Question:

My 10-year-old daughter was prescribed two teaspoons of promethazine and codeine to be taken at bedtime while she also had two 20 mg doses of dexamethasone, two days apart during a recent problem with asthma.

After she took the cough syrup and fell asleep, I checked on her. Her breathing was very, very shallow. This alarmed me, so I woke her and had her stay awake until five hours had gone by. When she returned to sleep, her breathing was strong. I stayed awake longer, checking on her frequently, and she was fine.

The dexamethasone helped the cough, and I didn`t give her anymore cough syrup. She also has Albuterol inhaler.

I later saw online that there was an FDA boxed warning about promethazine and codeine, not to give it to children under the age of 16. Are physicians generally prescribing this combination, anyway? Can you comment on what the boxed warning means?

When I called the nurse the next day to report the shallow breathing, I was told that the doctor must have thought she needed this cough syrup and if I didn`t want her to have it, then I could try an over the counter remedy. I have not talked with the doctor about it, though. Thank you.

Answer:

The combination of Promethazine and codeine does have a black box warning; however, it pertains to patients under the age of six. You can review both the black box warning http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm121083.htm and the prescribing information http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008306s030lbl.pdf on the FDA website.

The black box warning is in place to prevent the use of this drug combination in patients under the age of six due to the risk of harm from slowed respirations. While your 10-year-old is obviously exempt from this warning, the dosing information available from the second link recommends 2.5 to 5ml (½ to 1 teaspoonful) as the dose for patients’ age 6 to 12. The dose prescribed by the physician appears to be higher than this recommendation. Drugs are generally more accurately dosed according to weight in the pediatric population. Without knowing your child’s weight and other medical history, I cannot comment on the appropriateness of this dose.

I highly recommend that you speak with the physician if you have any further concerns.

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