Company:
Alcon
Pharmacologic class:
Antihistamine (H1 blocker)
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Active ingredient:
Olopatadine (as HCl) 0.6% (665 µg/spray); aqueous nasal spray; contains benzalkonium chloride.
Indication:
Seasonal allergic rhinitis.
Pharmacology:
Seasonal allergic rhinitis describes an array of symptoms, such as congestion, sneezing, itchy nose, and rhinorrhea, caused by a sensitivity to seasonal pollens. Olopatadine is an antihistamine that relieves these symptoms by interfering with the inflammatory response to the allergens.
This nasal spray formulation of the drug enables the patient to directly target the area of the inflammatory symptoms.
Clinical trials:
Three randomized, double-blind, placebo-controlled, parallel-group, multicenter, two-week studies were conducted to establish the safety and efficacy of olopatadine nasal spray in the treatment of seasonal allergic rhinitis. In these studies, 1,598 adult and adolescent patients were treated with either olopatadine 0.4%, olopatadine 0.6%, or placebo (vehicle nasal spray). Efficacy was assessed by patient recordings of four separate nasal symptom scores (nasal congestion, rhinorrhea, itchy nose, and sneezing). Symptoms were recorded as reflective (symptom severity over the past 12 hours) or instantaneous (symptom severity at the time of recording) on a scale of 0-3 (absent, mild, moderate, or severe). The primary efficacy end point was the difference from placebo in the percentage change from baseline in the sum of am and pm reflective total nasal symptom scores, averaged over the two-week period. In each trial, patients treated with the study drug (2 sprays in each nostril twice daily) had statistically significantly greater decreases in the reflective total nasal symptom score, compared with vehicle. For olopatadine 0.6%, the changes from baseline in the two studies were -3.63 and -2.90, respectively, compared with -2.67 and -1.92 for placebo.
The onset of action was assessed by an instantaneous recording of the total nasal symptom score twice daily after the first dose of study drug. Onset of action was apparent after one day of dosing. In three environmental-exposure single-dose studies, patients were exposed to high levels of pollen and then treated with either olopatadine nasal spray or placebo.
They then recorded their allergy symptoms hourly as instantaneous scores for the next 12 hours. In these studies, olopatadine 0.6% nasal spray had an onset of action of 30 minutes post-dose. Adults: Two sprays in each nostril twice daily.
Children:
Not recommended.
Precautions:
Other nasal diseases: not recommended. Avoid eyes. Monitor for nasal mucosal changes.
Pregnancy (Cat. C). Nursing mothers.
Interactions:
Potentiates central nervous system (CNS) depression with alcohol, other CNS depressants. Adverse reactions: Bitter taste, headache, epistaxis, throat pain, postnasal drip, cough, nasal ulceration, somnolence.
Additional patient information:
Prime pump before first use (five sprays) and if not used for seven days (two sprays). Discard after 240 sprays have been dispensed.
How supplied:
Nasal spray pump—30.5 g (240 sprays)
For more information, call 800.757.9195 or visit www.Patanase.com
