Is Nasal Spray Safe for Infants Under Two Years Old? - Pediatrics

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The appropriate age for using Spravato nasal spray?


Hello, can the nasal spray "Spray Stop" be used for infants under two years old? The instructions only mention dosage for children five years and older.

Xiao Fei Xia, 40~49 year old female. Ask Date: 2020/09/01

Dr. Xiao Kaiwen reply Pediatrics


The recommended age for using Spravato nasal spray in children is 5 years and older, indicating that there are no research studies on the use of this medication for children under 5 years old during the drug development process.
Therefore, it is not recommended for use in children under 2 years old.

Reply Date: 2020/09/01

More Info


When it comes to the use of nasal sprays, particularly those like Nasal Spray (often referred to as "噴立停" in Mandarin), safety and efficacy are paramount, especially for infants under two years old. The official guidelines and product labeling are crucial in determining whether a medication is appropriate for a specific age group. In the case of Nasal Spray, the manufacturer recommends its use for children aged five and older. This recommendation is based on clinical studies and safety data that have been gathered during the drug's development.
The absence of data for children under five indicates that there have not been sufficient studies to establish the safety and efficacy of this nasal spray in younger children, particularly infants. Therefore, it is generally advised against using this product for infants under two years old. The potential risks associated with using medications that have not been adequately tested in young children include adverse reactions, ineffective treatment, and the possibility of worsening the child's condition.

Infants have unique physiological characteristics that make them more vulnerable to the effects of medications. Their respiratory systems, for example, are still developing, and their ability to metabolize drugs differs significantly from that of older children and adults. This is why many medications, including nasal sprays, have age-specific guidelines.
In cases where an infant is experiencing nasal congestion or other respiratory issues, it is essential to consult a pediatrician or a healthcare professional. They can provide alternative treatments that are safe and effective for infants. Common recommendations for managing nasal congestion in infants include saline nasal drops or sprays, which can help moisten the nasal passages and facilitate mucus clearance without the risks associated with medicated sprays. Additionally, using a humidifier in the child's room can help maintain moisture in the air, which may alleviate congestion.

For parents concerned about their child's nasal symptoms, it's also important to consider environmental factors that may contribute to nasal congestion, such as allergens or irritants. Keeping the living environment free from smoke, strong odors, and allergens can significantly improve respiratory health in infants.

In summary, while Nasal Spray may be effective for older children and adults, it is not recommended for infants under two years old due to the lack of safety data and potential risks. Parents should always consult healthcare professionals for appropriate treatments tailored to their child's age and specific health needs. Safe alternatives, such as saline solutions and environmental adjustments, can often provide relief without the risks associated with untested medications.

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