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Codeine is an FDA approved opioid for treating mild to moderate pain but has a black box warning. It is contraindicated in children after tonsillectomy due to risk of respiratory depression and is also contraindicated in patients with respiratory issues or paralytic ileus. Dosages for adults are provided but pediatric use has not been established.

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17 views2 pages

Doc8 2

Codeine is an FDA approved opioid for treating mild to moderate pain but has a black box warning. It is contraindicated in children after tonsillectomy due to risk of respiratory depression and is also contraindicated in patients with respiratory issues or paralytic ileus. Dosages for adults are provided but pediatric use has not been established.

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georgepiper292
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Overview

Codeine is an analgesic opioid that is FDA approved for the treatment of mild to moderate pain.
There is a Black Box Warning for this drug as shown here. Common adverse reactions
include constipation, nausea, vomiting, dizziness, lightheadedness, sedation, somnolence,
and dyspnea.

Adult Indications and Dosage


FDA-Labeled Indications and Dosage (Adult)
 Pain (mild to moderate): 15 to 60 mg orally up to every 4 hours as needed; MAX 360
mg/24 h
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Codeine in adult
patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Codeine in adult
patients.

Pediatric Indications and Dosage


FDA-Labeled Indications and Dosage (Pediatric)
 Safety and effectiveness in pediatric patients younger than 18 years have not been
established.
 Contraindicated for postoperative pain control in pediatric patients
undergoing tonsillectomy or adenoidectomy.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Codeine in pediatric
patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Codeine in
pediatric patients.

Contraindications
Codeine sulfate is contraindicated for postoperative pain management in children who have
undergone tonsillectomy and/or adenoidectomy.

 Codeine sulfate is contraindicated in patients with known hypersensitivity to codeine


or any components of the product. Persons known to be hypersensitive to certain
other opioids may exhibit cross-sensitivity to codeine.
 Codeine sulfate is contraindicated in patients with respiratory depression in the
absence of resuscitative equipment.
 Codeine sulfate is contraindicated in patients with acute or severe bronchial
asthma or hypercarbia.
 Codeine sulfate is contraindicated in any patient who has or is suspected of
having paralytic ileus.

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