Patanase: Indications, Dosage, Precautions, Adverse Effects
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Patanase - Product Information

Manufacture: Alcon
Country: United States
Condition: Allergic Rhinitis
Class: Nasal antihistamines and decongestants
Form: Spray
Ingredients: Olopatadine hydrochloride, Benzalkonium chloride, Dibasic sodium phosphate, Sodium chloride, Edetate disodium, Sodium hydroxide and/or Hydrochloric acid and Purified water.

Indications and Usage

Patanase Nasal Spray is an H1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older.

Dosage and Administration

Administer Patanase Nasal Spray by the intranasal route only.

Adults and Adolescents 12 Years of Age and Older

The recommended dosage is two sprays per nostril twice daily.

Children 6 to 11 Years of Age

The recommended dosage is one spray per nostril twice daily.

Administration Information

Priming: Before initial use, prime Patanase Nasal Spray by releasing 5 sprays or until a fine mist appears. When Patanase Nasal Spray has not been used for more than 7 days, re-prime by releasing 2 sprays. Avoid spraying Patanase Nasal Spray into the eyes.

Dosage Forms and Strengths

Patanase Nasal Spray is a nasal spray solution supplied in a white plastic bottle with a metered-dose manual spray pump, a white nasal applicator, and a blue overcap. Each spray (100 microliters) delivers 665 mcg of olopatadine hydrochloride.

Contraindications

None.

Warnings and 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 (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.

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]
  • Somnolence [see Warnings and Precautions]

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
 Adult and Adolescent Patients 12 Years and Older
Adverse ReactionPatanase Nasal Spray
N = 587
Vehicle Nasal Spray
N = 593
Bitter taste75 (12.8%)5 (0.8%)
Headache26 (4.4%)24 (4.0%)
Epistaxis19 (3.2%)10 (1.7%)
Pharyngolaryngeal Pain13 (2.2%)8 (1.3%)
Post-nasal drip9 (1.5%)5 (0.8%)
Cough8 (1.4%)3 (0.5%)
Urinary tract infection7 (1.2%)3 (0.5%)
CPK elevation5 (0.9%)2 (0.3%)
Dry mouth5 (0.9%)1 (0.2%)
Fatigue5 (0.9%)4 (0.7%)
Influenza5 (0.9%)1 (0.2%)
Nasopharyngitis5 (0.9%)4 (0.7%)
Somnolence5 (0.9%)2 (0.3%)
Throat irritation5 (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
Pediatric Patients 6 to 11 Years of Age
Adverse ReactionPatanase Nasal Spray 1 spray per nostril
N = 297
Vehicle Nasal Spray 1 spray per nostril
N = 298
Epistaxis17 (5.7%)11 (3.7%)
Headache13 (4.4%)11 (3.7%)
Upper respiratory tract infection8 (2.6%)0
Pyrexia3 (1.0%)0
Bitter taste4 (1.3%)3 (1.0%)
Rash4 (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.

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.

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 (6.1)]. 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 Nasal Spray 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.

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 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.

Overdosage

There have been no reported overdosages with Patanase Nasal Spray.

Acute overdosage with this dosage form is unlikely due to the configuration of the primary container closure system. However, symptoms of antihistamine overdose may include drowsiness in adults and, initially, agitation and restlessness, followed by drowsiness in children. There is no known specific antidote to Patanase Nasal Spray. Should overdose occur, symptomatic or supportive treatment is recommended, taking into account any concomitantly ingested medications.

No mortality was observed in rats at an intranasal dose of 3.6 mg/kg (approximately 6 times the MRHD for adults and adolescents ≥12 years of age and 7 times the MRHD for children 6- 11 years of age on a mg/m2 basis), or in dogs at an oral dose of 5 g/kg (approximately 28,000 times the MRHD for adults and adolescents ≥12 years of age and 33,000 the MRHD for children 6-11 years of age on a mg/m2 basis). The oral median lethal dose (MLD) in mice and rats were 1,490 mg/kg and 3,870 mg/kg respectively (approximately 1,200 times and 6,500 times the MRHD for adults and adolescents ≥12 years of age and 1,500 times and 7,700 times the MRHD for children 6-11 years of age, on a mg/m2 basis, respectively).

For additional information about overdose treatment, call a poison control center (1-800-222-1222).

How Supplied/Storage and Handling

How Supplied

Patanase Nasal Spray, 665 mcg is supplied in a white plastic bottle with a metered-dose manual spray pump, a white nasal applicator and a blue overcap in a box of 1 (NDC 0065-0332-30). Each trade size bottle contains 30.5 g of clear, colorless liquid and will provide 240 metered sprays. After priming [see Dosage and Administration], each spray delivers a fine mist containing 665 mcg of olopatadine hydrochloride in 100 microliters of formulation through the nozzle.

Before initial use, prime Patanase Nasal Spray by releasing 5 sprays or until a fine mist appears. After periods of non-use greater than 7 days, re-prime Patanase Nasal Spray by releasing 2 sprays. The correct amount of medication cannot be assured before the initial priming and after 240 sprays have been used, even though the bottle is not completely empty. The nasal device should be discarded after 240 sprays (enough for 30 days of dosing) have been used.

Net content 30.5 g, 240 sprays: NDC 0065-0332-30 (trade size)

Storage

Store at 4° to 25° C (39° to 77° F). Rx Only.

Patient Counseling Information

See FDA-approved Patient Labeling accompanying the product.

Local Nasal Effects and Other Common Adverse Reactions

Inform patients 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. Caution patients 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

Advise patients that 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 (5.2)].

Keep Spray Out of Eyes

Inform patients to avoid spraying Patanase Nasal Spray in their eyes.

U.S. Pat.: www.alconpatents.com

Distributed by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

2009, 2012, 2015 Novartis

Alcon

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