Formulation & safety

The medicine, in full.

A personalized, patient-specific intranasal formulation combining up to four individually FDA-approved actives, selected to the patient's symptom profile.

Composition

Up to four actives, by role.

Triamcinolone acetonide0.055–0.11%Anti-inflammatory corticosteroid

Azelastine hydrochloride0.137%Intranasal antihistamine

Ipratropium bromide0.015–0.09%Anti-secretory anticholinergic

Micro-dosed oxymetazoline0.003125–0.0125%Decongestant, ~1/12 to 1/48 of OTC strength

Claims discipline

Allermi is compounded from individually FDA-approved ingredients under 503A and is patient-specific. The combination itself is not FDA-approved. This distinction appears on every page and in every downloadable.

Personalization

Up to four actives are selected to the patient's symptom profile, with roughly 80 formula variations and adjustment over time. Reformulation occurs within the program at no additional patient cost.

How it is made and prescribed

The formulation is compounded under 503A as a patient-specific prescription, through a licensed pharmacy (ClearMedix; NPI 1215764907), following a telehealth evaluation by an Allermi-affiliated, licensed prescriber. Under 503A, prescriptions are patient-specific. The referring clinician is a referrer, not a prescriber or dispenser of Allermi.

Safety and tolerability

Component-level safety is well established. The most commonly reported adverse effects, shown honestly:

Bitter taste

~13%

Somnolence

~12%

Headache

5–10%

Epistaxis

8–9%

Nasal irritation

~3%

Dryness

<5%

Exclusion criteria include age under 13, pregnancy, untreated glaucoma, recent sinus surgery, and immunosuppression, among others reviewed at intake.