Important Safety Info

OXECTA® 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, or 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® must be used with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale, and in patients having substantially decreased respiratory reserve (e.g., severe kyphoscoliosis), hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of OXECTA® may decrease respiratory drive to the point of apnea. In these patients, alternative non-opioid analgesics should be considered, and opioids must be employed only after careful medical supervision at the lowest effective dose.

OXECTA® contains oxycodone HCl, an opioid agonist and a 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 prescribing or dispensing 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. OXECTA® should not be given to anyone other than the individual for whom it was prescribed. Keep OXECTA® in a locked cabinet, drawer or medicine safe so that it will not be stolen.

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

Take each OXECTA® tablet with enough water to ensure complete swallowing immediately after placing in the mouth, and OXECTA® must be swallowed whole. As OXECTA® is not amenable to crushing and dissolution, do not use OXECTA® in nasogastric, gastric or other feeding tubes as it may cause obstruction of feeding tubes.

Patients who have not been receiving opioid analgesics should be started on OXECTA® in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain. The dose should be titrated based upon the individual patient’s response to their first dose of OXECTA®. Patients with chronic pain may need to be dosed at the lowest dosage level that will achieve acceptable analgesia and tolerable adverse reactions, on an around-the-clock basis rather than on an as needed basis. When a patient no longer requires therapy with OXECTA® after chronic use, it is important that therapy be gradually tapered over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal).

Other central nervous system (CNS) depressants including sedatives, hypnotics, general anesthetics, antiemetics, phenothiazines, other tranquilizers, and alcohol increase the risk of respiratory depression, hypotension, profound sedation, or coma. Use OXECTA® with caution and in reduced dosages in patients taking these agents. Patients should not consume alcoholic beverages or any medications containing alcohol while taking OXECTA®.

Use OXECTA® with caution in patients with head injuries or other conditions that increase pressure in the brain, shock with low blood volume, severe undiagnosed abdominal conditions, history of seizures, severe kidney or liver disease, gall bladder disease, Addison’s disease, hypothyroidism, enlarged prostate or other illnesses that make urination difficult and elderly or debilitated patients. Do not use OXECTA® in patients with intestinal obstruction especially paralytic ileus.

OXECTA® may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating heavy machinery.

The most common adverse reactions are nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.

Keep OXECTA® out of the reach of children. If a child accidently takes OXECTA®, seek emergency medical help immediately.

Full Prescribing Information for OXECTA® can be found here http://www.pfizerpro.com/hcp/oxecta/dosing.