Olopatadine - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS • Epistaxis, Nasal Ulceration, and Nasal Septal Perforation : Monitor patients periodically for signs of adverse effects on the nasal mucosa.

Discontinue if ulcerations or perforations occur.

Avoid use in patients with nasal disease other than allergic rhinitis . • Avoid engaging in hazardous occupations requiring complete mental alertness and coordination, such as driving or operating machinery when taking olopatadine hydrochloride nasal solution (nasal spray) . • Avoid concurrent use of alcohol or other central nervous system depressants with olopatadine hydrochloride nasal solution (nasal spray) .

5.1 Local Nasal Effects Epistaxis and Nasal Ulceration In placebo-controlled clinical trials (vehicle nasal spray) of 2 weeks to 12 months duration, epistaxis and nasal ulcerations were reported [ see Adverse Reactions 6.1 ].

Nasal Septal Perforation Three placebo-controlled long term (12 months) safety trials (vehicle nasal spray) were conducted.

In the first safety trial, patients were treated with an investigational formulation of olopatadine hydrochloride nasal solution (nasal spray) containing povidone (not the commercially marketed formulation) or a vehicle nasal spray containing povidone.

Nasal septal perforations were reported in one patient treated with the investigational formulation of olopatadine hydrochloride nasal solution (nasal spray) and 2 patients treated with the vehicle nasal spray.

In the second safety trial with olopatadine hydrochloride nasal solution (nasal spray), which does not contain povidone, there were no reports of nasal septal perforation.

In the third safety trial, one patient exposed to the 3.7 pH vehicle nasal spray (containing no povidone) reported a nasal septal perforation [ see Adverse Reactions ].

Before starting olopatadine hydrochloride nasal solution (nasal spray), conduct a nasal examination to ensure that patients are free of nasal disease other than allergic rhinitis.

Perform nasal examinations periodically for signs of adverse effects on the nasal mucosa and consider stopping olopatadine hydrochloride nasal solution (nasal spray) if patients develop nasal ulcerations.

5.2 Somnolence and Impaired Mental Alertness In clinical trials, the occurrence of somnolence has been reported in some patients taking olopatadine hydrochloride nasal solution (nasal spray) [ see Adverse Reactions ].

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 olopatadine hydrochloride nasal solution (nasal spray).

Concurrent use of olopatadine hydrochloride nasal solution (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.