What is the minimum age for FDA‑approved use of topical mometasone and is there a low‑potency mometasone formulation?

Mometasone FDA-Approved Minimum Age and Potency Classification

Topical mometasone furoate is FDA-approved for use in children as young as 2 years of age for intranasal formulations, and mometasone is classified as a medium-to-high potency (not low-potency) topical corticosteroid with no low-potency formulation available. 1

FDA-Approved Age Indications by Formulation

Intranasal Mometasone (Allergic Rhinitis)

• Minimum age: 2 years for intranasal mometasone furoate nasal spray 1, 2
• Children 2-11 years: 1 spray per nostril once daily (100 μg total daily dose) 1
• Children ≥12 years and adults: 2 sprays per nostril once daily (200 μg total daily dose) 1

Inhaled Mometasone (Asthma)

• Minimum age: 4 years for mometasone dry powder inhaler 1
• Dosing based on asthma severity with once-daily administration as effective as divided dosing 1

Topical Dermatologic Formulations

• The evidence does not specify an FDA-approved minimum age for topical mometasone cream/ointment formulations in the provided guidelines
• However, clinical trials have demonstrated safety in children with atopic dermatitis, including a 6-week study in 48 children showing no plasma cortisol suppression 3

Potency Classification: No Low-Potency Formulation Exists

Mometasone furoate 0.1% is classified as a medium-to-high potency ("potent") topical corticosteroid—there is no low-potency mometasone formulation available. 4, 5

Comparative Potency Evidence

• Mometasone demonstrates greater anti-inflammatory activity and longer duration of action than betamethasone 4, 5
• In psoriasis trials, mometasone 0.1% once daily was significantly more effective than fluocinolone acetonide 0.025% three times daily and triamcinolone acetonide 0.1% twice daily 6
• In atopic dermatitis, mometasone 0.1% once daily was significantly superior to hydrocortisone 1.0% twice daily, particularly in patients with >25% body surface area involvement 3
• The British Association of Dermatologists guidelines classify mometasone as effective for lichen sclerosus, though less potent than clobetasol propionate (ultra-potent) 7

Safety Profile Despite Higher Potency

• Low systemic bioavailability (approximately 1% oral bioavailability) minimizes hypothalamic-pituitary-adrenal (HPA) axis suppression risk 1, 4
• Low atrophogenic potential due to molecular biotransformation resulting in lower affinity for dermal cells compared to epidermal cells 5
• In a comparative study, mometasone showed less skin atrophy than betamethasone dipropionate, with atrophy not observed before 4-12 weeks of treatment 8
• One-year treatment with intranasal mometasone 100 μg daily in children aged 6-11 years showed no evidence of HPA axis suppression or ocular changes 1

Critical Clinical Considerations

Proper Administration Technique

• Intranasal spray must be directed away from the nasal septum to prevent repetitive direct application and reduce risk of septal perforation 1
• Regular (not as-needed) administration is required to maintain symptom control 1

Drug Interactions

• Contraindicated with potent CYP3A4 inhibitors (ritonavir, ketoconazole) due to risk of increased systemic concentrations potentially causing Cushing syndrome or adrenal insufficiency 1

Common Pitfall to Avoid

• Do not prescribe mometasone expecting "low-potency" effects—it is a medium-to-high potency corticosteroid that requires appropriate monitoring and patient counseling regarding duration of use 4, 5