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Patanase Product Information Patanase Rebate Form

HIGHLIGHTS OF 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.

PATANASE (olopatadine hydrochloride) Nasal Spray
Initial U.S. Approval: 1996

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. (1)

DOSAGE AND ADMINISTRATION
For intranasal use only.
The recommended dose of PATANASE Nasal Spray in patients 12 years and older is two sprays per nostril twice daily. (2) Priming Information: Prime PATANASE Nasal Spray before initial use and when PATANASE Nasal Spray has not been used for more than 7 days. (2.2)

DOSAGE FORMS AND STRENGTHS
Nasal spray 0.6%: 665 mcg of olopatadine hydrochloride in each 100-microliter spray. (3) Supplied as a 30.5 g bottle containing 240 sprays.

Alcon

CONTRAINDICATIONS
None.

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 (5.1).
  • Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking PATANASE Nasal Spray (5.2).
  • Avoid concurrent use of alcohol or other central nervous system depressants with PATANASE Nasal Spray (5.2)

ADVERSE REACTIONS
The most common adverse reactions (>1%) included bitter taste, headache, epistaxis, pharyngolaryngeal pain, postnasal drip, cough, and urinary tract infection (6.1).

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