of each of the current opioids to be converted by their appropriate multiplication factor to obtain the equivalent total daily dose of oral oxycodone. Divide the calculated 24-hour oxycodone dose in half to approximate the every 12-hour dose of OxyContin. Round down, if necessary, to the appropriate OxyContin tablet strengths available. Close observation and frequent titration are indicated until patients are stable on the new therapy. TABLE 1 Multiplication Factors for Converting the Daily Dose
  of Current Opioids to the Daily Dose of Oral Oxycodone1* * To be used only for conversion to oral oxycodone. 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.   (mg/Day Opioid x Factor = mg/Day Oral Oxycodone)   Oral Opioid Parenteral Opioid Oxycodone 1 -- Codeine 0.15 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Levorphanol 7.5 15 Meperidine 0.1 0.4 Methadone 1.5 3 Morphine 0.5 3 2.3  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated.  Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg every 12 hours of OxyContin, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch.  Follow the patient closely during conversion from transdermal fentanyl to OxyContin, as there is limited documented experience with this conversion.

  2.4  Hepatic Impairment

  For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the usual starting dose followed by careful dose titration [see Clinical Pharmacology (12.3)].

  2.5  Managing Expected Opioid Adverse Reactions

  Most patients receiving OxyContin, especially those who are opioid-naive, will experience adverse reactions. Patients do not usually become tolerant to the constipating effects of opioids, therefore, anticipate constipation  and treat aggressively and prophylactically with a stimulant laxative with or without a stool softener. If nausea persists and is unacceptable to the patient, consider treatment with antiemetics or other modalities to relieve these symptoms.

  2.6  Individualization of Dosage

  Once therapy is initiated, assess pain relief and other opioid effects frequently.  Titrate patients to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours).  Patients who experience breakthrough pain may require dosage adjustment or rescue medication.  Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. 

  There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours.  Increase the OxyContin dose by increasing the total daily dose, not by changing the 12-hour dosing interval. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose, each time an increase is clinically indicated.

  If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced.  If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given.  Alternatively, non-opioid analgesic adjuvants may be employed.  Adjust the dose to obtain an appropriate balance between pain relief and opioid-related adverse reactions.

  During periods of changing analgesic requirements, including initial titration, maintain frequent contact between physician, other members of the healthcare team, the patient and, with proper consent, the caregiver/family.

  2.7  Special Instructions for Patients who are not Opioid Tolerant

  Do not begin treatment with OxyContin 60 mg and 80 mg Tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg in patients who are not already tolerant to the respiratory-depressant and sedating effects of opioids.  Use of these doses in patients who are not opioid tolerant may cause fatal respiratory depression.  These doses are only for use in opioid-tolerant patients. 

  Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

  Instruct patients not to share or permit use by individuals other than the patient for whom OxyContin was prescribed, as such inappropriate use may have severe medical consequences, including death.

  2.8  Continuation of Therapy

  During chronic therapy, especially for non-cancer pain syndromes, reassess the continued need for around-the-clock opioid therapy regularly (e.g., every 6 to 12 months) as appropriate.

  2.9  Cessation of Therapy

  When the patient no longer requires therapy with OxyContin, taper the dose gradually to prevent signs and symptoms of withdrawal in the physically-dependent patient.

  2.10  Conversion from OxyContin to Parenteral Opioids

  To avoid overdose, follow conservative dose conversion ratios. When converting from OxyContin to parenteral opioids, it is advisable to calculate an equivalent parenteral dose and then initiate treatment at half of this calculated value.

  Close
  No Recall

  More Info
• Rebel Distributors Corp
  

  ×

  Oxycontin | Rebel Distributors Corp

  

  ---

  2.1  Safe Administration Instructions

  OxyContin tablets must be swallowed whole and must not be cut, broken, chewed, crushed or dissolved. Taking cut, broken, chewed, crushed or dissolved OxyContin tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone.

  OxyContin tablets should be taken one tablet at a time. Take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17.1)].

  Selection of patients for treatment with OxyContin should be governed by the same principles that apply to the use of similar opioid analgesics. Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, Federation of State Medical Boards Model Policy, and the American Pain Society.  Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring.

  2.2  Initiating Therapy with OxyContin

  It is critical to initiate the dosing regimen for each patient individually.  Attention should be given to:

  risk factors for abuse or addiction; including whether the patient has a previous or current substance abuse problem, a family history of substance abuse, or a history of mental illness or depression; the age, general condition and medical status of the patient; the patient's opioid exposure and opioid tolerance (if any); the daily dose, potency, and kind of the analgesic(s) the patient has been taking; the reliability of the conversion estimate used to calculate the dose of oxycodone; the special instructions for OxyContin  60 mg and 80 mg tablets, a single dose greater than 40 mg, or total daily doses greater than 80 mg [see Dosage and Administration (2.7)]; and the balance between pain control and adverse reactions.

  Use low initial doses of OxyContin in patients who are not already opioid-tolerant [see Dosage and Administration (2.7)], especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications [see Warnings and Precautions (5.1, 5.3) and Drug Interactions (7.1, 7.3)].

  Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg every 12 hours.  Individually titrate OxyContin to a dose that provides adequate analgesia and minimizes adverse reactions while maintaining an every-twelve-hour dosing regimen.

  For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios found in Table 1 are a reasonable starting point, although not verified in well-controlled, multiple-dose trials. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses.  A reasonable approach for converting from existing opioid therapy to OxyContin is as follows:

  Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated. Using standard conversion ratio estimates (see Table 1), multiply the mg/day of each of the current opioids to be converted by their appropriate multiplication factor to obtain the equivalent total daily dose of oral oxycodone. Divide the calculated 24-hour oxycodone dose in half to approximate the every 12-hour dose of OxyContin. Round down, if necessary, to the appropriate OxyContin tablet strengths available. Close observation and frequent titration are indicated until patients are stable on the new therapy. TABLE 1 Multiplication Factors for Converting the Daily Dose
  of Current Opioids to the Daily Dose of Oral Oxycodone1* * To be used only for conversion to oral oxycodone. 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.   (mg/Day Opioid x Factor = mg/Day Oral Oxycodone)   Oral Opioid Parenteral Opioid Oxycodone 1 -- Codeine 0.15 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Levorphanol 7.5 15 Meperidine 0.1 0.4 Methadone 1.5 3 Morphine 0.5 3 2.3  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated.  Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg every 12 hours of OxyContin, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch.  Follow the patient closely during conversion from transdermal fentanyl to OxyContin, as there is limited documented experience with this conversion.

  2.4  Hepatic Impairment

  For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the usual starting dose followed by careful dose titration [see Clinical Pharmacology (12.3)].

  2.5  Managing Expected Opioid Adverse Reactions

  Most patients receiving OxyContin, especially those who are opioid-naive, will experience adverse reactions. Patients do not usually become tolerant to the constipating effects of opioids, therefore, anticipate constipation  and treat aggressively and prophylactically with a stimulant laxative with or without a stool softener. If nausea persists and is unacceptable to the patient, consider treatment with antiemetics or other modalities to relieve these symptoms.

  2.6  Individualization of Dosage

  Once therapy is initiated, assess pain relief and other opioid effects frequently.  Titrate patients to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours).  Patients who experience breakthrough pain may require dosage adjustment or rescue medication.  Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. 

  There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours.  Increase the OxyContin dose by increasing the total daily dose, not by changing the 12-hour dosing interval. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose, each time an increase is clinically indicated.

  If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced.  If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given.  Alternatively, non-opioid analgesic adjuvants may be employed.  Adjust the dose to obtain an appropriate balance between pain relief and opioid-related adverse reactions.

  During periods of changing analgesic requirements, including initial titration, maintain frequent contact between physician, other members of the healthcare team, the patient and, with proper consent, the caregiver/family.

  2.7  Special Instructions for Patients who are not Opioid Tolerant

  Do not begin treatment with OxyContin 60 mg and 80 mg Tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg in patients who are not already tolerant to the respiratory-depressant and sedating effects of opioids.  Use of these doses in patients who are not opioid tolerant may cause fatal respiratory depression.  These doses are only for use in opioid-tolerant patients. 

  Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

  Instruct patients not to share or permit use by individuals other than the patient for whom OxyContin was prescribed, as such inappropriate use may have severe medical consequences, including death.

  2.8  Continuation of Therapy

  During chronic therapy, especially for non-cancer pain syndromes, reassess the continued need for around-the-clock opioid therapy regularly (e.g., every 6 to 12 months) as appropriate.

  2.9  Cessation of Therapy

  When the patient no longer requires therapy with OxyContin, taper the dose gradually to prevent signs and symptoms of withdrawal in the physically-dependent patient.

  2.10  Conversion from OxyContin to Parenteral Opioids

  To avoid overdose, follow conservative dose conversion ratios. When converting from OxyContin to parenteral opioids, it is advisable to calculate an equivalent parenteral dose and then initiate treatment at half of this calculated value.

  Close
  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Oxycontin | Bryant Ranch Prepack

  

  ---

  2.1 Initial Dosing

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with OxyContin [see Warnings and Precautions (5.2)].

  Consider the following factors when selecting an initial dose of OxyContin:

  Total daily dose, potency, and any prior opioid the patient has been taking previously; Reliability of the relative potency estimate used to calculate the equivalent dose of oxycodone needed (Note: potency estimates may vary with the route of administration); Patient's degree of opioid experience and opioid tolerance; General condition and medical status of the patient; Concurrent medication; Type and severity of the patient's pain.

  Use of OxyContin as the First Opioid Analgesic

  Initiate therapy with 10 mg every 12 hours.

  Conversion from other Oral Oxycodone Formulations to OxyContin

  Patients receiving other oral oxycodone formulations may be converted to OxyContin by administering one-half of the patient's total daily oral oxycodone dose as OxyContin every 12 hours.

  Conversion from other Opioids to OxyContin

  While there are useful tables of oral and parenteral equivalents, there is substantial inter-patient variation in the relative potency of different opioid drugs and formulations. Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. As such, it is safer to underestimate a patient's 24-hour oral oxycodone requirement and provide rescue medication (e.g., immediate-release oxycodone) than to overestimate and precipitate an adverse reaction. In general, begin with half of the estimated daily oxycodone requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release oxycodone.

  Published relative potency data are available and may be referred to in clinical practice guidelines such as those published by authorities in the field of pain medicine, but such ratios are approximations. Consider contacting your specific state medical or pharmacy professional societies for further information on how to safely convert patients from one opioid to another.

  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg every 12 hours of OxyContin, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to OxyContin, as there is limited documented experience with this conversion.

  2.2 Titration and Maintenance of Therapy

  Individually titrate OxyContin to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OxyContin to assess the maintenance of pain control and the relative incidence of adverse reactions. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.

  If the level of pain increases, attempt to identify the source of increased pain, while adjusting the OxyContin dose to decrease the level of pain. Because steady-state plasma concentrations are approximated in 1 day, OxyContin dosage adjustments may be done every 1 to 2 days. Patients who experience breakthrough pain may require dosage adjustment or rescue medication with an appropriate dose of an immediate-release opioid and non-opioid medication.

  If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced. Adjust the dose 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, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose, each time an increase is clinically indicated.

  During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, reassess the continued need for around-the-clock opioid therapy regularly (e.g., every 6 to 12 months) as appropriate.

  2.3 Patients with Hepatic Impairment

  For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the usual starting dose followed by careful dose titration [see Clinical Pharmacology (12.3)].

  2.4 Discontinuation of OxyContin

  When the patient no longer requires therapy with OxyContin tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue OxyContin.

  2.5 Administration of OxyContin

  Instruct patients to swallow OxyContin tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions (5.1, 5.2)].

  Instruct patients to take OxyContin one tablet at a time and with enough water to ensure complete swallowing immediately after placing in the mouth [see Warnings and Precautions (5.9), and Patient Counseling Information (17)].

  Close
  No Recall

  More Info
• Lake Erie Medical Dba Quality Care Products Llc
  

  ×

  Oxycontin | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  2.1 Initial Dosing

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with OxyContin [see Warnings and Precautions (5.2)].

  Consider the following factors when selecting an initial dose of OxyContin:

  Total daily dose, potency, and any prior opioid the patient has been taking previously; Reliability of the relative potency estimate used to calculate the equivalent dose of oxycodone needed (Note: potency estimates may vary with the route of administration); Patient's degree of opioid experience and opioid tolerance; General condition and medical status of the patient; Concurrent medication; Type and severity of the patient's pain.

  Use of OxyContin as the First Opioid Analgesic

  Initiate therapy with 10 mg every 12 hours.

  Conversion from other Oral Oxycodone Formulations to OxyContin

  Patients receiving other oral oxycodone formulations may be converted to OxyContin by administering one-half of the patient's total daily oral oxycodone dose as OxyContin every 12 hours.

  Conversion from other Opioids to OxyContin

  While there are useful tables of oral and parenteral equivalents, there is substantial inter-patient variation in the relative potency of different opioid drugs and formulations. Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. As such, it is safer to underestimate a patient's 24-hour oral oxycodone requirement and provide rescue medication (e.g., immediate-release oxycodone) than to overestimate and precipitate an adverse reaction. In general, begin with half of the estimated daily oxycodone requirement as the initial daily OxyContin estimate, then divide into two doses taken 12 hours apart, and manage inadequate analgesia by supplementation with immediate-release oxycodone.

  Published relative potency data are available and may be referred to in clinical practice guidelines such as those published by authorities in the field of pain medicine, but such ratios are approximations. Consider contacting your specific state medical or pharmacy professional societies for further information on how to safely convert patients from one opioid to another.

  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg every 12 hours of OxyContin, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to OxyContin, as there is limited documented experience with this conversion.

  2.2 Titration and Maintenance of Therapy

  Individually titrate OxyContin to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OxyContin to assess the maintenance of pain control and the relative incidence of adverse reactions. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.

  If the level of pain increases, attempt to identify the source of increased pain, while adjusting the OxyContin dose to decrease the level of pain. Because steady-state plasma concentrations are approximated in 1 day, OxyContin dosage adjustments may be done every 1 to 2 days. Patients who experience breakthrough pain may require dosage adjustment or rescue medication with an appropriate dose of an immediate-release opioid and non-opioid medication.

  If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced. Adjust the dose 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, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose, each time an increase is clinically indicated.

  2.3 Patients with Hepatic Impairment

  For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the usual starting dose followed by careful dose titration [see Clinical Pharmacology (12.3)].

  2.4 Discontinuation of OxyContin

  When the patient no longer requires therapy with OxyContin tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue OxyContin.

  2.5 Administration of OxyContin

  Instruct patients to swallow OxyContin tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions (5.1, 5.2)].

  Instruct patients to take OxyContin one tablet at a time and with enough water to ensure complete swallowing immediately after placing in the mouth [see Warnings and Precautions (5.9), and Patient Counseling Information (17)].

  Close
  No Recall

  More Info
• Pd-rx Pharmaceuticals, Inc.
  

  ×

  Oxycontin | Pd-rx Pharmaceuticals, Inc.

  

  ---

  2.1 Initial Dosing

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

  OXYCONTIN 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.  Patients considered opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid.

  Initiate the dosing regimen for each patient individually, taking into account the patient's 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 with OXYCONTIN [see Warnings and Precautions (5.2)].

  OXYCONTIN tablets must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17)]. Crushing, chewing, or dissolving OXYCONTIN tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death [see Warnings and Precautions (5.1)].

  Use of OXYCONTIN as the First Opioid Analgesic
  
  Initiate treatment with OXYCONTIN with one 10 mg tablet orally every 12 hours.
  
  Use of OXYCONTIN in Patients who are not Opioid Tolerant
  
  The starting dose for patients who are not opioid tolerant is OXYCONTIN 10 mg orally every 12 hours. 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, or an equianalgesic dose of another opioid.
  
  Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

  Conversion from other Oral Oxycodone Formulations to OXYCONTIN

  Patients receiving other oral oxycodone formulations may be converted to OXYCONTIN by administering one-half of the patient's total daily oral oxycodone dose as OXYCONTIN every 12 hours.

  Conversion from other Opioids to OXYCONTIN
  
  Discontinue all other around-the-clock opioid drugs when OXYCONTIN therapy is initiated.
  
  There are no established conversion ratios for conversion from other opioids to OXYCONTIN defined by clinical trials. Discontinue all other around-the-clock opioid drugs when OXYCONTIN therapy is initiated and initiate dosing using OXYCONTIN 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 requirements which could result in adverse reactions. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.
  
  Conversion from Methadone to OXYCONTIN
  
  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 OXYCONTIN

  Eighteen hours following the removal of the transdermal fentanyl patch, OXYCONTIN treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg every 12 hours of OXYCONTIN, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to OXYCONTIN, as there is limited documented experience with this conversion.

  2.2 Titration and Maintenance of Therapy

  Individually titrate OXYCONTIN to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OXYCONTIN to assess the maintenance of pain control and the relative incidence of 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 dose increase of OXYCONTIN 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 OXYCONTIN dose. Because steady-state plasma concentrations are approximated in 1 day, OXYCONTIN dosage may be adjusted every 1 to 2 days. If unacceptable opioid-related adverse reactions are observed, the subsequent dose may be reduced. Adjust the dose 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, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose, each time an increase is clinically indicated.

  2.3 Patients with Hepatic Impairment

  For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the usual starting dose followed by careful dose titration [see Clinical Pharmacology (12.3)].

  2.4 Discontinuation of OXYCONTIN

  When the patient no longer requires therapy with OXYCONTIN tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically dependent patient. Do not abruptly discontinue OXYCONTIN.

  2.5 Administration of OXYCONTIN

  Instruct patients to swallow OXYCONTIN tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions (5.1)].

  Instruct patients to take OXYCONTIN one tablet at a time and with enough water to ensure complete swallowing immediately after placing in the mouth [see Warnings and Precautions (5.9) and Patient Counseling Information (17)].

  Close
  No Recall

  More Info
• Purdue Pharma Lp
  

  ×

  Oxycontin | Purdue Pharma Lp

  

  ---

  2.1 Important Dosage and Administration Instructions

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

  Initiate the dosing regimen for each patient individually, taking into account the patient's 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 OXYCONTIN therapy [see Warnings and Precautions (5.2)]. Must take OXYCONTIN tablets whole, with enough water to ensure complete swallowing immediately after placing in the mouth. Must take OXYCONTIN tablets one tablet at a time and must not pre-soak, lick or otherwise wet the tablet prior to placing in the mouth [see Warnings and Precautions (5.9)]. Cutting, breaking, crushing, chewing, or dissolving OXYCONTIN tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death. [see Warnings and Precautions (5.1)]. OXYCONTIN 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. 2.2 Initial Dosage in Adults who are not Opioid-Tolerant

  The starting dosage for patients who are not opioid tolerant is OXYCONTIN 10 mg orally every 12 hours. 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, or an equianalgesic dose of another opioid.

  Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression [see Warnings and Precautions (5.2)].

  2.3 Conversion from Opioids to OXYCONTIN in Adults

  Conversion from Other Oral Oxycodone Formulations to OXYCONTIN
  If switching from other oral oxycodone formulations to OXYCONTIN, administer one half of the patient's total daily oral oxycodone dose as OXYCONTIN every 12 hours

  Conversion from other Opioids to OXYCONTIN
  There are no established conversion ratios for conversion from other opioids to OXYCONTIN defined by clinical trials. Discontinue all other around-the-clock opioid drugs when OXYCONTIN therapy is initiated and initiate dosing using OXYCONTIN 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 requirements which could result in adverse reactions. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioids.

  Conversion from Methadone to OXYCONTIN
  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 OXYCONTIN
  If switching from transdermal fentanyl patch to OXYCONTIN, ensure that the patch has been removed for at least 18 hours prior to starting OXYCONTIN. Although there has been no systematic assessment of such conversion, start with a conservative conversion: substitute 10 mg of OXYCONTIN every 12 hours for each 25 mcg per hour fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to OXYCONTIN, as there is limited documented experience with this conversion.

  2.4 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 OXYCONTIN, patients must be taking a minimum of 20 mg per day of oxycodone or its equivalent. OXYCONTIN 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 OXYCONTIN.

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

  Although tables of oral and parenteral equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and formulations. As such, it is preferable 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.

  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 OXYCONTIN. The table cannot be used to convert from OXYCONTIN 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 OXYCONTIN is mg per day of prior opioid x factor = mg per day of OXYCONTIN. Divide the calculated total daily dose by 2 to get the every-12-hour OXYCONTIN dose. If rounding is necessary, always round the dose down to the nearest OXYCONTIN tablet strength available. Table 1: Conversion Factors When Switching Pediatric Patients 11 Years and Older to OXYCONTIN *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. Prior Opioid Conversion Factor   Oral Parenteral* Oxycodone 1 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Morphine 0.5 3 Tramadol 0.17 0.2

  Step #1: To calculate the estimated total OXYCONTIN daily dose 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 OXYCONTIN 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 OXYCONTIN 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 OXYCONTIN tablet strength available and initiate OXYCONTIN therapy with that dose. If the calculated OXYCONTIN total daily dosage is less than 20 mg, there is no safe strength for conversion and do not initiate OXYCONTIN.

  Example conversion from a single opioid (e.g., hydrocodone) to OXYCONTIN: 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 OXYCONTIN every 12 hours. After rounding down to the nearest strength available, the recommended OXYCONTIN 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 OXYCONTIN. See Dosage and Administration (2.5) for important instructions on titration and maintenance of therapy.

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

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

  2.5 Titration and Maintenance of Therapy in Adults and Pediatric Patients 11 Years and Older

  Individually titrate OXYCONTIN to a dosage that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OXYCONTIN 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 increase of OXYCONTIN 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 OXYCONTIN dosage. Because steady-state plasma concentrations are approximated in 1 day, OXYCONTIN dosage may be adjusted every 1 to 2 days. If unacceptable opioid-related adverse reactions are observed, the subsequent dose may be reduced. 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. As a guideline for adults, the total daily oxycodone dosage usually can be increased by 25% to 50% of the current total daily dosage, each time an increase is clinically indicated.

  2.6 Dosage Modifications with Concomitant Use of Central Nervous System Depressants

  If the patient is currently taking a central nervous system (CNS) depressant and the decision is made to begin OXYCONTIN, start with 1/3 to 1/2 the recommended starting dosage of OXYCONTIN and monitor patients for signs of respiratory depression, sedation, and hypotension [see Warnings and Precautions (5.4), Drug Interactions (7.1)].

  2.7 Dosage Modifications in Geriatric Patients who are Debilitated and not Opioid-Tolerant

  For geriatric patients who are debilitated and not opioid tolerant, start dosing patients at 1/3 to 1/2 the recommended starting dosage and titrate the dosage cautiously [see Use in Specific Populations (8.5)].

  2.8 Dosage Modifications in Patients with Hepatic Impairment

  For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the recommended starting dosage followed by careful dosage titration [see Clinical Pharmacology (12.3)].

  2.9 Discontinuation of OXYCONTIN

  When the patient no longer requires therapy with OXYCONTIN, gradually titrate the dosage downward to prevent signs and symptoms of withdrawal in the physically dependent patient. Do not abruptly discontinue OXYCONTIN.

  Close
  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Oxycontin | Bryant Ranch Prepack

  

  ---

  2.1 Initial Dosing

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

  OXYCONTIN 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.  Patients considered opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid.

  Initiate the dosing regimen for each patient individually, taking into account the patient's 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 with OXYCONTIN [see Warnings and Precautions (5.2)].

  OXYCONTIN tablets must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17)]. Crushing, chewing, or dissolving OXYCONTIN tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death [see Warnings and Precautions (5.1)].

  Use of OXYCONTIN as the First Opioid Analgesic
  
  Initiate treatment with OXYCONTIN with one 10 mg tablet orally every 12 hours.
  
  Use of OXYCONTIN in Patients who are not Opioid Tolerant
  
  The starting dose for patients who are not opioid tolerant is OXYCONTIN 10 mg orally every 12 hours. 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, or an equianalgesic dose of another opioid.
  
  Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

  Conversion from other Oral Oxycodone Formulations to OXYCONTIN

  Patients receiving other oral oxycodone formulations may be converted to OXYCONTIN by administering one-half of the patient's total daily oral oxycodone dose as OXYCONTIN every 12 hours.

  Conversion from other Opioids to OXYCONTIN
  
  Discontinue all other around-the-clock opioid drugs when OXYCONTIN therapy is initiated.
  
  There are no established conversion ratios for conversion from other opioids to OXYCONTIN defined by clinical trials. Discontinue all other around-the-clock opioid drugs when OXYCONTIN therapy is initiated and initiate dosing using OXYCONTIN 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 requirements which could result in adverse reactions. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.
  
  Conversion from Methadone to OXYCONTIN
  
  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 OXYCONTIN

  Eighteen hours following the removal of the transdermal fentanyl patch, OXYCONTIN treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg every 12 hours of OXYCONTIN, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to OXYCONTIN, as there is limited documented experience with this conversion.

  2.2 Titration and Maintenance of Therapy

  Individually titrate OXYCONTIN to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OXYCONTIN to assess the maintenance of pain control and the relative incidence of 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 dose increase of OXYCONTIN 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 OXYCONTIN dose. Because steady-state plasma concentrations are approximated in 1 day, OXYCONTIN dosage may be adjusted every 1 to 2 days. If unacceptable opioid-related adverse reactions are observed, the subsequent dose may be reduced. Adjust the dose 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, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose, each time an increase is clinically indicated.

  2.3 Patients with Hepatic Impairment

  For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the usual starting dose followed by careful dose titration [see Clinical Pharmacology (12.3)].

  2.4 Discontinuation of OXYCONTIN

  When the patient no longer requires therapy with OXYCONTIN tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically dependent patient. Do not abruptly discontinue OXYCONTIN.

  2.5 Administration of OXYCONTIN

  Instruct patients to swallow OXYCONTIN tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions (5.1)].

  Instruct patients to take OXYCONTIN one tablet at a time and with enough water to ensure complete swallowing immediately after placing in the mouth [see Warnings and Precautions (5.9) and Patient Counseling Information (17)].

  Close
  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Oxycontin | Bryant Ranch Prepack

  

  ---

  2.1 Initial Dosing

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

  OXYCONTIN 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.  Patients considered opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid.

  Initiate the dosing regimen for each patient individually, taking into account the patient's 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 with OXYCONTIN [see Warnings and Precautions (5.2)].

  OXYCONTIN tablets must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17)]. Crushing, chewing, or dissolving OXYCONTIN tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death [see Warnings and Precautions (5.1)].

  Use of OXYCONTIN as the First Opioid Analgesic
  
  Initiate treatment with OXYCONTIN with one 10 mg tablet orally every 12 hours.
  
  Use of OXYCONTIN in Patients who are not Opioid Tolerant
  
  The starting dose for patients who are not opioid tolerant is OXYCONTIN 10 mg orally every 12 hours. 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, or an equianalgesic dose of another opioid.
  
  Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

  Conversion from other Oral Oxycodone Formulations to OXYCONTIN

  Patients receiving other oral oxycodone formulations may be converted to OXYCONTIN by administering one-half of the patient's total daily oral oxycodone dose as OXYCONTIN every 12 hours.

  Conversion from other Opioids to OXYCONTIN
  
  Discontinue all other around-the-clock opioid drugs when OXYCONTIN therapy is initiated.
  
  There are no established conversion ratios for conversion from other opioids to OXYCONTIN defined by clinical trials. Discontinue all other around-the-clock opioid drugs when OXYCONTIN therapy is initiated and initiate dosing using OXYCONTIN 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 requirements which could result in adverse reactions. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.
  
  Conversion from Methadone to OXYCONTIN
  
  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 OXYCONTIN

  Eighteen hours following the removal of the transdermal fentanyl patch, OXYCONTIN treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg every 12 hours of OXYCONTIN, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to OXYCONTIN, as there is limited documented experience with this conversion.

  2.2 Titration and Maintenance of Therapy

  Individually titrate OXYCONTIN to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OXYCONTIN to assess the maintenance of pain control and the relative incidence of 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 dose increase of OXYCONTIN 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 OXYCONTIN dose. Because steady-state plasma concentrations are approximated in 1 day, OXYCONTIN dosage may be adjusted every 1 to 2 days. If unacceptable opioid-related adverse reactions are observed, the subsequent dose may be reduced. Adjust the dose 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, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose, each time an increase is clinically indicated.

  2.3 Patients with Hepatic Impairment

  For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the usual starting dose followed by careful dose titration [see Clinical Pharmacology (12.3)].

  2.4 Discontinuation of OXYCONTIN

  When the patient no longer requires therapy with OXYCONTIN tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically dependent patient. Do not abruptly discontinue OXYCONTIN.

  2.5 Administration of OXYCONTIN

  Instruct patients to swallow OXYCONTIN tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions (5.1)].

  Instruct patients to take OXYCONTIN one tablet at a time and with enough water to ensure complete swallowing immediately after placing in the mouth [see Warnings and Precautions (5.9) and Patient Counseling Information (17)].

  Close
  No Recall

  More Info
• Lake Erie Medical Dba Quality Care Products Llc
  

  ×

  Oxycontin | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  General Principles

  OXYCONTIN IS AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE. OXYCODONE, LIKE MORPHINE AND OTHER OPIOIDS USED IN ANALGESIA, CAN BE ABUSED AND IS SUBJECT TO CRIMINAL DIVERSION.

  OxyContin Tablets must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Taking cut, broken, chewed, crushed or dissloved OxyContin® Tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone.

  One OxyContin 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets (see DOSAGE AND ADMINISTRATION).

  Patients should be started on the lowest appropriate dose (see DOSAGE AND ADMINISTRATION: Initiation of Therapy). In treating pain it is vital to assess the patient regularly and systematically. Therapy should also be regularly reviewed and adjusted based upon the patient's own reports of pain and side effects and the health professional's clinical judgment.

  OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The controlled-release nature of the formulation allows OxyContin to be effectively administered every 12 hours (see CLINICAL PHARMACOLOGY; PHARMACOKINETICS AND METABOLISM). While symmetric (same dose AM and PM), around-the-clock, q12h dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern. It is usually appropriate to treat a patient with only one opioid for around-the-clock therapy.

  Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring (see BOXED WARNING).

  Initiation of Therapy

  It is critical to initiate the dosing regimen for each patient individually, taking into account the patient's prior opioid and non-opioid analgesic treatment. Attention should be given to:

  (1) risk factors for abuse or addiction; including whether the patient has a previous or current substance abuse problem, a family history of substance abuse, or a history of mental illness or depression; (2) the age, general condition and medical status of the patient; (3) the daily dose, potency, and kind of the analgesic(s) the patient has been taking; (4) the reliability of the conversion estimate used to calculate the dose of oxycodone; (5) the patient's opioid exposure and opioid tolerance (if any); (6) the Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg; and (7) the balance between pain control and adverse experiences.

  Care should be taken to use low initial doses of OxyContin in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications (see PRECAUTIONS: Drug-Drug Interactions).

  For initiation of OxyContin therapy for patients previously taking opioids, the conversion ratios from Foley, KM. [NEJM, 1985; 313:84-95], found below, are a reasonable starting point, although not verified in well-controlled, multiple-dose trials.

  Experience indicates a reasonable starting dose of OxyContin for patients who are taking non-opioid analgesics and require continuous around-the-clock therapy for an extended period of time is 10 mg q12h. If a non-opioid analgesic is being provided, it may be continued. OxyContin should be individually titrated to a dose that provides adequate analgesia and minimizes side effects.

  Using standard conversion ratio estimates (see Table 4 below), multiply the mg/day of the previous opioids by the appropriate multiplication factors to obtain the equivalent total daily dose of oral oxycodone. When converting from oxycodone, divide the 24-hour oxycodone dose in half to obtain the twice a day (q12h) dose of OxyContin. Round down to a dose which is appropriate for the tablet strengths available. Discontinue all other around-the-clock opioid drugs when OxyContin therapy is initiated. No fixed conversion ratio is likely to be satisfactory in all patients, especially patients receiving large opioid doses. The recommended doses shown in Table 4 are only a starting point, and close observation and frequent titration are indicated until patients are stable on the new therapy. TABLE 4. Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Daily Dose of Oral Oxycodone* * To be used only for conversion to oral oxycodone. 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. (Mg/Day Prior Opioid x Factor = Mg/Day Oral
  Oxycodone) Oral Prior Opioid Parenteral Prior Opioid Oxycodone 1 -- Codeine 0.15 -- Hydrocodone 0.9 -- Hydromorphone 4 20 Levorphanol 7.5 15 Meperidine 0.1 0.4 Methadone 1.5 3 Morphine 0.5 3

  In all cases, supplemental analgesia should be made available in the form of a suitable short-acting analgesic.

  OxyContin® can be safely used concomitantly with usual doses of non-opioid analgesics and analgesic adjuvants, provided care is taken to select a proper initial dose (see PRECAUTIONS).

  Conversion from Transdermal Fentanyl to OxyContin

  Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg q12h of OxyContin, should be initially substituted for each 25 µg/hr fentanyl transdermal patch. The patient should be followed closely for early titration, as there is very limited clinical experience with this conversion.

  Managing Expected Opioid Adverse Experiences

  Most patients receiving opioids, especially those who are opioid-naive, will experience side effects. Frequently the side effects from OxyContin are transient, but may require evaluation and management. Adverse events such as constipation should be anticipated and treated aggressively and prophylactically with a stimulant laxative and/or stool softener. Patients do not usually become tolerant to the constipating effects of opioids.

  Other opioid-related side effects such as sedation and nausea are usually self-limited and often do not persist beyond the first few days. If nausea persists and is unacceptable to the patient, treatment with antiemetics or other modalities may relieve these symptoms and should be considered.

  Patients receiving OxyContin® may pass an intact matrix "ghost" in the stool or via colostomy. These ghosts contain little or no residual oxycodone and are of no clinical consequence.

  Individualization of Dosage

  Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. Patients should be titrated to adequate effect (generally mild or no pain with the regular use of no more than two doses of supplemental analgesia per 24 hours). Patients who experience breakthrough pain may require dosage adjustment or rescue medication. Because steady-state plasma concentrations are approximated within 24 to 36 hours, dosage adjustment may be carried out every 1 to 2 days. It is most appropriate to increase the q12h dose, not the dosing frequency. There is no clinical information on dosing intervals shorter than q12h. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose at each increase.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of immediate-release oxycodone may be given. Alternatively, non-opioid analgesic adjuvants may be employed. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences.

  If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are under control, upward titration should continue to an acceptable level of pain control.

  During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family.

  Special Instructions for OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a Single Dose Greater Than 40 mg (for use in opioid-tolerant patients only)

  OxyContin 60 mg, 80 mg, and 160 mg Tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in opioid-tolerant patients, as they may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory-depressant, or sedating effects of opioids. Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

  Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

  One OxyContin® 160 mg tablet is comparable to two 80 mg tablets when taken on an empty stomach. With a high-fat meal, however, there is a 25% greater peak plasma concentration following one 160 mg tablet. Dietary caution should be taken when patients are initially titrated to 160 mg tablets.

  Supplemental Analgesia

  Most patients given around-the-clock therapy with controlled-release opioids may need to have immediate-release medication available for exacerbations of pain or to prevent pain that occurs predictably during certain patient activities (incident pain).

  Maintenance of Therapy

  The intent of the titration period is to establish a patient-specific q12h dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary. Should pain recur then the dose can be incrementally increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to re-establish pain control.

  During chronic therapy, especially for non-cancer pain syndromes, the continued need for around-the-clock opioid therapy should be reassessed periodically (e.g., every 6 to 12 months) as appropriate.

  Cessation of Therapy

  When the patient no longer requires therapy with OxyContin Tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

  Conversion from OxyContin to Parenteral Opioids

  To avoid overdose, conservative dose conversion ratios should be followed.

  Close
  No Recall

  More Info