WARNING

HEPATOTOXICITY: ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF LIVER INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN AT DOSES THAT EXCEED 4000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT.

Important Safety Information

PRIMLEV should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product.

Oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression and patients with acute or severe bronchial asthma or hypercarbia.

Precaution should be taken in patients with liver disease. Hepatotoxicity and severe hepatic failure occurred in chronic alcoholics following therapeutic doses.

Special precaution should be given when determining the dosing amount and frequency of PRIMLEV for geriatric patients, since clearance of oxycodone may be slightly reduced in this patient population when compared to younger patients.

The total daily dosage of acetaminophen should not exceed 4 grams. The toxicity of oxycodone and acetaminophen in combination is unknown.