Classes
DEA Class; Rx
Common Brand Names; Tylenol with Codeine, Tylenol, Tylenol
- Analgesics, Opioid Combos
Description
Oral combination of analgesics, which include an opioid agonist
Used for the treatment of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate
Acetaminophen doses above the maximum recommended are associated with hepatotoxicity
Indications
For the treatment of mild pain to moderate pain requiring an opioid is appropriate and for which alternative treatments are inadequate.
Contraindications
Children <12 years
Post-operative management in children <18 years following tonsillectomy and/or adenoidectomy
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 last 14 days
Known or suspected gastrointestinal obstruction, including paralytic ileus
Hypersensitivity to codeine, acetaminophen, or ingredients
Hepatitis or severe hepatic/renal impairment
Adverse Effects
Constipation
Drowsiness
Hypotension
Tachycardia or bradycardia
Confusion
Dizziness
False feeling of well being
Headache
Lightheadedness
Malaise
Paradoxical CNS stimulation
Restlessness
Rash
Urticaria
Anorexia
Nausea
Vomiting
Xerostomia
Ureteral spasm
Decreased urination
Increased LFTs
Burning at injection site
Warnings
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplantation and death; risk increases in individuals with underlying liver disease, alcohol ingestion, and/or use of more than 1 acetaminophen-containing product (see Black Box Warnings)
Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash
Acetaminophen may cause serious an potentially fatal skin reactions
Patients with G6PD deficiency
Use caution in repeated administration in patients with anemia or with cardiovascular, pulmonary, or renal disease
Use caution in patients with history of porphyria
May cause hypotension; use with caution in patients with hypovolemia
Codeine may cause depression; avoid driving car or operating heavy machinery
Use caution in patients with conditions associated with hypoxia, hypercapnia, upper respiratory obstruction, or debilitated patients
Pregnancy and Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women; use during pregnancy only if potential benefit justifies potential risk to fetus
Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in neonate and neonatal opioid withdrawal syndrome shortly after birth
Inform female patients of reproductive potential that prolonged use of drug during pregnancy can result in neonatal opioid withdrawal syndrome,which may be life-threatening if not recognized and treated
Lactation:
Codeine and its active metabolite, morphine, are present in human milk; there are published studies and cases that have reported excessive sedation, respiratory depression, and death in infants exposed to codeine via breast milk; women who are ultra-rapid metabolizers of codeine achieve higher than expected serum levels of morphine, potentially leading to higher levels of morphine in breast milk that can be dangerous in their breastfed infants; in women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent
There is no information on effects of codeine milk production; because of potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, breastfeeding is not recommended during treatment
Withdrawal seizures in newborns whose mothers had taken butalbital-containing drug during pregnancy reported
Maximum Dosage
NOTE: For combination products containing acetaminophen, total daily intake of acetaminophen from all sources should be considered and may be the dose-limiting consideration for acetaminophen; codeine products.
Acetaminophen 4,000 mg/day PO; codeine 60 mg/dose PO; some clinicians have recommended the following maximum dosages: for pain, codeine 360 mg/day PO; as an antitussive, codeine 120 mg/day PO.
Acetaminophen 4,000 mg/day PO; codeine 60 mg/dose PO; some clinicians have recommended the following maximum dosages: for pain, codeine 360 mg/day PO; as an antitussive, codeine 120 mg/day PO.
Safety and efficacy have not been established.
12 years: Safety and efficacy have not been established.
1 to 11 years: Use is contraindicated.
Use is contraindicated.
