Oxymorphone Hydrochloride

Oxymorphone Hydrochloride Manufacturers

• Roxane Laboratories, Inc
  

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  Oxymorphone Hydrochloride | Supervalu Inc.

  

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  adults: chew 1 or 2 tablets as needed after meals and at bedtime do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician

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• Kvk-tech, Inc.
  

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  Oxymorphone Hydrochloride | Kvk-tech, Inc.

  

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  Selection of patients for treatment with oxymorphone hydrochloride tablets should be governed by the same principles that apply to the use of similar opioid analgesics [see Indications and Usage (1)]. Physicians should individualize treatment in every case [see Dosage and Administration (2.1)], using non-opioid analgesics, opioids on an as needed basis, combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  Oxymorphone hydrochloride tablets should be administered on an empty stomach, at least one hour prior to or two hours after eating [see Clinical Pharmacology (12.3)]

  2.1 Individualization of Dosage

  As with any opioid drug product, it is necessary to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of oxymorphone hydrochloride tablets, attention should be given to the following:

  The total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; The relative potency estimate used to calculate the equivalent oxymorphone dose needed; The patient’s degree of opioid tolerance; The age, general condition, and medical status of the patient; Concurrent non-opioid analgesics and other medications; The type and severity of the patient's pain; The balance between pain control and adverse experiences; Risk factors for abuse or addiction, including a prior history of abuse or addiction.

  Once therapy is initiated, frequently assess pain relief and other opioid effects. Titrate dose to adequate pain relief (generally mild or no pain). Patients who experience breakthrough pain may require dosage adjustment.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. Adjust dosing 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 adequately managed, continue upward titration 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. Advise patients and family members of the potential common adverse reactions associated with changing opioid doses.

  The dosing recommendations below, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  2.2 Initiation of Therapy

  Titrate dose to adequate pain relief (generally mild or no pain).

  Opioid-Naïve Patients
  Patients who have not been receiving opioid analgesics should be started on oxymorphone hydrochloride tablets in a dosing range of 10 to 20 mg every four to six hours depending on the initial pain intensity. If deemed necessary to initiate therapy at a lower dose (e.g., for renal or hepatic impairment or for geriatric patients), patients may be started with oxymorphone hydrochloride tablets 5 mg. The dose should be titrated based upon the individual patient’s response to their initial dose of oxymorphone hydrochloride tablets. This dose can then be adjusted to an acceptable level of analgesia taking into account the pain intensity and adverse reactions experienced by the patient.

  Initiation of therapy with doses higher than 20 mg is not recommended because of potential serious adverse reactions [see Clinical Studies (14.1)].

  Conversion from Parenteral Oxymorphone to Oxymorphone Hydrochloride
  Given oxymorphone hydrochloride tablet’s absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to oxymorphone hydrochloride tablets by administering 10 times the patient’s total daily parenteral oxymorphone dose as oxymorphone hydrochloride tablets, in four or six equally divided doses (e.g., [IV dose x 10] divided by 4 or 6). For example, approximately 10 mg of oxymorphone hydrochloride four times daily may be required to provide pain relief equivalent to a total daily IM dose of 4 mg oxymorphone. Due to patient variability with regard to opioid analgesic response, upon conversion patients should be closely monitored to ensure adequate analgesia and to minimize side effects.

  Conversion from Other Oral Opioids to Oxymorphone Hydrochloride Tablets
  For conversion from other opioids to oxymorphone hydrochloride tablets, physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate. In general, it is safest to start oxymorphone hydrochloride tablets therapy by administering half of the calculated total daily dose of oxymorphone hydrochloride in 4 to 6 equally divided doses, every 4-6 hours. The initial dose of oxymorphone hydrochloride tablets can be gradually adjusted until adequate pain relief and acceptable side effects have been achieved.

  2.3 Maintenance of Therapy

  During therapy, continual re-evaluation of the patient receiving oxymorphone hydrochloride tablets is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose [see Dosage and Administration (2.1)].

  2.4 Cessation of Therapy

  When the patient no longer requires therapy with oxymorphone hydrochloride tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient [see Drug Abuse and Dependence (9.3)].

  2.5 Patients with Hepatic Impairment

  Oxymorphone hydrochloride tablets are contraindicated in patients with moderate or severe hepatic impairment. Use oxymorphone hydrochloride tablets with caution in patients with mild hepatic impairment, starting with the lowest dose (e.g., 5 mg) and titrating slowly while carefully monitoring side effects [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3)].

  2.6 Patients with Renal Impairment

  There are 57% and 65% increases in oxymorphone bioavailability in patients with moderate and severe renal impairment, respectively; treated with extended-release oxymorphone tablets [see Clinical Pharmacology (12.3)]. Accordingly, oxymorphone hydrochloride tablets should be administered cautiously and in reduced dosages to patients with creatinine clearance rates less than 50 mL/min.

  2.7 Use with Central Nervous System Depressants

  Oxymorphone hydrochloride tablets, like all opioid analgesics, should be started at 1/3 to 1/2 of the usual dose in patients who are concurrently receiving other central nervous system (CNS) depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, and alcohol, because respiratory depression, hypotension and profound sedation, coma or death may result [see Warnings and Precautions (5.3) and Drug Interactions (7.1)]. When combined therapy with any of the above medications is considered, the dose of one or both agents should be reduced.

  Although no specific interaction between oxymorphone and monoamine oxidase inhibitors has been observed, oxymorphone hydrochloride tablets are not recommended for use in patients who have received MAO inhibitors within 14 days [see Drug Interactions (7.5)].

  2.8 Geriatric Patients

  Exercise caution in the selection of the starting dose of oxymorphone hydrochloride tablets for an elderly patient by starting at the low end of the dosing range (e.g., 5 mg) [see Use in Specific Populations (8.5)].

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• Physicians Total Care, Inc.
  

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  Oxymorphone Hydrochloride | Physicians Total Care, Inc.

  

  ---

  Selection of patients for treatment with oxymorphone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics [see Indications and Usage (1)]. Physicians should individualize treatment in every case [see Dosage and Administration (2.1)], using non-opioid analgesics, opioids on an as needed basis, combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  Oxymorphone hydrochloride should be administered on an empty stomach, at least one hour prior to or two hours after eating [see Clinical Pharmacology (12.3)].

  2.1 Individualization of Dosage

  As with any opioid drug product, it is necessary to adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of oxymorphone hydrochloride, attention should be given to the following:

  The total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; The relative potency estimate used to calculate the equivalent oxymorphone dose needed; The patient’s degree of opioid tolerance; The age, general condition, and medical status of the patient; Concurrent non-opioid analgesics and other medications; The type and severity of the patient’s pain; The balance between pain control and adverse experiences; Risk factors for abuse or addiction, including a prior history of abuse or addiction.

  Once therapy is initiated, frequently assess pain relief and other opioid effects. Titrate dose to adequate pain relief (generally mild or no pain). Patients who experience breakthrough pain may require dosage adjustment.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. Adjust dosing 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 adequately managed, continue upward titration 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. Advise patients and family members of the potential common adverse reactions associated with changing opioid doses.

  The dosing recommendations below, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  2.2 Initiation of Therapy

  Titrate dose to adequate pain relief (generally mild or no pain).

  Opioid-Naïve Patients: Patients who have not been receiving opioid analgesics should be started on oxymorphone hydrochloride in a dosing range of 10 to 20 mg every four to six hours depending on the initial pain intensity. If deemed necessary to initiate therapy at a lower dose (e.g., for renal or hepatic impairment or for geriatric patients), patients may be started with oxymorphone hydrochloride 5 mg. The dose should be titrated based upon the individual patient’s response to their initial dose of oxymorphone hydrochloride. This dose can then be adjusted to an acceptable level of analgesia taking into account the pain intensity and adverse reactions experienced by the patient.

  Initiation of therapy with doses higher than 20 mg is not recommended becauseof potential serious adverse reactions [see Clinical Studies (14.1)].

  Conversion from Parenteral Oxymorphone to Oxymorphone Hydrochloride: Given oxymorphone hydrochloride’s absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to oxymorphone hydrochloride by administering 10 times the patient’s total daily parenteral oxymorphone dose as oxymorphone hydrochloride, in four or six equally divided doses (e.g., [IV dose x 10] divided by 4 or 6). For example, approximately 10 mg of oxymorphone hydrochloride four times daily may be required to provide pain relief equivalent to a total daily IM dose of 4 mg oxymorphone. Due to patient variability with regard to opioid analgesic response, upon conversion patients should be closely monitored to ensure adequate analgesia and to minimize side effects.

  Conversion from Other Oral Opioids to Oxymorphone Hydrochloride: For conversion from other opioids to oxymorphone hydrochloride, physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate. In general, it is safest to start oxymorphone hydrochloride therapy by administering half of the calculated total daily dose of oxymorphone hydrochloride in 4 to 6 equally divided doses, every 4 to 6 hours. The initial dose of oxymorphone hydrochloride can be gradually adjusted until adequate pain relief and acceptable side effects have been achieved.

  2.3 Maintenance of Therapy

  During therapy, continual re-evaluation of the patient receiving oxymorphone hydrochloride is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose [see Dosage and Administration (2.1)].

  2.4 Cessation of Therapy

  When the patient no longer requires therapy with oxymorphone hydrochloride, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient [see Drug Abuse and Dependence (9.3)].

  2.5 Patients with Hepatic Impairment

  Oxymorphone hydrochloride is contraindicated in patients with moderate or severe hepatic impairment. Use oxymorphone hydrochloride with caution in patients with mild hepatic impairment, starting with the lowest dose (e.g., 5 mg) and titrating slowly while carefully monitoring side effects [see Warnings and Precautions (5.6) and

  Clinical Pharmacology (12.3)].

  2.6 Patients with Renal Impairment

  There are 57% and 65% increases in oxymorphone bioavailability in patients with moderate and severe renal impairment, respectively; treated with extended-release oxymorphone tablets [see Clinical Pharmacology (12.3)]. Accordingly, oxymorphone hydrochloride should be administered cautiously and in reduced dosages to patients with creatinine clearance rates less than 50 mL/min.

  2.7 Use with Central Nervous System Depressants

  Oxymorphone hydrochloride, like all opioid analgesics, should be started at 1/3 to 1/2 of the usual dose in patients who are concurrently receiving other central nervous system (CNS) depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, and alcohol, because respiratory depression, hypotension and profound sedation, coma or death may result [see Warnings and Precautions (5.3) andDrug Interactions (7.1)]. When combined therapy with any of the above medications is considered, the dose of one or both agents should be reduced.

  Although no specific interaction between oxymorphone and monoamine oxidase inhibitors has been observed, oxymorphone hydrochloride is not recommended for use in patients who have received MAO inhibitors within 14 days [see Drug Interactions (7.5)].

  2.8 Geriatric Patients

  Exercise caution in the selection of the starting dose of oxymorphone hydrochloride for an elderly patient by starting at the low end of the dosing range (e.g., 5 mg) [see Use in Specific Populations (8.5)].

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• Lake Erie Medical Dba Quality Care Products Llc
  

  ×

  Oxymorphone Hydrochloride | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  Selection of patients for treatment with oxymorphone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics [see Indications and Usage (1)]. Physicians should individualize treatment in every case [see Dosage and Administration (2.1)], using non-opioid analgesics, opioids on an as needed basis, combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  Oxymorphone hydrochloride should be administered on an empty stomach, at least one hour prior to or two hours after eating [see Clinical Pharmacology (12.3)].

  2.1 Individualization of Dosage

  As with any opioid drug product, it is necessary to adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of oxymorphone hydrochloride, attention should be given to the following:

  The total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; The relative potency estimate used to calculate the equivalent oxymorphone dose needed; The patient’s degree of opioid tolerance; The age, general condition, and medical status of the patient; Concurrent non-opioid analgesics and other medications; The type and severity of the patient’s pain; The balance between pain control and adverse experiences; Risk factors for abuse or addiction, including a prior history of abuse or addiction.

  Once therapy is initiated, frequently assess pain relief and other opioid effects. Titrate dose to adequate pain relief (generally mild or no pain). Patients who experience breakthrough pain may require dosage adjustment.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. Adjust dosing 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 adequately managed, continue upward titration 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. Advise patients and family members of the potential common adverse reactions associated with changing opioid doses.

  The dosing recommendations below, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  2.2 Initiation of Therapy

  Titrate dose to adequate pain relief (generally mild or no pain).

  Opioid-Naïve Patients: Patients who have not been receiving opioid analgesics should be started on oxymorphone hydrochloride in a dosing range of 10 to 20 mg every four to six hours depending on the initial pain intensity. If deemed necessary to initiate therapy at a lower dose (e.g., for renal or hepatic impairment or for geriatric patients), patients may be started with oxymorphone hydrochloride 5 mg. The dose should be titrated based upon the individual patient’s response to their initial dose of oxymorphone hydrochloride. This dose can then be adjusted to an acceptable level of analgesia taking into account the pain intensity and adverse reactions experienced by the patient.

  Initiation of therapy with doses higher than 20 mg is not recommended becauseof potential serious adverse reactions [see Clinical Studies (14.1)].

  Conversion from Parenteral Oxymorphone to Oxymorphone Hydrochloride: Given oxymorphone hydrochloride’s absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to oxymorphone hydrochloride by administering 10 times the patient’s total daily parenteral oxymorphone dose as oxymorphone hydrochloride, in four or six equally divided doses (e.g., [IV dose x 10] divided by 4 or 6). For example, approximately 10 mg of oxymorphone hydrochloride four times daily may be required to provide pain relief equivalent to a total daily IM dose of 4 mg oxymorphone. Due to patient variability with regard to opioid analgesic response, upon conversion patients should be closely monitored to ensure adequate analgesia and to minimize side effects.

  Conversion from Other Oral Opioids to Oxymorphone Hydrochloride: For conversion from other opioids to oxymorphone hydrochloride, physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate. In general, it is safest to start oxymorphone hydrochloride therapy by administering half of the calculated total daily dose of oxymorphone hydrochloride in 4 to 6 equally divided doses, every 4 to 6 hours. The initial dose of oxymorphone hydrochloride can be gradually adjusted until adequate pain relief and acceptable side effects have been achieved.

  2.3 Maintenance of Therapy

  During therapy, continual re-evaluation of the patient receiving oxymorphone hydrochloride is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose [see Dosage and Administration (2.1)].

  2.4 Cessation of Therapy

  When the patient no longer requires therapy with oxymorphone hydrochloride, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient [see Drug Abuse and Dependence (9.3)].

  2.5 Patients with Hepatic Impairment

  Oxymorphone hydrochloride is contraindicated in patients with moderate or severe hepatic impairment. Use oxymorphone hydrochloride with caution in patients with mild hepatic impairment, starting with the lowest dose (e.g., 5 mg) and titrating slowly while carefully monitoring side effects [see Warnings and Precautions (5.6) and

  Clinical Pharmacology (12.3)].

  2.6 Patients with Renal Impairment

  There are 57% and 65% increases in oxymorphone bioavailability in patients with moderate and severe renal impairment, respectively; treated with extended-release oxymorphone tablets [see Clinical Pharmacology (12.3)]. Accordingly, oxymorphone hydrochloride should be administered cautiously and in reduced dosages to patients with creatinine clearance rates less than 50 mL/min.

  2.7 Use with Central Nervous System Depressants

  Oxymorphone hydrochloride, like all opioid analgesics, should be started at 1/3 to 1/2 of the usual dose in patients who are concurrently receiving other central nervous system (CNS) depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, and alcohol, because respiratory depression, hypotension and profound sedation, coma or death may result [see Warnings and Precautions (5.3) andDrug Interactions (7.1)]. When combined therapy with any of the above medications is considered, the dose of one or both agents should be reduced.

  Although no specific interaction between oxymorphone and monoamine oxidase inhibitors has been observed, oxymorphone hydrochloride is not recommended for use in patients who have received MAO inhibitors within 14 days [see Drug Interactions (7.5)].

  2.8 Geriatric Patients

  Exercise caution in the selection of the starting dose of oxymorphone hydrochloride for an elderly patient by starting at the low end of the dosing range (e.g., 5 mg) [see Use in Specific Populations (8.5)].

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• Qualitest Pharmaceuticals
  

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  Oxymorphone Hydrochloride | Qualitest Pharmaceuticals

  

  ---

  Selection of patients for treatment with oxymorphone hydrochloride tablets should be governed by the same principles that apply to the use of similar opioid analgesics [see Indications and Usage (1)]. Physicians should individualize treatment in every case [see Dosage and Administration (2.1)], using non-opioid analgesics, opioids on an as needed basis, combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  Oxymorphone hydrochloride tablets should be administered on an empty stomach, at least one hour prior to or two hours after eating [see Clinical Pharmacology (12.3)]

  2.1 Individualization of Dosage

  As with any opioid drug product, it is necessary to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of oxymorphone hydrochloride tablets, attention should be given to the following:

  The total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; The relative potency estimate used to calculate the equivalent oxymorphone dose needed; The patient’s degree of opioid tolerance; The age, general condition, and medical status of the patient; Concurrent non-opioid analgesics and other medications; The type and severity of the patient's pain; The balance between pain control and adverse experiences; Risk factors for abuse or addiction, including a prior history of abuse or addiction.

  Once therapy is initiated, frequently assess pain relief and other opioid effects. Titrate dose to adequate pain relief (generally mild or no pain). Patients who experience breakthrough pain may require dosage adjustment.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. Adjust dosing 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 adequately managed, continue upward titration 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. Advise patients and family members of the potential common adverse reactions associated with changing opioid doses.

  The dosing recommendations below, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  2.2 Initiation of Therapy

  Titrate dose to adequate pain relief (generally mild or no pain).

  Opioid-Naïve Patients
  Patients who have not been receiving opioid analgesics should be started on oxymorphone hydrochloride tablets in a dosing range of 10 to 20 mg every four to six hours depending on the initial pain intensity. If deemed necessary to initiate therapy at a lower dose (e.g., for renal or hepatic impairment or for geriatric patients), patients may be started with oxymorphone hydrochloride tablets 5 mg. The dose should be titrated based upon the individual patient’s response to their initial dose of oxymorphone hydrochloride tablets. This dose can then be adjusted to an acceptable level of analgesia taking into account the pain intensity and adverse reactions experienced by the patient.

  Initiation of therapy with doses higher than 20 mg is not recommended because of potential serious adverse reactions [see Clinical Studies (14.1)].

  Conversion from Parenteral Oxymorphone to Oxymorphone Hydrochloride Tablets
  Given oxymorphone hydrochloride tablet’s absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to oxymorphone hydrochloride tablets by administering 10 times the patient’s total daily parenteral oxymorphone dose as oxymorphone hydrochloride tablets, in four or six equally divided doses (e.g., [IV dose x 10] divided by 4 or 6). For example, approximately 10 mg of oxymorphone hydrochloride four times daily may be required to provide pain relief equivalent to a total daily IM dose of 4 mg oxymorphone. Due to patient variability with regard to opioid analgesic response, upon conversion patients should be closely monitored to ensure adequate analgesia and to minimize side effects.

  Conversion from Other Oral Opioids to Oxymorphone Hydrochloride Tablets
  For conversion from other opioids to oxymorphone hydrochloride tablets, physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate. In general, it is safest to start oxymorphone hydrochloride tablets therapy by administering half of the calculated total daily dose of oxymorphone hydrochloride in 4 to 6 equally divided doses, every 4-6 hours. The initial dose of oxymorphone hydrochloride tablets can be gradually adjusted until adequate pain relief and acceptable side effects have been achieved.

  2.3 Maintenance of Therapy

  During therapy, continual re-evaluation of the patient receiving oxymorphone hydrochloride tablets is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose [see Dosage and Administration (2.1)].

  2.4 Cessation of Therapy

  When the patient no longer requires therapy with oxymorphone hydrochloride tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient [see Drug Abuse and Dependence (9.3)].

  2.5 Patients with Hepatic Impairment

  Oxymorphone hydrochloride tablets are contraindicated in patients with moderate or severe hepatic impairment. Use oxymorphone hydrochloride tablets with caution in patients with mild hepatic impairment, starting with the lowest dose (e.g., 5 mg) and titrating slowly while carefully monitoring side effects [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3)].

  2.6 Patients with Renal Impairment

  There are 57% and 65% increases in oxymorphone bioavailability in patients with moderate and severe renal impairment, respectively; treated with extended-release oxymorphone tablets [see Clinical Pharmacology (12.3)]. Accordingly, oxymorphone hydrochloride tablets should be administered cautiously and in reduced dosages to patients with creatinine clearance rates less than 50 mL/min.

  2.7 Use with Central Nervous System Depressants

  Oxymorphone hydrochloride tablets, like all opioid analgesics, should be started at 1/3 to 1/2 of the usual dose in patients who are concurrently receiving other central nervous system (CNS) depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, and alcohol, because respiratory depression, hypotension and profound sedation, coma or death may result [see Warnings and Precautions (5.3) and Drug Interactions (7.1)]. When combined therapy with any of the above medications is considered, the dose of one or both agents should be reduced.

  Although no specific interaction between oxymorphone and monoamine oxidase inhibitors has been observed, oxymorphone hydrochloride tablets are not recommended for use in patients who have received MAO inhibitors within 14 days [see Drug Interactions (7.5)].

  2.8 Geriatric Patients

  Exercise caution in the selection of the starting dose of oxymorphone hydrochloride tablets for an elderly patient by starting at the low end of the dosing range (e.g., 5 mg) [see Use in Specific Populations (8.5)].

  Close
  No Recall

  More Info
• Lake Erie Medical Dba Quality Care Products Llc
  

  ×

  Oxymorphone Hydrochloride | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  Selection of patients for treatment with oxymorphone hydrochloride tablets should be governed by the same principles that apply to the use of similar opioid analgesics [see Indications and Usage (1)]. Physicians should individualize treatment in every case [see Dosage and Administration (2.1)], using non-opioid analgesics, opioids on an as needed basis, combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  Oxymorphone hydrochloride tablets should be administered on an empty stomach, at least one hour prior to or two hours after eating [see Clinical Pharmacology (12.3)]

  2.1 Individualization of Dosage

  As with any opioid drug product, it is necessary to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of oxymorphone hydrochloride tablets, attention should be given to the following:

  The total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; The relative potency estimate used to calculate the equivalent oxymorphone dose needed; The patient’s degree of opioid tolerance; The age, general condition, and medical status of the patient; Concurrent non-opioid analgesics and other medications; The type and severity of the patient's pain; The balance between pain control and adverse experiences; Risk factors for abuse or addiction, including a prior history of abuse or addiction.

  Once therapy is initiated, frequently assess pain relief and other opioid effects. Titrate dose to adequate pain relief (generally mild or no pain). Patients who experience breakthrough pain may require dosage adjustment.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. Adjust dosing 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 adequately managed, continue upward titration 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. Advise patients and family members of the potential common adverse reactions associated with changing opioid doses.

  The dosing recommendations below, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  2.2 Initiation of Therapy

  Titrate dose to adequate pain relief (generally mild or no pain).

  Opioid-Naïve Patients
  Patients who have not been receiving opioid analgesics should be started on oxymorphone hydrochloride tablets in a dosing range of 10 to 20 mg every four to six hours depending on the initial pain intensity. If deemed necessary to initiate therapy at a lower dose (e.g., for renal or hepatic impairment or for geriatric patients), patients may be started with oxymorphone hydrochloride tablets 5 mg. The dose should be titrated based upon the individual patient’s response to their initial dose of oxymorphone hydrochloride tablets. This dose can then be adjusted to an acceptable level of analgesia taking into account the pain intensity and adverse reactions experienced by the patient.

  Initiation of therapy with doses higher than 20 mg is not recommended because of potential serious adverse reactions [see Clinical Studies (14.1)].

  Conversion from Parenteral Oxymorphone to Oxymorphone Hydrochloride
  Given oxymorphone hydrochloride tablet’s absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to oxymorphone hydrochloride tablets by administering 10 times the patient’s total daily parenteral oxymorphone dose as oxymorphone hydrochloride tablets, in four or six equally divided doses (e.g., [IV dose x 10] divided by 4 or 6). For example, approximately 10 mg of oxymorphone hydrochloride four times daily may be required to provide pain relief equivalent to a total daily IM dose of 4 mg oxymorphone. Due to patient variability with regard to opioid analgesic response, upon conversion patients should be closely monitored to ensure adequate analgesia and to minimize side effects.

  Conversion from Other Oral Opioids to Oxymorphone Hydrochloride Tablets
  For conversion from other opioids to oxymorphone hydrochloride tablets, physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate. In general, it is safest to start oxymorphone hydrochloride tablets therapy by administering half of the calculated total daily dose of oxymorphone hydrochloride in 4 to 6 equally divided doses, every 4-6 hours. The initial dose of oxymorphone hydrochloride tablets can be gradually adjusted until adequate pain relief and acceptable side effects have been achieved.

  2.3 Maintenance of Therapy

  During therapy, continual re-evaluation of the patient receiving oxymorphone hydrochloride tablets is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose [see Dosage and Administration (2.1)].

  2.4 Cessation of Therapy

  When the patient no longer requires therapy with oxymorphone hydrochloride tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient [see Drug Abuse and Dependence (9.3)].

  2.5 Patients with Hepatic Impairment

  Oxymorphone hydrochloride tablets are contraindicated in patients with moderate or severe hepatic impairment. Use oxymorphone hydrochloride tablets with caution in patients with mild hepatic impairment, starting with the lowest dose (e.g., 5 mg) and titrating slowly while carefully monitoring side effects [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3)].

  2.6 Patients with Renal Impairment

  There are 57% and 65% increases in oxymorphone bioavailability in patients with moderate and severe renal impairment, respectively; treated with extended-release oxymorphone tablets [see Clinical Pharmacology (12.3)]. Accordingly, oxymorphone hydrochloride tablets should be administered cautiously and in reduced dosages to patients with creatinine clearance rates less than 50 mL/min.

  2.7 Use with Central Nervous System Depressants

  Oxymorphone hydrochloride tablets, like all opioid analgesics, should be started at 1/3 to 1/2 of the usual dose in patients who are concurrently receiving other central nervous system (CNS) depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, and alcohol, because respiratory depression, hypotension and profound sedation, coma or death may result [see Warnings and Precautions (5.3) and Drug Interactions (7.1)]. When combined therapy with any of the above medications is considered, the dose of one or both agents should be reduced.

  Although no specific interaction between oxymorphone and monoamine oxidase inhibitors has been observed, oxymorphone hydrochloride tablets are not recommended for use in patients who have received MAO inhibitors within 14 days [see Drug Interactions (7.5)].

  2.8 Geriatric Patients

  Exercise caution in the selection of the starting dose of oxymorphone hydrochloride tablets for an elderly patient by starting at the low end of the dosing range (e.g., 5 mg) [see Use in Specific Populations (8.5)].

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  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 to 72 hours of initiating therapy with oxymorphone hydrochloride extended-release tablets [see Warnings and Precautions (5.2)].

  Consider the following factors when selecting an initial dose of oxymorphone hydrochloride extended-release tablets:

  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 oxymorphone 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.

  Oxymorphone hydrochloride extended-release tablets are administered at a frequency of twice daily (every 12 hours). Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating.

  Use of Oxymorphone Hydrochloride Extended-Release Tablets as the First Opioid Analgesic

  Initiate oxymorphone hydrochloride extended-release tablet therapy with the 5 mg tablet twice daily (at 12-hour intervals). Adjust the dose of oxymorphone hydrochloride extended-release tablet in increments of 5 to 10 mg every 12 hours every 3 to 7 days.

  Conversion from Oxymorphone Hydrochloride Tablets to Oxymorphone Hydrochloride Extended-Release Tablets

  Patients receiving oxymorphone hydrochloride tablets may be converted to oxymorphone hydrochloride extended-release tablets by administering half the patient's total daily oral oxymorphone hydrochloride tablets dose as oxymorphone hydrochloride extended-release tablets, every 12 hours.

  Conversion from Parenteral Oxymorphone to Oxymorphone Hydrochloride Extended-Release Tablets

  The absolute oral bioavailability of oxymorphone hydrochloride extended-release tablets is approximately 10%. Convert patients receiving parenteral oxymorphone to oxymorphone hydrochloride extended-release tablets by administering 10 times the patient's total daily parenteral oxymorphone dose as oxymorphone hydrochloride extended-release tablets in two equally divided doses (e.g., [IV dose x 10] divided by 2). Due to patient variability with regards to opioid analgesic response, upon conversion monitor patients closely to evaluate for adequate analgesia and side effects.

  Conversion from Other Oral Opioids to Oxymorphone Hydrochloride Extended-Release Tablets

  While there are useful tables of oral and parenteral equivalents, there is substantial inter-patient variability in the relative potency of different opioid drugs and formulations. As such, it is safer to underestimate a patient’s 24-hour oral oxymorphone dose and provide rescue medication (e.g. immediate-release oxymorphone) than to overestimate the 24-hour oral oxymorphone dose and manage an adverse reaction. Consider the following general points:

  In a Phase 3 clinical trial with an open-label titration period, patients were converted from their prior opioid to oxymorphone hydrochloride extended-release tablets using the following table as a guide for the initial oxymorphone hydrochloride extended-release tablet dose.

  The table is not a table of equianalgesic doses. The conversion ratios in this table are only to be used for the conversion from oral therapy with one of the listed opioid analgesics to oxymorphone hydrochloride extended-release tablets. Do not use this table to convert from oxymorphone hydrochloride extended-release tablets to another opioid. Doing so will result in an over-estimation of the dose of the new opioid and may result in fatal overdose.

  For example, a patient receiving oxycodone at a total daily dose of 40 mg would then be converted to a total daily dose of 20 mg of oxymorphone (40 mg x 0.5), dosed as oxymorphone hydrochloride extended-release tablets 10 mg twice daily.

  CONVERSION RATIOS TO OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS   Oral   Opioid   Total Daily Oral Dose   Conversion Ratio  Oxymorphone  10 mg  1  Hydrocodone  20 mg  0.5  Oxycodone  20 mg  0.5  Methadone  20 mg  0.5  Morphine  30 mg  0.333 2.2 Titration and Maintenance of Therapy

  Individually titrate oxymorphone hydrochloride extended-release tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving oxymorphone hydrochloride extended-release tablets 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 oxymorphone hydrochloride extended-release tablet dose to decrease the level of pain. Because steady-state plasma concentrations are approximated within 3 days, oxymorphone hydrochloride extended-release tablet dosage adjustments, preferably at increments of 5 to 10 mg every 12 hours, may be done every 3 to 7 days. Patients who experience breakthrough pain may require dosage adjustment or rescue medication with a small dose of an immediate-release medication (e.g. immediate-release oxymorphone).

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

  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.

  2.3 Discontinuation of Oxymorphone Hydrochloride Extended-Release Tablets

  When a patient no longer requires therapy with oxymorphone hydrochloride extended-release tablets, use a gradual downward titration of the dose every two to four days, to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue oxymorphone hydrochloride extended-release tablets.

  2.4 Administration of Oxymorphone Hydrochloride Extended-Release Tablets

  Instruct patients to swallow oxymorphone hydrochloride extended-release 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 oxymorphone [see Warnings and Precautions (5.2)]. Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating.

  2.5 Patients with Hepatic Impairment

  Oxymorphone hydrochloride extended-release tablets are contraindicated in patients with moderate or severe hepatic impairment.

  In opioid-naïve patients with mild hepatic impairment, initiate treatment with the 5 mg dose. For patients on prior opioid therapy, start oxymorphone hydrochloride extended-release tablets at 50% lower than the starting dose for a patient with normal hepatic function on prior opioids and titrate slowly. Monitor patients closely for signs of respiratory or central nervous system depression [see Warnings and Precautions (5.2), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.6 Patients with Renal Impairment

  In patients with creatinine clearance rates less than 50 mL/min, start oxymorphone hydrochloride extended-release tablets in the opioid-naïve patient with the 5 mg dose. For patients on prior opioid therapy, start oxymorphone hydrochloride extended-release tablets at 50% lower than the starting dose for a patient with normal renal function on prior opioids and titrate slowly. Monitor patients closely for signs of respiratory or central nervous system depression [see Warnings and Precautions (5.2), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.7 Geriatric Patients

  The steady-state plasma concentrations of oxymorphone are approximately 40% higher in elderly subjects than in young subjects. Initiate dosing with oxymorphone hydrochloride extended-release tablets in patients 65 years of age and over using the 5 mg dose and monitor closely for signs of respiratory and central nervous system depression when initiating and titrating oxymorphone hydrochloride extended-release tablets to adequate analgesia [see Warnings and Precautions (5.2), Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)]. For patients on prior opioid therapy, start oxymorphone hydrochloride extended-release tablets at 50% lower than the starting dose for a younger patient on prior opioids and titrate slowly.

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  2.1 Initial Dosing

  To avoid medication errors, prescribers and pharmacists must be aware that oxymorphone is available as both immediate-release 5 mg and 10 mg tablets and extended-release 5 mg and 10 mg tablets [see Dosage Forms and Strengths].

  Oxymorphone hydrochloride extended-release 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 therapy with oxymorphone hydrochloride extended-release [see Warnings and Precautions (5.2)].

  Oxymorphone hydrochloride extended-release 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 oxymorphone hydrochloride extended-releasetablets will result in uncontrolled delivery of oxymorphone and can lead to overdose or death [see Warnings and Precautions (5.2)].

  Oxymorphone hydrochloride extended-release tablets are administered at a frequency of twice daily (every 12 hours).  Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating.

  Use of Oxymorphone Hydrochloride Extended-Release as the First Opioid Analgesic
  Initiate treatment with oxymorphone hydrochloride extended-release with the 5 mg tablet orally every 12-hours. 

  Use of Oxymorphone Hydrochloride Extended-Release in Patients who are not Opioid Tolerant
  The starting dose for patients who are not opioid tolerant is oxymorphone hydrochloride extended-release tablet 5 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 Oxymorphone Hydrochloride to Oxymorphone Hydrochloride Extended-Release
  Patients receiving oxymorphone hydrochloride may be converted to oxymorphone hydrochloride extended-release by administering half the patient's total daily oral oxymorphone hydrochloride dose as oxymorphone hydrochloride extended-release, every 12 hours.

  Conversion from Parenteral Oxymorphone to Oxymorphone Hydrochloride Extended-Release Tablets
  The absolute oral bioavailability of oxymorphone hydrochloride extended-release tablets is approximately 10%.  Convert patients receiving parenteral oxymorphone to oxymorphone hydrochloride extended-release tablets by administering 10 times the patient's total daily parenteral oxymorphone dose as oxymorphone hydrochloride extended-release tablets in two equally divided doses (e.g., [IV dose x 10] divided by 2).  Due to patient variability with regards to opioid analgesic response, upon conversion monitor patients closely to evaluate for adequate analgesia and side effects.

  Conversion from Other Oral Opioids to Oxymorphone Hydrochloride Extended-Release
  Discontinue all other around-the-clock opioid drugs when oxymorphone hydrochloride extended-release therapy is initiated.

  While there are useful tables of opioid equivalents readily available, there is substantial inter- patient variability in the relative potency of different opioid drugs and products. As such, it is preferable to underestimate a patient’s 24-hour oral oxymorphone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral oxymorphone requirements which could result in adverse reactions.  In an oxymorphone hydrochloride extended-release clinical trial with an open-label titration period, patients were converted from their prior opioid to oxymorphone hydrochloride extended-release using Table 1 as a guide for the initial oxymorphone hydrochloride extended-release dose.

  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 oxymorphone hydrochloride extended-release.   This table cannot be used to convert from oxymorphone hydrochloride extended-release to another opioid. Doing so will result in an over-estimation of the dose of the new opioid and may result in fatal overdose.

  CONVERSION FACTORS TO OXYMORPHONE HYDROCHLORIDE
  EXTENDED-RELEASE

  Prior Oral Opioid

  Approximate Oral
  Conversion Factor

  Oxymorphone

  1

  Hydrocodone

  0.5

  Oxycodone

  0.5

  Methadone

  0.5

  Morphine

  0.333

  To calculate the estimated oxymorphone hydrochloride extended-release dose using Table 1:

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

  Always round the dose down, if necessary, to the appropriate oxymorphone hydrochloride extended-release strength(s) available.

  Example conversion from a single opioid to oxymorphone hydrochloride extended-release:

      Step 1:  Sum the total daily dose of the opioid oxycodone 20 mg BID
                  20 mg former opioid 2 times daily = 40 mg total daily dose of former opioid

      Step 2:  Calculate the approximate equivalent dose of oral (active opioid) based on the total daily dose of the current opioid using Table 1
                  40 mg total daily dose of former opioid x 0.5 mg Conversion Factor = 20 mg of oral (active opioid) daily

      Step 3:  Calculate the approximate starting dose of oxymorphone hydrochloride extended-release to be given every 12 hours. Round down, if necessary, to the appropriate oxymorphone hydrochloride extended-release tablets strengths available.
                  10 mg oxymorphone hydrochloride extended-release every 12 hours

  Conversion from Methadone to Oxymorphone Hydrochloride Extended-Release
  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.

  2.2 Titration and Maintenance of Therapy

  Individually titrate oxymorphone hydrochloride extended-release to a dose that provides adequate analgesia and minimizes adverse reactions.  Continually reevaluate patients receiving oxymorphone hydrochloride extended-release 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.

  If the level of pain increases, attempt to identify the source of increased pain, while adjusting the oxymorphone hydrochloride extended-release dose to decrease the level of pain. Because steady-state plasma concentrations are approximated within 3 days, oxymorphone hydrochloride extended-release dosage adjustments, preferably at increments of 5-10 mg every 12 hours, may be done every 3 to 7 days.            

  Patients who experience breakthrough pain may require a dose increase of oxymorphone hydrochloride extended-release, 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 oxymorphone hydrochloride extended-release dose. 

  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.

  2.3 Discontinuation of Oxymorphone Hydrochloride Extended-Release

  When a patient no longer requires therapy with oxymorphone hydrochloride extended-release, use a gradual downward titration of the dose every two to four days, to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue oxymorphone hydrochloride extended-release.

  2.4 Administration of Oxymorphone Hydrochloride Extended-Release Tablets

  Instruct patients to swallow oxymorphone hydrochloride extended-release 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 oxymorphone [see Warnings and Precautions (5.2)]. Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating.

  2.5 Patients with Hepatic Impairment

  Oxymorphone hydrochloride extended-release is contraindicated in patients with moderate or severe hepatic impairment.

  In opioid-naïve patients with mild hepatic impairment, initiate treatment with the 5 mg dose.  For patients on prior opioid therapy, start oxymorphone hydrochloride extended-release at 50% lower than the starting dose for a patient with normal hepatic function on prior opioids and titrate slowly.  Monitor patients closely for signs of respiratory or central nervous system depression [see Warnings and Precautions (5.2), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.6 Patients with Renal Impairment

  In patients with creatinine clearance rates less than 50 mL/min, start oxymorphone hydrochloride extended-release in the opioid-naïve patient with the 5 mg dose.  For patients on prior opioid therapy, start oxymorphone hydrochloride extended-release at 50% lower than the starting dose for a patient with normal renal function on prior opioids and titrate slowly. Monitor patients closely for signs of respiratory or central nervous system depression [see Warnings and Precautions (5.2), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.7 Geriatric Patients

  The steady-state plasma concentrations of oxymorphone are approximately 40% higher in elderly subjects than in young subjects.  Initiate dosing with oxymorphone hydrochloride extended-release in patients 65 years of age and over using the 5 mg dose and monitor closely for signs of respiratory and central nervous system depression when initiating and titrating oxymorphone hydrochloride extended-release to adequate analgesia [see Warnings and Precautions (5.2), Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].For patients on prior opioid therapy, start oxymorphone hydrochloride extended-release at 50% lower than the starting dose for a younger patient on prior opioids and titrate slowly.

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  Selection of patients for treatment with oxymorphone hydrochloride tablets should be governed by the same principles that apply to the use of similar opioid analgesics [see Indications and Usage (1)]. Physicians should individualize treatment in every case [see Dosage and Administration (2.1)], using non-opioid analgesics, opioids on an as needed basis, combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.
  
  Oxymorphone hydrochloride tablets should be administered on an empty stomach, at least one hour prior to or two hours after eating [see Clinical Pharmacology (12.3)].

  2.1 Individualization of Dosage

  As with any opioid drug product, it is necessary to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of oxymorphone hydrochloride tablets, attention should be given to the following:
  
  

  The total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; The relative potency estimate used to calculate the equivalent oxymorphone dose needed; The patient’s degree of opioid tolerance; The age, general condition, and medical status of the patient; Concurrent non-opioid analgesics and other medications; The type and severity of the patient's pain; The balance between pain control and adverse experiences; Risk factors for abuse or addiction, including a prior history of abuse or addiction.
  

  Once therapy is initiated, frequently assess pain relief and other opioid effects. Titrate dose to adequate pain relief (generally mild or no pain). Patients who experience breakthrough pain may require dosage adjustment.
  
  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. Adjust dosing 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 adequately managed, continue upward titration 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. Advise patients and family members of the potential common adverse reactions associated with changing opioid doses.
  
  The dosing recommendations below, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  2.2 Initiation of Therapy

  Titrate dose to adequate pain relief (generally mild or no pain).
  
  Opioid-Naïve Patients
  
  Patients who have not been receiving opioid analgesics should be started on oxymorphone hydrochloride tablets in a dosing range of 10 to 20 mg every four to six hours depending on the initial pain intensity. If deemed necessary to initiate therapy at a lower dose (e.g., for renal or hepatic impairment or for geriatric patients), patients may be started with oxymorphone hydrochloride tablets 5 mg. The dose should be titrated based upon the individual patient’s response to their initial dose of oxymorphone hydrochloride tablets. This dose can then be adjusted to an acceptable level of analgesia taking into account the pain intensity and adverse reactions experienced by the patient.
  
  Initiation of therapy with doses higher than 20 mg is not recommended because of potential serious adverse reactions [see Clinical Studies (14.1)].
  
  Conversion from Parenteral Oxymorphone to Oxymorphone Hydrochloride Tablets
  
  Given oxymorphone hydrochloride tablets’s absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to oxymorphone hydrochloride tablets by administering 10 times the patient’s total daily parenteral oxymorphone dose as oxymorphone hydrochloride tablets, in four or six equally divided doses (e.g., [IV dose x 10] divided by 4 or 6).  For example, approximately 10 mg of oxymorphone hydrochloride tablets four times daily may be required to provide pain relief equivalent to a total daily IM dose of 4 mg oxymorphone. Due to patient variability with regard to opioid analgesic response, upon conversion patients should be closely monitored to ensure adequate analgesia and to minimize side effects.
  
  Conversion from Other Oral Opioids to Oxymorphone Hydrochloride Tablets
  
  For conversion from other opioids to oxymorphone hydrochloride tablets, physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate. In general, it is safest to start oxymorphone hydrochloride tablets therapy by administering half of the calculated total daily dose of oxymorphone hydrochloride tablets in 4 to 6 equally divided doses, every 4 to 6 hours. The initial dose of oxymorphone hydrochloride tablets can be gradually adjusted until adequate pain relief and acceptable side effects have been achieved.
  

  2.3 Maintenance of Therapy

  During therapy, continual reevaluation of the patient receiving oxymorphone hydrochloride tablets is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose [see Dosage and Administration (2.1)].
  
  

  2.4 Cessation of Therapy

  When the patient no longer requires therapy with oxymorphone hydrochloride tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient [see Drug Abuse and Dependence (9.3)].

  2.5 Patients with Hepatic Impairment

  Oxymorphone hydrochloride tablets are contraindicated in patients with moderate or severe hepatic impairment. Use oxymorphone hydrochloride tablets with caution in patients with mild hepatic impairment, starting with the lowest dose (e.g., 5 mg) and titrating slowly while carefully monitoring side effects [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3)].

  2.6 Patients with Renal Impairment

  There are 57% and 65% increases in oxymorphone bioavailability in patients with moderate and severe renal impairment, respectively; treated with extended-release oxymorphone tablets [see Clinical Pharmacology (12.3)]. Accordingly, oxymorphone hydrochloride tablets should be administered cautiously and in reduced dosages to patients with creatinine clearance rates less than 50 mL/min.

  2.7 Use with Central Nervous System Depressants

  Oxymorphone hydrochloride tablets, like all opioid analgesics, should be started at 1/3 to 1/2 of the usual dose in patients who are concurrently receiving other central nervous system (CNS) depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, and alcohol, because respiratory depression, hypotension and profound sedation, coma or death may result [see Warnings and Precautions (5.3) and Drug Interactions (7.1)]. When combined therapy with any of the above medications is considered, the dose of one or both agents should be reduced.
  
  Although no specific interaction between oxymorphone and monoamine oxidase inhibitors has been observed, oxymorphone hydrochloride tablets are not recommended for use in patients who have received MAO inhibitors within 14 days [see Drug Interactions (7.5)].
  
  

  2.8 Geriatric Patients

  Exercise caution in the selection of the starting dose of oxymorphone hydrochloride tablets for an elderly patient by starting at the low end of the dosing range (e.g., 5 mg) [see Use in Specific Populations (8.5)].

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  2.1 Initial Dosing

  To avoid medication errors, prescribers and pharmacists must be aware that oxymorphone is available as both immediate-release 5 mg and 10 mg tablets and extended-release 5 mg and 10 mg tablets [see Dosage Forms and Strengths].

  Oxymorphone hydrochloride extended-release tablets 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 to 72 hours of initiating therapy with oxymorphone hydrochloride extended-release tablets [see Warnings and Precautions (5.2)].

  Oxymorphone hydrochloride extended-release 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 oxymorphone hydrochloride extended-release tablets will result in uncontrolled delivery of oxymorphone and can lead to overdose or death [see Warnings and Precautions (5.2)].

  Oxymorphone hydrochloride extended-release tablets are administered at a frequency of twice daily (every 12 hours). Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating.

  Use of Oxymorphone Hydrochloride Extended-Release Tablets as the First Opioid Analgesic

  Initiate treatment with oxymorphone hydrochloride extended-release tablets with the 5 mg tablet orally every 12 hours.

  Use of Oxymorphone Hydrochloride Extended-Release Tablets in Patients who are not Opioid Tolerant

  The starting dose for patients who are not opioid tolerant is oxymorphone hydrochloride extended-release tablets 5 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 Oxymorphone Hydrochloride Tablets to Oxymorphone Hydrochloride Extended-Release Tablets

  Patients receiving oxymorphone hydrochloride tablets may be converted to oxymorphone hydrochloride extended-release tablets by administering half the patient's total daily oral oxymorphone hydrochloride tablets dose as oxymorphone hydrochloride extended-release tablets, every 12 hours.

  Conversion from Parenteral Oxymorphone to Oxymorphone Hydrochloride Extended-Release Tablets

  The absolute oral bioavailability of oxymorphone hydrochloride extended-release tablets is approximately 10%. Convert patients receiving parenteral oxymorphone to oxymorphone hydrochloride extended-release tablets by administering 10 times the patient's total daily parenteral oxymorphone dose as oxymorphone hydrochloride extended-release tablets in two equally divided doses (e.g., [IV dose × 10] divided by 2). Due to patient variability with regards to opioid analgesic response, upon conversion monitor patients closely to evaluate for adequate analgesia and side effects.

  Conversion from Other Oral Opioids to Oxymorphone Hydrochloride Extended-Release Tablets

  Discontinue all other around-the-clock opioid drugs when oxymorphone hydrochloride extended-release tablets therapy is initiated.

  While there are useful tables of opioid equivalents readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products. As such, it is preferable to underestimate a patient's 24-hour oral oxymorphone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral oxymorphone requirements which could result in adverse reactions. In an oxymorphone hydrochloride extended-release tablets clinical trial with an open-label titration period, patients were converted from their prior opioid to oxymorphone hydrochloride extended-release tablets using Table 1 as a guide for the initial oxymorphone hydrochloride extended-release tablets dose.

  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 oxymorphone hydrochloride extended-release tablets. This table cannot be used to convert from oxymorphone hydrochloride extended-release tablets to another opioid. Doing so will result in an over-estimation of the dose of the new opioid and may result in fatal overdose. CONVERSION FACTORS TO OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS Prior Oral Opioid Approximate Oral Conversion Factor Oxymorphone 1 Hydrocodone 0.5 Oxycodone 0.5 Methadone 0.5 Morphine 0.333

  To calculate the estimated oxymorphone hydrochloride extended-release tablets dose using Table 1:

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

  Always round the dose down, if necessary, to the appropriate oxymorphone hydrochloride extended-release tablets strength(s) available.

  Example conversion from a single opioid to oxymorphone hydrochloride extended-release tablets:

  Step 1: Sum the total daily dose of the opioid oxycodone 20 mg BID 20 mg former opioid 2 times daily = 40 mg total daily dose of former opioid Step 2: Calculate the approximate equivalent dose of oral (active opioid) based on the total daily dose of the current opioid using Table 1 40 mg total daily dose of former opioid × 0.5 mg Conversion Factor = 20 mg of oral (active opioid) daily Step 3: Calculate the approximate starting dose of oxymorphone hydrochloride extended-release tablets to be given every 12 hours. Round down, if necessary, to the appropriate oxymorphone hydrochloride extended-release tablets strengths available.
  10 mg oxymorphone hydrochloride extended-release tablets every 12 hours

  Conversion from Methadone to Oxymorphone Hydrochloride Extended-Release Tablets

  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.

  2.2 Titration and Maintenance of Therapy

  Individually titrate oxymorphone hydrochloride extended-release tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving oxymorphone hydrochloride extended-release tablets 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.

  If the level of pain increases, attempt to identify the source of increased pain, while adjusting the oxymorphone hydrochloride extended-release tablets dose to decrease the level of pain. Because steady-state plasma concentrations are approximated within 3 days, oxymorphone hydrochloride extended-release tablets dosage adjustments, preferably at increments of 5 to 10 mg every 12 hours, may be done every 3 to 7 days.

  Patients who experience breakthrough pain may require a dose increase of oxymorphone hydrochloride extended-release tablets, 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 oxymorphone hydrochloride extended-release tablets dose.

  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.

  2.3 Discontinuation of Oxymorphone Hydrochloride Extended-Release Tablets

  When a patient no longer requires therapy with oxymorphone hydrochloride extended-release tablets, use a gradual downward titration of the dose every two to four days, to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue oxymorphone hydrochloride extended-release tablets.

  2.4 Administration of Oxymorphone Hydrochloride Extended-Release Tablets

  Instruct patients to swallow oxymorphone hydrochloride extended-release 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 oxymorphone [see Warnings and Precautions (5.2)]. Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating.

  2.5 Patients with Hepatic Impairment

  Oxymorphone hydrochloride extended-release tablets are contraindicated in patients with moderate or severe hepatic impairment.

  In opioid-naïve patients with mild hepatic impairment, initiate treatment with the 5 mg dose. For patients on prior opioid therapy, start oxymorphone hydrochloride extended-release tablets at 50% lower than the starting dose for a patient with normal hepatic function on prior opioids and titrate slowly. Monitor patients closely for signs of respiratory or central nervous system depression [see Warnings and Precautions (5.2), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.6 Patients with Renal Impairment

  In patients with creatinine clearance rates less than 50 mL/min, start oxymorphone hydrochloride extended-release tablets in the opioid-naïve patient with the 5 mg dose. For patients on prior opioid therapy, start oxymorphone hydrochloride extended-release tablets at 50% lower than the starting dose for a patient with normal renal function on prior opioids and titrate slowly. Monitor patients closely for signs of respiratory or central nervous system depression [see Warnings and Precautions (5.2), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.7 Geriatric Patients

  The steady-state plasma concentrations of oxymorphone are approximately 40% higher in elderly subjects than in young subjects. Initiate dosing with oxymorphone hydrochloride extended-release tablets in patients 65 years of age and over using the 5 mg dose and monitor closely for signs of respiratory and central nervous system depression when initiating and titrating oxymorphone hydrochloride extended-release tablets to adequate analgesia [see Warnings and Precautions (5.2), Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)]. For patients on prior opioid therapy, start oxymorphone hydrochloride extended-release tablets at 50% lower than the starting dose for a younger patient on prior opioids and titrate slowly.

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  Oxymorphone Hydrochloride | Teva Pharmaceuticals Usa Inc

  

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  Selection of patients for treatment with oxymorphone hydrochloride tablets should be governed by the same principles that apply to the use of similar opioid analgesics [see Indications and Usage (1)]. Physicians should individualize treatment in every case [see Dosage and Administration (2.1)], using non-opioid analgesics, opioids on an as needed basis, combination products, and chronic opioid therapy in a progressive  plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

  Oxymorphone hydrochloride tablets should be administered on an empty stomach, at least one hour prior to or two hours after eating [see Clinical Pharmacology (12.3)].

  2.1 Individualization of Dosage

  As with any opioid drug product, it is necessary to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of oxymorphone hydrochloride tablets, attention should be given to the following:

  • The total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; • The relative potency estimate used to calculate the equivalent oxymorphone dose needed; • The patient’s degree of opioid tolerance; • The age, general condition, and medical status of the patient; • Concurrent non-opioid analgesics and other medications; • The type and severity of the patient's pain; • The balance between pain control and adverse experiences; • Risk factors for abuse or addiction, including a prior history of abuse or addiction.

  Once therapy is initiated, frequently assess pain relief and other opioid effects. Titrate dose to adequate pain relief (generally mild or no pain). Patients who experience breakthrough pain may require dosage adjustment.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. Adjust dosing 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 adequately managed, continue upward titration 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. Advise patients and family members of the potential common adverse reactions associated with changing opioid doses.

  The dosing recommendations below, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  2.2 Initiation of Therapy

  Titrate dose to adequate pain relief (generally mild or no pain).

  Opioid-Naïve Patients

  Patients who have not been receiving opioid analgesics should be started on oxymorphone hydrochloride tablets in a dosing range of 10 to 20 mg every four to six hours depending on the initial pain intensity. If deemed necessary to initiate therapy at a lower dose (e.g., for renal or hepatic impairment or for geriatric patients), patients may be started with oxymorphone hydrochloride tablets, 5 mg. The dose should be titrated based upon the individual patient’s response to their initial dose of oxymorphone hydrochloride tablets. This dose can then be adjusted to an acceptable level of analgesia taking into account the pain intensity and adverse reactions experienced by the patient.

  Initiation of therapy with doses higher than 20 mg is not recommended because of potential serious adverse reactions  [see Clinical Studies (14.1)].

  Conversion From Parenteral Oxymorphone to Oxymorphone Hydrochloride Tablets

  Given oxymorphone hydrochloride tablets’ absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to oxymorphone hydrochloride tablets by administering 10 times the patient’s total daily parenteral oxymorphone dose as oxymorphone hydrochloride tablets, in four or six equally divided doses (e.g., [IV dose x 10] divided by 4 or 6). For example, approximately 10 mg of oxymorphone hydrochloride tablets four times daily may be required to provide pain relief equivalent to a total daily IM dose of 4 mg oxymorphone. Due to patient variability with regard to opioid analgesic response, upon conversion patients should be closely monitored to ensure adequate analgesia and to minimize side effects.

  Conversion From Other Oral Opioids to Oxymorphone Hydrochloride Tablets

  For conversion from other opioids to oxymorphone hydrochloride tablets, physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate. In general, it is safest to start oxymorphone hydrochloride tablets therapy by administering half of the calculated total daily dose of oxymorphone hydrochloride tablets in 4 to 6 equally divided doses, every 4 to 6 hours. The initial dose of oxymorphone hydrochloride tablets can be gradually adjusted until adequate pain relief and acceptable side effects have been achieved.

  2.3 Maintenance of Therapy

  During therapy, continual re-evaluation of the patient receiving oxymorphone hydrochloride tablets is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose [see Dosage and Administration (2.1)].

  2.4 Cessation of Therapy

  When the patient no longer requires therapy with oxymorphone hydrochloride tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient [see Drug Abuse and Dependence (9.3)].

  2.5 Patients With Hepatic Impairment

  Oxymorphone hydrochloride tablets are contraindicated in patients with moderate or severe hepatic impairment. Use oxymorphone hydrochloride tablets with caution in patients with mild hepatic impairment, starting with the lowest dose (e.g., 5 mg) and titrating slowly while carefully monitoring side effects [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3)].

  2.6 Patients With Renal Impairment

  There are 57% and 65% increases in oxymorphone bioavailability in patients with moderate and severe renal impairment, respectively; treated with extended-release oxymorphone tablets [see Clinical Pharmacology (12.3)]. Accordingly, oxymorphone hydrochloride tablets should be administered cautiously and in reduced dosages to patients with creatinine clearance rates less than 50 mL/min.

  2.7 Use With Central Nervous System Depressants

  Oxymorphone hydrochloride tablets, like all opioid analgesics, should be started at 1/3 to 1/2 of the usual dose in patients who are concurrently receiving other central nervous system (CNS) depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, and alcohol, because respiratory depression, hypotension and profound sedation, coma or death may result [see Warnings and Precautions (5.3) and Drug Interactions (7.1)]. When combined therapy with any of the above medications is considered, the dose of one or both agents should be reduced.

  Although no specific interaction between oxymorphone and monoamine oxidase inhibitors has been observed, oxymorphone hydrochloride tablets are not recommended for use in patients who have received MAO inhibitors within 14 days [see Drug Interactions (7.5)].

  2.8 Geriatric Patients

  Exercise caution in the selection of the starting dose of oxymorphone hydrochloride tablets for an elderly patient by starting at the low end of the dosing range (e.g., 5 mg) [see Use in Specific Populations (8.5)].

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