From the Guidelines
Triprolidine drops are not recommended for use in children, especially those under 6 years of age, due to the potential risk of toxicity and lack of established efficacy in this age group. The use of over-the-counter (OTC) cough and cold medications, including triprolidine, in young children has been associated with significant risks, including fatalities 1. According to the Journal of Allergy and Clinical Immunology, the efficacy of cold and cough medications for symptomatic treatment of upper respiratory tract infections has not been established for children younger than 6 years, and their use should be avoided in this age group 1.
Some key points to consider when evaluating the use of triprolidine in children include:
- The potential for toxicity, including overdose and adverse effects such as drowsiness, excitability, and dry mouth
- The lack of established efficacy in children under 6 years of age
- The availability of alternative antihistamines with better safety profiles in children, such as cetirizine or loratadine
- The importance of consulting with a pediatrician before using any medication in children, especially those under 6 years of age
It's essential to prioritize the safety and well-being of children when considering the use of any medication, including triprolidine. The risks associated with triprolidine use in children outweigh any potential benefits, and alternative treatments should be considered. If a doctor does prescribe triprolidine, they will provide specific dosing instructions based on the child's weight and age that should be followed exactly 1.
From the FDA Drug Label
Directions do not exceed recommended dosage. use only the enclosed dropper do not use enclosed dropper for any other drug product. AGEDOSE Adults & Children 12 years of age or older: 2.67 mL (2.5 milligrams) every 4 to 6 hours, not to exceed 10.67 mL (10 milligrams) in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1.33 mL (1.25 milligrams) every 4 to 6 hours, not to exceed 5.33 mL (5 milligrams) in 24 hours, or as directed by a doctor. Children under 6 years of age:consult a doctor. The safety of Triprolidine drops in children is as follows:
- Children 12 years and older: Safe to use as directed, with a maximum dose of 10 milligrams in 24 hours.
- Children 6 to under 12 years: Safe to use as directed, with a maximum dose of 5 milligrams in 24 hours.
- Children under 6 years: Consult a doctor before use, as the label does not provide a recommended dose for this age group 2.
From the Research
Safety of Triprolidine in Children
- There are no studies provided that directly assess the safety of triprolidine drops in children.
- The available studies focus on the efficacy and safety of triprolidine in adults, with no mention of pediatric populations 3, 4, 5, 6, 7.
- However, it is known that first-generation antihistamines like triprolidine can cause somnolence or other CNS adverse effects in adults, which may also be a concern in children 4, 5.
- The studies provided do not provide sufficient evidence to determine the safety of triprolidine drops in children, and therefore, caution should be exercised when considering its use in pediatric populations.
Pharmacokinetics and Adverse Effects
- A study on the bioavailability of triprolidine in healthy adults found that the safety profile of this sedating antihistamine was as expected, but adverse effects were reported in a higher proportion of women than men 7.
- Another study compared the tolerability and safety of first-generation and second-generation H1-receptor antagonists, including triprolidine, and found that first-generation antihistamines frequently cause somnolence or other CNS adverse effects 4.
- The adverse effects of triprolidine and other antihistamines are also discussed in a study on H1-receptor antagonists, which notes that an H1-antagonist absolutely free from adverse effects under all circumstances is not yet available for use 5.