Brompheniramine / Codeine Dosage

Usual Adult Dose for Cold Symptoms

5 mL to 10 mL orally every 4 to 6 hours. Not to exceed 30 mL in 24 hours.

Usual Pediatric Dose for Cold Symptoms

Less than 12 years: Not Recommended

12 years or older: 5 mL to 10 mL orally every 4 to 6 hours. Not to exceed 30 mL in 24 hours.

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

Further information

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

Medical Disclaimer