Olopatadine hydrochloride nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older. Olopatadine hydrochloride nasal spray is an H 1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older ( 1 ).
Contraindications
None. None ( 4 ).
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 ( 5.1 ).
Avoid engaging in hazardous occupations requiring complete mental alertness and coordination, such as driving or operating machinery when taking olopatadine hydrochloride nasal spray ( 5.2 ).
Avoid concurrent use of alcohol or other central nervous system depressants with olopatadine hydrochloride nasal spray ( 5.2 ).
5.1Local 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 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 spray and 2 patients treated with the vehicle nasal spray. In the second safety trial with olopatadine hydrochloride 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 ( 6.1 ) ].
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Before starting olopatadine hydrochloride 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 spray if patients develop nasal ulcerations.
5.2Somnolence and Impaired Mental Alertness
In clinical trials, the occurrence of somnolence has been reported in some patients taking olopatadine hydrochloride nasal spray [ see Adverse Reactions 6.1 ]. 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 spray. Concurrent use of olopatadine hydrochloride 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.
Interactions
Formal drug-drug interaction studies were not conducted for olopatadine hydrochloride 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 ( 12.3 ) ].
Pregnancy and breastfeeding
8.1Pregnancy Risk Summary
Published data from postmarketing experience with antihistamines, with similar mechanism of action to olopatadine hydrochloride nasal spray, have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, there are no published human data specific to olopatadine hydrochloride nasal spray. In animal reproductive studies, oral administration of olopatadine hydrochloride to pregnant rats and rabbits caused a decrease in the number of live fetuses at maternal doses approximately 110 and 1460 times the maximum recommended human daily intranasal dose (MRHDID) on a mg/m 2 basis, respectively (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively. Data Animal Data In an oral embryo-fetal development study, pregnant rabbits were dosed throughout the period of organogenesis at doses up to 400 mg/kg/day.
A decrease in the number of live fetuses was observed at 400 mg/kg/day (1460 times the MRHDID, on a mg/m 2 basis). In an oral embryo-fetal development study, pregnant rats were dosed throughout the period of organogenesis at doses up to 600 mg/kg/day. Maternal toxicity, producing death and reduced maternal body weight gain was observed at 600 mg/kg/day (approximately 1100 times the MRHDID on a mg/m 2 basis). Olopatadine produced cleft palate at 60 mg/kg/day (approximately 110 times the MRHDID on a mg/m 2 basis) and decreased embryo-fetal viability and reduced fetal weight in rats at 600 mg/kg/day (approximately 1100 times the MRHDID on a mg/m 2 basis).
In peri-/postnatal toxicity studies, pregnant rats received oral doses of olopatadine up to 600 mg/kg/day during late gestation and throughout the lactation period. Olopatadine produced decreased neonatal survival at 60 mg/kg/day (approximately 110 times the MRHDID on a mg/m 2 basis) and reduced body weight gain in pups at 4 mg/kg/day (approximately 7 times the MRHDID on a mg/m 2 basis). These effects appeared attributable to exposure of pups via the milk as demonstrated in a cross-fostered study in which pups of untreated dams cross-fostered to dams treated with 60 mg/kg/day olopatadine orally during the lactation period exhibited decreased body weight gain.
Adverse reactions
The most clinically significant adverse reactions described in other sections of labeling include:
Epistaxis, Nasal Ulceration, and Nasal Septal Perforation [ see Warnings and Precautions ( 5.1 ) ]
Somnolence and Impaired Mental Alertness [ see Warnings and Precautions ( 5.2 ) ] The most common (>1%) adverse reactions, included bitter taste, headache, epistaxis, pharyngolaryngeal pain, post-nasal drip, cough, and urinary tract infection in patients 12 years of age and older and epistaxis, headache, upper respiratory tract infection, bitter taste, pyrexia, and rash in patients 6 to 11 years of age ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience
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. The safety data described below reflect exposure to olopatadine hydrochloride nasal spray in 2770 patients with seasonal or perennial allergic rhinitis in 10 controlled clinical trials of 2 weeks to 12 months duration.
Olopatadine hydrochloride nasal spray is not indicated for use in patients with perennial allergic rhinitis. The safety data from adults and adolescents are based upon 6 placebo-controlled clinical trials (3.7 pH vehicle nasal spray or 7.0 pH vehicle nasal spray) in which 1834 patients with seasonal or perennial allergic rhinitis (652 males and 1182 females) 12 years of age and older were treated with olopatadine hydrochloride nasal spray two sprays per nostril twice daily.
There were 1180 patients (olopatadine hydrochloride nasal spray, 587; vehicle nasal spray, 593) that participated in 3 efficacy and safety trials of 2 weeks duration. There were 2840 patients (olopatadine hydrochloride nasal spray, 1247; 3.7 pH vehicle nasal spray, 1251; 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 olopatadine hydrochloride 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 olopatadine hydrochloride nasal spray and vehicle nasal spray. Overall, 4.7% of the 1834 adult and adolescent patients across all 6 studies treated with olopatadine hydrochloride nasal spray, 3.5% of the 1844 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 to 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 olopatadine hydrochloride nasal spray one or two sprays per nostril twice daily for 2 weeks. The racial distribution of pediatric patients receiving olopatadine hydrochloride 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 olopatadine hydrochloride nasal spray and vehicle nasal spray. Overall, 1.4% of the 870 pediatric patients across all 3 studies treated with olopatadine hydrochloride nasal spray and 1.3% of the 872 pediatric patients treated with vehicle nasal spray discontinued due to adverse reactions. Adults and Adolescents 12 Years of Age and Older in Short-Term (2-week) Trials There were 1180 patients 12 years of age and older (olopatadine hydrochloride 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 olopatadine hydrochloride nasal spray) that occurred more frequently in patients treated with olopatadine hydrochloride 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 Olopatadine Hydrochloride 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 Olopatadine Hydrochloride 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 1742 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 olopatadine hydrochloride nasal spray.
One study evaluated the safety of olopatadine hydrochloride nasal spray at doses of one and two sprays per nostril twice daily in 1188 patients, in which 298 were exposed to olopatadine hydrochloride nasal spray 1 spray, 296 were exposed to olopatadine hydrochloride nasal spray 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 to 11 years of age treated with olopatadine hydrochloride nasal spray one spray per nostril) that occurred more frequently with olopatadine hydrochloride 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 Olopatadine Hydrochloride Nasal Spray in Pediatric Patients 6 to 11 Years of Age With Seasonal Allergic Rhinitis Adverse Reaction Pediatric Patients 6 to 11 Years of Age Olopatadine Hydrochloride Nasal Spray One Spray per Nostril N = 298 Vehicle Nasal Spray One Spray per Nostril N = 297 Epistaxis Headache Upper respiratory tract infection Bitter taste 17 (5.7%) 13 (4.4%) 8 (2.6%) 3 (1.0%) 11 (3.7%) 11 (3.7%) 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.
Long-Term (12 month) Safety Trials In a 12-month, placebo-controlled, safety trial (vehicle nasal spray), 890 patients 12 years of age and older with perennial allergic rhinitis were randomized to treatment with olopatadine hydrochloride nasal spray two sprays per nostril twice daily (445 patients) or vehicle nasal spray (445 patients). In the olopatadine hydrochloride nasal spray 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 reaction. The most frequently reported adverse reaction was epistaxis, which occurred in 25% of patients treated with olopatadine hydrochloride nasal spray and 28% in patients treated with vehicle nasal spray. Epistaxis resulted in discontinuation of 0.9% of patients treated with olopatadine hydrochloride nasal spray and 0.2% of patients treated with vehicle nasal spray.
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Composition
Active ingredients
OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
