Age Recommendations for Pataday and Zaditor in Babies
Pataday (olopatadine) is FDA-approved for children 2 years and older, while Zaditor (ketotifen) is approved for children 3 years and older—neither medication should be used in babies under these age thresholds. 1, 2
FDA-Approved Age Restrictions
Pataday (Olopatadine)
- Approved for ages 2 years and older with dosing of 1 drop in affected eye(s) twice daily, every 6-8 hours 1
- Children under 2 years: consult a doctor per FDA labeling 1
- The 0.1% formulation requires twice-daily dosing, while 0.2% can be dosed once daily 3
Zaditor (Ketotifen)
- Approved for ages 3 years and older with dosing of 1 drop in affected eye(s) twice daily, every 8-12 hours 2
- Children under 3 years: consult a doctor per FDA labeling 2
- Demonstrated efficacy and safety in pediatric subjects aged 8-16 years in controlled trials 4
Critical Safety Considerations for Young Children
Antihistamine eye drops are unlikely to be beneficial and should not be used in children under 7 years with ocular surface disorders according to consensus guidelines, and their use should not delay ophthalmology referral 3
Systemic Antihistamine Safety Data
- Between 1969-2006, there were 69 fatalities associated with antihistamines in children under 6 years, with 41 deaths in children under 2 years due to overdose and toxicity 5
- The FDA recommended in 2007 that OTC antihistamine medications not be used for children below 6 years of age due to safety concerns 5
- Most second-generation antihistamines have approval only starting at age 2 years, with some extending down to 6 months in controlled studies—but not below 6 months 5
Recommended Alternatives for Babies and Young Children
For Children Under 7 Years
Ophthalmology consultation is recommended before initiating antihistamine eye drop treatment 6, 3
Safe Ocular Lubricants
- Preservative-free lubricant drops (such as CMC) applied 2-4 times daily during the day, with ointment at bedtime if needed provide optimal treatment for ocular surface symptoms in young children 6
- These simple lubricants do not require ophthalmology consultation before use 6
- Preservative-free formulations minimize irritation with frequent use 6
For Allergic Symptoms in Infants
- Intranasal corticosteroids are the most effective medication class for controlling allergic symptoms in children under 2 years, including sneezing, itching, rhinorrhea, and nasal congestion 5
- Isotonic and hypertonic saline solutions provide modest benefit with minimal side effects, low cost, and good patient acceptance 5
Clinical Pitfalls to Avoid
- Do not use antihistamine eye drops off-label in babies or children under the FDA-approved age thresholds 1, 2
- Many antihistamines are prescribed off-label in children younger than 2 years, which is the age group where most safety data are lacking 7
- First-generation antihistamines have never been adequately studied for pediatric age groups and should be avoided 8
- Antihistamine eye drops showed only 42% response rate compared to 89% for tacrolimus ointment and 74% for corticosteroid eyedrops in treating ocular surface disorders 6