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Codeine / Pseudoephedrine Dosage

Applies to the following strength(s): 20 mg-60 mg/5 mL ; 10 mg-30 mg/5 mL ; 20 mg-60 mg ; 8 mg-30 mg/5 mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Cough and Nasal Congestion

Codeine 8 mg/pseudoephedrine 30 mg per 5 mL oral liquid:
Usual dose: Codeine 16 mg/pseudoephedrine 60 mg (10 mL) orally every 4 to 6 hours as needed
Maximum dose: Codeine 64 mg/pseudoephedrine 240 mg (40 mL) per 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

Age: Less than 2 years:
-Not recommended

Age: 2 to less than 6 years:
Under physician supervision
Codeine 8 mg/pseudoephedrine 30 mg per 5 mL oral liquid:
Usual dose: Codeine 4 mg/pseudoephedrine 15 mg (2.5 mL) orally every 4 to 6 hours as needed
Maximum dose: Codeine 16 mg/pseudoephedrine 60 mg (20 mL) per 24 hours

Age: 6 to less than 12 years:
Codeine 8 mg/pseudoephedrine 30 mg per 5 mL oral liquid:
Usual dose: Codeine 8 mg/pseudoephedrine 30 mg (5 mL) orally every 4 to 6 hours as needed
Maximum dose: Codeine 32 mg/pseudoephedrine 120 mg (20 mL) per 24 hours

Age: 12 years or older:
Codeine 8 mg/pseudoephedrine 30 mg per 5 mL oral liquid:
-Codeine 16 mg/pseudoephedrine 60 mg (10 mL) orally every 4 to 6 hours as needed
Maximum dose: Codeine 64 mg/pseudoephedrine 240 mg (40 mL) per 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.
- Consumer Healthcare Products Association (CHPA) has recommended 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 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.
-Pseudoephedrine may cause sleeplessness, especially if it is taken up to several hours before going to bed.

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