Codeine sulfate

CODEINE SULFATE

Manufacturer: Hikma Pharmaceuticals USA Inc.

Score: 144.0

Quick Summary

Codeine Sulfate is an opioid agonist used for the management of mild to moderate pain. It is available in tablet form and should be prescribed by healthcare professionals knowledgeable about opioid use and risks. The drug has several contraindications, including use in children under 12 years old, and has potential for addiction, abuse, and misuse. Dosing should be individualized, starting at 15-60 mg every 4 hours as needed, with a maximum 24-hour dose of 360 mg. Special population considerations include use during pregnancy, pediatric and geriatric use, and caution is advised due to the risk of respiratory depression and other adverse effects.

Key Clinical Findings and Indications

Management of mild to moderate pain
Opioid agonist
Available in 15 mg, 30 mg, and 60 mg tablets

Important Safety Information

Warning

Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression; Accidental Ingestion; Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants; Neonatal Opioid Withdrawal Syndrome

Contraindications

All children younger than 12 years of age
Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy
Significant respiratory depression
Acute or severe bronchial asthma
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days
Known or suspected gastrointestinal obstruction
Hypersensitivity to codeine

Adverse Reactions

Drowsiness
Lightheadedness
Dizziness
Sedation
Shortness of breath
Nausea
Vomiting
Sweating
Constipation

Dosing Recommendations

General Guidance

Titrate dose based on individual patient response, with a maximum 24-hour dose of 360 mg

Mild to moderate pain

Adult Dose

15-60 mg every 4 hours as needed

Pediatric Dose

Not recommended for children under 12 years old

Special Population Considerations

Pregnancy

Use of opioid analgesics for an extended period during pregnancy may cause neonatal opioid withdrawal syndrome
Codeine Sulfate is not recommended for use in pregnant women during or immediately prior to labor

Nursing Mothers

Caution advised due to potential for codeine to be excreted in breast milk

Pediatric Use

Contraindicated in children under 12 years old
Contraindicated for post-operative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy