Tylenol 3®
Acetaminophen 300 mg / Codeine 30 mg · oral tablet
Analgesics
Approved uses
Mild to moderate acute pain where an opioid is appropriate
1 to 2 tablets (codeine 30 mg / acetaminophen 300 mg) every 4 hours as needed; maximum in 24 hours is codeine 360 mg and acetaminophen 4,000 mg
Watch total acetaminophen if the patient is also taking an over-the-counter product containing it
Contraindications
Acetaminophen and codeine phosphate tablets are contraindicated for all children younger than 12 years of age and for postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. They are also contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days, known or suspected gastrointestinal obstruction including paralytic ileus, or hypersensitivity to codeine, acetaminophen, or any of the formulation excipients.
Available FormsAcetaminophen 300 mg with codeine phosphate 30 mg tablets.
Mechanism of ActionAcetaminophen is thought to work by reducing the production of prostaglandins in the brain. Codeine is an opioid that alters the perception and response to pain by binding to opioid receptors in the CNS
Warnings & Precautions
- Addiction, abuse and misuse can occur even at recommended doses and can lead to overdose and death.
- Life-threatening respiratory depression may occur, most often early in therapy or after a dose increase.
- Accidental ingestion, especially by a child, can be fatal.
- Acetaminophen has been associated with acute liver failure, at times fatal, usually at doses above 4,000 mg per day and often from more than one product.
- Concomitant use with benzodiazepines or other CNS depressants may cause profound sedation, respiratory depression, coma and death.
- Prolonged use during pregnancy can cause neonatal opioid withdrawal syndrome.
- Ultra-rapid CYP2D6 metabolizers convert codeine to morphine faster and can reach life-threatening levels at ordinary doses; contraindicated in children under 12.
Common Side Effects
The most frequently observed adverse reactions with codeine administration include drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, sweating, and constipation.
Pregnancy & LactationPregnancy: Prolonged use during pregnancy can cause neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.
Lactation: Codeine and its metabolites pass into breast milk and have caused infant death in ultra-rapid metabolizers; not recommended while breastfeeding.
Pediatric UseThe safety and effectiveness of acetaminophen and codeine phosphate tablets in pediatric patients below the age of 18 have not been established. Life-threatening respiratory depression and death have occurred in children who received codeine; in most of the reported cases, these events followed tonsillectomy and/or adenoidectomy, and many of the children had evidence of being ultra-rapid metabolizers of codeine. Contraindicated for all children younger than 12 years of age, and for postoperative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid use in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine unless the benefits outweigh the risks.