Patanase Information
Patanase (Olopatadine) Dosage And Administration
Administer Patanase (Olopatadine) Nasal Spray by the intranasal route only.
Patanase (Olopatadine) Dosage Forms And Strengths
Patanase (Olopatadine) 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.
Patanase (Olopatadine) Contraindications
Patanase (Olopatadine) Warnings And Precautions
Nasal Septal Perforation
Two 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 (Olopatadine) 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 (Olopatadine) Nasal Spray and 2 patients treated with the vehicle nasal spray. In the second safety trial with Patanase (Olopatadine) Nasal Spray, which does not contain povidone, there were no reports of nasal septal perforation [see ].
Before starting Patanase (Olopatadine) 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 (Olopatadine) Nasal Spray if patients develop nasal ulcerations.
Patanase (Olopatadine) Adverse Reactions
Use of Patanase (Olopatadine) Nasal Spray has been associated with epistaxis, nasal ulcerations, and somnolence [see and )].
The safety data described below reflect exposure to Patanase (Olopatadine) Nasal Spray in 2,427 patients with seasonal or perennial allergic rhinitis in 9 controlled clinical trials of 2 weeks to 12 months duration.
The safety data from adults and adolescents are based upon 5 placebo (vehicle nasal spray)-controlled clinical trials in which 1,491 patients with seasonal or perennial allergic rhinitis (513 males and 978 females) 12 years of age and older were treated with Patanase (Olopatadine) Nasal Spray two sprays per nostril twice daily. There were 1,180 patients (Patanase (Olopatadine) Nasal Spray, 587; vehicle nasal spray, 593) that participated in 3 efficacy and safety trials of 2 weeks duration. There were 1,814 patients (Patanase (Olopatadine) Nasal Spray, 904; vehicle nasal spray, 910) that participated in 2 long-term clinical trials of 1 year duration. The racial distribution of adult and adolescent patients receiving Patanase (Olopatadine) Nasal Spray was 76% white, 8% black, 12% Hispanic and 3% other. The incidence of discontinuation due to adverse reactions in these controlled clinical trials was comparable for Patanase (Olopatadine) Nasal Spray and vehicle nasal spray. Overall, 3.9% of the 1,491 adult and adolescent patients across all 5 studies treated with Patanase (Olopatadine) Nasal Spray and 3.2% of the 1,503 patients treated with 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 (Olopatadine) Nasal Spray 1 or 2 sprays per nostril twice daily for 2 weeks. The racial distribution of pediatric patients receiving Patanase (Olopatadine) 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 (Olopatadine) Nasal Spray and vehicle nasal spray.
Overall, 1.4% of the 870 pediatric patients across all 3 studies treated with Patanase (Olopatadine) 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 ].
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
Table 1: Adverse Reactions Occurring at an Incidence of 0.9% or Greater in Controlled Clinical Trials of 2 Weeks Duration with Patanase (Olopatadine) Nasal Spray in Adolescent and Adult Patients 12 Years of Age and Older with Seasonal Allergic Rhinitis
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
Table 2. Adverse Reactions Occurring at an Incidence of Greater than 1.0% in a Controlled Clinical Trial of 2 Weeks Duration with Patanase (Olopatadine) Nasal Spray in Pediatric Patients 6-11 Years of Age With Seasonal Allergic Rhinitis
There were no differences in the incidence of adverse reactions based on gender, race, or ethnicity.
The safety of Patanase (Olopatadine) 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 (Olopatadine) Nasal Spray, 66; vehicle nasal spray. 66) 2 to 5 years of age with allergic rhinitis [see ].
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 (Olopatadine) Nasal Spray 2 sprays per nostril twice daily (445 patients) or vehicle nasal spray (445 patients). In the Patanase (Olopatadine) 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 (Olopatadine) Nasal Spray and 28% in patients treated with vehicle nasal spray. Epistaxis resulted in discontinuation of 0.9% of patients treated with Patanase (Olopatadine) Nasal Spray and 0.2% of patients treated with vehicle nasal spray. Nasal ulcerations occurred in 10% of patients treated with Patanase (Olopatadine) Nasal Spray and 9% of patients treated with vehicle nasal spray. Nasal ulcerations resulted in discontinuation of 0.4% of patients treated with Patanase (Olopatadine) 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 (Olopatadine) Nasal Spray and 1 patient treated with vehicle nasal spray. Weight increase was reported in 6 patients treated with Patanase (Olopatadine) Nasal Spray and 1 patient treated with vehicle nasal spray. Depression or worsening of depression occurred in 9 patients treated with Patanase (Olopatadine) 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 (Olopatadine) 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 (Olopatadine) 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 (Olopatadine) 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 (Olopatadine) Nasal Spray and 12% of patients treated with vehicle nasal spray. Somnolence was reported in 3 patients treated with the investigational formulation of Patanase (Olopatadine) Nasal Spray compared to 1 patient treated with vehicle nasal spray. Fatigue was reported in 5 patients treated with the investigational formulation of Patanase (Olopatadine) Nasal Spray compared to 1 patient treated with vehicle nasal spray.
There were no long-term clinical trials in children below 12 years of age.
Patanase (Olopatadine) Drug Interactions
Formal drug-drug interaction studies were not conducted for Patanase (Olopatadine) 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 ].
Patanase (Olopatadine) 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 (Olopatadine) 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.
The safety and effectiveness of Patanase (Olopatadine) 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 ]. Doses studied included 1 and 2 sprays per nostril twice daily. One of these studies evaluated the safety of Patanase (Olopatadine) Nasal Spray at doses of 1 and 2 sprays per nostril twice daily in 1188 patients, of which, 298 patients were exposed to Patanase (Olopatadine) 1 spray and 297 patients were exposed to vehicle 1 spray. In this study, the incidence of epistaxis with Patanase (Olopatadine) Nasal Spray treatment was 5.7%, compared to 3.2% seen in adult and adolescent studies. This study also evaluated the effectiveness of Patanase (Olopatadine) Nasal Spray in patients 6 through 11 years of age with seasonal allergic rhinitis [see ].
The safety of Patanase (Olopatadine) 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 (Olopatadine) Nasal Spray. The racial distribution of patients receiving Patanase (Olopatadine) 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 (Olopatadine) 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 (
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%).
Patanase (Olopatadine) Overdosage
There have been no reported overdosages with Patanase (Olopatadine) 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 (Olopatadine) 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).
Patanase (Olopatadine) Description
Patanase (Olopatadine) (olopatadine hydrochloride) Nasal Spray, 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of Patanase (Olopatadine) Nasal Spray, is a white, water-soluble crystalline powder. The chemical name for olopatadine hydrochloride is (Z)-11-[3-(dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is CHNO • HCl with the following chemical structure:
Patanase (Olopatadine) Nasal Spray contains 0.6% w/v olopatadine (base) in a nonsterile aqueous solution with pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 microliters of the aqueous solution containing 665 mcg of olopatadine hydrochloride, which is equivalent to 600 mcg of olopatadine (base) [see ]. Patanase (Olopatadine) Nasal Spray also contains benzalkonium chloride (0.01%), dibasic sodium phosphate, edetate disodium, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water.
Patanase (Olopatadine) Clinical Pharmacology
The pharmacokinetic properties of olopatadine were studied after administration by the nasal, oral, intravenous, and topical ocular routes. Olopatadine exhibited linear pharmacokinetics across the routes studied over a large dose range.
Absorption:
Healthy Subjects:
Seasonal Allergic Rhinitis (SAR) Patients:
Distribution:
14
Elimination:
14
Special Population:
Hepatic Impairment:
Renal Impairment:
Gender:
Race:
Pediatric Patients 2 to 5 Years of Age: The systemic pharmacokinetics of olopatadine, olopatadine N-oxide, and N-desmethyl olopatadine were characterized using population pharmacokinetic methods applied to sparse data (approximately 5 samples per patient) obtained from 66 pediatric patients (2 to less than 6 years of age) administered one-half the recommended adult dose (1 spray per nostril) of Patanase (Olopatadine) Nasal Spray twice daily for a minimum of 14 days. The mean C and AUC of olopatadine were 13.4 ± 4.6 ng/mL and 75.0± 26.4 ng*hr/mL respectively. The mean C and AUC of olopatdine N-oxide and N-desmethyl olopatadine were similar to that of patients 6 to 11 years of age.
Drug Interaction Studies
Drug interactions with inhibitors of liver enzymes are not anticipated because olopatadine is eliminated predominantly by renal excretion. Olopatadine did not inhibit the metabolism of specific substrates for CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4. Based on these data, drug interactions involving P450 inhibition are not expected. Due to the modest protein binding of olopatadine (55%), drug interactions through displacement from plasma proteins are also not expected.
Patanase (Olopatadine) Nonclinical Toxicology
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 bacteria reverse mutation test (Ames), an mammalian chromosome aberration assay or an 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).
Reproductive Toxicology Studies
Olopatadine was not teratogenic in rabbits and rats at oral doses of up to 400 or 600 mg/kg/day, respectively (approximately 1,400 and 1,000 times the MRHD for adults on a mg/m2 basis, respectively). However, a decrease in the number of live fetuses was observed in rabbits at the oral olopatadine doses of 25 mg/kg (approximately 88 times the MRHD for adults on a mg/m2 basis) and above, and in rats at oral doses of 60 mg/kg (approximately 100 times the MRHD for adults on a mg/m2 basis) and above. In rats, viability and body weights of pups were reduced on day 4 post partum at the oral doses of 60 mg/kg (approximately 100 times the MRHD for adults on a mg/m2 basis) and above, but no effect on viability was observed at the dose of 20 mg/kg (approximately 35 times the MRHD for adults on a mg/m2 basis).
Patanase (Olopatadine) How Supplied/storage And Handling
Patanase (Olopatadine) 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 (2)], 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 (Olopatadine) Nasal Spray by releasing 5 sprays or until a fine mist appears. After periods of non-use greater than 7 days, re-prime Patanase (Olopatadine) 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)
Patanase (Olopatadine) Patient Counseling Information
See FDA-approved Patient Labeling accompanying the product.
Patients should be informed to avoid spraying Patanase (Olopatadine) Nasal Spray in their eyes.
U.S. Pat. No. 5,116,863
Revised: April 2010
Mfd for:
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Mfd by:
ALCON CUSI, S.A.
08320 El Masnou-Barcelona
Spain
© 2009, 2010 Alcon, Inc.
6-15-332
Patanase (Olopatadine) Patient Information
Read the Patient Information that comes with Patanase (Olopatadine) Nasal Spray carefully before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your health care provider about your medical condition or your treatment.
Patanase (Olopatadine) Nasal Spray is a prescription medicine used to provide relief of seasonal allergy symptoms in adults and children 6 years and older.
Patanase (Olopatadine) Nasal Spray contains an antihistamine medicine that may help reduce nasal symptoms of seasonal allergic rhinitis.
• allergic to any of the ingredients in Patanase (Olopatadine) Nasal Spray. See the end of this leaflet for a complete list of the ingredients in Patanase (Olopatadine) Nasal Spray.
• pregnant or planning to become pregnant. It is not known if Patanase (Olopatadine) Nasal Spray will harm your unborn baby.
• breast-feeding a baby. It is not known if Patanase (Olopatadine) Nasal Spray passes into your breast milk.
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
• Patanase (Olopatadine) Nasal Spray is for use in the nose only.
• Use Patanase (Olopatadine) Nasal Spray exactly as your health care provider tells you. Do not stop taking Patanase (Olopatadine) Nasal Spray without talking to your health care provider.
• This nasal device should be discarded after the labeled number of sprays (240) or after
the expiration date on the medicine label or box.
• Do not use Patanase (Olopatadine) Nasal Spray after the expiration date on the medicine label and box.
Follow the Patient Instructions for Use below.
Side effects of Patanase (Olopatadine) Nasal Spray include:
• bad or bitter taste
• headache
• nosebleeds
• sores in your nose
• hole in the nasal septum
Tell your health care provider if you have any side effect that bothers you or does not go away.
These are not all of the possible side effects of Patanase (Olopatadine) Nasal Spray. For more information, ask your health care provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Avoid the following while using Patanase (Olopatadine) Nasal Spray:
• operating machinery, driving a motor vehicle, or doing other dangerous activities
• using alcohol or other medicines that can also make you sleepy, such as sedatives and tranquilizers
Medicines are sometimes prescribed for conditions that are not mentioned in the patient leaflet. Do not use Patanase (Olopatadine) Nasal Spray for a condition for which it was not prescribed. Do not give Patanase (Olopatadine) Nasal Spray to other people, even if they have the same symptoms you have. It may harm them.
This patient information leaflet summarizes the most important information about Patanase (Olopatadine) Nasal Spray. If you would like more information about Patanase (Olopatadine) Nasal Spray talk with your health care provider. You can ask your health care provider or pharmacist for information about Patanase (Olopatadine) Nasal Spray that is written for health professionals. For more information go to www.Patanase (Olopatadine) .com or call 1-800-757-9195.
Active ingredient: olopatadine hydrochloride 665 micrograms per 100 microliter spray.
Inactive ingredients: 0.01% benzalkonium chloride, sodium phosphate, dibasic, edentate disodium, sodium chloride, hydrochloric acid, sodium hydroxide and water.
"Rhinitis" means inflammation of the lining of the nose. Seasonal allergic rhinitis is sometimes called "hay fever". Seasonal allergic rhinitis can be caused by allergies to pollen. If you have allergic rhinitis, your nose becomes stuffy, runny and itchy. You may also sneeze a lot. You may also have red, itchy, watery eyes and itchy throat, or blocked itchy ears.
PHARMACIST Give to Patient
Patient Instructions for Use
Use Patanase (Olopatadine) ® Nasal Spray exactly how your doctor tells you to. The usual dose of Patanase (Olopatadine) Nasal Spray for people ages 12 and older is two sprays in each nostril, two times each day and for children 6 to 11, one spray in each nostril two times a day.
1. Remove the blue plastic overcap (Figure 1).
2. Hold the bottle and press down on the shoulders of the white nasal applicator with your forefinger and middle finger.
Support the bottom (base) of the bottle with your thumb while you do this (Figure 2). Prime the bottle five (5) times or until you see a fine mist come out of the nasal spray applicator. After you start using a bottle of Patanase (Olopatadine) Nasal Spray, if you do not use it for more than seven (7) days, you will need to prime the pump again two (2) times before use.
3. Gently blow your nose to clear the nostrils. Close one nostril. With your head tipped down (chin toward chest), place the nasal applicator 1/4 to 1/2 inch into a nostril. Hold the medicine bottle upright with the nasal applicator tip aimed toward the cheek side of the nose, away from the center of the nose (Figure 3).
4. Breathe in gently through your nose. While breathing in press firmly and quickly on the applicator to release the spray (Figure 3).
5. Breathe out through your mouth. Do not tip your head back or blow your nose right after using Patanase (Olopatadine) Nasal Spray. This may cause you to get a bitter taste in your mouth.
6. Change between the nostrils (alternate). Spray two sprays in each nostril.
7. Wipe the nasal applicator with a clean tissue and replace the blue plastic overcap. (Figure 4)
8. This nasal device should be discarded after the labeled number of sprays (240) or after the expiration date on the medicine label or box.
9. Do not take extra doses or stop taking Patanase (Olopatadine) Nasal Spray without talking with your doctor.
1. If the nasal applicator becomes clogged, do not attempt to clear it using a pointed object. (Figure 5)
2. To clean the nasal applicator, remove the plastic cap and then gently pull upwards to free the nasal applicator. (Figure 6 & 7)
3. With the nasal applicator pointing downwards, wash by running warm tap water into the nasal applicator for about one minute. (Figure 8)
4. Shake the applicator to remove any water and put the applicator back on the bottle.
5. Prime by spraying two (2) times or until you see a fine mist.
6. Repeat the above steps if needed.
• Store Patanase (Olopatadine) Nasal Spray between 39° to 77°F (4° to 25°C).
• Do not use your Patanase (Olopatadine) Nasal Spray after the expiration date on the label or box.
Keep Patanase (Olopatadine) Nasal Spray and all medicines out of the reach of children.
For more information about Patanase (Olopatadine) Nasal Spray visit www.Patanase (Olopatadine) .com or call 1-800-757-9195.
Mfd. for:
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Mfd. by:
ALCON CUSI, S.A.
08320 El Masnou - Barcelona
Spain
© 2008, 2009 Alcon, Inc.
Revised: December 2009
6-15-323
Patanase (Olopatadine) Principal Display Panel
(olopatadine hydrochloride)
Nasal Spray, 665 mcg
240 Metered Sprays
Net Fill Weight 30.5g
