Prescription Appropriateness Assessment
This prescription is NOT appropriate for a patient expecting ear drops—the pharmacy has sent a cough/cold syrup containing pseudoephedrine, dexbrompheniramine, and dextromethorphan, which is intended for oral administration to treat upper respiratory symptoms, not ear conditions. 1
Critical Mismatch Between Prescription and Patient Expectation
The medication dispensed (Bromphed/Pseudoephedrine-Dexbrompheniramine-Dextromethorphan combination) is an oral liquid formulation designed to treat nasal congestion, rhinorrhea, and cough associated with upper respiratory infections or allergic rhinitis. 1
This combination contains three active ingredients: pseudoephedrine (decongestant), dexbrompheniramine (first-generation antihistamine), and dextromethorphan (cough suppressant)—none of which are appropriate for treating ear conditions requiring topical otic therapy. 1, 2
The patient's expectation of ear drops suggests a completely different clinical indication (likely otitis externa, cerumen impaction, or ear pain), which requires otic preparations, not oral cold medications. 1
Appropriate Use of This Medication (If Upper Respiratory Symptoms Were Intended)
If the original intent was to treat upper respiratory tract infection or allergic rhinitis, this combination would be appropriate:
First-generation antihistamine/decongestant combinations (like dexbrompheniramine/pseudoephedrine) are specifically recommended for treating cough due to upper airway cough syndrome (UACS) or postviral upper respiratory infections. 1
The American College of Chest Physicians guidelines specifically endorse the combination of dexbrompheniramine maleate (6 mg bid) plus sustained-release pseudoephedrine sulfate (120 mg bid) for chronic cough, noting that older-generation antihistamines work through their anticholinergic properties. 1, 2
Dextromethorphan is recommended for cough suppression in chronic bronchitis, though its efficacy in acute URI-related cough is more limited. 1
Dosing Concerns with Current Prescription
The prescribed dose of 15 mL every 6 hours translates to:
Pseudoephedrine 60 mg every 6 hours (240 mg/day)
Dexbrompheniramine 2 mg every 6 hours (8 mg/day)
Dextromethorphan 30 mg every 6 hours (120 mg/day)
This dosing is within acceptable ranges for adults with upper respiratory symptoms, as pseudoephedrine 60-120 mg every 4-6 hours (maximum 4 doses/24 hours) is standard. 2, 3
However, pseudoephedrine carries cardiovascular risks, including increased systolic blood pressure (0.99 mmHg) and heart rate (2.83 beats/min), requiring caution in patients with hypertension, coronary artery disease, or cerebrovascular disease. 4
Critical Safety Concerns
Serious toxicity can occur with overmedication of this combination:
Fatal intoxication has been reported in infants with pseudoephedrine (14.4 mg/L blood), brompheniramine (0.40 mg/L), and dextromethorphan (0.50 mg/L) concentrations. 5
Neurologic toxicity including agitated psychosis, hyperirritability, and ataxia has been documented with pseudoephedrine/dextromethorphan overmedication, even in therapeutic use scenarios. 6
Combining this medication with other sympathomimetics or topical nasal decongestants can precipitate hypertensive crisis. 4
Immediate Action Required
Contact the prescriber immediately to clarify the intended indication:
If ear drops were truly needed, request an appropriate otic preparation (e.g., ciprofloxacin/dexamethasone otic solution for otitis externa, or carbamide peroxide for cerumen removal). 1
If upper respiratory symptoms were the actual indication, confirm that the patient understands this is an oral medication for cold/allergy symptoms, not ear drops, and verify no contraindications to pseudoephedrine exist. 2, 4
Do not dispense this medication until the indication is clarified, as giving oral cold medication to a patient expecting ear drops represents a fundamental medication error with potential for harm. 1