Indication

OXECTA (oxycodone HCl) is an opioid agonist indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

Important Safety Information

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

Respiratory depression is the primary risk of OXECTA. Use with extreme caution in patients at risk of respiratory depression, including the elderly, debilitated patients, and those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction; or following large initial doses of opioids given to opioid-intolerant patients.

OXECTA contains oxycodone HCl, an opioid agonist and Schedule II controlled substance. Such drugs are sought by drug abusers and people with addictions. OXECTA can be abused in a manner similar to other opioids and narcotics when prescribed or dispensed in situations where there is concern about an increased risk of misuse or abuse. Abuse by crushing, chewing, snorting or injecting OXECTA poses a significant risk to the abuser that could result in overdose and death.

Patients may exhibit an additive central nervous system depression when OXECTA is used concomitantly with other CNS depressants, such as sedatives, hypnotics, anesthetics, alcohol, other opioids, or illicit drugs, which may increase the risk of respiratory depression, hypotension, profound sedation, or coma. Patients should not consume alcohol while taking OXECTA.

Elevation of intracranial pressure may be markedly exaggerated in the presence of head injury, or other intracranial lesions. OXECTA may cause severe hypotension in patients with a compromised ability to maintain blood pressure. Do not use OXECTA in patients with gastrointestinal obstruction, especially paralytic ileus. Use with caution in patients with biliary tract disease, as oxycodone HCl may cause spasm of the sphincter of Oddi and diminish biliary and pancreatic secretions.

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. Keep OXECTA out of the reach of children and seek emergency medical help immediately if a child accidentally takes OXECTA.

OXECTA may impair mental/physical abilities; use caution with potentially hazardous activities such as driving a car or operating heavy machinery. Concomitant use of CYP3A4 inhibitors may increase opioid effects. The most common adverse reactions are nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.

Because OXECTA is not amenable to crushing and dissolution, do not use OXECTA in nasogastric, gastric, or other feeding tubes, as it may cause tube obstruction. OXECTA must be swallowed whole and taken with enough water to ensure complete swallowing immediately after placing inthe mouth. There is no evidence that OXECTA has a reduced abuse liability compared to immediate-release oxycodone.