Acetaminophen & Codeine Phosphate Tablets, USP CIII 300/15 mg
This information is intended for U.S. healthcare professionals only.
INDICATIONS AND DOSAGE
Acetaminophen and Codeine Phosphate Tablets, USP (CIII) are indicated for the relief of mild to moderately severe pain.
IMPORTANT RISK INFORMATION
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.
WARNING: Death Related to Ultra-Rapid Metabolism of Codeine to Morphine
Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism.
- Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.
- Acetaminophen and codeine phosphate tablets are contraindicated in patients who have previously exhibited hypersensitivity to codeine or acetaminophen.
WARNINGS AND PRECAUTIONS
- Patients who are CYP2D6 ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing due to rapid conversion of codeine to morphine. Children with obstructive sleep apnea may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine.
- There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen.
- In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of the patients with head injuries.
- Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.
- Codeine is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
- Codeine-containing products may enhance the effects of other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.
- Codeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.
- Serious adverse reactions may include shortness of breath, respiratory depression, thrombocytopenia, and agranulocytosis.
- Common adverse reactions: drowsiness, lightheadedness, dizziness, sedation, nausea and vomiting, euphoria, dysphoria, constipation, abdominal pain, pruritus, and rash.
USE IN SPECIFIC POPULATIONS
- Pregnancy: Use of narcotics during pregnancy may produce physical dependence in the neonate.
- Breast feeding: Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies.
||Tylenol® with Codeine
||Debossed "2" on one side and an "M" in a box on reverse side
For additional information on Acetaminophen & Codeine Phosphate Tablets, USP CIII 300/15 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.
Tylenol is a registered trademark of its respective owner.