Codeine / Pyrilamine Dosage

Usual Adult Dose for Cold Symptoms

10 mL orally every 4 hours as needed
Maximum dose: 60 mL in 24 hours

Comments:

• Each 5 mL contains codeine 9 mg-pyrilamine 8.33 mg
• 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 Adult Dose for Cough

10 mL orally every 4 hours as needed
Maximum dose: 60 mL in 24 hours

Comments:

• Each 5 mL contains codeine 9 mg-pyrilamine 8.33 mg
• 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 Cold Symptoms

12 years or older:
10 mL orally every 4 hours as needed
Maximum dose: 60 mL in 24 hours

Comments:

• Each 5 mL contains codeine 10 mg-pyrilamine 8.33 mg
• Liquid preparations 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 and upper respiratory symptoms associated with allergy or the common cold.

Usual Pediatric Dose for Cough

12 years or older:
10 mL orally every 4 hours as needed
Maximum dose: 60 mL in 24 hours

Comments:

• Each 5 mL contains codeine 10 mg-pyrilamine 8.33 mg
• Liquid preparations 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 and upper respiratory symptoms associated with allergy or the common cold.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

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.

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

• 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.

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 used 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.
• Over the counter cough and cold products can be harmful, especially if more than the recommended amount is consumed and this may occur if more than 1 product containing the same active ingredient is used.

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
• 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.
• Patients should be instructed to pay close attention to drugs labels, particularly to the active ingredients section to ensure they are not receiving duplicate medications.
• This drug may cause drowsiness, dizziness, or impair thinking or motor skills; patients should avoid driving or operating machinery while taking this drug.
• 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 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer