Armonair Respiclick

Name: Armonair Respiclick

Overdose

Chronic overdosage may result in signs/symptoms of hypercorticism [see WARNINGS AND PRECAUTIONS]. Inhalation by healthy volunteers of a single dose of 4,000 mcg of fluticasone propionate inhalation powder or single doses of 1,760 or 3,520 mcg of fluticasone propionate CFC inhalation aerosol was well tolerated. Fluticasone propionate given by inhalation aerosol at dosages of 1,320 mcg twice daily for 7 to 15 days to healthy human volunteers was also well tolerated. Repeat oral doses up to 80 mg daily for 10 days in healthy volunteers and repeat oral doses up to 20 mg daily for 42 days in subjects were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups.

Commonly used brand name(s)

In the U.S.

  • Armonair Respiclick
  • Arnuity Ellipta
  • Flovent
  • Flovent Diskus
  • Flovent HFA
  • Flovent Rotadisk

Available Dosage Forms:

  • Powder
  • Disk
  • Aerosol Powder

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Before Using Armonair Respiclick

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Corticosteroids taken by mouth or injection have been shown to slow or stop growth in children and cause reduced adrenal gland function. If enough fluticasone is absorbed following inhalation, it is possible it also could cause these effects. Your doctor will want you to use the lowest possible dose of fluticasone that controls asthma. This will lessen the chance of an effect on growth or adrenal gland function. It is also important that children taking fluticasone visit their doctors regularly so that their growth rates may be monitored. Children who are taking this medicine may be more susceptible to infections, such as chickenpox or measles. Care should be taken to avoid exposure to chickenpox or measles. If the child is exposed or the disease develops, the doctor should be contacted and his or her directions should be followed carefully. Before this medicine is given to a child, you and your child's doctor should talk about the good this medicine will do as well as the risks of using it.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluticasone in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving fluticasone. .

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atazanavir
  • Bemiparin
  • Boceprevir
  • Bupropion
  • Ceritinib
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Darunavir
  • Dasabuvir
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lumacaftor
  • Nadroparin
  • Nefazodone
  • Nelfinavir
  • Pixantrone
  • Posaconazole
  • Ritonavir
  • Saquinavir
  • Telaprevir
  • Telithromycin
  • Tipranavir
  • Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma attack, acute or
  • Bronchospasm (difficulty with breathing), acute or
  • Milk protein allergy, severe—Should not be used in patients with these conditions.
  • Bone problems (eg, osteoporosis) or
  • Blood vessel disease (eg, Churg-Strauss syndrome) or
  • Cataracts or
  • Glaucoma—Use with caution. May make these conditions worse.
  • Chickenpox (including recent exposure) or
  • Herpes simplex (virus) infection of the eye or
  • Infections (virus, bacteria, or fungus) or
  • Measles or
  • Tuberculosis, active or history of—Inhaled fluticasone can reduce the body's ability to fight off these infections.
  • Infection or
  • Stress or
  • Surgery or
  • Trauma—Supplementary oral corticosteroids may be needed. Check with your doctor.
  • Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of fluticasone

This section provides information on the proper use of a number of products that contain fluticasone. It may not be specific to Armonair Respiclick. Please read with care.

Inhaled fluticasone is used to prevent asthma attacks. It is not used to relieve an attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects. The full benefit of this medicine may take 1 to 2 weeks or longer to achieve.

Inhaled fluticasone comes with patient information leaflet. Read the instructions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

Gargling and rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. However, do not swallow the water after rinsing.

To use the Arnuity™ Ellipta®:

  • This medicine comes in foil tray. Peel back the lid to open.
  • Before you use this medicine, the counter should show the number 30. The counter counts down by 1 each time you open the cover.
  • Open the cover of the inhaler until you hear a clicking sound. The inhaler is now ready to use.
  • Do not close the cover until you have taken your dose. If you open and close the cover without inhaling the dose, you will lose the medicine.
  • Hold the inhaler away from your mouth and breathe out fully. Do not breathe out into the mouthpiece.
  • Close your lips around the mouthpiece. Do not cover the air holes on the side of the mouthpiece.
  • Breathe in through your mouth as steadily and as deeply as you can until you have taken a full deep breath. Do not breathe in through your nose.
  • Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 3 to 4 seconds before breathing out. This gives the medicine time to settle in your airways and lungs.
  • Hold the inhaler well away from your mouth and breathe out slowly and gently.
  • You may clean the mouthpiece with a dry tissue before you close the cover.
  • When the dose counter reaches "10", call your doctor or pharmacist if refill is needed. Throw away the inhaler when the dose counter is at "0".

To use the Flovent® HFA inhaler:

  • When you use the inhaler for the first time, or if you have not used it for 4 weeks or longer, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine into the air four times. (Spray the inhaler once into the air if it has not been used in 1 to 3 weeks.) The inhaler will now be ready to give the right amount of medicine when you use it.
  • Shake the inhaler well for 15 seconds immediately before each use.
  • Take the cap off the mouthpiece (the strap will stay attached to the actuator). Check the mouthpiece and remove any foreign objects. Make sure the canister is fully and firmly inserted into the actuator.
  • Hold the mouthpiece away from your mouth and breathe out slowly and completely.
  • Use the inhalation method recommended by your doctor.
    • Open-mouth method—Place the mouthpiece about 1 or 2 inches (two fingerwidths) in front of your widely opened mouth. Make sure the inhaler is aimed into your mouth so that the spray does not hit the roof of your mouth or your tongue.
    • Closed-mouth method—Place the mouthpiece in your mouth between your teeth and over your tongue, with your lips closed tightly around it. Do not block the mouthpiece with your teeth or tongue.
  • Tilt your head back a little. Start to breathe in slowly and deeply through your mouth and, at the same time, press the top of the canister one time to get one puff of the medicine. Continue to breathe in slowly for 5 to 10 seconds. Count the seconds while inhaling. It is important to press the top of the canister and breathe in slowly at the same time so the medicine is pulled into your lungs. This step may be difficult at first. If you are using the closed-mouth method and you see a fine mist coming from your mouth or nose, the inhaler is not being used correctly.
  • Hold your breath as long as you can up to 10 seconds. This gives the medicine time to settle in your airways and lungs. Take the mouthpiece away from your mouth and breathe out slowly.
  • If your doctor has told you to inhale more than one puff of medicine at each dose, wait about 30 seconds and then gently shake the inhaler again, and take the second puff following exactly the same steps you used for the first puff.
  • When you are finished, wipe off the mouthpiece and replace the cover to keep the mouthpiece clean and free of foreign objects.
  • The inhaler has a dose counter that keeps track of how many more times you can use it before you need to open a new one. When the dose counter reaches "020", call your doctor or pharmacist if refill is needed.
  • If the dose counter is not working correctly, do not use the inhaler and return it to your pharmacy or doctor. Do not change the numbers or remove the counter from the canister. .

To use the ArmonAir™ RespiClick®:

  • Take the inhaler out of the pouch before you use it for the first time.
  • Do not use the inhaler for this medicine with any other medicine.
  • This medicine does not require priming. Do not use it with a spacer or volume holding chamber.
  • Hold the inhaler upright and open the green cap all the way until it clicks. Do not open the green cap until you are ready to take a dose of this medicine.
  • To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue. Do not block the vent above the mouthpiece with your lips or fingers.
  • Breathe in through your mouth quickly and deeply as you can until you have taken a full deep breath. Hold your breath for about 10 seconds.
  • Close the green cap after each inhalation. Rinse your mouth with water without swallowing after each inhalation.
  • Keep the inhaler dry and clean at all times. Gently wipe the mouthpiece with a dry cloth or tissue as needed.
  • The inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The doses counting down from 20 to 0 will show up in red to remind you to refill your prescription. Throw away the inhaler when the dose counter displays 0, 30 days after opening the pouch.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For preventing an asthma attack:
    • For inhalation dosage form (aerosol):
      • Adults and children 12 years of age and older—88 to 880 micrograms (mcg) two times a day, morning and evening.
      • Children 4 to 11 years of age—88 mcg two times a day.
      • Children younger than 4 years of age—Use and dose must be determined by your doctor. .
    • For inhalation dosage form (powder):
      • Adults and children 12 years of age and older—
        • Arnuity™ Ellipta®: At first, 100 micrograms (mcg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mcg per day.
        • ArmonAir™ RespiClick®: At first, 55 mcg two times a day (about 12 hours apart). Your doctor may adjust your dose as needed. Do not use this medicine more than 2 times every 24 hours.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of ArmonAir™ Respiclick®, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Armonair Respiclick Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • White patches in the mouth and throat
Less common
  • Diarrhea
  • ear ache
  • fever
  • lower abdominal or stomach pain
  • nausea
  • pain on passing urine
  • redness or discharge of the eye, eyelid, or lining of the eye
  • shortness of breath
  • sore throat
  • trouble swallowing
  • vaginal discharge (creamy white) and itching
  • vomiting
Rare
  • Blindness, blurred vision, eye pain
  • bone fractures
  • excess facial hair in women
  • fullness or roundness of the face, neck, and trunk
  • growth reduction in children or adolescents
  • heart problems
  • high blood pressure
  • hives and skin rash
  • impotence in males
  • increased hunger, thirst, or urination
  • lack of menstrual periods
  • muscle wasting
  • numbness and weakness of hands and feet
  • swelling of the face, lips, or eyelids
  • tightness in the chest, troubled breathing
  • weakness
Incidence not known
  • Dizziness
  • fast heartbeat

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Darkening of skin
  • fainting
  • loss of appetite
  • mental depression
  • unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Cough
  • general aches and pains or general feeling of illness
  • greenish-yellow mucus in the nose
  • headache
  • hoarseness or other voice changes
  • runny, sore, or stuffy nose
Less common
  • Bloody mucus or unexplained nosebleeds
  • eye irritation
  • fainting
  • headache, severe and throbbing
  • irregular or painful menstrual periods
  • joint pain
  • mouth irritation
  • muscle soreness, sprain, or strain
  • sneezing
  • stomach pain
Rare
  • Aggression
  • agitation
  • bruising
  • itching
  • restlessness
  • weight gain
Incidence not known
  • Blurred vision
  • decrease in height
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • loss of voice
  • pain in the back, ribs, arms or legs
  • sweating
  • trouble sitting still
  • unexplained weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Dosage Forms and Strengths

Inhalation Powder. ArmonAir Respiclick is a multidose, inhalation-driven, dry powder inhaler for oral inhalation that meters 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate from the device reservoir and delivers 51 mcg, 103 mcg, or 210 mcg of fluticasone propionate, respectively, from the mouthpiece per actuation. ArmonAir Respiclick is supplied as a white dry powder inhaler with a green cap in a sealed foil pouch with desiccant.

Adverse Reactions

Systemic and local corticosteroid use may result in the following:

    • Candida albicans infection [see Warnings and Precautions (5.1)] • Immunosuppression [see Warnings and Precautions (5.3)] • Hypercorticism and adrenal suppression [see Warnings and Precautions (5.5)] • Reduction in bone mineral density [see Warnings and Precautions (5.7)] • Growth effects in pediatrics [see Warnings and Precautions (5.8)] • Glaucoma and cataracts [see Warnings and Precautions (5.9)]

Clinical Trials Experience

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

The incidence of adverse reactions associated with ArmonAir Respiclick in Table 1is based upon two placebo-controlled, 12-week, clinical studies (Study 1 and 2). A total of 822 adolescent and adult patients previously treated with inhaled corticosteroids were treated with twice daily ArmonAir Respiclick 55 mcg, 113 mcg, 232 mcg or placebo. Sixty percent of patients were female and 80% of patients were white. The average duration of exposure was 82 days in ArmonAir Respiclick groups compared with 75 days in the placebo group.

  Table 1: Adverse Reactions with ≥ 3% Incidence with ArmonAir Respiclick, and More Common than Placebo in Subjects with Asthma
Adverse Reaction ArmonAir Respiclick 55 mcg
(n=129)
%
ArmonAir Respiclick 113 mcg
(n=274)
%
ArmonAir Respiclick 232 mcg
(n=146)
%
Placebo
(n=273)
%

Infections and infestations

Nasopharyngitis

5.4

5.8

4.8

4.4

URTI

5.4

4.7

5.5

4.8

Oral candidiasis*

3.1

2.9

4.8

0.7

Nervous system disorders

Headache

1.6

7.3

4.8

4.4

Respiratory disorders

Cough

1.6

1.8

3.4

2.6

* Oral candidiasis includes oropharyngeal candidiasis, oral fungal infection, oropharyngitis fungal

URTI = upper respiratory tract infection

Other adverse reactions not previously listed (and occurring in <3% of patients and in three or more patients on ArmonAir Respiclick), whether considered drug-related or not by the investigators, that were reported more frequently by patients with asthma treated with ArmonAir Respiclick compared with patients treated with placebo include the following: Oropharyngeal pain, hypertension, rhinitis allergic, influenza, pyrexia, dizziness, respiratory tract infection, muscle spasms, rhinitis, epistaxis, ligament sprain, musculoskeletal pain, pain in extremity, throat irritation, and vomiting.

Long Term Safety Study: This was a 26-week, open label study of 674 patients previously treated with inhaled corticosteroids who were treated twice daily with ArmonAir Respiclick 113 mcg, 232 mcg, AIRDUO RESPICLICK 113/14 mcg, 232/14 mcg, fluticasone propionate aerosol 110 mcg, 220 mcg, fluticasone propionate and salmeterol inhalation powder 250/50 mcg, 500/50 mcg. The types of adverse reactions among ArmonAir Respiclick treatments were similar to those reported above in placebo controlled studies.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during post‑approval use of fluticasone propionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate or a combination of these factors.

Ear, Nose, and Throat: Aphonia, facial and oropharyngeal edema, and throat soreness.

Endocrine and Metabolic: Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, and osteoporosis.

Eye: Cataracts.

Immune System Disorders: Immediate and delayed hypersensitivity reactions, including anaphylaxis, rash, angioedema, and bronchospasm, have been reported. Anaphylactic reactions in patients with severe milk protein allergy have been reported.

Infections and Infestations: Esophageal candidiasis.

Psychiatry: Agitation, aggression, anxiety, depression, and restlessness. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.

Respiratory: Asthma exacerbation, bronchospasm, chest tightness, dyspnea, immediate bronchospasm, pneumonia, and wheeze.

Skin: Contusions and ecchymoses.

Drug Interactions

Inhibitors of Cytochrome P450 3A4

Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with ArmonAir Respiclick is not recommended because increased systemic corticosteroid adverse effects may occur.

Ritonavir: A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology (12.3)]. During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.

Ketoconazole: Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9‑fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.

Side effects

Systemic and local corticosteroid use may result in the following:

  • Candida albicans infection [see WARNINGS AND PRECAUTIONS]
  • Immunosuppression [see WARNINGS AND PRECAUTIONS]
  • Hypercorticism and adrenal suppression [see WARNINGS AND PRECAUTIONS]
  • Reduction in bone mineral density [see WARNINGS AND PRECAUTIONS]
  • Growth effects in pediatrics [see WARNINGS AND PRECAUTIONS]
  • Glaucoma and cataracts [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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

The incidence of adverse reactions associated with ARMONAIR RESPICLICK in Table 1 is based upon two placebo-controlled, 12-week, clinical studies (Study 1 and 2). A total of 822 adolescent and adult patients previously treated with inhaled corticosteroids were treated with twice daily ARMONAIR RESPICLICK 55 mcg, 113 mcg, 232 mcg or placebo. Sixty percent of patients were female and 80% of patients were white. The average duration of exposure was 82 days in ARMONAIR RESPICLICK groups compared with 75 days in the placebo group.

Table 1: Adverse Reactions with ≥ 3% Incidence with ARMONAIR RESPICLICK, and More Common than Placebo in Subjects with Asthma

Adverse Reaction ARMONAIR
RESPICLICK
55 mcg
(n=129)
%
ARMONAIR
RESPICLICK
113 mcg
(n=274)
%
ARMONAIR
RESPICLICK
232 mcg
(n=146)
%
Placebo
(n=273)
%
Infections and infestations
Nasopharyngitis 5.4 5.8 4.8 4.4
URTI 5.4 4.7 5.5 4.8
Oral candidiasis* 3.1 2.9 4.8 0.7
Nervous system disorders
Headache 1.6 7.3 4.8 4.4
Respiratory disorders
Cough 1.6 1.8 3.4 2.6
* Oral candidiasis includes oropharyngeal candidiasis, oral fungal infection, oropharyngitis fungal
URTI = upper respiratory tract infection

Other adverse reactions not previously listed (and occurring in <3% of patients and in three or more patients on ARMONAIR RESPICLICK), whether considered drug-related or not by the investigators, that were reported more frequently by patients with asthma treated with ARMONAIR RESPICLICK compared with patients treated with placebo include the following: Oropharyngeal pain, hypertension, rhinitis allergic, influenza, pyrexia, dizziness, respiratory tract infection, muscle spasms, rhinitis, epistaxis, ligament sprain, musculoskeletal pain, pain in extremity, throat irritation, and vomiting.

Long Term Safety Study

This was a 26-week, open label study of 674 patients previously treated with inhaled corticosteroids who were treated twice daily with ARMONAIR RESPICLICK 113 mcg, 232 mcg, AIRDUO RESPICLICK 113/14 mcg, 232/14 mcg, fluticasone propionate aerosol 110 mcg, 220 mcg, fluticasone propionate and salmeterol inhalation powder 250/50 mcg, 500/50 mcg. The types of adverse reactions among ARMONAIR RESPICLICK treatments were similar to those reported above in placebo controlled studies.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during post-approval use of fluticasone propionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate or a combination of these factors.

Ear, Nose, And Throat

Aphonia, facial and oropharyngeal edema, and throat soreness.

Endocrine And Metabolic

Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, and osteoporosis.

Eye

Cataracts.

Immune System Disorders

Immediate and delayed hypersensitivity reactions, including anaphylaxis, rash, angioedema, and bronchospasm, have been reported. Anaphylactic reactions in patients with severe milk protein allergy have been reported.

Infections And Infestations

Esophageal candidiasis.

Psychiatry

Agitation, aggression, anxiety, depression, and restlessness. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.

Respiratory

Asthma exacerbation, bronchospasm, chest tightness, dyspnea, immediate bronchospasm, pneumonia, and wheeze.

Skin

Contusions and ecchymoses.

Read the entire FDA prescribing information for ArmonAir RespiClick (Fluticasone Propionate Multidose Dry Powder Inhaler for Oral Inhalation)

Read More »

Fluticasone Breastfeeding Warnings

Benefit should outweigh risk Excreted into human milk: Unknown Excreted into animal milk: Yes Comment: Inhaled corticosteroids are generally considered acceptable to use during breastfeeding as the amount, if excreted into breastmilk, would probably be too small to affect a breastfed infant.

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