Oxycodone Hydrochloride

OXYCODONE HYDROCHLORIDE

Manufacturer: Aurolife Pharma, LLC

Score: 148.0

Quick Summary

Oxycodone Hydrochloride is an opioid agonist used for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is available in an oral solution form and should be prescribed only by healthcare professionals knowledgeable about the use of opioids. The drug has several warnings, including the risk of addiction, abuse, and misuse, life-threatening respiratory depression, and neonatal opioid withdrawal syndrome. Patients should be closely monitored for signs of opioid withdrawal and overdose, and the dosage should be titrated carefully to minimize adverse reactions.

Key Clinical Findings and Indications

Management of pain severe enough to require an opioid analgesic
Relief of pain in opioid-tolerant adults
Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults

Important Safety Information

Warning

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE HYDROCHLORIDE ORAL SOLUTION

Contraindications

Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Hypersensitivity to oxycodone

Adverse Reactions

Nausea
Constipation
Vomiting
Headache
Pruritus
Insomnia
Dizziness
Asthenia
Somnolence

Dosing Recommendations

General Guidance

Titrate the dose based upon the individual patient’s response to their initial dose of Oxycodone Hydrochloride Oral Solution

Pain management

Adult Dose

Initiate dosing with a range of 5 to 15 mg every 4 to 6 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia

Pediatric Dose

The safety and effectiveness of Oxycodone Hydrochloride Oral Solution have not been established in pediatric patients

Special Population Considerations

Pregnancy

Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome
Available data with Oxycodone Hydrochloride Oral Solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage

Nursing Mothers

Use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential
It is not known whether these effects on fertility are reversible

Pediatric Use

The safety and effectiveness of Oxycodone Hydrochloride Oral Solution have not been established in pediatric patients
The safety and pharmacokinetics of a single-dose of an Oxycodone Hydrochloride Oral Solution were evaluated in an open-label clinical trial in 89 pediatric patients 2 years to less than 17 years of age with postoperative pain

Geriatric Use

Elderly patients (aged 65 years or older) may have increased sensitivity to oxycodone
In general, use caution when selecting a dose for an elderly patient, usually starting at the low end of the dosing range