At what age can Benzydamine (benzydamine hydrochloride) throat spray be prescribed to children?

Age Recommendations for Benzydamine Throat Spray in Children

Benzydamine hydrochloride throat spray should not be used in children under 3 years of age unless specifically directed by a physician, and consultation with a physician is required for all children under 12 years of age. 1

FDA-Approved Age Guidelines

The FDA labeling for benzydamine provides clear age-based restrictions:

• Children under 3 years: Do not use unless directed by a physician 1
• Children 3-12 years: Requires physician consultation before use 1
• Children 5 years and older: Standard dosing is 5-10 drops orally, 3 times daily 1

Critical Safety Considerations

Severe sore throat warning: If sore throat is severe, persistent, or accompanied by high fever, headache, nausea, or vomiting, this may indicate a serious condition requiring prompt physician evaluation. Do not use for more than 2 days without medical supervision. 1

Clinical Context and Alternatives

While benzydamine is used in pediatric populations, the evidence for its efficacy in children is mixed:

• A randomized controlled trial in children aged 6-12 years found that prophylactic benzydamine spray did not reduce postoperative sore throat compared to control 2
• However, an older study in children aged 4-11 years post-tonsillectomy showed benzydamine was more effective than placebo for pain control 3
• Survey data indicates that approximately 40% of general practitioners prescribe benzydamine in pediatric patients, though it is not typically recommended as first-line treatment 4

Practical Prescribing Algorithm

For children presenting with sore throat:

1. Age < 3 years: Avoid benzydamine unless specifically indicated by physician evaluation 1
2. Age 3-5 years: Physician consultation mandatory; consider alternative treatments first 1
3. Age 5-12 years: Physician consultation required; if prescribed, use 5-10 drops orally 3 times daily 1
4. Age ≥ 12 years: Can be used with standard adult dosing under appropriate indications 1

Duration limits: Do not exceed 2 days of use without physician re-evaluation 1