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^®. This is more common in elderly or debilitated patients, in those suffering from conditions such as COPD, severe asthma, or upper airway obstruction, or following large initial doses of opioids given to non-tolerant patients.

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. This should be considered when prescribing or dispensing oxycodone HCl in situations where the physician or pharmacist is concerned about an increased risk of misuse or abuse. OXECTA^® may be abused by crushing, chewing, snorting or injecting the product. These practices pose 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 start 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 pain relief and tolerable adverse reactions, on an around-the-clock basis rather than on an as needed basis. When a patient no longer needs treatment with OXECTA^® after long-term use, it is important to gradually taper OXECTA^® over time to prevent withdrawal symptoms.

Patients taking OXECTA^® in combination with other medicines like sedatives, anesthetics or narcotics may have serious problems such as respiratory depression, low blood pressure, profound sedation, or coma. Do not drink alcoholic beverages or take any medicines 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.

Patients taking OXECTA^® should use caution when driving a car, operating heavy machinery or doing similar, potentially dangerous tasks as OXECTA^® may impair abilities needed to drive or perform potentially dangerous activities.

The most common adverse reactions are nausea, constipation, vomiting, headache, itchiness, trouble sleeping, dizziness, loss of strength/energy, and sleepiness.

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.pfizer.com/products/rx/prescription.jsp.