Achoo…PLEASE! FDA approves OTC status for nasal antihistamine

Of the many things that can make it hard to get through your day — let alone sleep — one of the most-frustrating set of symptoms comes from a stuffy nose and head. You long for your runny, itchy nose, watery eyes and related issues to just stop and your nasal passages to clear so you can breathe more easily.

Millions of patients suffer from seasonal and perennial allergies, and the fall season is coming. Many people can find at least some relief with salt-water nasal sprays, but others need more. They typically turn to nasal antihistamine sprays, which like many OTC meds began as being by prescription only. This blog will briefly review the FDA’s most-recent update on the first-in-class OTC nasal antihistamine spray azelastine (brand names Astepro or Astelin). 

Azelastine (Astepro, Astelin)


Azelastine 0.15% nasal spray is approved for seasonal and perennial allergic rhinitis in adults and children aged 6 years and older. Previously available only by prescription, the FDA has now granted azelastine nonprescription status. 

Azelastine is the only OTC nasal antihistamine available at this time. However, note this approval is only considered a partial change, as the 0.1% strength indicated for perennial allergies in children 6 months to 6 years old and seasonal allergies for children aged 2 to 6 years old will continue to be by prescription only.

OTC dosing and side effects


For treatment of perennial allergies:

  • Adults and children 12 years of age — 2 sprays in each nostril two times a day
  • Children 6 to 11 years of age — 1 spray in each nostril two times a day

For treatment of seasonal allergies:

  • Adults and children 12 years of age — 1 or 2 sprays in each nostril two times a day, or 2 sprays in each nostril once a day
  • Children 6 to 11 years of age — 1 spray in each nostril two times a day

Patients typically can expect relief within 3 hours. Nasal antihistamines are well-tolerated, but we advise that side effects of this medication may include drowsiness, and that patients should avoid alcohol and use caution when driving. Patients may also experience a bitter taste in their mouth but, as with most other nasal sprays, this can be prevented by not tilting their head back after using it. 

Instructions for nasal spray use

  • Prime the spray prior to first use, or if not used in more than 3 days. This means to typically shake the bottle a time or two, remove the safety seal and cap, and then spray it into the air until you see 1 or 2 full sprays.
  • Blow your nose to clear your nostrils
  • Tilt your head down, looking at your toes, and insert the tip of the spray bottle into your nostril. Hold bottle upright and aim the spray tip toward the back of your nose.
  • Close your other nostril with a finger. Press the pump 1 time and sniff gently at the same time, keeping your head tilted forward and down.
  • Repeat in your other nostril using the same steps
  • Do not blow your nose or tip your head back for a bit after using the spray
  • Wipe the tip of the outside of the nose piece with a clean, dry tissue and replace the cap

Olopatadine (Patanase) is another nasal antihistamine available to patients for allergy symptoms, but this product is by prescription only.

By staying current on OTC treatment options, RxLive clinical pharmacists are dedicated to empowering our patients to take charge of their health and, in collaboration with their physicians, help them safely self-manage common conditions. We’re proud to do so.

Resources


WebMD highlights first OTC nasal spray antihistamine for allergic rhinitis

Author avatar
Kristen Engelen, PharmD
Kristen Engelen, PharmD, is the chief pharmacy officer of RxLive and a certified consultant pharmacist; she has over a decade of experience in retail pharmacy settings. Kristen became an RxLive co-founder because of her passion for geriatric pharmacy, with a focus on the intersection of pharmacy and aging.