Oxycodone Hydrochloride

OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride solution
Safecor Health, LLC

WARNING: RISK OF MEDICATION ERRORS

Oxycodone Hydrochloride Oral Solution is available as a 100 mg/5 mL (20 mg/mL) concentration and is indicated for use in opioid-tolerant patients only.
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.
Keep Oxycodone Hydrochloride Oral Solution out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately.

1 INDICATIONS AND USAGE

Oxycodone hydrochloride oral solution 100 mg/5 mL (20 mg/mL) is an opioid analgesic indicated for the management of moderate to severe acute and chronic pain in opioid-tolerant patients.
Oxycodone hydrochloride oral solution 100 mg/5 mL (20 mg/mL) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. Patients considered to be opioid tolerant are those who are taking at least 30 mg of oral oxycodone per day, or at least 60 mg oral morphine per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer.

2 DOSAGE AND ADMINISTRATION

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.

3 DOSAGE FORMS AND STRENGTHS

The 100 mg/5 mL (20 mg/mL) strength: Each 5 mL of yellow Oxycodone Hydrochloride oral solution, USP contains oxycodone hydrochloride 100 mg. The concentration of this solution is 20 mg/mL.

4 CONTRAINDICATIONS

Oxycodone hydrochloride is contraindicated in patients with respiratory depression in the absence of resuscitative equipment.
Oxycodone hydrochloride is contraindicated in any patient who has or is suspected of having paralytic ileus.
Oxycodone hydrochloride is contraindicated in patients with acute or severe bronchial asthma or hypercarbia.
Oxycodone hydrochloride is contraindicated in patients with known hypersensitivity to oxycodone, oxycodone salts, or any components of the product.

5 WARNINGS AND PRECAUTIONS

5.1 Risk of Medication Errors

Oxycodone Hydrochloride Oral Solution is available in 100 mg/5 mL (20 mg/mL) concentration. Use caution when prescribing, dispensing, 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. Use caution to ensure the dose is communicated clearly and dispensed accurately. 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.

5.2 Respiratory Depression

Respiratory depression is the primary risk of oxycodone hydrochloride. Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation.
Use oxycodone hydrochloride with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale and in patients having a substantially decreased respiratory reserve (e.g., severe kyphoscoliosis), hypoxia, hypercapnia, or preexisting respiratory depression. In such patients, even usual therapeutic doses of oxycodone hydrochloride may increase airway resistance and decrease respiratory drive to the point of apnea. Consider alternative non-opioid analgesics, and use oxycodone hydrochloride only under careful medical supervision at the lowest effective dose in such patients.
Oxycodone hydrochloride 100 mg/5 mL (20 mg/mL) oral solution is for use in opioid-tolerant patients only. Administration of this formulation may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids.

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