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Patanase Nasal Spray

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Patanase Nasal Spray

Side Effects
Interactions

SIDE EFFECTS

The most clinically significant adverse reactions described in other sections of labeling include;

Clinical Trials Experience

The safety data described below reflect exposure to PATANASE Nasal Spray in 2,770 patients with seasonal or perennial allergic rhinitis in 10 controlled clinical trials of 2 weeks to 12 months duration.

The safety data from adults and adolescents are based upon 6 placebo (3.7 pH vehicle nasal spray or 7.0 pH vehicle nasal spray)-controlled clinical trials in which 1,834 patients with seasonal or perennial allergic rhinitis (652 males and 1,182 females) 12 years of age and older were treated with PATANASE Nasal Spray two sprays per nostril twice daily. There were 1,180 patients (PATANASE Nasal Spray, 587; vehicle nasal spray, 593) that participated in 3 efficacy and safety trials of 2 weeks duration. There were 2,840 patients (PATANASE Nasal Spray, 1,247; 3.7 pH vehicle nasal spray, 1,251; 7.0 pH vehicle nasal spray, 342) that participated in 3 long-term clinical trials of 1 year duration. The racial distribution of adult and adolescent patients receiving PATANASE Nasal Spray was 77% white, 9% black, and 14% other. The incidence of discontinuation due to adverse reactions in these controlled clinical trials was comparable for PATANASE Nasal Spray and vehicle nasal spray. Overall, 4.7% of the 1,834 adult and adolescent patients across all 6 studies treated with PATANASE Nasal Spray, 3.5% of the 1,844 patients treated with 3.7 pH vehicle nasal spray discontinued due to adverse reactions, and 2.9% of the 342 patients treated with 7.0 pH vehicle nasal spray discontinued due to adverse reactions.

The safety data from pediatric patients 6-11 years of age are based upon 3 clinical trials in which 870 children with seasonal allergic rhinitis (376 females and 494 males) were treated with PATANASE Nasal Spray 1 or 2 sprays per nostril twice daily for 2 weeks. The racial distribution of pediatric patients receiving PATANASE Nasal Spray was 68.6% white, 16.6% black, and 14.8% other. The incidence of discontinuation due to adverse reactions in these controlled clinical trials was comparable for PATANASE Nasal Spray and vehicle nasal spray. Overall, 1.4% of the 870 pediatric patients across all 3 studies treated with PATANASE Nasal Spray and 1.3% of the 872 pediatric patients treated with vehicle nasal spray discontinued due to adverse reactions.

Safety information for pediatric patients 2 to 5 years of age is obtained from one vehicle-controlled study of 2 weeks duration [See Pediatric Use].

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults and Adolescents 12 Years of Age and Older in Short-Term (2-week) Trials

There were 1,180 patients 12 years of age and older (PATANASE Nasal Spray, 587; vehicle nasal spray, 593) that participated in 3 efficacy and safety trials of 2 weeks duration. Table 1 presents the most common adverse reactions (0.9% or greater in patients treated with PATANASE Nasal Spray) that occurred more frequently in patients treated with PATANASE Nasal Spray compared with vehicle nasal spray in the 3 clinical trials of 2 weeks duration.

Table 1: Adverse Reactions Occurring at an Incidence of 0.9% or Greater in Controlled Clinical Trials of 2 Weeks Duration with PATANASE Nasal Spray in Adolescent and Adult Patients 12 Years of Age and Older with Seasonal Allergic Rhinitis

Adverse Reaction Adult and Adolescent Patients 12 Years and Older
PATANASE Nasal Spray
N = 587
Vehicle Nasal Spray
N = 593
Bitter taste 75 (12.8%) 5 (0.8%)
Headache 26 (4.4%) 24 (4.0%)
Epistaxis 19 (3.2%) 10 (1.7%)
Pharyngolaryngeal Pain 13 (2.2%) 8 (1.3%)
Post-nasal drip 9 (1.5%) 5 (0.8%)
Cough 8 (1.4%) 3 (0.5%)
Urinary tract infection 7 (1.2%) 3 (0.5%)
CPK elevation 5 (0.9%) 2 (0.3%)
Dry mouth 5 (0.9%) 1 (0.2%)
Fatigue 5 (0.9%) 4 (0.7%)
Influenza 5 (0.9%) 1 (0.2%)
Nasopharyngitis 5 (0.9%) 4 (0.7%)
Somnolence 5 (0.9%) 2 (0.3%)
Throat irritation 5 (0.9%) 0 (0.0%)

There were no differences in the incidence of adverse reactions based on gender or race. Clinical trials did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger subjects.

Pediatric Patients 6 to 11 Years of Age

There were 1,742 pediatric patients 6 to 11 years of age (Olopatadine nasal spray, 870; vehicle nasal spray, 872) with seasonal allergic rhinitis that participated in 3 clinical trials of 2 weeks duration. Two of the studies used the investigational formulation of olopatadine nasal spray, and one of the studies used PATANASE Nasal Spray. One study evaluated the safety of PATANASE Nasal Spray at doses of 1 and 2 sprays per nostril twice daily in 1188 patients, in which 298 were exposed to PATANASE 1 spray, 296 were exposed to PATANASE 2 sprays, 297 were exposed to vehicle 1 spray, and 297 were exposed to vehicle 2 sprays twice daily for 2 weeks. Table 2 presents the most common adverse reactions (greater than 1.0% in pediatric patients 6-11 years of age treated with PATANASE Nasal Spray 1 spray/nostril) that occurred more frequently with PATANASE Nasal Spray compared with vehicle nasal spray.

Table 2: Adverse Reactions Occurring at an Incidence of Greater than 1.0% in a Controlled Clinical Trial of 2 Weeks Duration with PATANASE Nasal Spray in Pediatric Patients 6-11 Years of Age With Seasonal Allergic Rhinitis

Adverse Reaction Pediatric Patients 6 to 11 Years of Age
PATANASE Nasal Spray 1 spray per nostril
N = 298
Vehicle Nasal Spray 1 spray per nostril
N = 297
Epistaxis 17 (5.7%) 11 (3.7%)
Headache 13 (4.4%) 11 (3.7%)
Upper respiratory tract infection 8 (2.6%) 0
Bitter taste 3 (1.0%) 0
Pyrexia 4 (1.3%) 3 (1.0%)
Rash 4 (1.3%) 0

There were no differences in the incidence of adverse reactions based on gender, race, or ethnicity.

Pediatric Patients 2 to 5 Years of Age

The safety of PATANASE Nasal Spray at a dose of 1 spray per nostril twice daily was evaluated in one 2-week vehicle-controlled study in 132 patients (PATANASE Nasal Spray, 66; vehicle nasal spray. 66) 2 to 5 years of age with allergic rhinitis [see Pediatric Use].

Long-Term (12-month) Safety Trials

In a 12-month, placebo (vehicle nasal spray)-controlled, safety trial, 890 patients 12 years of age and older with perennial allergic rhinitis were randomized to treatment with PATANASE Nasal Spray 2 sprays per nostril twice daily (445 patients) or vehicle nasal spray (445 patients). ). In the PATANASE and vehicle nasal spray groups, 72% and 74% of patients, respectively, completed the trial. Overall, 7% and 5%, respectively, discontinued study participation due to an adverse event. The most frequently reported adverse reaction was epistaxis, which occurred in 25% of patients treated with PATANASE Nasal Spray and 28% in patients treated with vehicle nasal spray. Epistaxis resulted in discontinuation of 0.9% of patients treated with PATANASE Nasal Spray and 0.2% of patients treated with vehicle nasal spray. Nasal ulcerations occurred in 10% of patients treated with PATANASE Nasal Spray and 9% of patients treated with vehicle nasal spray. Nasal ulcerations resulted in discontinuation of 0.4% of patients treated with PATANASE Nasal Spray and 0.2% patients treated with vehicle nasal spray. There were no patients with nasal septal perforation in either treatment group. Somnolence was reported in 1 patient treated with PATANASE Nasal Spray and 1 patient treated with vehicle nasal spray. Weight increase was reported in 6 patients treated with PATANASE Nasal Spray and 1 patient treated with vehicle nasal spray. Depression or worsening of depression occurred in 9 patients treated with PATANASE Nasal Spray and in 5 patients treated with vehicle nasal spray. Three patients, two of whom had pre-existing histories of depression, who received PATANASE Nasal Spray were hospitalized for depression compared to none who received vehicle nasal spray.

In a second 12-month, placebo (vehicle nasal spray)-controlled, safety trial, 459 patients 12 years of age and older with perennial allergic rhinitis were treated with 2 sprays per nostril of an investigational formulation of PATANASE Nasal Spray containing povidone (not the commercially marketed formulation) and 465 patients were treated with 2 sprays of 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. Epistaxis was reported in 19% of patients treated with the investigational formulation of PATANASE Nasal Spray and 12% of patients treated with vehicle nasal spray. Somnolence was reported in 3 patients treated with the investigational formulation of PATANASE Nasal Spray compared to 1 patient treated with vehicle nasal spray. Fatigue was reported in 5 patients treated with the investigational formulation of PATANASE Nasal Spray compared to 1 patient treated with vehicle nasal spray.

In a third 3-arm 12-month, placebo (vehicle nasal spray)-controlled, safety trial conducted post approval, 1,026 patients 12 years of age and older with perennial allergic rhinitis were randomized to treatment with PATANASE Nasal Spray (343 patients), a 3.7 pH vehicle nasal spray (341 patients), or a 7.0 pH vehicle nasal spray (342 patients). All treatments were administered as 2 sprays per nostril, twice daily. Overall, 5% of PATANASE Nasal Spray patients, 2% of 3.7 pH vehicle patients and 3% of 7.0 pH vehicle patients discontinued due to adverse events. The most frequently reported adverse event was epistaxis, which occurred in 24% of patients treated with PATANASE Nasal Spray, 20% of patients treated with 3.7 pH vehicle nasal spray, and 23% of patients treated with 7.0 pH vehicle nasal spray. Epistaxis resulted in the discontinuation of 2 patients treated with PATANASE Nasal Spray and 1 patient treated with 7.0 pH vehicle nasal spray. Nasal septal perforation was reported for one patient treated with the 3.7 pH vehicle nasal spray. Nasal ulcerations occurred in 9% of patients treated with PATANASE Nasal Spray, 8% of patients treated with 3.7 pH vehicle nasal spray, and 9% of patients treated with 7.0 pH vehicle nasal spray. Nasal ulceration resulted in the discontinuation of 1 patient treated with PATANASE Nasal Spray. Hyposmia and anosmia were each reported by one patient treated with PATANASE Nasal Spray. Neither somnolence nor weight loss was reported. Depression occurred in 3 patients treated with PATANASE Nasal Spray, 2 patients treated with 3.7 pH vehicle nasal spray, and 3 patients treated with 7.0 pH vehicle nasal spray.

There were no long-term clinical trials in children below 12 years of age.

Post-Marketing Experience

During the post approval use of PATANASE Nasal Spray, the following adverse reactions have been identified. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions reported include dizziness, dysgeusia, epistaxis, headache, nasal discomfort, oropharyngeal pain, and somnolence. Additionally, hyposmia and anosmia have been reported with the use of PATANASE Nasal Spray.

Read the Patanase Nasal Spray (olopatadine hydrochloride nasal spray) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Formal drug-drug interaction studies were not conducted for PATANASE Nasal Spray. Drug interactions with inhibitors of liver enzymes are not anticipated because olopatadine is eliminated predominantly by renal excretion. Drug interactions involving P450 inhibition and plasma protein binding are also not expected. [See CLINICAL PHARMACOLOGY].

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

Side Effects
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