WARNINGS AND PRECAUTIONS
Local Nasal Effects
Epistaxis and Nasal Ulceration: In placebo (vehicle nasal spray)-controlled clinical trials of 2 weeks to 6 months duration, epistaxis and nasal ulcerations were reported [ see Adverse Reactions ( 6 )].
Nasal Septal Perforation:
Two placebo (vehicle nasal spray)-controlled long term (6 and 12 months) safety trials were conducted. In the 12-month safety trial, patients were treated with an investigational formulation of PATANASE 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 PATANASE Nasal Spray and 2 patients treated with the vehicle nasal spray. In a 6-month trial with PATANASE Nasal Spray, which does not contain povidone, there were no reports of nasal septal perforation [ see Adverse Reactions ( 6 )].
Before starting PATANASE 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 PATANASE Nasal Spray if patients develop nasal ulcerations.
Activities Requiring Mental Alertness
In clinical trials, the occurrence of somnolence has been reported in some patients taking PATANASE Nasal Spray [ see Adverse Reactions (6) ]. 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 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.
USE IN SPECIFIC POPULATIONS
Pregnancy Category C:
No adequate and well-controlled studies in pregnant women have been conducted. Animal reproductive studies in rats and rabbits revealed treatment-related effects on fetuses or pups. Because animal studies are not always predictive of human responses, PATANASE Nasal Spray should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
A decrease in the number of live fetuses was observed in rabbits and rats at the oral olopatadine doses approximately 88 times and 100 times the maximum recommended human dose (MRHD) and above, respectively, for adults on a mg/m2 basis. In rats, viability and body weights of pups were reduced on day 4 post partum at the oral dose approximately 100 times the MRHD for adults on a mg/m2 basis, but no effect on viability was observed at the dose approximately 35 times the MRHD for adults on a mg/m2 basis.
Olopatadine has been identified in the milk of nursing rats following oral administration. It is not known whether topical nasal administration could result in sufficient systemic absorption to produce detectable quantities in human breast milk. PATANASE Nasal Spray should be used by nursing mothers only if the potential benefit to the patient outweighs the potential risks to the infant.
Safety and effectiveness in pediatric patients below the age of 12 years have not yet been established.
Clinical studies of PATANASE Nasal Spray did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.