Patanase Nasal Spray

Generic Name: olopatadine hydrochloride
Date of Approval: April 15, 2008
Company: Alcon, Inc.

Treatment for: Allergic Rhinitis

FDA Approves Patanase

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The U.S. Food and Drug Administration (FDA) has approved Patanase (olopatadine hydrochloride) nasal spray for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older.

FDA approval of Patanase nasal spray was based primarily on multiple clinical studies for the evaluation of safety, efficacy and onset of action. The studies were two-week, randomized, double-blind clinical trials in seasonal allergic rhinitis patients and were conducted to determine the ability of Patanase to relieve allergy symptoms based on total nasal symptom scores (TNSS, a composite of stuffy, runny, itchy nose and sneezing). The results of these clinical studies were that patients treated with Patanase, two sprays per nostril, twice daily, demonstrated significantly greater decreases in TNSS compared to the placebo nasal spray.

Additionally, onset of action was evaluated in three environmental exposure unit studies. In these studies, patients with seasonal allergic rhinitis were exposed to high levels of pollen and then treated with either Patanase or placebo nasal spray, two sprays in each nostril, after which they self-reported their allergy symptoms hourly for the subsequent 12 hours. Patanase nasal spray was found to have an onset of action of 30 minutes and a 12 hour duration of affect after dosing, which was statistically significant compared to the placebo spray.

About Patanase Nasal Spray

Patanase nasal spray is indicated for patients 12 years of age and older for the relief of symptoms of seasonal allergic rhinitis. Nasal allergy symptoms are measured by the patient's Total Nasal Symptom Score (TNSS) which is a combination of stuffy, runny, itchy nose and sneezing. Patanase is intended only for intranasal administration. The most common side effects experienced with the use of Patanase include: bitter taste, headache, epistaxis, pharyngolaryngeal pain, post-nasal drip, cough, and urinary tract infection.

About Seasonal Allergic Rhinitis

Seasonal allergic rhinitis, also known as "hay fever," refers to an allergic complex of symptoms caused by sensitivity to seasonal pollens. Symptoms may include congestion, sneezing, itchy nose, runny nose, watery eyes and itchy eyes.

According to the American College of Allergy, Asthma & Immunology (ACAAI), allergies affect an estimated 40 to 50 million people in the United States. Allergies are not only bothersome, but have been linked to a variety of common and serious chronic respiratory illnesses, such as sinusitis and asthma. In addition, they may interfere with day-to-day activities or lessen the quality of life.

Source: Alcon

Highlights of Patanase Prescribing Information

These highlights do not include all the information needed to use Patanase Nasal Spray safely and effectively. See full prescribing information for Patanase Nasal Spray.

Indications and Usage

Patanase Nasal Spray is an H1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older.

Dosage and Administration

Patanase Nasal Spray is for intranasal use only.

The recommended dose of Patanase Nasal Spray in patients 12 years and older is two sprays per nostril twice daily. Priming Information: Prime Patanase Nasal Spray before initial use and when Patanase Nasal Spray has not been used for more than 7 days.

Dosage Forms and Strengths

Patanase Nasal spray 0.6%: 665 mcg of olopatadine hydrochloride in each 100- microliter spray.

Supplied as a 30.5 g bottle containing 240 sprays.

Contraindications

None.

Patanase Warnings and Precautions

Epistaxis, nasal ulceration, and nasal septal perforation. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with nasal disease other than allergic rhinitis.
Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking Patanase Nasal Spray.
Avoid concurrent use of alcohol or other central nervous system depressants with Patanase Nasal Spray.

Adverse Reactions

The most common adverse reactions (>1%) associated with Patanase Nasal spray included bitter taste, headache, epistaxis, pharyngolaryngeal pain, postnasal drip, cough, and urinary tract infection.

To report Patanase Nasal Spray SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757- 9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Patient Counseling Information

Local Nasal Effects and Other Common Adverse Reactions
Patients should be informed that treatment with Patanase Nasal Spray may lead to adverse reactions, which include epistaxis and nasal ulcerations. Other common adverse reactions reported with use of Patanase Nasal Spray include bitter taste, headache, pharyngolaryngeal pain, post-nasal drip, cough, and urinary tract infection.

Activities Requiring Mental Alertness
Somnolence has been reported in some patients taking Patanase Nasal Spray. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of Patanase Nasal Spray.

Concurrent Use of Alcohol and other Central Nervous System Depressants
Concurrent use of Patanase Nasal Spray with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur.

Keep Spray Out of Eyes
Patients should be informed to avoid spraying Patanase Nasal Spray in their eyes.

For more information, please visit www.patanase.com