Primlev | Contact Us

Contact Us

Corporate Headquarters
Akrimax Pharmaceuticals, LLC
11 Commerce Dr. Cranford, N.J. 07016
(908) 372-0506
info@akrimax.com

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 is contraindicated in patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product, in any situation where opioids are contraindicated including patients with significant respiratory depression, patients with acute or severe bronchial asthma or hypercarbia, and in the setting of suspected or known paralytic ileus.
The full prescribing information contains warnings regarding the potential for misuse, abuse and diversion of opioids. Oxycodone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.
Administration of PRIMLEV should be closely monitored for the respiratory depression that may be serious. Respiratory depression is a hazard with the use of oxycodone, one of the active ingredients in PRIMLEV, as with all opioid agonists.
Oxycodone should be used with extreme caution in patients with acute asthma, chronic obstructive pulmonary disorder (COPD), cor pulmonale, or preexisting respiratory impairment. Oxycodone may cause severe hypotension and should be administered with caution to patients in circulatory shock.
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. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen.
Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen.
Opioid analgesics should be used with caution when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension. The administration of PRIMLEV or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
PRIMLEV should be given with caution to patients with CNS depression, elderly or debilitated patients, patients with severe impairment of hepatic, pulmonary, or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy, urethral stricture, acute alcoholism, delirium tremens, kyphoscoliosis with respiratory depression, myxedema, and toxic psychosis.
PRIMLEV may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.
Patients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, centrally-acting anti-emetics, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with PRIMLEV may exhibit an additive CNS depression.
Agonist/antagonist analgesics should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as oxycodone.
Oxycodone and other morphine-like opioids have been shown to decrease bowel motility, may cause spasm of the Sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.
Physical dependence and tolerance are not unusual during chronic opioid therapy.