Oxycodone Hydrochloride Solution

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Oxycodone Hydrochloride Oral Solution, USP is an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe acute and chronic pain where the use of an opioid analgesic is appropriate.

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Oxycodone Hydrochloride Oral Solution, USP, 5mg/5mL: Each 5 mL's is for oral administration and contains 5 mg of oxycodone hydrochloride USP.

Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7).

Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula:

The 5 mg per 5 mL Oxycodone Hydrochloride Oral Solution contains equivalent of 4.5 mg of oxycodone free base per 5 mL's and contains the following inactive ingredients: Poloxamer 188 NF, Sodium Benzoate NF, Citric Acid Anhydrous USP, Glycerin USP, Sorbitol Solution 70% USP, FD&C Red #40 , Raspberry Flavor and Water.

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Oxycodone Hydrochloride Solution Manufacturers

Morton Grove Pharmaceuticals, Inc.

Oxycodone Hydrochloride Solution | Morton Grove Pharmaceuticals, Inc.

Take care when prescribing and administering Oxycodone Hydrochloride Oral Solution, USP to avoid dosing errors due to confusion between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Always use the enclosed calibrated oral syringe when administering Oxycodone Hydrochloride Oral Solution, USP to ensure the dose is measured and administered accurately.

Selection of patients for treatment with oxycodone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis 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.
2.1 Individualization of Dosage
As with any opioid drug product, 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 oxycodone hydrochloride, give attention to the following:
the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent oxycodone hydrochloride dose needed; the patient's degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient's pain; 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 suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Continual re-evaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.

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.
2.2 Initiation of Therapy
Start patients who have not been receiving opioid analgesics on Oxycodone Hydrochloride Oral Solution, USP in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain.

Titrate the dose based upon the individual patient's response to their initial dose of Oxycodone Hydrochloride Oral Solution. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the oxycodone by the patient.
2.3 Conversion to Oral Oxycodone Oral Solution
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of Oxycodone Hydrochloride. It is better to underestimate a patient's 24-hour oral Oxycodone Hydrochloride dose and make available rescue medication than to overestimate the 24-hour oral Oxycodone Hydrochloride dose and manage an adverse experience of overdose.
2.3.1 Conversion from Fixed-Ratio Opioid/Acetaminophen, Opioid/Aspirin, or Opioid/Nonsteroidal Combination Drugs
When converting patients from fixed ratio opioid/non-opioid drug regimens it may be necessary to titrate the dose of Oxycodone Hydrochloride Oral Solution, USP in response to the level of analgesia and adverse effects.
2.3.2 Conversion from Non-Oxycodone Opioids
In converting patients from other opioids to oxycodone hydrochloride, close observation and adjustment of dosage based upon the patient's response to oxycodone hydrochloride is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.
2.4 Conversion from Oral Oxycodone Hydrochloride to Controlled-Release Oral Oxycodone
The relative bioavailability of Oxycodone Hydrochloride Oral Solution, USP compared to controlled-release oxycodone is unknown, so conversion to controlled-release tablets must be accompanied by close observation for signs of excessive sedation.
2.5 Maintenance of Therapy
Continual re-evaluation of the patient receiving Oxycodone Hydrochloride Oral Solution, USP is important, with special attention to the maintenance of pain management 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 as described above to decrease the level of pain.

During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), the continued need for the use of opioid analgesics should be re-assessed as appropriate.
2.6 Cessation of Therapy
When a patient no longer requires therapy with Oxycodone Hydrochloride Oral Solution, USP for the treatment of their pain, it is important that therapy be gradually discontinued over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal [see Drug Abuse and Dependence (9.3) section for description of the signs and symptoms of withdrawal]. If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. It is not known at what dose of Oxycodone Hydrochloride Oral Solution that treatment may be discontinued without risk of the opioid abstinence syndrome.
2.7 Dosage in patients with Hepatic or Renal Impairment
Follow a conservative approach to dose initiation in patients with hepatic or renal impairment. Monitor patients closely and adjust dose based on clinical response.

No Recall
Roxane Laboratories, Inc.

Oxycodone Hydrochloride Solution | Roxane Laboratories, Inc.

Take care when prescribing and administering Oxycodone Hydrochloride Oral Solution USP to avoid dosing errors due to confusion between mg and mL, and other oxycodone solutions with different concentrations, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Always use the enclosed calibrated measuring cup when administering Oxycodone Hydrochloride Oral Solution USP to ensure the dose is measured and administered accurately.

Selection of patients for treatment with oxycodone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on as needed basis 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.
2.1 Individualization of Dosage
As with any opioid drug product, 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 oxycodone hydrochloride, give attention to the following:
• the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; • the reliability of the relative potency estimate used to calculate the equivalent oxycodone hydrochloride dose needed; • the patient’s degree of opioid tolerance; • the general condition and medical status of the patient; • concurrent medications; • the type and severity of the patient’s pain; • 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.

Continual reevaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain management and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically reassess the continued need for the use of opioid analgesics.

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.
2.2 Initiation of Therapy
Start patients who have not been receiving opioid analgesics on Oxycodone Hydrochloride Oral Solution USP in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain.

Titrate the dose based upon the individual patient's response to their initial dose of Oxycodone Hydrochloride Oral Solution USP. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the oxycodone by the patient.
2.3 Conversion to Oral Oxycodone Oral Solution
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of Oxycodone Hydrochloride. It is better to underestimate a patient’s 24-hour oral Oxycodone Hydrochloride dose and make available rescue medication than to overestimate the 24-hour oral Oxycodone Hydrochloride dose and manage an adverse experience of overdose.
2.3.1 Conversion from Fixed-Ratio Opioid/Acetaminophen, Opioid/Aspirin, or Opioid/Nonsteroidal Combination Drugs
When converting patients from fixed ratio opioid/non-opioid drug regimens it may be necessary to titrate the dose of Oxycodone Hydrochloride Oral Solution USP in response to the level of analgesia and adverse effects.
2.3.2 Conversion from Non-Oxycodone Opioids
In converting patients from other opioids to oxycodone hydrochloride, close observation and adjustment of dosage based upon the patient’s response to oxycodone hydrochloride is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.
2.4 Conversion from Oral Oxycodone Hydrochloride to Controlled-Release Oral Oxycodone
The relative bioavailability of Oxycodone Hydrochloride Oral Solution USP compared to controlled-release oxycodone is unknown, so conversion to controlled-release tablets must be accompanied by close observation for signs of excessive sedation.
2.5 Maintenance of Therapy
Continual reevaluation of the patient receiving Oxycodone Hydrochloride Oral Solution USP is important, with special attention to the maintenance of pain management 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 as described above to decrease the level of pain.

During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), the continued need for the use of opioid analgesics should be re-assessed as appropriate.
2.6 Cessation of Therapy
When a patient no longer requires therapy with Oxycodone Hydrochloride Oral Solution USP for the treatment of their pain, it is important that therapy be gradually discontinued over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal [see Drug Abuse and Dependence (9.3) section for description of the signs and symptoms of withdrawal]. If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. It is not known at what dose of Oxycodone Hydrochloride Oral Solution USP that treatment may be discontinued without risk of the opioid abstinence syndrome.
2.7 Dosage in patients with Hepatic or Renal Impairment
Follow a conservative approach to dose initiation in patients with hepatic or renal impairment. Monitor patients closely and adjust dose based on clinical response.

No Recall
Glenmark Generics, Inc

Oxycodone Hydrochloride Solution | Glenmark Generics, Inc

Take care when prescribing and administering Oxycodone Hydrochloride Oral Solution to avoid dosing errors due to confusion between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Always use the enclosed calibrated oral syringe when administering Oxycodone Hydrochloride Oral Solution, 100 mg/5 mL (20 mg/mL), to ensure the dose is measured and administered accurately.

Selection of patients for treatment with oxycodone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis 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.
2.1 Individualization of Dosage
As with any opioid drug product, 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 oxycodone hydrochloride, give attention to the following:
the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent oxycodone hydrochloride dose needed; the patient's degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient's pain; 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 suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Continual re-evaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.

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.
2.2 Conversion to Oral Oxycodone Hydrochloride
The 100 mg/5 mL (20 mg/mL) oral solution formulation is for use in opioid-tolerant patients only who have already been receiving opioid therapy. Use this strength only for patients that have already been titrated to a stable analgesic regimen using lower strengths of oxycodone hydrochloride and who can benefit from use of a smaller volume of oral solution.

There is inter-patient variability in the potency of opioid drugs and opioid formulations.

Therefore, a conservative approach is advised when determining the total daily dose of Oxycodone Hydrochloride. It is better to underestimate a patient's 24-hour oral Oxycodone Hydrochloride dose and make available rescue medication than to overestimate the 24-hour oral Oxycodone Hydrochloride dose and manage an adverse experience of overdose.

Consider the following general points regarding opioid conversions.

Conversion From Non-Oxycodone Opioids to Oral Oxycodone Hydrochloride.

In converting patients from other opioids to oxycodone hydrochloride, close observation and adjustment of dosage based upon the patient's response to oxycodone hydrochloride is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

Conversion From Controlled-Release Oral Oxycodone to Oral Oxycodone Hydrochloride.

The relative bioavailability of Oxycodone Hydrochloride Oral Solution compound to controlled-release oxycodone is unknown. The extended duration of release of oxycodone hydrochloride from controlled-release tablets results in reduced maximum and increased minimum plasma oxycodone hydrochloride concentrations than with shorter acting oxycodone hydrochloride products. Conversion from controlled-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

Conversion From Oral Oxycodone Hydrochloride to Controlled-Release Oral Oxycodone

The relative bioavailability of Oxycodone Hydrochloride Oral Solution compared to controlled-release oxycodone is unknown, so conversion to controlled-release tablets must be accompanied by close observation for signs of excessive sedation.
2.3 Maintenance of Therapy
Continual re-evaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain management 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 as described above to decrease the level of pain. 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.
2.4 Cessation of Therapy
When a patient no longer requires therapy with oxycodone hydrochloride gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

No Recall
Vistapharm Inc.

Oxycodone Hydrochloride Solution | Vistapharm Inc.

Take care when prescribing and administering Oxycodone Hydrochloride Oral Solution to avoid dosing errors due to confusion between mg and mL, and other oxycodone solutions with different concentrations, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Always use the enclosed calibrated measuring cup when administering Oxycodone Hydrochloride Oral Solution to ensure the dose is measured and administered accurately.

Selection of patients for treatment with oxycodone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on as needed basis 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.
2.1 Individualization of Dosage
As with any opioid drug product, 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 oxycodone hydrochloride, give attention to the following:
the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent oxycodone hydrochloride dose needed; the patient's degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient's pain; 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.

Continual re-evaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain management and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.

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.
2.2 Initiation of Therapy
Start patients who have not been receiving opioid analgesics on Oxycodone Hydrochloride Oral Solution in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain.

Titrate the dose based upon the individual patient's response to their initial dose of Oxycodone Hydrochloride Oral Solution. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the oxycodone by the patient.
2.3 Conversion to Oral Oxycodone Oral Solution
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of Oxycodone Hydrochloride. It is better to underestimate a patient's 24-hour oral Oxycodone Hydrochloride dose and make available rescue medication than to overestimate the 24-hour oral Oxycodone Hydrochloride dose and manage an adverse experience of overdose.

2.3.1 Conversion from Fixed-Ratio Opioid/Acetaminophen, Opioid/Aspirin, or Opioid/Nonsteroidal Combination Drugs

When converting patients from fixed ratio opioid/non-opioid drug regimens it may be necessary to titrate the dose of Oxycodone Hydrochloride Oral Solution in response to the level of analgesia and adverse effects.

2.3.2 Conversion from Non-Oxycodone Opioids

In converting patients from other opioids to oxycodone hydrochloride, close observation and adjustment of dosage based upon the patient's response to oxycodone hydrochloride is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.
2.4 Conversion from Oral Oxycodone Hydrochloride to Controlled-Release Oral Oxycodone
The relative bioavailability of Oxycodone Hydrochloride Oral Solution compared to controlled-release oxycodone is unknown, so conversion to controlled-release tablets must be accompanied by close observation for signs of excessive sedation.
2.5 Maintenance of Therapy
Continual re-evaluation of the patient receiving Oxycodone Hydrochloride Oral Solution is important, with special attention to the maintenance of pain management 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 as described above to decrease the level of pain.

During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), the continued need for the use of opioid analgesics should be re-assessed as appropriate.
2.6 Cessation of Therapy
When a patient no longer requires therapy with Oxycodone Hydrochloride Oral Solution for the treatment of their pain, it is important that therapy be gradually discontinued over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal [see Drug Abuse and Dependence (9.3) section for description of the signs and symptoms of withdrawal]. If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. It is not known at what dose of Oxycodone Hydrochloride Oral Solution that treatment may be discontinued without risk of the opioid abstinence syndrome.
2.7 Dosage in patients with Hepatic or Renal Impairment
Follow a conservative approach to dose initiation in patients with hepatic or renal impairment. Monitor patients closely and adjust dose based on clinical response.

No Recall
Vistapharm, Inc.

Oxycodone Hydrochloride Solution | Vistapharm, Inc.

Take care when prescribing and administering oxycodone hydrochloride oral solution to avoid dosing errors due to confusion between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Always use the enclosed 1 mL oral syringe when administering oxycodone hydrochloride oral solution 100 mg/5 mL (20 mg/mL), to ensure the dose is measured and administered accurately.

Selection of patients for treatment with oxycodone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis 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.
2.1 Individualization of Dosage
As with any opioid drug product, 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 oxycodone hydrochloride, give attention to the following:
the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent oxycodone hydrochloride dose needed; the patient's degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient's pain; 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 suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Continual reevaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically reassess the continued need for the use of opioid analgesics.

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.
2.2 Conversion to Oral Oxycodone Hydrochloride, USP
The 100 mg/5 mL (20 mg/mL) oral solution formulation is for use in opioid-tolerant patients only who have already been receiving opioid therapy. Use this strength only for patients that have already been titrated to a stable analgesic regimen using lower strengths of oxycodone hydrochloride and who can benefit from use of a smaller volume of oral solution.

There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of oxycodone hydrochloride. It is better to underestimate a patient's 24-hour oral oxycodone hydrochloride dose and make available rescue medication than to overestimate the 24-hour oral oxycodone hydrochloride dose and manage an adverse experience of overdose.

Consider the following general points regarding opioid conversions.

Conversion from non-oxycodone opioids to oral oxycodone hydrochloride.

In converting patients from other opioids to oxycodone hydrochloride, close observation and adjustment of dosage based upon the patient's response to oxycodone hydrochloride is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

Conversion from controlled-release oral oxycodone to oral oxycodone hydrochloride.

The relative bioavailability of oxycodone hydrochloride oral solution compound to controlled-release oxycodone is unknown. The extended duration of release of oxycodone hydrochloride from controlled-release tablets results in reduced maximum and increased minimum plasma oxycodone hydrochloride concentrations than with shorter acting oxycodone hydrochloride products. Conversion from controlled-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

Conversion from oral oxycodone hydrochloride to controlled-release oral oxycodone

The relative bioavailability of oxycodone hydrochloride oral solution compared to controlled-release oxycodone is unknown, so conversion to controlled-release tablets must be accompanied by close observation for signs of excessive sedation.
2.3 Maintenance of Therapy
Continual reevaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain management 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 as described above to decrease the level of pain. 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.
2.4 Cessation of Therapy
When a patient no longer requires therapy with oxycodone hydrochloride gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

No Recall
Roxane Laboratories, Inc.

Oxycodone Hydrochloride Solution | Bayer Healthcare Consumer Care

Adults
Take 1 capsule every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 capsule, 2 capsules may be used, but do not exceed 6 capsules in 24 hours, unless directed by a doctor. The smallest effective dose should be used.
Children
Do not give this product to children under 12 unless directed by a doctor.

Do not exceed recommended dose.

No Recall
Roxane Laboratories, Inc.

Oxycodone Hydrochloride Solution | Roxane Laboratories, Inc.

Take care when prescribing and administering oxycodone hydrochloride oral solution to avoid dosing errors due to confusion between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Always use the enclosed calibrated oral syringe when administering oxycodone hydrochloride oral solution, 100 mg per 5 mL (20 mg/mL), to ensure the dose is measured and administered accurately.

Selection of patients for treatment with oxycodone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis 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.
2.1 Individualization of Dosage
As with any opioid drug product, 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 oxycodone hydrochloride, give attention to the following:
• the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; • the reliability of the relative potency estimate used to calculate the equivalent oxycodone hydrochloride dose needed; • the patient’s degree of opioid tolerance; • the general condition and medical status of the patient; • concurrent medications; • the type and severity of the patient’s pain; • 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 suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Continual reevaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically reassess the continued need for the use of opioid analgesics.

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.
2.2 Conversion to Oral Oxycodone Hydrochloride
The 100 mg per 5 mL (20 mg/mL) oral solution formulation is for use in opioid-tolerant patients only who have already been receiving opioid therapy. Use this strength only for patients that have already been titrated to a stable analgesic regimen using lower strengths of oxycodone hydrochloride and who can benefit from use of a smaller volume of oral solution.

There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of oxycodone hydrochloride. It is better to underestimate a patient’s 24-hour oral oxycodone hydrochloride dose and make available rescue medication than to overestimate the 24-hour oral oxycodone hydrochloride dose and manage an adverse experience of overdose.

Consider the following general points regarding opioid conversions.

Conversion From Non-Oxycodone Opioids to Oral Oxycodone Hydrochloride.

In converting patients from other opioids to oxycodone hydrochloride, close observation and adjustment of dosage based upon the patient’s response to oxycodone hydrochloride is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

Conversion From Controlled-Release Oral Oxycodone to Oral Oxycodone Hydrochloride.

The relative bioavailability of oxycodone hydrochloride oral solution compound to controlled-release oxycodone is unknown. The extended duration of release of oxycodone hydrochloride from controlled-release tablets results in reduced maximum and increased minimum plasma oxycodone hydrochloride concentrations than with shorter acting oxycodone hydrochloride products. Conversion from controlled-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

Conversion From Oral Oxycodone Hydrochloride to Controlled-Release Oral Oxycodone

The relative bioavailability of oxycodone hydrochloride oral solution compared to controlled-release oxycodone is unknown, so conversion to controlled-release tablets must be accompanied by close observation for signs of excessive sedation.
2.3 Maintenance of Therapy
Continual reevaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain management 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 as described above to decrease the level of pain. 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.
2.4 Cessation of Therapy
When a patient no longer requires therapy with oxycodone hydrochloride gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

No Recall
Safecor Health, Llc

Oxycodone Hydrochloride Solution | Safecor Health, Llc

Take care when prescribing and administering Oxycodone Hydrochloride Oral Solution to avoid dosing errors due to confusion between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Always use the enclosed calibrated oral syringe when administering Oxycodone Hydrochloride Oral Solution, 100 mg/5 mL (20 mg/mL), to ensure the dose is measured and administered accurately.
Selection of patients for treatment with oxycodone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis 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.
2.1 Individualization of Dosage
As with any opioid drug product, 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 oxycodone hydrochloride, give attention to the following:
the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent oxycodone hydrochloride dose needed; the patient's degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient's pain; 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 suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.
Continual re-evaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.
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.
2.2 Conversion to Oral Oxycodone Hydrochloride
The 100 mg/5 mL (20 mg/mL) oral solution formulation is for use in opioid-tolerant patients only who have already been receiving opioid therapy. Use this strength only for patients that have already been titrated to a stable analgesic regimen using lower strengths of oxycodone hydrochloride and who can benefit from use of a smaller volume of oral solution.
There is inter-patient variability in the potency of opioid drugs and opioid formulations.
Therefore, a conservative approach is advised when determining the total daily dose of Oxycodone Hydrochloride. It is better to underestimate a patient's 24-hour oral Oxycodone Hydrochloride dose and make available rescue medication than to overestimate the 24-hour oral Oxycodone Hydrochloride dose and manage an adverse experience of overdose.
Consider the following general points regarding opioid conversions.

Conversion From Non-Oxycodone Opioids to Oral Oxycodone Hydrochloride.

In converting patients from other opioids to oxycodone hydrochloride, close observation and adjustment of dosage based upon the patient's response to oxycodone hydrochloride is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

Conversion From Controlled-Release Oral Oxycodone to Oral Oxycodone Hydrochloride.

The relative bioavailability of Oxycodone Hydrochloride Oral Solution compound to controlled-release oxycodone is unknown. The extended duration of release of oxycodone hydrochloride from controlled-release tablets results in reduced maximum and increased minimum plasma oxycodone hydrochloride concentrations than with shorter acting oxycodone hydrochloride products. Conversion from controlled-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

Conversion From Oral Oxycodone Hydrochloride to Controlled-Release Oral Oxycodone

The relative bioavailability of Oxycodone Hydrochloride Oral Solution compared to controlled-release oxycodone is unknown, so conversion to controlled-release tablets must be accompanied by close observation for signs of excessive sedation.
2.3 Maintenance of Therapy
Continual re-evaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain management 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 as described above to decrease the level of pain. 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.
2.4 Cessation of Therapy
When a patient no longer requires therapy with oxycodone hydrochloride gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

No Recall
Midlothian Laboratories

Oxycodone Hydrochloride Solution | Midlothian Laboratories

Oxycodone hydrochloride oral solution is available in two concentrations: 5 mg per 5 mL and 100 mg per 5 mL (20 mg per mL).

Take care when prescribing and administering oxycodone hydrochloride oral solution to avoid dosing errors due to confusion between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Always use the enclosed calibrated oral syringe when administering oxycodone hydrochloride oral solution, 100 mg per 5 mL (20 mg per mL), to ensure the dose is measured and administered accurately.

Selection of patients for treatment with oxycodone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis 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.
2.1 Individualization of Dosage
As with any opioid drug product, 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 oxycodone hydrochloride, give attention to the following:
the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent oxycodone hydrochloride dose needed; the patient's degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient's pain; 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 suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Continual reevaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically reassess the continued need for the use of opioid analgesics.

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.
2.2 Initiation of Therapy in Opioid Naïve Patients
Start patients who have not been receiving opioid analgesics on oxycodone hydrochloride in the following dosing range using oral solution, 5 mg per 5 mL strength. Oxycodone hydrochloride oral solution: 5 to 15 mg every 4 to 6 hours as needed for pain.

Titrate the dose based upon the individual patient's response to their initial dose of oxycodone hydrochloride. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and tolerability of the oxycodone by the patient.

The 100 mg per 5 mL (20 mg per mL) oral solution formulation is for use in opioid-tolerant patients only who have already been receiving opioid therapy. Use this strength only for patients that have already been titrated to a stable analgesic regimen using lower strengths of oxycodone hydrochloride and who can benefit from use of a smaller volume of oral solution.
Instruct patients how to measure and take the correct dose of oxycodone hydrochloride oral solution. Advise patients to always use the enclosed oral syringe when administering oxycodone hydrochloride oral solution 100 mg per 5 mL (20 mg per mL) to ensure the dose is measured and administered accurately. 2.3 Conversion to Oral Oxycodone Hydrochloride
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of oxycodone hydrochloride. It is better to underestimate a patient's 24-hour oral oxycodone hydrochloride dose and make available rescue medication than to overestimate the 24-hour oral oxycodone hydrochloride dose and manage an adverse experience of overdose.

Consider the following general points regarding opioid conversions.

Conversion From Non-Oxycodone Opioids to Oral Oxycodone Hydrochloride

In converting patients from other opioids to oxycodone hydrochloride, close observation and adjustment of dosage based upon the patient's response to oxycodone hydrochloride is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

Conversion From Controlled-Release Oral Oxycodone to Oral Oxycodone Hydrochloride

The relative bioavailability of oxycodone hydrochloride oral solution compared to controlled-release oxycodone is unknown. The extended duration of release of oxycodone hydrochloride from controlled-release tablets results in reduced maximum and increased minimum plasma oxycodone hydrochloride concentrations than with shorter acting oxycodone hydrochloride products. Conversion from controlled-release tablets could lead to excessive sedation at peak serum levels. Therefore, dose adjustment with close observation is necessary.

Conversion From Oral Oxycodone Hydrochloride to Controlled-Release Oral Oxycodone

The relative bioavailability of oxycodone hydrochloride oral solution compared to controlled-release oxycodone is unknown, so conversion to controlled-release tablets must be accompanied by close observation for signs of excessive sedation.
2.4 Maintenance of Therapy
Continual reevaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain management 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 as described above to decrease the level of pain. 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.
2.5 Cessation of Therapy
When a patient no longer requires therapy with oxycodone hydrochloride gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

No Recall
Lehigh Valley Technologies, Inc.

Oxycodone Hydrochloride Solution | Lehigh Valley Technologies, Inc.

Oxycodone Hydrochloride Oral Solution is available in two concentrations: 5 mg per 5 mL and 100 mg per 5 mL (20 mg per mL). Take care when prescribing and administering Oxycodone Hydrochloride Oral Solution to avoid dosing errors due to confusion between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Always use the enclosed calibrated oral syringe when administering Oxycodone Hydrochloride Oral Solution, 100 mg per 5 mL (20 mg per mL), to ensure the dose is measured and administered accurately.

Selection of patients for treatment with oxycodone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis 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.
2.1 Individualization of Dosage
As with any opioid drug product, 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 oxycodone hydrochloride, give attention to the following:
the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent oxycodone hydrochloride dose needed; the patient's degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient's pain; 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 suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Continual re-evaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.

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.
2.2 Initiation of Therapy in Opioid Naïve Patients
Start patients who have not been receiving opioid analgesics on oxycodone hydrochloride in the following dosing range using oral solution, 5 mg per 5 mL strength. Oxycodone HCl Oral Solution: 5 to 15 mg every 4 to 6 hours as needed for pain.

Titrate the dose based upon the individual patient's response to their initial dose of oxycodone hydrochloride. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and tolerability of the oxycodone by the patient.

The 100 mg per 5 mL (20 mg per mL) oral solution formulation is for use in opioid-tolerant patients only who have already been receiving opioid therapy. Use this strength only for patients that have already been titrated to a stable analgesic regimen using lower strengths of oxycodone hydrochloride and who can benefit from use of a smaller volume of oral solution.
Instruct patients how to measure and take the correct dose of Oxycodone Hydrochloride Oral Solution. Advise patients to always use the enclosed oral syringe when administering Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg per mL) to ensure the dose is measured and administered accurately. 2.3 Conversion to Oral Oxycodone Hydrochloride
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of Oxycodone Hydrochloride. It is better to underestimate a patient's 24-hour oral Oxycodone Hydrochloride dose and make available rescue medication than to overestimate the 24-hour oral Oxycodone Hydrochloride dose and manage an adverse experience of overdose.

Consider the following general points regarding opioid conversions.

Conversion From Non-Oxycodone Opioids to Oral Oxycodone Hydrochloride.

In converting patients from other opioids to oxycodone hydrochloride, close observation and adjustment of dosage based upon the patient's response to oxycodone hydrochloride is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

Conversion From Controlled-Release Oral Oxycodone to Oral Oxycodone Hydrochloride.

The relative bioavailability of Oxycodone Hydrochloride Oral Solution compared to controlled-release oxycodone is unknown. The extended duration of release of oxycodone hydrochloride from controlled-release tablets results in reduced maximum and increased minimum plasma oxycodone hydrochloride concentrations than with shorter acting oxycodone hydrochloride products. Conversion from controlled-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

Conversion From Oral Oxycodone Hydrochloride to Controlled-Release Oral Oxycodone

The relative bioavailability of Oxycodone Hydrochloride Oral Solution compared to controlled-release oxycodone is unknown, so conversion to controlled-release tablets must be accompanied by close observation for signs of excessive sedation.
2.4 Maintenance of Therapy
Continual re-evaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain management 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 as described above to decrease the level of pain. 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.
2.5 Cessation of Therapy
When a patient no longer requires therapy with oxycodone hydrochloride gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

No Recall
Lannett Company, Inc.

Oxycodone Hydrochloride Solution | Lannett Company, Inc.

Oxycodone hydrochloride oral solution is available in two concentrations: 5 mg per 5 mL and 100 mg per 5 mL (20 mg per mL).

Take care when prescribing and administering oxycodone hydrochloride oral solution to avoid dosing errors due to confusion between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Always use the enclosed calibrated oral syringe when administering oxycodone hydrochloride oral solution USP, 100 mg per 5 mL (20 mg per mL), to ensure the dose is measured and administered accurately.

Selection of patients for treatment with oxycodone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis 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.
2.1 Individualization of Dosage
As with any opioid drug product, 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 oxycodone hydrochloride, give attention to the following:
the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent oxycodone hydrochloride dose needed; the patient’s degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient’s pain; 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 suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Continual reevaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically reassess the continued need for the use of opioid analgesics.

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.
2.2 Initiation of Therapy in Opioid Naïve Patients
Start patients who have not been receiving opioid analgesics on oxycodone hydrochloride in the following dosing range using oral solution, 5 mg per 5 mL strength. Oxycodone hydrochloride oral solution: 5 to 15 mg every 4 to 6 hours as needed for pain.

Titrate the dose based upon the individual patient’s response to their initial dose of oxycodone hydrochloride. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and tolerability of the oxycodone by the patient.

The 100 mg per 5 mL (20 mg per mL) oral solution formulation is for use in opioid-tolerant patients only who have already been receiving opioid therapy. Use this strength only for patients that have already been titrated to a stable analgesic regimen using lower strengths of oxycodone hydrochloride and who can benefit from use of a smaller volume of oral solution.
Instruct patients how to measure and take the correct dose of oxycodone hydrochloride oral solution. Advise patients to always use the enclosed oral syringe when administering Oxycodone Hydrochloride Oral Solution USP, 100 mg per 5 mL (20 mg per mL) to ensure the dose is measured and administered accurately. 2.3 Conversion to Oral Oxycodone Hydrochloride
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of oxycodone hydrochloride. It is better to underestimate a patient’s 24-hour oral oxycodone hydrochloride dose and make available rescue medication than to overestimate the 24-hour oral oxycodone hydrochloride dose and manage an adverse experience of overdose.

Consider the following general points regarding opioid conversions.

Conversion From Non-Oxycodone Opioids to Oral Oxycodone Hydrochloride.

In converting patients from other opioids to oxycodone hydrochloride, close observation and adjustment of dosage based upon the patient’s response to oxycodone hydrochloride is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

Conversion From Controlled-Release Oral Oxycodone to Oral Oxycodone Hydrochloride.

The relative bioavailability of oxycodone hydrochloride oral solution compared to controlled-release oxycodone is unknown. The extended duration of release of oxycodone hydrochloride from controlled-release tablets results in reduced maximum and increased minimum plasma oxycodone hydrochloride concentrations than with shorter acting oxycodone hydrochloride products. Conversion from controlled-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

Conversion From Oral Oxycodone Hydrochloride to Controlled-Release Oral Oxycodone

The relative bioavailability of oxycodone hydrochloride oral solution compared to controlled-release oxycodone is unknown, so conversion to controlled-release tablets must be accompanied by close observation for signs of excessive sedation.
2.4 Maintenance of Therapy
Continual reevaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain management 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 as described above to decrease the level of pain. 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.
2.5 Cessation of Therapy
When a patient no longer requires therapy with oxycodone hydrochloride, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

No Recall
Novel Laboratories, Inc.

Oxycodone Hydrochloride Solution | Teva Pharmaceuticals Usa Inc

2.1 General Considerations
Dose once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10 mg/320 mg tablet once daily as needed to control blood pressure. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose.

Amlodipine and valsartan tablets may be administered with or without food.

Amlodipine and valsartan tablets may be administered with other antihypertensive agents.
2.2 Add-on Therapy
A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine calcium-channel blocker) alone or with valsartan (or another angiotensin II receptor blocker) alone may be switched to combination therapy with amlodipine and valsartan tablets.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to amlodipine and valsartan tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to amlodipine and valsartan tablets should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 10 mg/320 mg.
2.3 Replacement Therapy
For convenience, patients receiving amlodipine and valsartan from separate tablets may instead wish to receive amlodipine and valsartan tablets containing the same component doses.
2.4 Initial Therapy
A patient may be initiated on amlodipine and valsartan tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is amlodipine and valsartan tablets, 5 mg/160 mg once daily in patients who are not volume-depleted.

No Recall
Roxane Laboratories, Inc.

Oxycodone Hydrochloride Solution | Roxane Laboratories, Inc.

Take care when prescribing and administering oxycodone hydrochloride oral solution to avoid dosing errors due to confusion between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Always use the enclosed calibrated oral syringe when administering oxycodone hydrochloride oral solution, 100 mg per 5 mL (20 mg/mL), to ensure the dose is measured and administered accurately.

Selection of patients for treatment with oxycodone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis 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.
2.1 Individualization of Dosage
As with any opioid drug product, 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 oxycodone hydrochloride, give attention to the following:
• the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; • the reliability of the relative potency estimate used to calculate the equivalent oxycodone hydrochloride dose needed; • the patient’s degree of opioid tolerance; • the general condition and medical status of the patient; • concurrent medications; • the type and severity of the patient’s pain; • 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 suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Continual reevaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically reassess the continued need for the use of opioid analgesics.

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.
2.2 Conversion to Oral Oxycodone Hydrochloride
The 100 mg per 5 mL (20 mg/mL) oral solution formulation is for use in opioid-tolerant patients only who have already been receiving opioid therapy. Use this strength only for patients that have already been titrated to a stable analgesic regimen using lower strengths of oxycodone hydrochloride and who can benefit from use of a smaller volume of oral solution.

There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of oxycodone hydrochloride. It is better to underestimate a patient’s 24-hour oral oxycodone hydrochloride dose and make available rescue medication than to overestimate the 24-hour oral oxycodone hydrochloride dose and manage an adverse experience of overdose.

Consider the following general points regarding opioid conversions.

Conversion From Non-Oxycodone Opioids to Oral Oxycodone Hydrochloride.

In converting patients from other opioids to oxycodone hydrochloride, close observation and adjustment of dosage based upon the patient’s response to oxycodone hydrochloride is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.

Conversion From Controlled-Release Oral Oxycodone to Oral Oxycodone Hydrochloride.

The relative bioavailability of oxycodone hydrochloride oral solution compound to controlled-release oxycodone is unknown. The extended duration of release of oxycodone hydrochloride from controlled-release tablets results in reduced maximum and increased minimum plasma oxycodone hydrochloride concentrations than with shorter acting oxycodone hydrochloride products. Conversion from controlled-release tablets could lead to excessive sedation at peak serum levels. Therefore, dosage adjustment with close observation is necessary.

Conversion From Oral Oxycodone Hydrochloride to Controlled-Release Oral Oxycodone

The relative bioavailability of oxycodone hydrochloride oral solution compared to controlled-release oxycodone is unknown, so conversion to controlled-release tablets must be accompanied by close observation for signs of excessive sedation.
2.3 Maintenance of Therapy
Continual reevaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain management 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 as described above to decrease the level of pain. 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.
2.4 Cessation of Therapy
When a patient no longer requires therapy with oxycodone hydrochloride gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.

No Recall
Ani Pharmaceuticals, Inc.

Oxycodone Hydrochloride Solution | Ani Pharmaceuticals, Inc.

Take care when prescribing and administering Oxycodone Hydrochloride Oral Solution to avoid dosing errors due to confusion between mg and mL, and other oxycodone solutions with different concentrations, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Always use the enclosed calibrated measuring cup when administering Oxycodone Hydrochloride Oral Solution to ensure the dose is measured and administered accurately.

Selection of patients for treatment with oxycodone hydrochloride should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on as needed basis 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.
2.1 Individualization of Dosage
As with any opioid drug product, 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 oxycodone hydrochloride, give attention to the following:
• the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; • the reliability of the relative potency estimate used to calculate the equivalent oxycodone hydrochloride dose needed; • the patient's degree of opioid tolerance; • the general condition and medical status of the patient; • concurrent medications; • the type and severity of the patient's pain; • 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.

Continual re-evaluation of the patient receiving oxycodone hydrochloride is important, with special attention to the maintenance of pain management and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.

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.
2.2 Initiation of Therapy
Start patients who have not been receiving opioid analgesics on Oxycodone Hydrochloride Oral Solution in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain.

Titrate the dose based upon the individual patient's response to their initial dose of Oxycodone Hydrochloride Oral Solution. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the oxycodone by the patient.
2.3 Conversion to Oral Oxycodone Oral Solution
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of Oxycodone Hydrochloride. It is better to underestimate a patient's 24-hour oral Oxycodone Hydrochloride dose and make available rescue medication than to overestimate the 24-hour oral Oxycodone Hydrochloride dose and manage an adverse experience of overdose.
2.3.1 Conversion from Fixed-Ratio Opioid/Acetaminophen, Opioid/Aspirin, or Opioid/Nonsteroidal Combination Drugs
When converting patients from fixed ratio opioid/non-opioid drug regimens it may be necessary to titrate the dose of Oxycodone Hydrochloride Oral Solution in response to the level of analgesia and adverse effects.
2.3.2 Conversion from Non-Oxycodone Opioids
In converting patients from other opioids to oxycodone hydrochloride, close observation and adjustment of dosage based upon the patient's response to oxycodone hydrochloride is imperative. Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate.
2.4 Conversion from Oral Oxycodone Hydrochloride to Controlled-Release Oral Oxycodone
The relative bioavailability of Oxycodone Hydrochloride Oral Solution compared to controlled-release oxycodone is unknown, so conversion to controlled-release tablets must be accompanied by close observation for signs of excessive sedation.
2.5 Maintenance of Therapy
Continual re-evaluation of the patient receiving Oxycodone Hydrochloride Oral Solution is important, with special attention to the maintenance of pain management 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 as described above to decrease the level of pain.

During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), the continued need for the use of opioid analgesics should be re-assessed as appropriate.
2.6 Cessation of Therapy
When a patient no longer requires therapy with Oxycodone Hydrochloride Oral Solution for the treatment of their pain, it is important that therapy be gradually discontinued over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal [see Drug Abuse and Dependence (9.3) section for description of the signs and symptoms of withdrawal]. If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. It is not known at what dose of Oxycodone Hydrochloride Oral Solution that treatment may be discontinued without risk of the opioid abstinence syndrome.
2.7 Dosage in Patients with Hepatic or Renal Impairment
Follow a conservative approach to dose initiation in patients with hepatic or renal impairment. Monitor patients closely and adjust dose based on clinical response.

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