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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

Usual dose: 10 mL orally every 4 to 6 hours as needed
Maximum dose: Codeine 64 mg/pseudoephedrine 240 mg (40 mL) per 24 hours

Comments:
-Each 5 mL contains codeine 8 mg/pseudoephedrine 30 mg.
-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

Less than 12 years: Not recommended

12 years or older:
Usual dose: 10 mL orally every 4 to 6 hours as needed
Maximum dose: Codeine 64 mg/pseudoephedrine 240 mg (40 mL) per 24 hours

Comments:
-Each 5 mL contains codeine 8 mg/pseudoephedrine 30 mg.
-Oral liquid should be measured with an accurate milliliter measuring device.
-Codeine should not be used in adolescents who are obese or have conditions such as sleep apnea or severe lung disease which may increase the risk of serious breathing problems.

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

The US FDA has issued a Drug Safety Communication restricting use of prescription codeine pain and cough medicines in children less than 12 years. This update follows previous communications evaluating the potential risks of codeine. Children less than 12 years appear to be at the greatest risk of codeine associated serious adverse events including slowed or difficult breathing and death. The FDA is considering additional regulatory action for over the counter (OTC) combination cough and cold products containing codeine. At this time, it appears prudent to avoid codeine use in all children less than 12 years and avoid use in adolescents between 12 and 18 years who are obese, or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.

Safety and efficacy have not been established in patients younger than 12 years.

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.

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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