{"id":"fluticasone","rwe":[],"_fda":{"id":"49fdba31-142a-2157-e063-6294a90a01f3","set_id":"0107ad1c-1d8e-434c-a91f-dd2caf4fa5e5","openfda":{"upc":["0372888248011"],"unii":["O2GMZ0LF5W"],"route":["NASAL"],"rxcui":["1797907"],"spl_id":["49fdba31-142a-2157-e063-6294a90a01f3"],"brand_name":["Fluticasone Propionate"],"spl_set_id":["0107ad1c-1d8e-434c-a91f-dd2caf4fa5e5"],"package_ndc":["72888-248-01"],"product_ndc":["72888-248"],"generic_name":["FLUTICASONE PROPIONATE NASAL"],"product_type":["HUMAN OTC DRUG"],"substance_name":["FLUTICASONE PROPIONATE"],"manufacturer_name":["Advagen Pharma Ltd."],"application_number":["ANDA219060"],"is_original_packager":[true]},"purpose":["Purpose Allergy symptom reliever"],"version":"2","warnings":["Warnings Only for use in the nose. Do not spray into your eyes or mouth."],"questions":["Questions or comments? call toll-free 866-488-0312 Distributed by: Advagen Pharma Ltd., East Windsor, NJ 08520 Made in Italy Rev. 02, 01/2025"],"ask_doctor":["Ask a doctor before use if you have or had glaucoma or cataracts Ask a doctor or pharmacist before use if you are taking medicine for HIV infection (such as ritonavir) a steroid medicine for asthma, allergies or skin rash ketoconazole pills (medicine for fungal infection) When using this product the growth rate of some children may be slower stinging or sneezing may occur for a few seconds right after use do not share this bottle with anyone else as this may spread germs remember to tell your doctor about all the medicines you take, including this one Stop use and ask a doctor if you have, or come into contact with someone who has, chicken pox, measles or tuberculosis your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection. you get a constant whistling sound from your nose. This may be a sign of damage inside your nose. you get an allergic reaction to this product. Seek medical help right away. you get new changes to your vision that develop after starting this product you have severe or frequent nosebleeds If pregnant or breast –feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"do_not_use":["Do not use in children under 4 years of age to treat asthma if you have an injury or surgery to your nose that is not fully healed if you have ever had an allergic reaction to this product or any of the ingredients"],"effective_time":"20260204","active_ingredient":["Active Ingredient (in each spray) Fluticasone propionate (glucocorticold) 50 mcg"],"inactive_ingredient":["Inactive ingredients benzalkonium chloride, dextrose, microcrystalline cellulose, phenylethyl alcohol, polysorbate 80, purified water, sodium carboxymethylcellulose"],"indications_and_usage":["Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion itchy, watery eyes itchy nose runny nose sneezing"],"spl_unclassified_section":["FLUTICASONE PROPIONATE NASAL SPRAY, USP QUESTIONS & ANSWERS WHAT FLUTICASONE PROPIONATE NASAL SPRAY , USP IS, HOW TO USE IT, AND WHAT TO EXPECT UNDERSTANDING FLUTICASONE PROPIONATE NASAL SPRAY, USP What Fluticasone Propionate Nasal Spray, USP is, and how it works. What is Fluticasone Propionate Nasal Spray, USP? Fluticasone Propionate Nasal Spray, USP is an effective allergy medicine that you can buy without a prescription. It works directly in the nose to help block your allergic reactions. Fluticasone Propionate Nasal Spray, USP relieves allergy symptoms caused by pollen, mold, dust and pets. What is the active ingredient in Fluticasone Propionate Nasal Spray, USP? The active ingredient in Fluticasone Propionate Nasal Spray, USP is called fluticasone propionate. Fluticasone propionate is a glucocorticoid – a substance produced naturally by your body to help fight inflammation. It works in your nose to relieve your allergy symptoms. Barely any of it travels through your body. It’s been prescribed by doctors for over 20 years, and used effectively by millions. A glucocorticoid is a kind of steroid that is different from the anabolic (muscle-building) steroids sometimes misused by athletes. In fact, world class athletes are allowed to use glucocorticoids during competition to treat their allergies. Who should not use Fluticasone Propionate Nasal Spray, USP? For complete guidance, check the Drug Facts label on the back of the Fluticasone Propionate Nasal Spray, USP package. Can I use Fluticasone Propionate Nasal Spray, USP for asthma? No, Fluticasone Propionate Nasal Spray, USP is not a treatment for asthma. Ask your doctor what medicine to take for your asthma. Can I use Fluticasone Propionate Nasal Spray, USP for colds? No, use Fluticasone Propionate Nasal Spray, USP to treat only your allergies – not your cold symptoms. If you’re not sure whether your symptoms come from allergies or a cold, ask your doctor. What happens when you have allergies? Allergies start when allergens like pollen or pet dander enter your body and trigger your immune system to respond. Your body’s natural response is to release multiple inflammatory substances, (also referred to as mediators) that cause your allergy symptoms. How does Fluticasone Propionate Nasal Spray, USP work? Fluticasone Propionate Nasal Spray, USP works right in your nose to help block your allergic reaction at the source to relieve the symptoms that make you uncomfortable. Fluticasone Propionate Nasal Spray, USP acts on multiple inflammatory substances, including histamine, prostaglandins, cytokines, tryptases, chemokines and leukotrienes. Most common OTC allergy pills act on histamine alone. Because of the way it works, it may take several days for Fluticasone Propionate Nasal Spray, USP to reach maximum effect. That’s why it’s best to use Fluticasone Propionate Nasal Spray, USP regularly, once a day. Fluticasone Propionate Nasal Spray, USP not only relieves sneezing, itchy nose, runny nose and itchy, watery eyes, but also relieves nasal congestion. What problems can Fluticasone Propionate Nasal Spray, USP help with? Allergies can cause uncomfortable symptoms like congestion and itchy eyes. These symptoms can be triggered by allergens like pollen, mold, dust or pet dander. Fluticasone Propionate Nasal Spray, USP helps relieve a broad range of symptoms from many allergens. For example, Fluticasone Propionate Nasal Spray, USP helps with: Who should not use Fluticasone Propionate Nasal Spray, USP or check with a doctor first? Some people should not use Fluticasone Propionate Nasal Spray, USP or need to check with a health professional first. This table offers a quick summary of these situations. If you… Here’s what to do… Are younger than 4 Do not use Fluticasone Propionate Nasal Spray, USP Are pregnant or breast-feeding Talk to a health professional before using Fluticasone Propionate Nasal Spray, USP Have or had glaucoma or cataracts Talk to your doctor before using Fluticasone Propionate Nasal Spray, USP Have an injury or surgery to your nose that is not fully healed Do not use Fluticasone Propionate Nasal Spray, USP Have ever had an allergic reaction to Fluticasone Propionate Nasal Spray, USP or any of its ingredients Do not use Fluticasone Propionate Nasal Spray, USP Are taking a medicine for HIV infection (such as ritonavir) Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray, USP Are taking ketoconazole pills (medicine for fungal infection) Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray, USP Are using a steroid medicine for asthma, allergies, skin rash, allergic reactions, inflammation or eye conditions Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray, USP USING FLUTICASONE PROPIONATE NASAL SPRAY, USP How to get the best results with Fluticasone Propionate Nasal Spray, USP. Read the Drug Facts label on the back of the package or the Quick Start Guide on the other side for simple directions on using Fluticasone Propionate Nasal Spray, USP. Watch for purple color - it shows where there is different information for children ages 4-11, compared to users age 12 or older. If you still have questions about using Fluticasone Propionate Nasal Spray, USP after reading the Quick Start Guide, read this section for answers. I know how to use a nasal spray. Why do I have to follow the directions? If you don’t use the spray bottle correctly, you might not get a full dose. Without a full dose each time, you might not get the relief you deserve. Follow the simple directions in the Quick Start Guide on other side If my symptoms go away, should I stop using Fluticasone Propionate Nasal Spray, USP? You may be tempted to stop using Fluticasone Propionate Nasal Spray, USP when you start to feel better. It’s important you keep using Fluticasone Propionate Nasal Spray, USP daily as long as you’re exposed to allergens that bother you, like pollen, mold, dust or pet dander. This way you’ll keep feeling relief. If you suffer allergy symptoms only during certain times, like when pollen levels are high, you may stop using Fluticasone Propionate Nasal Spray, USP when that time ends. If you are age 12 or older and need to use daily for longer than 6 months or age 4-11 and need to use for longer than 2 months a year, check with your doctor. What if I miss a dose by accident? If you miss a dose, just use your regular dose the next day. Don’t add an extra dose to make up for it. Can I keep using Fluticasone Propionate Nasal Spray, USP year round ? Some people suffer from allergies all year. If you are age 12 or older and have used Fluticasone Propionate Nasal Spray, USP steadily for six months or age 4-11 and have used for two months a year, check with your doctor to make sure it’s OK to keep using Fluticasone Propionate Nasal Spray, USP daily. In fact, it’s a good idea for anyone with persistent allergies to talk with a doctor every so often about symptoms and medicines. Can I share my Fluticasone Propionate Nasal Spray, USP? Do not share a bottle of Fluticasone Propionate Nasal Spray, USP. Sharing the bottle can spread germs, because you insert the nozzle in your nose. Can I spray Fluticasone Propionate Nasal Spray, USP in my eyes or mouth? No, Fluticasone Propionate Nasal Spray, USP is meant to work only in your nose to relieve your allergy symptoms, including itchy, watery eyes. Never spray Fluticasone Propionate Nasal Spray, USP in your eyes or your mouth. Some decongestants may increase blood pressure. Does Fluticasone Propionate Nasal Spray, USP increase blood pressure? When used as directed, Fluticasone Propionate Nasal Spray, USP does not increase blood pressure. Won’t I waste product by priming? It’s not a waste to prime the pump, because it helps you get a full dose. Getting a full dose is important for getting the relief you deserve. See the Quick Start Guide for when and how to prime the pump. Don’t worry about running out due to priming. There is enough medicine in the spray bottle to allow for priming sprays plus the number of sprays labeled on the bottle. Always point the spray bottle away from your face when priming. How long should a bottle of Fluticasone Propionate Nasal Spray, USP last? This table shows roughly how long your bottle will last. It assumes you follow the instructions for priming the pump, and that those age 12 or older use two sprays in each nostril every day while children age 4-11 use one spray in each nostril every day. After you’ve used the number of sprays shown on the label, each spray may not deliver a full dose — even if there is liquid left in the bottle. If the label says… The bottle should last age 12+… The bottle should last age 4-11… 120 sprays 4 weeks 8 weeks Is Fluticasone Propionate Nasal Spray, USP OK to use with other medicines? You should tell your doctor about all the medicines you take, including Fluticasone Propionate Nasal Spray, USP. Fluticasone Propionate Nasal Spray, USP can be used with most non-prescription and prescription medicines. However, there are a few medicines to look out for because they may cause the level of Fluticasone Propionate Nasal Spray, USP in your body to become too high. Just to be safe, check the table on next plane to see if you’re taking any of these medicines. If you’re taking… Here’s what to do… Medicines for HIV infection (such as ritonavir) Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray, USP Medicines with glucocorticoids including some medicines for skin rash such as eczema, asthma, inflammation, allergic reactions or eye conditions Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray, USP Ketoconazole Pills for fungal infection Talk to your doctor or pharmacist before using Fluticasone Propionate Nasal Spray, USP What are the differences in the way children age 4-11 should use Fluticasone Propionate Nasal Spray, USP? Children age 4-11 should use a lower dose of Fluticasone Propionate Nasal Spray, USP for a shorter period of time. Ages Children 4-11 years of age Users 12 years of age and older Dosage 1 spray in each nostril once daily Up to 2 sprays in each nostril once daily Duration before checking with a doctor Up to 2 months of use a year Up to 6 months of daily use Why is the use of Fluticasone Propionate Nasal Spray, USP for children age 4-11 limited to 2 months a year before checking with a doctor? When used long-term, intranasal glucocorticoids like Fluticasone Propionate Nasal Spray, USP may cause the growth rate of some children to be slower. Whether this will affect a child’s ultimate height is not known. As a precaution, children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than 2 months a year. WHAT TO EXPECT What it’s like to use Fluticasone Propionate Nasal Spray, USP. How soon will I get relief? You may start to feel relief the first day you use Fluticasone Propionate Nasal Spray, USP. Keep using it every day, though. It takes several days before Fluticasone Propionate Nasal Spray, USP builds up to full effectiveness. How long will the relief last? Fluticasone Propionate Nasal Spray, USP is meant to control your symptoms every day, all day and all night. To help you get this lasting relief, it’s important to use Fluticasone Propionate Nasal Spray, USP regularly, once a day. Does Fluticasone Propionate Nasal Spray, USP cause a “rebound” effect? No, Fluticasone Propionate Nasal Spray, USP does not cause a rebound effect. Some nasal decongestant sprays may cause your nasal passages to swell up even more when you use them too often or for longer than their label says you should (three days). This is sometimes called a “rebound effect.” Fluticasone Propionate Nasal Spray, USP is a different kind of medicine and does not cause any rebound effect. You can use Fluticasone Propionate Nasal Spray, USP for up to six months if you are age 12 or older or up to two months a year if you are age 4-11 before checking with a doctor. Will Fluticasone Propionate Nasal Spray, USP make me drowsy? No, Fluticasone Propionate Nasal Spray, USP does not cause drowsiness. Some allergy medications can cause drowsiness, but Fluticasone Propionate Nasal Spray, USP does not. Why does Fluticasone Propionate Nasal Spray, USP have a smell? The light floral scent you may notice comes from one of the important ingredients in the Fluticasone Propionate Nasal Spray, USP formula. No fragrance is added to Fluticasone Propionate Nasal Spray, USP. What if little or nothing is spraying out? Try priming the spray bottle. It may take a few pumps to get the dispenser spraying again. If that doesn’t work, the spray nozzle may be clogged. You can clean it following the directions in the Quick Start Guide on the other side. What if I feel stinging in my nose, or I sneeze? Some people may feel a slight stinging, or may sneeze, after spraying Fluticasone Propionate Nasal Spray, USP in their nostrils. This feeling should go away in a few seconds. What if I feel or taste the medicine in my throat? Generally, you can avoid this by taking a shallower breath next time you spray Fluticasone Propionate Nasal Spray, USP into your nostrils. For example, take the kind of breath you would use to smell a flower. What if I have chicken pox, measles or tuberculosis or come into contact with someone who does? Stop using Fluticasone Propionate Nasal Spray, USP and ask your doctor. What if I’m having severe sinus pain? If you feel severe pain in your face, have thick nasal discharge, or think you may have a sinus infection, stop using Fluticasone Propionate Nasal Spray, USP and see your doctor. Your doctor may want to consider if other medicines are needed. What if my symptoms aren’t better after one week? If you have used Fluticasone Propionate Nasal Spray, USP for a week and your allergy symptoms are not getting better, stop use and ask your doctor. You may have an infection. Does Fluticasone Propionate Nasal Spray, USP have side effects? Serious side effects are rare with Fluticasone Propionate Nasal Spray, USP because Fluticasone Propionate Nasal Spray, USP works in your nose, and barely any of it travels through your body. However, like all medicines, Fluticasone Propionate Nasal Spray, USP can cause side effects in some people. Here are some side effects that have been reported when using Fluticasone Propionate Nasal Spray, USP. If you have any concerns about side effects, talk with your doctor. Side effect What could happen What to do Allergic reaction to the product Sudden swelling of face or tongue A rash Wheezing or feeling faint If you feel any of these symptoms, stop using Fluticasone Propionate Nasal Spray, USP and see a doctor right away. Nose injury Severe or frequent nosebleeds Apply pressure to your nose. Stop using Fluticasone Propionate Nasal Spray, USP and see a doctor. Constant whistling sound that does not go away This could be a sign of damage to your nose. Stop using Fluticasone Propionate Nasal Spray, USP and see a doctor right away. Eye Conditions such as cataracts or glaucoma Cloudy vision Reduced vision Have a yearly eye exam to check for these conditions. Read the Drug Facts on the back of the Fluticasone Propionate Nasal Spray, USP package for more details. Growth effects Slower growth rate in some children while using product Talk to your doctor if you are concerned or if a child age 4-11 needs to use Fluticasone Propionate Nasal Spray, USP for longer than two months a year. Other side effects Headaches or sneezing Bad taste or smell Minor nosebleeds Dry or irritated nose or throat Talk to your doctor or pharmacist if you are concerned. STILL HAVE QUESTIONS? Call 866-488-0312 Distributed by: Advagen Pharma Ltd., East Windsor, NJ 08520 Made in Italy Rev 02, 01/2025 image description image description image description image description image description","FLUTICASONE PROPIONATE NASAL SPRAY, USP QUICK START GUIDE HOW TO START GETTING ALLERGY RELIEF RIGHT NOW USE THE RIGHT DOSE Fluticasone Propionate Nasal Spray, USP works best when you use it daily. Here’s how to get started. Children age 4-11 An adult should supervise use Use one spray in each nostril Don’t use more than one spray in each nostril per day. If you miss a dose, just use your regular dose the next day. Don’t add an extra dose. Check with doctor if a child needs to use Fluticasone Propionate Nasal Spray, USP for longer than two months a year. Users age 12 or older In your first week Use two sprays in each nostril every day. Don’t use more than two sprays in each nostril per day. After your first week if your symptoms are under control, you may reduce to one spray in each nostril every day. If your symptoms get worse, go back to two sprays in each nostril. If you miss a dose, just use your regular dose the next day. Don’t add an extra dose. WARNING: Do not spray in your eyes. Only for use in your nose. KEEP IT CLEAN A clean spray nozzle helps ensure a full dose. Clean it weekly, or if it’s clogged. Don’t try to unblock nozzle with pin or sharp object — that can damage it. Remove spray nozzle by grasping at base and pulling up. Aim away from your face and gently replace spray nozzle until you hear a soft click. Rinse under running tap, and dry at room temperature. If spray nozzle is clogged , soak in warm water. Then repeat steps 2 and 3 . GET THE RELIEF YOU NEED. Fluticasone Propionate Nasal Spray, USP can relieve your allergy symptoms. For best results, it’s important to get a full dose. Here’s how, in five easy steps. 1. Shake Gently shake the bottle. Remove clear cap 2. Prime Do this when: Starting new bottle Haven’t used it in a week Just cleaned nozzle Otherwise go to Step 3. Aim away from face. Grasp spray bottle as shown. Pump until fine mist appears. Pumped six times and still no mist? Spray nozzle may be clogged. See KEEP IT CLEAN 3. Blow Blow nose gently to clear nostrils. 4. Aim Close one nostril and put tip of spray nozzle in other nostril. Put just the tip into your nose. Aim slightly away from center of nose. 5. Breathe and Spray While sniffing gently, press down on spray nozzle once or twice (according to dosing instructions). You’ll feel a light mist in your nose. Breathe out through your mouth. Repeat in other nostril . Wipe spray nozzle with clean tissue and replace cap Distributed by: Advagen Pharma Ltd., East Windsor, NJ 08520 Made in Italy image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description image description"],"dosage_and_administration":["Directions read the Quick Start Guide for how to: prime the bottle use the spray clean the spray nozzle shake gently before each use use this product only once a day do not use more than directed ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER Week 1- use 2 sprays in each nostril once daily Week 2 through 6 months- use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms After 6 months of daily use – ask your doctor if you can keep using CHILDREN 4 TO 11 YEARS OF AGE the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. an adult should supervise use use 1 spray in each nostril once daily CHILDREN UNDER 4 YEARS OF AGE do not use"],"spl_product_data_elements":["Fluticasone Propionate Fluticasone Propionate Nasal BENZALKONIUM CHLORIDE DEXTROSE MICROCRYSTALLINE CELLULOSE PHENYLETHYL ALCOHOL POLYSORBATE 80 WATER CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FLUTICASONE PROPIONATE FLUTICASONE"],"keep_out_of_reach_of_children":["Other information you may start to feel relief the first day and full effect after several days of regular, once-a-day use store between 4° and 30°C (39° and 86°F) keep this label and enclosed materials. They contain important additional information."],"spl_unclassified_section_table":["
FLUTICASONE PROPIONATE NASAL SPRAY, USP
QUESTIONS & ANSWERS
","
If you…Here’s what to do…
Are younger than 4Do not use Fluticasone PropionateNasal Spray, USP
Are pregnant or breast-feedingTalk to a health professional beforeusing Fluticasone Propionate Nasal Spray, USP
Have or had glaucoma or cataractsTalk to your doctor before using Fluticasone Propionate Nasal Spray, USP
Have an injury or surgery to yournosethat is not fully healed Do not use Fluticasone PropionateNasal Spray, USP
Have ever had an allergic reactionto Fluticasone Propionate Nasal Spray, USP or any of its ingredientsDo not use Fluticasone PropionateNasal Spray, USP
Are taking a medicine for HIV infection (such as ritonavir)Talk to your doctor or pharmacistbefore using Fluticasone Propionate Nasal Spray, USP
Are taking ketoconazole pills(medicine for fungal infection) Talk to your doctor or pharmacistbefore using Fluticasone Propionate Nasal Spray, USP
Are using a steroid medicine for asthma, allergies, skin rash, allergic reactions, inflammation or eye conditionsTalk to your doctor or pharmacistbefore using Fluticasone Propionate Nasal Spray, USP
","
If the label says…The bottle shouldlast age 12+…The bottle shouldlast age 4-11…
120 sprays4 weeks8 weeks
","
If you’re taking…Here’s what to do…
Medicines for HIV infection (such as ritonavir)Talk to your doctor or pharmacistbefore using Fluticasone PropionateNasal Spray, USP
Medicines with glucocorticoidsincluding some medicines for skinrash such as eczema, asthma,inflammation, allergic reactions oreye conditionsTalk to your doctor or pharmacistbefore using Fluticasone PropionateNasal Spray, USP
KetoconazolePills for fungal infectionTalk to your doctor or pharmacistbefore using Fluticasone PropionateNasal Spray, USP
","
AgesChildren 4-11 yearsof ageUsers 12 years of age and older
Dosage1 spray in each nostril once dailyUp to 2 sprays in each nostril once daily
Duration before checking with a doctorUp to 2 months of use a yearUp to 6 months of daily use
","
Side effectWhat could happenWhat to do
Allergic reaction tothe productSudden swelling of face or tongueA rashWheezing or feeling faintIf you feel any of these symptoms, stop using Fluticasone Propionate Nasal Spray, USP and see a doctor right away.
Nose injurySevere or frequent nosebleedsApply pressure to your nose. Stop using Fluticasone Propionate Nasal Spray, USP and see a doctor.
Constant whistling sound that does not go awayThis could be a sign of damage to your nose. Stop using Fluticasone Propionate Nasal Spray, USP and see a doctor right away.
Eye Conditionssuch as cataractsor glaucomaCloudy visionReduced visionHave a yearly eye exam to check for these conditions. Read the Drug Factson the back of the Fluticasone Propionate Nasal Spray, USP package for more details.
Growth effectsSlower growth rate in some children while using productTalk to your doctor if you are concerned or if a child age 4-11 needs to use Fluticasone Propionate Nasal Spray, USP for longer than two months a year.
Other side effectsHeadaches or sneezingBad taste or smellMinor nosebleedsDry or irritated nose or throatTalk to your doctor or pharmacist if you are concerned.
","
HOW TO START GETTING ALLERGY RELIEF RIGHT NOW
USE THE RIGHT DOSEFluticasone Propionate Nasal Spray, USP works best when you use it daily. Here’s how to get started.
Children age 4-11
An adult should supervise use Use one spray in each nostril Don’t use more than one spray in each nostril per day.If you miss a dose,just use your regular dose the next day. Don’t add an extra dose. Check with doctorif a child needs to use Fluticasone Propionate Nasal Spray, USP for longer than two months a year.
Users age 12 or older
In your first weekUse two sprays in each nostril every day.Don’t use more than two sprays in each nostril per day.After your first weekif your symptoms are under control, you may reduce to one spray in each nostril every day. If your symptoms get worse, go back to two sprays in each nostril. If you miss a dose,just use your regular dose the next day. Don’t add an extra dose. WARNING: Do not spray in your eyes. Only for use in your nose.
KEEP IT CLEANA clean spray nozzle helps ensure a full dose. Clean it weekly, or if it’s clogged. Don’t try to unblock nozzle with pin or sharp object — that can damage it.
Remove spray nozzle by grasping at base and pulling up.Aim away from your face and gently replace spray nozzle until you hear a soft click.Rinse under running tap, and dry at room temperature.If spray nozzle is clogged, soak in warm water. Then repeat steps 2and 3.
GET THE RELIEF YOU NEED.Fluticasone Propionate Nasal Spray, USP can relieve your allergy symptoms. For best results, it’s important to get a full dose. Here’s how, in five easy steps.
1. ShakeGently shake the bottle.Remove clear cap
2. Prime Do this when:Starting new bottleHaven’t used it in a weekJust cleaned nozzleOtherwise go to Step 3.Aim away from face.Grasp spray bottle as shown. Pump until fine mist appears.Pumped six times and still no mist? Spray nozzle may be clogged. See KEEP IT CLEAN
3. BlowBlow nose gently to clear nostrils. 4. AimClose one nostril and put tip of spray nozzle in other nostril. Put just the tip into your nose.Aim slightly away from center of nose.
5. Breathe and SprayWhile sniffing gently, press down on spray nozzle once or twice (according to dosing instructions). You’ll feel a light mist in your nose. Breathe out through your mouth.Repeat in other nostril. Wipe spray nozzle with clean tissue and replace cap
"],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Fluticasone propionate Nasal Spray 50 mcg per Spray - NDC 72888-248-01 - 120 Metered Spray Container Label Fluticasone propionate Nasal Spray 50 mcg per Spray - NDC 72888-248-01 - 120 Metered Spray Carton Label image description image description"]},"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"21207 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"17325 reports"},{"date":"","signal":"ASTHMA","source":"FDA FAERS","actionTaken":"12424 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"10958 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"10633 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"10162 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"9707 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"8692 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"8227 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"7995 reports"}],"drugInteractions":[],"commonSideEffects":[{"effect":"Ear, nose, and throat adverse events","drugRate":"27%","severity":"common","organSystem":""},{"effect":"Tremor","drugRate":"21%","severity":"common","organSystem":""},{"effect":"Nervousness","drugRate":"19%","severity":"common","organSystem":""},{"effect":"Palpitations","drugRate":"13%","severity":"common","organSystem":""},{"effect":"Muscle cramps","drugRate":"12%","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"12%","severity":"common","organSystem":""},{"effect":"Tachycardia","drugRate":"10%","severity":"common","organSystem":""},{"effect":"Gastrointestinal upset","drugRate":"8%","severity":"common","organSystem":""},{"effect":"Hypokalemia","drugRate":"8%","severity":"common","organSystem":""},{"effect":"Arrhythmias","drugRate":"8%","severity":"common","organSystem":""},{"effect":"Muscle stiffness and rigidity","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Lower respiratory symptoms","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Sleep disorders","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Oral ulcerations","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Musculoskeletal pain","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Pain","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Chest symptoms","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Fluid retention","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Viral infections","drugRate":"3%","severity":"common","organSystem":""}],"contraindications":["Acute tuberculosis","Adrenal cortical hypofunction","Atrophoderma","Bacterial infectious disease","Bilateral cataracts","Candidiasis of mouth","Chronic myocardial ischemia","Conduction disorder of the heart","Congenital long QT syndrome","Diabetes mellitus","Disease caused by parasite","Disease of liver","Epistaxis","Exacerbation of asthma","Exposure to varicella","Glaucoma","Hypercortisolism","Hyperglycemia","Hypertensive disorder","Hypokalemia","Hypopituitarism","Inactive tuberculosis","Ketoacidosis","Measles","Mycosis","Nasal Candidiasis","Nasal Septal Ulcers","Nasal Trauma","Ocular hypertension","Operation on nose","Ophthalmic herpes simplex","Osteopenia","Osteoporosis","Perforation of nasal septum","Peripheral vascular disease","Prolonged QT interval","Pulmonary tuberculosis","Seizure disorder","Telangiectasia disorder","Thyrotoxicosis","Uncontrolled Bacterial Infections","Untreated Fungal Infection","Varicella-zoster virus infection","Viral disease"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Pneumonia","drugRate":"","severity":"serious"},{"effect":"Bacterial infections","drugRate":"","severity":"serious"},{"effect":"Hepatic enzyme elevation","drugRate":"1%","severity":"serious"},{"effect":"Keratitis and conjunctivitis","drugRate":"","severity":"serious"},{"effect":"Fractures","drugRate":"","severity":"serious"},{"effect":"Compressed nerve syndromes","drugRate":"","severity":"serious"},{"effect":"Bone and cartilage disorders","drugRate":"","severity":"serious"},{"effect":"Wounds and lacerations","drugRate":"","severity":"serious"},{"effect":"Contusions and hematomas","drugRate":"","severity":"serious"},{"effect":"Throat irritation","drugRate":"","severity":"serious"}]},"status":"approved","trials":["NCT07329946","NCT07318350","NCT02175771","NCT00503009","NCT00609674","NCT01318681","NCT00239421","NCT02437604","NCT00980707","NCT02182492","NCT00655109","NCT01397201","NCT01647646","NCT02740543","NCT00542880","NCT01381471","NCT01702701","NCT00903227","NCT02924688","NCT04564456","NCT00646594","NCT00424008","NCT00734318","NCT01255579","NCT01879410","NCT03063086","NCT01192191","NCT01168310","NCT00393991","NCT04271839","NCT00479739","NCT01186653","NCT02729051","NCT05651750","NCT02474017","NCT01323621","NCT01868113","NCT02593123","NCT00961155","NCT01484210","NCT00660517","NCT00115622","NCT00235053","NCT00156819","NCT00540839","NCT00355342","NCT06482294","NCT03317015","NCT00116402","NCT00521222"],"aliases":["Flonase","Flovent","Cutivate","Arnuity"],"patents":[{"type":"Method of Use","number":"11554229","applicant":"PARATEK PHARMACEUTICALS INC","territory":"US","tradeName":"XHANCE","expiryDate":"2036-02-23"},{"type":"Method of Use","number":"12083270","applicant":"PARATEK PHARMACEUTICALS INC","territory":"US","tradeName":"XHANCE","expiryDate":"2031-04-04"},{"type":"Formulation","number":"11344685","applicant":"TEVA PHARMACEUTICAL INDUSTRIES LTD","territory":"US","tradeName":"ARMONAIR RESPICLICK","expiryDate":"2039-09-26"},{"type":"Formulation","number":"10195375","applicant":"TEVA PHARMACEUTICAL INDUSTRIES LTD","territory":"US","tradeName":"ARMONAIR RESPICLICK","expiryDate":"2031-02-14"},{"type":"Formulation","number":"7500444","applicant":"GLAXO GROUP LTD DBA GLAXOSMITHKLINE","territory":"US","tradeName":"FLOVENT HFA","expiryDate":"2026-02-26"},{"type":"Formulation","number":"11969544","applicant":"TEVA PHARMACEUTICAL INDUSTRIES LTD","territory":"US","tradeName":"ARMONAIR RESPICLICK","expiryDate":"2039-08-20"},{"type":"Formulation","number":"10918816","applicant":"TEVA PHARMACEUTICAL INDUSTRIES LTD","territory":"US","tradeName":"ARMONAIR RESPICLICK","expiryDate":"2035-12-14"},{"type":"Formulation","number":"11173259","applicant":"TEVA PHARMACEUTICAL INDUSTRIES LTD","territory":"US","tradeName":"ARMONAIR RESPICLICK","expiryDate":"2040-07-06"},{"type":"Compound","number":"7500444*PED","applicant":"GLAXO GROUP LTD DBA GLAXOSMITHKLINE","territory":"US","tradeName":"FLOVENT HFA","expiryDate":"2026-08-26"},{"type":"Compound","number":"10195375*PED","applicant":"TEVA PHARMACEUTICAL INDUSTRIES LTD","territory":"US","tradeName":"ARMONAIR RESPICLICK","expiryDate":"2031-08-14"},{"type":"Compound","number":"10918816*PED","applicant":"TEVA PHARMACEUTICAL INDUSTRIES LTD","territory":"US","tradeName":"ARMONAIR RESPICLICK","expiryDate":"2036-06-14"},{"type":"Compound","number":"11173259*PED","applicant":"TEVA PHARMACEUTICAL INDUSTRIES LTD","territory":"US","tradeName":"ARMONAIR RESPICLICK","expiryDate":"2041-01-06"},{"type":"Compound","number":"11344685*PED","applicant":"TEVA PHARMACEUTICAL INDUSTRIES LTD","territory":"US","tradeName":"ARMONAIR RESPICLICK","expiryDate":"2040-03-26"},{"type":"Compound","number":"11969544*PED","applicant":"TEVA PHARMACEUTICAL INDUSTRIES LTD","territory":"US","tradeName":"ARMONAIR RESPICLICK","expiryDate":"2040-02-20"}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=fluticasone propionate","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:06:36.944081+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T01:06:36.944009+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:06:43.269552+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:06:36.059144+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=fluticasone propionate","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:06:43.641255+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:06:33.828035+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:06:33.828058+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:06:45.547903+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201396/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:06:44.718410+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA219060","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:06:33.828061+00:00"}},"allNames":"flonase","offLabel":[],"timeline":[],"aiSummary":"Fluticasone (Flonase/Flovent) is one of the most prescribed corticosteroids, developed by GSK and approved in 1994. Available OTC as a nasal spray for allergies and as a prescription inhaler for asthma. Available generically.","brandName":"Flonase","companyId":"gsk","ecosystem":[],"mechanism":{"target":"Cytosolic phospholipase A2, Glucocorticoid receptor, Mineralocorticoid receptor","novelty":"","modality":"Small molecule","drugClass":"Inhaled/intranasal corticosteroid","explanation":"","oneSentence":"","technicalDetail":""},"commercial":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:06:46.945204+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"companyName":"GSK (GlaxoSmithKline)","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"},{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"fluticasone propionate","indications":{"approved":[{"name":"Allergic asthma","diseaseId":"allergic-asthma","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Allergic rhinitis","diseaseId":"allergic-rhinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Asthma management","diseaseId":"asthma-management","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Atopic dermatitis","diseaseId":"atopic-dermatitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Bronchospasm Prevention with COPD","diseaseId":"bronchospasm-prevention-with-copd","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"COPD Associated with Chronic Bronchitis","diseaseId":"copd-associated-with-chronic-bronchitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Chronic Non-Allergic Rhinitis","diseaseId":"chronic-non-allergic-rhinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Contact dermatitis","diseaseId":"contact-dermatitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Discoid lupus erythematosus","diseaseId":"discoid-lupus-erythematosus","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Eruption of skin","diseaseId":"eruption-of-skin","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Granuloma annulare","diseaseId":"granuloma-annulare","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Lichen simplex chronicus","diseaseId":"lichen-simplex-chronicus","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Non-allergic asthma","diseaseId":"non-allergic-asthma","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Plaque psoriasis","diseaseId":"plaque-psoriasis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Primary cutaneous T-cell lymphoma","diseaseId":"primary-cutaneous-t-cell-lymphoma","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Pruritus ani","diseaseId":"pruritus-ani","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Pruritus of genital organs","diseaseId":"pruritus-of-genital-organs","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Pulmonary emphysema","diseaseId":"pulmonary-emphysema","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Scalp psoriasis","diseaseId":"scalp-psoriasis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Seborrheic dermatitis","diseaseId":"seborrheic-dermatitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07329946","phase":"NA","title":"Erdosteine Effect on Oxidative Stress, Inflammatory Response and Immune Modulation in Patients With COPD. A Single Center, Open Label, Double Arm, Controlled, 4-week, Explorative, ex Vivo Study.\"","status":"NOT_YET_RECRUITING","sponsor":"Pierachille Santus, MD, PhD","isPivotal":false,"enrollment":30,"indication":"COPD","completionDate":"2027-12-31"},{"nctId":"NCT07318350","phase":"Phase 3","title":"Phase 3, Multicenter, Randomized, Parallel-group, Open-label, Non-inferiority Study of N0783 Versus Comparator (Formoterol 6 mcg / Budesonide 200 mcg) in the Treatment of Moderate Asthma","status":"NOT_YET_RECRUITING","sponsor":"Eurofarma Laboratorios S.A.","isPivotal":true,"enrollment":174,"indication":"Moderate Asthma","completionDate":"2028-09"},{"nctId":"NCT02175771","phase":"Phase 3","title":"A 26-Week Open-Label Study to Assess the Long-Term Safety of Fluticasone Propionate Multidose Dry Powder Inhaler and Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients 12 Years","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","isPivotal":true,"enrollment":758,"indication":"Persistent Asthma","completionDate":"2015-07"},{"nctId":"NCT00503009","phase":"Phase 4","title":"An Exploratory Study to Evaluate the Response of Salmeterol Plus Fluticasone vs Fluticasone Alone to Experimental Nasal Inoculation With Rhinovirus","status":"TERMINATED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":16,"indication":"Asthma","completionDate":"2008-07"},{"nctId":"NCT00609674","phase":"Phase 4","title":"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110mcg ","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":315,"indication":"Rhinitis, Allergic, Perennial","completionDate":"2008-06"},{"nctId":"NCT01318681","phase":"NA","title":"Effects of Treated and Untreated Allergic Rhinitis on Mood, Cognitive Functions and Actual Driving Performance","status":"COMPLETED","sponsor":"Maastricht University Medical Center","isPivotal":false,"enrollment":22,"indication":"Seasonal Allergic Rhinitis, Driving Ability","completionDate":"2012-10"},{"nctId":"NCT00239421","phase":"Phase 4","title":"A Six-Week, Randomized, Double-Blind, Quadruple-Dummy Parallel Group Multiple Dose Study Comparing the Efficacy and Safety of Tiotropium Inhalation Capsules Plus Formoterol Inhalation Capsules to Salm","status":"COMPLETED","sponsor":"Boehringer Ingelheim","isPivotal":false,"enrollment":605,"indication":"Pulmonary Disease, Chronic Obstructive","completionDate":"2004-09"},{"nctId":"NCT02437604","phase":"Phase 1","title":"An Open-Label, Crossover Study to Determine the Pharmacokinetic Profile and Tolerability of Single Doses of High Strength Fluticasone Propionate Multidose Dry Powder Inhaler and Fluticasone Propionate","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","isPivotal":false,"enrollment":43,"indication":"Asthma","completionDate":"2015-09"},{"nctId":"NCT00980707","phase":"Phase 4","title":"Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarker of Asthma","status":"COMPLETED","sponsor":"Associated Scientists to Help Minimize Allergies","isPivotal":false,"enrollment":10,"indication":"Allergic Asthma","completionDate":"2010-11"},{"nctId":"NCT02182492","phase":"NA","title":"Comparison of Different Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis Patients After Endoscopic Sinus Surgery","status":"COMPLETED","sponsor":"Zheng Liu","isPivotal":false,"enrollment":187,"indication":"Chronic Rhinosinusitis, Endoscopic Sinus Surgery","completionDate":"2016-06"},{"nctId":"NCT00655109","phase":"Phase 4","title":"A Comparison of Olopatadine Versus Fluticasone Nasal Spray in the Prevention of the Signs and Symptoms of Allergic Conjunctivitis","status":"COMPLETED","sponsor":"Greiner, Jack V., OD DO PhD","isPivotal":false,"enrollment":60,"indication":"Conjunctivitis, Allergic","completionDate":"2008-03"},{"nctId":"NCT01397201","phase":"Phase 2","title":"A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess and Compare Efficacy and Safety of an 8-week Treatment With BI 54903 at Doses of 45.5, 90.9 and 181.8 mcg b","status":"TERMINATED","sponsor":"Boehringer Ingelheim","isPivotal":false,"enrollment":30,"indication":"Asthma","completionDate":"2011-12-23"},{"nctId":"NCT01647646","phase":"Phase 4","title":"Real Life Effectiveness in Patients With Not Optimally Controlled Asthma: Symbicort SMART, or Other ICS/LABA With as Needed SABA","status":"COMPLETED","sponsor":"Far Eastern Memorial Hospital","isPivotal":false,"enrollment":200,"indication":"Asthma","completionDate":"2012-03"},{"nctId":"NCT02740543","phase":"Phase 2","title":"Biomarkers of Irritant-Induced and Allergic Asthma","status":"COMPLETED","sponsor":"NYU Langone Health","isPivotal":false,"enrollment":18,"indication":"Asthma","completionDate":"2019-10-23"},{"nctId":"NCT00542880","phase":"Phase 4","title":"A Double-blind, Randomised, Cross-over, Multi-centre Study, to Evaluate Onset of Effect in the Morning in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort®Turbu","status":"COMPLETED","sponsor":"AstraZeneca","isPivotal":false,"enrollment":442,"indication":"Chronic Obstructive Pulmonary Disease (COPD)","completionDate":"2008-08"},{"nctId":"NCT01381471","phase":"N/A","title":"Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":11060,"indication":"Pulmonary Disease, Chronic Obstructive","completionDate":"2010-05"},{"nctId":"NCT01702701","phase":"Phase 3","title":"Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone","status":"WITHDRAWN","sponsor":"Medical College of Wisconsin","isPivotal":true,"enrollment":0,"indication":"Eosinophilic Esophagitis, Dysphagia","completionDate":"2017-07-20"},{"nctId":"NCT00903227","phase":"Phase 4","title":"A Proof Of Concept Study To Assess The Steroid Sparing Effect Of Combined Nasal And Inhaled Corticosteroid In Patients With Asthma And Persistent Rhinitis","status":"COMPLETED","sponsor":"University of Dundee","isPivotal":false,"enrollment":25,"indication":"Asthma, Allergic Rhinitis","completionDate":"2008-08"},{"nctId":"NCT02924688","phase":"Phase 3","title":"A Phase III, Randomized, Double-blind, Active Controlled, Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination FF/UMEC/VI With the Fixed Dose Dual Combin","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":true,"enrollment":2436,"indication":"Asthma","completionDate":"2019-02-22"},{"nctId":"NCT04564456","phase":"Phase 1","title":"A Pivotal, Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study Under Fasting Conditions to Examine the Bioequivalence Between Fluticasone Propionate 500 mcg a","status":"COMPLETED","sponsor":"Respirent Pharmaceuticals Co Ltd.","isPivotal":false,"enrollment":34,"indication":"Bioequivalence","completionDate":"2020-12-31"},{"nctId":"NCT00646594","phase":"Phase 3","title":"A Two Stage Randomized, Open-Label, Parallel Group, Phase III, Multicenter, 7 Month Study to Assess the Efficacy & Safety of SYMBICORT pMDI Adminstered Either as Fixed or as an Adjustable Regimen Vers","status":"COMPLETED","sponsor":"AstraZeneca","isPivotal":true,"enrollment":1200,"indication":"Asthma","completionDate":"2005-01"},{"nctId":"NCT00424008","phase":"Phase 3","title":"A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50mcg BID Delivered by Dry Powder Inhaler (Diskus) Versus Mometasone Furoate/Formoterol Fumarate 200/10mcg ","status":"COMPLETED","sponsor":"Organon and Co","isPivotal":true,"enrollment":722,"indication":"Asthma","completionDate":"2008-11"},{"nctId":"NCT00734318","phase":"Phase 3","title":"A Double Blind, Double Dummy, Randomised, Multicentre, Four Arm Parallel Group Study to Assess the Efficacy and Safety of FlutiForm® pMDI 250/10µg (2 Puffs Bid) vs Fluticasone pMDI 250µg (2 Puffs Bid)","status":"COMPLETED","sponsor":"Mundipharma Research Limited","isPivotal":true,"enrollment":1667,"indication":"Asthma, Bronchial","completionDate":"2009-10"},{"nctId":"NCT01255579","phase":"Phase 4","title":"Effects on Small Airways Obstruction of Two Long-term Treatments With Extrafine Beclomethasone/Formoterol vs Fluticasone/Salmeterol in Asthma","status":"COMPLETED","sponsor":"Università degli Studi di Brescia","isPivotal":false,"enrollment":10,"indication":"Bronchial Asthma","completionDate":""},{"nctId":"NCT01879410","phase":"Phase 3","title":"DB2114951: A Randomized, Multi-center, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy Umeclidinium/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks i","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":true,"enrollment":700,"indication":"Pulmonary Disease, Chronic Obstructive","completionDate":"2014-01-09"},{"nctId":"NCT03063086","phase":"Phase 2","title":"A Randomized, Double-blind, Double-dummy, Active-controlled, 3-period Complete Cross-over Study to Assess the Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combinati","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","isPivotal":false,"enrollment":116,"indication":"Asthma","completionDate":"2018-08-02"},{"nctId":"NCT01192191","phase":"Phase 3","title":"A Long-term Study to Evaluate the Safety and Tolerability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Japanese Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":true,"enrollment":187,"indication":"Pulmonary Disease, Chronic Obstructive","completionDate":"2012-01"},{"nctId":"NCT01168310","phase":"Phase 2","title":"A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Pharmacodynamic Response of Fluticasone Propionate in Fixed-Dose Combination With Formoterol F","status":"COMPLETED","sponsor":"Dey","isPivotal":false,"enrollment":468,"indication":"Chronic Obstructive Pulmonary Disease","completionDate":"2011-10"},{"nctId":"NCT00393991","phase":"Phase 3","title":"A Randomized, Double-blind, Placebo-controlled, Parallel, Stratified, Multi-center, 12-Week Study Comparing the Safety & Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm)100/10 µg Twic","status":"COMPLETED","sponsor":"SkyePharma AG","isPivotal":true,"enrollment":475,"indication":"Asthma","completionDate":"2008-04"},{"nctId":"NCT04271839","phase":"Phase 4","title":"Open Randomized Low Interventional Clinical Trial to Compare Efficiency in Control Symptoms Between Fluticasone Propionate/Formoterol K-haler (Medium Strength) vs High Strength ICS/LABA in the Treatme","status":"WITHDRAWN","sponsor":"Mundipharma Pharmaceuticals S.L.","isPivotal":false,"enrollment":0,"indication":"Persistent Asthma","completionDate":"2021-05"},{"nctId":"NCT00479739","phase":"Phase 4","title":"Randomised, Double-blind, Double-dummy, 52-week, Parallel Group Study of a Standard Dosing Regimen With Salmeterol/Fluticasone propionate50/250 Twice Daily Diskus Versus a Symptom-driven, Variable Dos","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":700,"indication":"Asthma","completionDate":"2004-07"},{"nctId":"NCT01186653","phase":"Phase 4","title":"Effect of High Dose Inhaled Budesonide and Fluticasone on Adrenal Function in Patients With Moderate to Severe COPD","status":"COMPLETED","sponsor":"Hull University Teaching Hospitals NHS Trust","isPivotal":false,"enrollment":22,"indication":"Chronic Obstructive Pulmonary Disease","completionDate":"2010-05"},{"nctId":"NCT02729051","phase":"Phase 3","title":"A Phase IIIB, 24-week Randomised, Double-blind Study to Compare 'Closed' Triple Therapy (FF/UMEC/VI) With 'Open' Triple Therapy (FF/VI + UMEC), in Subjects With Chronic Obstructive Pulmonary Disease (","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":true,"enrollment":1055,"indication":"Pulmonary Disease, Chronic Obstructive","completionDate":"2017-05-23"},{"nctId":"NCT05651750","phase":"Phase 4","title":"Medical vs Surgical Treatment Decision in Pediatric Obstructive Sleep Apnea Using Sleep Questionnaire","status":"UNKNOWN","sponsor":"Assaf-Harofeh Medical Center","isPivotal":false,"enrollment":90,"indication":"To Evaluate PSQ as Clinical Tool in the Decision Between Medical and Surgical Treatment for Adenotonsillar Hypertrophy, To Determine Clinical Response to Montelukast or Nasal Steroids Based on PSQ Results","completionDate":"2023-06-30"},{"nctId":"NCT02474017","phase":"Phase 1","title":"An Open Study to Assess the Robustness of the CRC749 Device by Pharmaceutical Performance Following Twice Daily Dosing of MGR001 Administered Via Oral Inhalation in Subjects With Asthma or Chronic Obs","status":"COMPLETED","sponsor":"Mylan Pharma UK Ltd.","isPivotal":false,"enrollment":111,"indication":"Asthma, COPD","completionDate":"2015-06"},{"nctId":"NCT01323621","phase":"Phase 3","title":"A 12-week Study to Evaluate the 24-hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inh","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":true,"enrollment":512,"indication":"Pulmonary Disease, Chronic Obstructive","completionDate":"2012-01-24"},{"nctId":"NCT01868113","phase":"Phase 3","title":"Acute Respiratory Infections and Asthma in U-5 Children: Improved Treatment to Reduce Morbidity and Mortality in Uganda, A Randomized Controlled Trial","status":"COMPLETED","sponsor":"Makerere University","isPivotal":true,"enrollment":1010,"indication":"Bacterial Pneumonia, Viral Pneumonia","completionDate":"2014-01"},{"nctId":"NCT02593123","phase":"Phase 2","title":"Adoptive Immunotherapy in Patients With Relapsed Hematological Malignancy: Effect of Duration and Intensity of Early GVHD Prophylaxis on Long-Term Clinical Outcomes","status":"COMPLETED","sponsor":"Virginia Commonwealth University","isPivotal":false,"enrollment":31,"indication":"Hodgkin's Lymphoma, Lymphoid Leukemia","completionDate":"2022-03-18"},{"nctId":"NCT00961155","phase":"Phase 2","title":"Usefulness of Exhaled Breath Condensate and FENO for Evaluation of Markers of Airway Inflammation in Children With Asthma","status":"UNKNOWN","sponsor":"Medical University of Lodz","isPivotal":false,"enrollment":200,"indication":"Asthma","completionDate":"2014-06"},{"nctId":"NCT01484210","phase":"Phase 3","title":"Phase III Therapeutic Evaluation Study Comparing the Efficacy and Safety of the Fluticasone/Salmeterol (500/50 μg) Combination Administered With Elpenhaler® (Rolenium®) Versus the Innovative One (Sere","status":"COMPLETED","sponsor":"Elpen Pharmaceutical Co. Inc.","isPivotal":true,"enrollment":28,"indication":"Asthma","completionDate":"2008-10"},{"nctId":"NCT00660517","phase":"Phase 3","title":"Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Astelin Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis","status":"COMPLETED","sponsor":"Meda Pharmaceuticals","isPivotal":true,"enrollment":607,"indication":"Seasonal Allergic Rhinitis","completionDate":"2008-04"},{"nctId":"NCT00115622","phase":"Phase 3","title":"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg ","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":true,"enrollment":304,"indication":"Hayfever, Rhinitis, Allergic, Seasonal","completionDate":"2005-01"},{"nctId":"NCT00235053","phase":"Phase 4","title":"A Pilot Study to Assess the Incidence of Local Oropharyngeal and Laryngeal Adverse Effects of Advair DISKUS 250/50 mcg BID as Assessed by the Development of Laryngitis and Oropharyngeal Candidiasis in","status":"COMPLETED","sponsor":"Allergy & Asthma Medical Group & Research Center","isPivotal":false,"enrollment":13,"indication":"Asthma, Candidiasis, Oral","completionDate":"2005-11"},{"nctId":"NCT00156819","phase":"Phase 4","title":"The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial","status":"COMPLETED","sponsor":"JHSPH Center for Clinical Trials","isPivotal":false,"enrollment":500,"indication":"Asthma","completionDate":"2006-08"},{"nctId":"NCT00540839","phase":"Phase 3","title":"A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma","status":"WITHDRAWN","sponsor":"Organon and Co","isPivotal":true,"enrollment":0,"indication":"Asthma, Bronchial","completionDate":""},{"nctId":"NCT00355342","phase":"Phase 4","title":"A Randomized, Double-Blind, Parallel-Group Clinical Trial Evaluating the Effect of the Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Twice Daily Via DISKUS® Inhaler Versus Salmeterol","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":186,"indication":"Pulmonary Disease, Chronic Obstructive","completionDate":"2007-09-06"},{"nctId":"NCT06482294","phase":"Phase 2","title":"CIVETTA: Correlating Inflammatory Values of FEno, SympToms, SpuTum and Lung Function in Asthma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Università degli Studi di Ferrara","isPivotal":false,"enrollment":80,"indication":"Asthma","completionDate":"2025-07-01"},{"nctId":"NCT03317015","phase":"Phase 3","title":"A Randomized, Double-blind, Parallel-group, Multicenter, Phase III Prospective Non-inferiority Clinical Trial to Assess Efficacy and Safety of Nasacort® Nasal Spray (Triamcinolone, 55µg) in Comparison","status":"COMPLETED","sponsor":"Sanofi","isPivotal":true,"enrollment":260,"indication":"Rhinitis Allergic","completionDate":"2017-07-10"},{"nctId":"NCT00116402","phase":"Phase 1","title":"A Pilot Study of the Mechanism of Synergism Between Fluticasone (FP) and Salmeterol in Preventing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations","status":"COMPLETED","sponsor":"University of Chicago","isPivotal":false,"enrollment":15,"indication":"Pulmonary Disease, Chronic Obstructive","completionDate":"2009-10"},{"nctId":"NCT00521222","phase":"NA","title":"Arg/Arg Genotype and Long Acting Beta Agonists in Asthma. Improved Quality of Care for Patients With Asthma.","status":"COMPLETED","sponsor":"Columbia University","isPivotal":false,"enrollment":90,"indication":"Asthma","completionDate":"2010-11"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"Nasal","frequency":"Once or twice daily","formulation":"Nasal spray, Metered-dose inhaler, Dry powder inhaler, Cream, Ointment"},"crossReferences":{"chemblId":"CHEMBL1201396"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":2748,"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"1994-11-04","companionDiagnostics":[],"firstApprovalCountry":"United States","genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2004-05-14T00:00:00.000Z","mah":"ENCUBE","brand_name_local":null,"application_number":"ANDA076633"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2006-03-03T00:00:00.000Z","mah":"COSETTE","brand_name_local":null,"application_number":"ANDA077168"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2019-01-07T00:00:00.000Z","mah":"GLAXO GRP LTD","brand_name_local":null,"application_number":"NDA021254"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2025-08-15T00:00:00.000Z","mah":"RUBICON","brand_name_local":null,"application_number":"ANDA219060"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2026-03-03T00:00:00.000Z","mah":"GLENMARK SPECLT","brand_name_local":null,"application_number":"ANDA219602"},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"patentsNormalised":[{"patent_number":"7500444","territory":"US","patent_type":"Formulation","expiry_date":"2026-02-26T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"7500444*PED","territory":"US","patent_type":"Compound","expiry_date":"2026-08-26T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"10195375","territory":"US","patent_type":"Formulation","expiry_date":"2031-02-14T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"12083270","territory":"US","patent_type":"Method of Use","expiry_date":"2031-04-04T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"10195375*PED","territory":"US","patent_type":"Compound","expiry_date":"2031-08-14T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"10918816","territory":"US","patent_type":"Formulation","expiry_date":"2035-12-14T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"11554229","territory":"US","patent_type":"Method of Use","expiry_date":"2036-02-23T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"10918816*PED","territory":"US","patent_type":"Compound","expiry_date":"2036-06-14T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"11969544","territory":"US","patent_type":"Formulation","expiry_date":"2039-08-20T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"11344685","territory":"US","patent_type":"Formulation","expiry_date":"2039-09-26T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"11969544*PED","territory":"US","patent_type":"Compound","expiry_date":"2040-02-20T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"11344685*PED","territory":"US","patent_type":"Compound","expiry_date":"2040-03-26T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"11173259","territory":"US","patent_type":"Formulation","expiry_date":"2040-07-06T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"11173259*PED","territory":"US","patent_type":"Compound","expiry_date":"2041-01-06T00:00:00.000Z","status":"active","paragraph_iv_filed":false}],"trialStats":{"total":2,"withResults":1},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:06:46.945204+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}