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Patanase Nasal Spray

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Patanase Nasal Spray

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Local Nasal Effects

Epistaxis and Nasal Ulceration

In placebo (vehicle nasal spray)-controlled clinical trials of 2 weeks to 12 months duration, epistaxis and nasal ulcerations were reported [see ADVERSE REACTIONS].

Nasal Septal Perforation

Three placebo (vehicle nasal spray)-controlled long term (12 months) safety trials were conducted. In the first 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 the second safety trial with PATANASE 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 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]. 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.

Patient Counseling Information

See FDA-approved Patient Labeling accompanying the product.

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. [see WARNINGS AND PRECAUTIONS] Other common adverse reactions reported with use of PATANASE Nasal Spray include bitter taste, headache, and pharyngolaryngeal pain, [see ADVERSE REACTIONS].

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 [see WARNINGS AND PRECAUTIONS].

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 [see WARNINGS AND PRECAUTIONS].

Keep Spray Out of Eyes

Patients should be informed to avoid spraying PATANASE Nasal Spray in their eyes.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Olopatadine administered orally was not carcinogenic in mice and rats at doses of up to 500 mg/kg/day and 200 mg/kg/day, respectively (approximately 420 and 340 times the MRHD for adults and adolescents ≥ 12 years of age and 500 and 400 times the MRHD for children 6-11 years of age by intranasal administration on a mg/m² basis, respectively).

There was no evidence of genotoxicity when olopatadine was tested in an in vitro bacteria reverse mutation test (Ames), an in vitro mammalian chromosome aberration assay or an in vivo mouse micronucleus test.

Olopatadine administered orally to male and female rats at dose of 400 mg/kg/day, (approximately 680 times the MRHD for adults on a mg/m² basis) resulted in a decrease in the fertility index and reduced implantation rate. No effects on fertility were observed at dose of 50 mg/kg/day (approximately 85 times the MRHD for adults on a mg/m² basis).

Use In Specific Populations

Pregnancy

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.

Nursing Mothers

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.

Pediatric Use

The safety and effectiveness of PATANASE Nasal Spray has not been established for patients under 6 years of age. The safety of olopatadine nasal spray was evaluated in 3 vehicle-controlled 2-week studies in 870 patients 6 to 11 years of age [see ADVERSE REACTIONS]. Doses studied included 1 and 2 sprays per nostril twice daily. One of these studies evaluated the safety of PATANASE Nasal Spray at doses of 1 and 2 sprays per nostril twice daily in 1188 patients, of which, 298 patients were exposed to PATANASE 1 spray and 297 patients were exposed to vehicle 1 spray. In this study, the incidence of epistaxis with PATANASE treatment was 5.7%, compared to 3.2% seen in adult and adolescent studies. This study also evaluated the effectiveness of PATANASE Nasal Spray in patients 6 through 11 years of age with seasonal allergic rhinitis [see Clinical Studies].

The safety of PATANASE Nasal Spray at a dose of 1 spray per nostril twice daily was evaluated in one 2week vehicle-controlled study in 132 children ages 2 to 5 years of age with allergic rhinitis. In this trial, 66 patients ( 28 females and 38 males) were exposed to PATANASE Nasal Spray. The racial distribution of patients receiving PATANASE Nasal Spray was 66.7% white, 27.3% black, and 6.4% other. Two patients exposed to vehicle nasal spray discontinued due to an adverse reaction (1 patient with pneumonia and 1 patient with rhinitis) compared to no patients exposed to PATANASE Nasal Spray. The most common (greater than 1.0%) adverse events reported were diarrhea (9.1%), epistaxis (6.1%), rhinorrhea (4.5%), bitter taste (3.0%) and wheezing (3.0%). Diarrhea was reported less frequently ( < 1%) in the 6 to 11 year old age group.

The incidence of epistaxis was higher in the pediatric population (5.7% in 6 -11 year old patients and 6.1% in 2-5 year old patients) compared to the adult and adolescent population (3.2%).

Geriatric Use

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.

Last reviewed on RxList: 3/5/2012
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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