Do not prescribe Acetaminophen and Codeine Phosphate Tablets, USP for patients with acetaminophen allergy. Instruct patients to discontinue Acetaminophen and Codeine Phosphate Tablets, USP immediately and seek medical care if they experience these symptoms. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. 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.
The remainder of the dose is excreted in the feces.Īt therapeutic doses, the analgesic effect reaches a peak within 2 hours and persists between 4 and 6 hours.Īcetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.
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The urinary secretion products consist of free and glucuronide conjugated codeine (about 70%), free and conjugated norcodeine (about 10%), free and conjugated morphine (about 10%), normorphine (4%), and hydrocodone (1%). The elimination of codeine is primarily via the kidneys, and about 90% of an oral dose is excreted by the kidneys within 24 hours of dosing. The plasma concentration does not correlate with brain concentration or relief of pain however, codeine is not bound to plasma proteins and does not accumulate in body tissues. Codeine crosses the blood-brain barrier, and is found in fetal tissue and breast milk. It is rapidly distributed from the intravascular spaces to the various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen and kidney. Codeine is readily absorbed from the gastrointestinal tract.