Dymista Nasal Spray Overdose Safety Profile
It is highly unlikely to experience a clinically significant overdose with Dymista nasal spray when used as directed, as one bottle contains limited amounts of active ingredients that are well below toxic thresholds. 1, 2
Understanding Dymista's Components and Safety Profile
Dymista is a combination nasal spray containing:
- Azelastine hydrochloride (antihistamine component)
- Fluticasone propionate (corticosteroid component) 3
Safety Profile of Individual Components
Azelastine Safety:
- One bottle of azelastine nasal spray contains approximately 30 mg of azelastine hydrochloride 2
- Clinical studies with single oral doses up to 16 mg have not resulted in serious adverse events 2
- Acute overdose by adults with the nasal spray formulation is unlikely to cause clinically significant adverse events beyond increased somnolence 2
Fluticasone Safety:
- Intranasal administration of 2 mg (10 times the recommended dose) twice daily for 7 days was well tolerated in healthy volunteers 1
- Single oral doses up to 16 mg and repeat oral doses up to 80 mg daily for 10 days have been studied without acute toxic effects 1
- One bottle of fluticasone nasal spray contains approximately 8 mg of fluticasone propionate, well below toxic thresholds 1
Common Side Effects of Normal Use
The most common side effects of Dymista include:
- Bitter taste
- Epistaxis (nosebleeds)
- Somnolence (sleepiness)
- Headache 3
Long-term safety studies of MP29-02 (Dymista) showed a low incidence of treatment-related adverse events (9.4%) with no evidence of late-occurring adverse events 4
Theoretical Overdose Concerns
Potential Systemic Effects:
- Chronic overdosage with fluticasone could potentially result in signs/symptoms of hypercorticism 1
- Excessive azelastine could potentially increase somnolence 2
Special Populations:
- Caution should be exercised in children, as oral ingestion of antihistamines has the potential to cause serious adverse effects in young children 2
- Dymista is only approved for patients 12 years and older 3
Clinical Evidence Supporting Safety
A 1-year randomized safety study of MP29-02 (Dymista) showed:
- No evidence of nasal mucosal ulcerations or septal perforations
- No unusual or unexpected ocular findings
- No clinically important laboratory findings
- No clinically important differences in fasting AM serum cortisol levels after 12 months of treatment 4
Multiple clinical trials have demonstrated that Dymista is well-tolerated with a safety profile similar to its individual components 5, 6, 7
Practical Advice
- Keep Dymista out of reach of children to prevent accidental ingestion 2
- If overdose is suspected, general supportive measures should be employed 2
- There is no known specific antidote to azelastine nasal spray 2
- Follow proper administration technique to minimize side effects and avoid excessive use 8
In conclusion, while any medication should be used as directed, the risk of clinically significant overdose with Dymista nasal spray is extremely low due to the limited amount of active ingredients in the formulation and their established safety profiles 1, 2, 4.