Opana

Opana Manufacturers

• Stat Rx Usa Llc
  

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  Opana | Stat Rx Usa Llc

  

  ---

  Selection of patients for treatment with OPANA 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.

  OPANA 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 OPANA, 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 OPANA 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 OPANA 5 mg. The dose should be titrated based upon the individual patient’s response to their initial dose of OPANA. 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 OPANA
  Given OPANA’s absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to OPANA by administering 10 times the patient’s total daily parenteral oxymorphone dose as OPANA, in four or six equally divided doses (e.g., [IV dose x 10] divided by 4 or 6). For example, approximately 10 mg of OPANA 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 OPANA
  For conversion from other opioids to OPANA, 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 OPANA therapy by administering half of the calculated total daily dose of OPANA in 4 to 6 equally divided doses, every 4-6 hours. The initial dose of OPANA 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 OPANA 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 OPANA, 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

  OPANA is contraindicated in patients with moderate or severe hepatic impairment. Use OPANA 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, OPANA 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

  OPANA, 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, OPANA 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 OPANA 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 & Surgical Supply Dba Quality Care Products Llc
  

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  Opana | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

  

  ---

  Selection of patients for treatment with OPANA 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.

  OPANA 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 OPANA, 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 OPANA 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 OPANA 5 mg. The dose should be titrated based upon the individual patient’s response to their initial dose of OPANA. 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 OPANA
  Given OPANA’s absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to OPANA by administering 10 times the patient’s total daily parenteral oxymorphone dose as OPANA, in four or six equally divided doses (e.g., [IV dose x 10] divided by 4 or 6). For example, approximately 10 mg of OPANA 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 OPANA
  For conversion from other opioids to OPANA, 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 OPANA therapy by administering half of the calculated total daily dose of OPANA in 4 to 6 equally divided doses, every 4-6 hours. The initial dose of OPANA 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 OPANA 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 OPANA, 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

  OPANA is contraindicated in patients with moderate or severe hepatic impairment. Use OPANA 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, OPANA 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

  OPANA, 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, OPANA 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 OPANA 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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• Bryant Ranch Prepack
  

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  Opana | Bryant Ranch Prepack

  

  ---

  Selection of patients for treatment with OPANA 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.

  OPANA 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 OPANA, 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 OPANA 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 OPANA 5 mg. The dose should be titrated based upon the individual patient’s response to their initial dose of OPANA. 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 OPANA
  Given OPANA’s absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to OPANA by administering 10 times the patient’s total daily parenteral oxymorphone dose as OPANA, in four or six equally divided doses (e.g., [IV dose x 10] divided by 4 or 6). For example, approximately 10 mg of OPANA 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 OPANA
  For conversion from other opioids to OPANA, 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 OPANA therapy by administering half of the calculated total daily dose of OPANA in 4 to 6 equally divided doses, every 4-6 hours. The initial dose of OPANA 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 OPANA 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 OPANA, 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

  OPANA is contraindicated in patients with moderate or severe hepatic impairment. Use OPANA 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, OPANA 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

  OPANA, 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, OPANA 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 OPANA 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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• Endo Pharmaceuticals Inc.
  

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  Opana | Endo Pharmaceuticals Inc.

  

  ---

  OPANA Injection is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine and other opioids.

  OPANA Injection, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion.

  Selection of patients for treatment with OPANA Injection should be governed by the same principles that apply to the use of similar opioid analgesics (see INDICATIONS AND USAGE). Physicians should individualize treatment in every case (see DOSAGE AND ADMINISTRATION), using non-opioid analgesics, prn opioids and/or 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.

  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 OPANA Injection, 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 analgesic and other medications; The type and severity of the patient's pain; The balance between pain control and adverse experiences. Risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.

  The following dosing recommendations, 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.

  Initiation of Therapy

  Subcutaneous or intramuscular administration: initially 1 mg to 1.5 mg, repeated every 4 to 6 hours as needed. Intravenous: 0.5 mg initially. In non debilitated patients the dose can be cautiously increased until satisfactory pain relief is obtained. For analgesia during labor 0.5 mg to 1 mg intramuscularly is recommended.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  Conversion from Oral OPANA to OPANA Injection
  Given the absolute oral bioavailability of approximately 10%, patients receiving oral OPANA may be converted to OPANA Injection by administering one-tenth the patient’s total daily oral oxymorphone dose as OPANA Injectable in four or six equally divided doses (e.g., total daily Oral dose/ [10 x 4]). For example, approximately 1 mg of OPANA Injectable IM every 6 hours (4 mg total IM dose) may be required to provide pain relief equivalent to a total daily dose of 40 mg oral OPANA. The dose can be titrated to optimal pain relief or combined with acetaminophen/NSAIDs for optimal pain relief. 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.

  Individualization of Dose

  Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. Patients should be titrated to adequate pain relief (generally mild or no pain). Patients who experience breakthrough pain may require dosage adjustment or non-opioid therapy such as acetaminophen or NSAIDs.

  If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. 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 health-care team, the patient and the caregiver/family. Patients and family members should be advised of the potential common side effects to decrease fear of the use of opioids and promote their optimal use.

  Patients with Hepatic Impairment

  The effects of OPANA Injection on hepatic impairment have not been studied. However, OPANA Injection is contraindicated in patients with moderate and severe hepatic dysfunction. OPANA Injection should be used with caution in patients with mild hepatic impairment. These patients with mild hepatic impairment should be started with the lowest dose and titrated slowly while carefully monitoring side effects (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, and PRECAUTIONS).

  Patients with Renal Impairment

  The effects of OPANA Injection on renal impairment have not been studied. However, there are 57% and 65% increases in oxymorphone bioavailability in patients with moderate to severe renal impairment, respectively, treated with OPANA ER (see CLINICAL PHARMACOLOGY and PRECAUTIONS). Accordingly, OPANA Injection should be administered cautiously and in reduced dosages to patients with creatinine clearance rate less than 50 mL/min.

  Use with CNS depressants

  OPANA Injection, 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 depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, and alcohol because respiratory depression, hypotension and profound sedation or coma may result. No specific interaction between oxymorphone and monoamine oxidase inhibitors has been observed, but caution in the use of any opioid in patients taking this class of drugs is appropriate (see PRECAUTIONS: General and PRECAUTIONS: Drug-Drug Interactions)

  Geriatrics

  Caution should be exercised in the selection of the starting dose of OPANA Injection for an elderly patient starting at the low end of the dosing range.

  Maintenance of Therapy

  OPANA Injection is intended as an opioid analgesic for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. During therapy, continual re-evaluation of the patient receiving OPANA Injection 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 and/or using adjuvant analgesics such as acetaminophen or NSAIDs.

  Cessation of Therapy

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

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• Endo Pharmaceuticals
  

  ×

  Opana | Endo Pharmaceuticals

  

  ---

  Selection of patients for treatment with OPANA 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.

  OPANA 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 OPANA, 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 OPANA 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 OPANA 5 mg. The dose should be titrated based upon the individual patient’s response to their initial dose of OPANA. 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 OPANA
  Given OPANA’s absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to OPANA by administering 10 times the patient’s total daily parenteral oxymorphone dose as OPANA, in four or six equally divided doses (e.g., [IV dose x 10] divided by 4 or 6). For example, approximately 10 mg of OPANA 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 OPANA
  For conversion from other opioids to OPANA, 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 OPANA therapy by administering half of the calculated total daily dose of OPANA in 4 to 6 equally divided doses, every 4-6 hours. The initial dose of OPANA 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 OPANA 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 OPANA, 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

  OPANA is contraindicated in patients with moderate or severe hepatic impairment. Use OPANA 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, OPANA 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

  OPANA, 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, OPANA 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 OPANA 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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