Oxycodone Hydrochloride

OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride solution
Atlantic Biologicals Corps

WARNING: RISK OF MEDICATION ERRORS

Oxycodone Hydrochloride Oral Solution USP is available as a 100 mg per 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 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.

Keep Oxycodone Hydrochloride Oral Solution USP out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately.

1 INDICATIONS AND USAGE

Oxycodone Hydrochloride Solution USP, 100 mg per 5 mL ( ) is an opioid analgesic indicated for the management of moderate to severe acute and chronic pain in opioid-tolerant patients. Oral 20 mg/mL

Oxycodone Hydrochloride Oral Solution USP, 100 mg per 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 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.

2.2 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.

3 DOSAGE FORMS AND STRENGTHS

The 100 mg per 5 mL (20 mg/mL) strength: Each 5 mL of clear, light yellow to yellow oxycodone hydrochloride oral solution contains oxycodone hydrochloride 100 mg. The concentration of this solution is 20 mg/mL.

4 CONTRAINDICATIONS

Oxycodone Hydrochloride Oral Solution USP is contraindicated in patients with respiratory depression in the absence of resuscitative equipment.

Oxycodone Hydrochloride Oral Solution USP is contraindicated in any patient who has or is suspected of having paralytic ileus.

Oxycodone Hydrochloride Oral Solution USP is contraindicated in patients with acute or severe bronchial asthma or hypercarbia.

Oxycodone Hydrochloride Oral Solution USP 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 per 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 syringe when administering oxycodone hydrochloride oral solution 100 mg per 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 per 5 mL (20 mg/mL) oral solution is for use in . Administration of this formulation may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids. opioid-tolerant patients only

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