Drug Topics - June 16, 2008 - (Page 21)

www.drugtopics.com JUNE 16, 2008 DRUG TOPICS 21 Rx Care New nasal antihistamine sprays away allergic rhinitis Heidi Belden, Pharm.D. S easonal allergy sufferers may now benefit from a new product from Alcon Laboratories that incorporates an antihistamine into a long-acting nasal spray. The Food & Drug Administration has approved olopatadine hydrochloride (Patanase) nasal spray 0.6% for the relief of symptoms of seasonal allergic rhinitis in patients 12 years of age and older. According to Alcon, the FDA approval of olopatadine nasal spray was based on three clinical trials, each two weeks in duration. Patients utilized invivodata’s DiaryPRO, a technology that collects realtime data, twice daily to record the frequency and severity of symptoms. Results showed that patients treated with olopatadine demonstrated significantly greater decreases in total nasal symptom scores (a measure of stuffy, itchy, runny nose, and sneezing) compared with placebo spray. The new entity exerts its principal effects via selective inhibition of H1receptors and its antihistaminic activity has been documented in isolated tissues, animal models, and humans. five sprays or until a fine mist appears. When the spray has not been used for more than seven days, the product should be re-primed by releasing two sprays. Monitor mucosa According to the manufacturer, the most common adverse reactions (>1%) include bitter taste (12.8%), epistaxis (3.2%), headache (4.4%), pharyngolaryngeal pain (2.2%), post-nasal drip (1.5%), cough (1.4%), and urinary tract infection (1.2%). Patients should be warned of the potential for epistaxis, nasal ulceration, and nasal septal perforation and should periodically be monitored for signs of adverse effects on the nasal mucosa. In addition, patients should be cautioned that somnolence was reported during clinical trials and could affect occupations requiring complete mental alertness or motor coordination. Simultaneous use with alcohol or other central nervous system depressants should be avoided. The percentage of patients who discontinued using the spray due to an adverse reaction was similar among both the olopatadineand placebo-treated groups at 3.9% and 3.2%, respectively. Patients suffer with symptoms every allergy season, which make their lives miserable during those months, Meltzer said. “Patanase offers relief beginning in minutes in a convenient steroidfree nasal spray.” According to Alcon, Patanase will be available by the end of May 2008. Patanase Nasal Spray 0.6% Quick relief The rapid onset of action of olopatadine could be one of its strongest selling points. Eli Meltzer, M.D., a lead investigator for one of olopatadine’s studies, believes that the spray’s rapid onset of action is important. “Patients in our fast-paced society want rapid improvement and relief from their nasal allergies,” he said. “Patanase offers relief in minutes in a convenient steroid-free nasal spray.” The product’s prescribing information describes the drug’s onset of action as 30 minutes, with a 12-hour duration of effect. Olopatadine should be administered as two sprays per nostril twice daily. Each 100-microliter spray contains 665 mcg of olopatadine. Before initial use, the olopatadine pump should be primed by releasing Tips to remember: The recommended dose of Patanase is two sprays per nostril twice daily. Patanase is indicated for patients 12 years of age and older. Patients should be periodically monitored for signs of adverse effects on the nasal mucosa. Patanase is supplied as a 30.5-g bottle containing 240 sprays. Patanase should be primed prior to initial use and when the spray has not been used for more than seven days. http://www.drugtopics.com

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Drug Topics - June 16, 2008 Contents Latebreakers Letters Latebreakers in Depth Pharmacists Lose in Final ESRD Rule New Drug Helps Palliative Patients on Opioids Take Care of Business Oral Treatment Reduces Multiple Sclerosis Flare-ups Beware of Inflammatory Masses From Implantable Infusion Systems Safer Therapeutic Options Emerging for Atrial Fibrillation Congressional Committee Chair Calls for Action Against Hospital Infections This Software System Helps Hospitals Manage Anticoagulation Therapy Rx Care Community Practice JP at Large Self-Care Cover Story Long-Term Care Chains and Business Technology Technology Update Continuing Education New Products Advertisers Index Classified Viewpoint

Drug Topics - June 16, 2008

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