Codeine / Phenylephrine Dosage

Usual Adult Dose for Cough and Nasal Congestion

Codeine 10 mg/phenylephrine 10 mg per 5 mL oral liquid:
5 mL orally every 4 hours as needed
Maximum dose: 30 mL in 24 hours

Comment: Oral liquid should be measured with an accurate milliliter measuring device.

Uses: Temporary relief of coughs due to the common cold, allergic rhinitis or other upper respiratory allergies; reduces swelling of nasal passages to relieve nasal congestion.

Usual Pediatric Dose for Cough and Nasal Congestion

Codeine 10 mg/phenylephrine 10 mg per 5 mL oral liquid:

Age: Less than 2 years: Not recommended

Age: 2 to less than 6 years:
Under physician supervision
Codeine 2.5 mg/phenylephrine 2.5 mg (1.25 mL) orally every 4 hours as needed
Maximum dose: Codeine: 1 mg/kg/day; Phenylephrine: 15 mg in 24 hours (7.5 mL)

Age: 6 to less than 12 years:
Codeine 5 mg/phenylephrine 5 mg (2.5 mL) orally every 4 hours as needed
Maximum dose: Codeine 30 mg/phenylephrine 30 mg (15 mL) in 24 hours

Age: 12 years or older:
Codeine 10 mg/phenylephrine 10 mg (5 mL) orally every 4 hours as needed
Maximum dose: Codeine 60 mg/phenylephrine 60 mg (30 mL) in 24 hours

Comments:
-Oral liquid should be measured with an accurate milliliter measuring device, especially in children under 6 years old.
-The America Academy of Pediatrics (AAP) warns against use of combination cough and cold products in children due to lack of well-controlled efficacy studies and the potential for adverse effects and overdose.
-This product should not be administered to children who have a chronic respiratory disease or shortness of breath, or those taking other medications unless directed by a physician.

Uses: Temporary relief of coughs due to the common cold, allergic rhinitis or other upper respiratory allergies; reduces swelling of nasal passages to relieve nasal congestion.

Renal Dose Adjustments

Dose adjustments not recommended

Liver Dose Adjustments

Dose adjustments not recommended

Precautions

US BOXED 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 CYP450 2D6 polymorphism.

Safety and efficacy have not been established in patients younger than 2 years.
-The Consumer Healthcare Products Association (CHPA) recommends all combination cough and cold products be labeled "Do not use in children under 4 years of age".

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule V

Dialysis

Data not available

Other Comments

Administration advice:
-Take orally with or without food
-Oral measuring devices should be provided to ensure accuracy in dosing; a household teaspoon should not be considered an accurate measuring device

Storage requirements:
-Protect from moisture and light

General:
-Patients who are ultra-rapid metabolizers of codeine due to a CYP450 2D6 polymorphism, will convert codeine more rapidly and completely to morphine resulting in unexpectedly high morphine levels, which may be life-threatening.
-Codeine use is contraindicated in the postoperative period in children who have undergone tonsillectomy and/or adenoidectomy.
-Professional organizations are concerned with use of all cough and cold medicines in children; prescription and non-prescription alternatives to codeine for cough also have risks.

Monitoring:
-Cardiovascular: Monitor for signs of hypotension, especially in those whose blood pressure is compromised
-Respiratory: Monitor for respiratory depression
-Gastrointestinal: Monitor for constipation and decreased bowel motility in post-operative patients.
-Patients should be monitored for the development of addiction, abuse, or misuse.

Patient advice:
-Patients should understand that codeine use can result in addiction, abuse, and misuse; recommended doses should not be exceeded.
-Patients should be understand that this product is for temporary relief of cough; if cough persists for longer than 1 week, recurs, or is accompanied by fever, rash, or persistent headache, a health care professional should be consulted.
-Patients should understand risks of life-threatening respiratory depression and when this risk is greatest; patients should be aware that a genetic mutation may result in greater codeine toxicity in some patients; breastfed infants of women who have this genetic mutation are also at risk.
-Women who are breastfeeding, pregnant, or planning to become pregnant should speak to their healthcare provider before using this product.
-This drug may cause drowsiness, dizziness, or impair thinking or motor skills; patients should avoid driving or operating machinery until adverse effects are determined.
-Concomitant use of alcohol, sedatives, and tranquilizers may increase drowsiness; patients should avoid alcohol and consult with their healthcare provider regarding concomitant use of other CNS depressants.
-Patients should be instructed to discontinue use if they experience nervousness, dizziness, or sleeplessness.