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Codeine / Promethazine Dosage

Applies to the following strength(s): 10 mg-6.25 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

Promethazine 6.25 mg/ Codeine 10 mg per 5 mL:
Average effective dose: 5 mL orally every 4 to 6 hours as needed
Maximum dose: 30 mL (promethazine 37.5 mg; codeine: 60 mg) in 24 hours

Comments:
-Liquid preparations should be measured with an accurate milliliter measuring device.

Uses: Temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

Usual Pediatric Dose for Cough

Less than 6 years of age: Contraindicated

6 to less than 12 years old:
Promethazine 6.25 mg/ Codeine 10 mg per 5 mL:
Average effective dose: 2.5 to 5 mL orally every 4 to 6 hours as needed
Maximum dose: 30 mL (promethazine 37.5 mg; codeine: 60 mg) in 24 hours

12 years and older:
Promethazine 6.25 mg/ Codeine 10 mg per 5 mL:
Average effective dose: 5 mL orally every 4 to 6 hours as needed
Maximum dose: 30 mL (promethazine 37.5 mg; codeine: 60 mg) in 24 hours

Comments:
-Liquid preparations should be measured with an accurate milliliter measuring device.
-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, persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).

Uses: Temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

Renal Dose Adjustments

Use with caution, especially in patients with severe renal impairment

Liver Dose Adjustments

Use with caution, especially in patients with severe hepatic impairment

Dose Adjustments

Elderly: Use with caution generally starting at the lower end of the dosing range.

Precautions

US BOXED WARNING: RESPIRATORY DEPRESSION IN CHILDREN AND DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE:
-The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients.
-Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients.
-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 6 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule V; prescription only

Dialysis

Data not available

Other Comments

Administration advice:
-Take orally with or without food
-Oral measuring devices should be used to ensure accuracy in dosing; a household teaspoon should not be considered an accurate measuring device
-Syrup contains 7% alcohol

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.
-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 cautioned to avoid prolonged sun exposure and report any involuntary muscle movement.

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