OXAYDO® is the FIRST and ONLY immediate-release oxycodone that discourages intranasal abuse.

There is no evidence that OXAYDO® has reduced abuse liability compared to immediate-release oxycodone.

Indications and Usage

OXAYDO® (oxycodone HCl, USP) is an immediate-release oral formulation of oxycodone HCl indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

Important Safety Information

Contraindications

OXAYDO® is contraindicated in patients with respiratory depression, paralytic ileus, acute or severe bronchial asthma or hypercarbia, or known hypersensitivity to oxycodone or any components of the product, or in any situation where opioids are contraindicated.

Warnings and Precautions

Respiratory depression is a risk of OXAYDO®, especially in elderly or debilitated patients, in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, or following large initial doses of opioids given to non-tolerant patients, or when given in conjunction with other agents that depress respiration. Use with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale.

OXAYDO® is a Schedule II controlled substance with an abuse liability similar to other opioids. OXAYDO® may be abused by crushing, chewing, snorting or injecting the product and these practices pose a significant risk to the abuser that could result in overdose and death.

Patients receiving central nervous system depressants concomitantly with OXAYDO® may exhibit an additive central nervous system depression, which may result in respiratory depression, hypotension, profound sedation, or coma. Patients should not consume alcoholic beverages, or any medications containing alcohol while taking OXAYDO®.

In the presence of a head injury or other intracranial lesions, OXAYDO® may cause markedly exaggerated elevation of intracranial pressure.

OXAYDO® may cause severe hypotension in patients whose ability to maintain blood pressure has been compromised, may produce orthostatic hypotension in ambulatory patients and must be administered with caution in patients in circulatory shock.

Do not administer OXAYDO® to patients with gastrointestinal obstruction. Use OXAYDO® with caution in patients with biliary tract disease, including pancreatitis.

Use with caution and in reduced dosages in patients with severe renal or hepatic impairment, Addison’s disease, hypothyroidism, prostatic hypertrophy, or urethral stricture, and in elderly or debilitated patients. Use with caution when administering to patients with CNS depression, toxic psychosis, acute alcoholism and delirium tremens; may aggravate convulsions in patients with convulsive disorders and may induce or aggravate seizures in some clinical settings.

Keep OXAYDO® out of the reach of children.

OXAYDO® may impair mental and/or physical abilities; use with caution with potentially hazardous activities.

Concomitant use of CYP3A4 inhibitors may increase opioid effects and of CYP3A4 inducers may decrease effects or possibly cause development of an abstinence syndrome in a patient who had developed physical dependence to oxycodone.

Adverse Reactions

Serious adverse reactions that may be associated with OXAYDO® include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock. The most common adverse reactions are nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia and somnolence.

Additional Drug Interactions

Muscle relaxants: enhances the neuromuscular blocking action of skeletal muscle relaxants and produces an increased degree of respiratory depression.

Mixed agonist/antagonist analgesics: may reduce the analgesic effects and/or may precipitate withdrawal symptoms.

Monoamine Oxidase Inhibitors (MAOIs): use not recommended with or within 14 days of stopping MAOIs.

Anticholinergics: increased risk for urinary retention and severe constipation.