Oxycodone HCl

OXYCODONE HCL

Manufacturer: Amneal Pharmaceuticals NY LLC

Score: 148.0

Quick Summary

Oxycodone HCl extended-release tablets are an opioid agonist used for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The drug has several key clinical findings and indications, including its use in adults and opioid-tolerant pediatric patients 11 years and older. Important safety information includes warnings about addiction, abuse, and misuse, as well as contraindications such as significant respiratory depression and acute or severe bronchial asthma. The main dosing recommendations include initial dosing and titration, with dose adjustments based on individual patient needs. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment
Use in adults and opioid-tolerant pediatric patients 11 years and older
Indicated for patients who are opioid-tolerant and require a total daily dose of at least 20 mg of oxycodone or its equivalent

Important Safety Information

Warning

Addiction, abuse, and misuse, life-threatening respiratory depression, accidental ingestion, neonatal opioid withdrawal syndrome, and risks from concomitant use with benzodiazepines or other CNS depressants

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

Constipation
Nausea
Somnolence
Dizziness
Vomiting
Pruritus
Headache
Dry mouth
Asthenia
Sweating

Dosing Recommendations

General Guidance

Dose adjustments should be made based on individual patient needs, with careful monitoring for signs of respiratory depression, sedation, and hypotension

Adults who are not opioid-tolerant

Adult Dose

10 mg orally every 12 hours

Pediatric Dose

Not recommended for use in pediatric patients less than 11 years of age

Pediatric patients 11 years and older

Adult Dose

Not applicable

Pediatric Dose

10 mg orally every 12 hours, with a minimum of 20 mg per day of oxycodone or its equivalent for at least two days immediately preceding dosing

Special Population Considerations

Pregnancy

Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome
Use with caution and only if the potential benefits outweigh the risks

Nursing Mothers

Oxycodone is present in breast milk and may cause sedation and respiratory depression in nursing infants
Use with caution and only if the potential benefits outweigh the risks

Pediatric Use

Safety and efficacy have been established in pediatric patients 11 years and older
Use with caution in pediatric patients, as the risk of adverse reactions is higher in this population

Geriatric Use

Use with caution in geriatric patients, as the risk of adverse reactions is higher in this population
Dose adjustments may be necessary based on individual patient needs and renal function