Usual Adult Dose for Cough and Nasal Congestion

Average effective dose: 5 mL orally every 4 to 6 hours as needed
Maximum dose: 30 mL (promethazine 37.5 mg; phenylephrine: 30 mg; codeine: 60 mg) in 24 hours

Comments:

• Each 5 mL contains Promethazine 6.25 mg/Phenylephrine 5 mg/Codeine 10 mg.
• Liquid preparations should be measured with an accurate milliliter measuring device.

Uses: Temporary relief of coughs and upper respiratory symptoms, including nasal congestion, 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

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for all opioids intended for outpatient use. The new FDA Opioid Analgesic REMS is a designed to assist in communicating the serious risks of opioid pain medications to patients and health care professionals. It includes a medication guide and elements to assure safe use. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNINGS: RESPIRATORY DEPRESSION IN CHILDREN; DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; RISK EVALUATION AND MITIGATION STRATEGY (REMS)

• 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.
• Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.
• Opioid Analgesic REMS: To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, a REMS is required for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program; counsel patients and/or their caregivers, with every prescription on safe use, serious risks, storage, and disposal of these products; emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.

The US FDA recommends against use of codeine-containing cough and cold medications in patients less than 18 years because it has been determined that the risks outweigh benefits.

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 7.15% 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.
• The US FDA recommends against use of codeine-containing cough and cold medications in patients less than 18 years because it has been determined that the risks outweigh benefits.

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.
• This drug may cause drowsiness, dizziness, or impair thinking or motor skills; patients should avoid driving or operating machinery until adverse effects are determined.
• Patients who experience nervousness, dizziness, or sleeplessness with this drug should discontinue use.
• 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 medications.
• Patients should be cautioned to avoid prolonged sun exposure and report any involuntary muscle movement.
• Women who are breastfeeding, pregnant, or planning to become pregnant should speak to their healthcare provider before using this product.
• Patients should be instructed to read the US FDA-approved Medication Guide each time this drug is dispensed; they should understand the safe use, serious risks, and proper storage and disposal of this drug.