Flovent HFA

Flovent HFA is a prescription medication used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Flovent HFA is in a class of medications called corticosteroids. It works by decreasing swelling and irritation in the airways to allow for easier breathing.

Flovent HFA comes as an aerosol for oral inhalation and is typically used twice daily. 

Common side effects of Flovent HFA include upper airway infection or inflammation, throat irritation, and cough.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYPA4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone (Serzone)

This is not a complete list of Flovent HFA drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Flovent HFA including the following:

• fungal infections (thrush) in your mouth and throat. Tell your doctor if you have any redness or white-colored coating in your mouth
• decreased adrenal function (adrenal insufficiency). Symptoms of decreased adrenal function include tiredness, weakness, nausea and vomiting, and low blood pressure. Decreased adrenal function can lead to death.
• allergic reaction (anaphylaxis). Call your doctor and stop Flovent HFA right away if you have any symptoms of an allergic reaction:
  • swelling of the face, throat and tongue
  • hives
  • rash
  • breathing problems
• decreased ability to fight infections. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your doctor about any signs of infection while you use Flovent HFA.
• slow growth in children. The growth of children using Flovent HFA should be checked regularly.
• eye problems including glaucoma and cataracts. Tell your doctor about any vision changes while using Flovent HFA. Your doctor may tell you to have your eyes checked.
• increased wheezing (bronchospasm). Increased wheezing can happen right away after using Flovent HFA. Always have a rescue inhaler with you to treat sudden wheezing.
• lower bone mineral density. This may be a problem for people who already have a higher chance of low bone density (osteoporosis).

• Store Flovent HFA at room temperature.
• Keep this and all medicines out of the reach of children.

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

• It is used to treat asthma.
• Do not use Flovent HFA (fluticasone HFA aerosol inhaler) to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Feeling tired or weak.
• Nose and throat irritation.
• Flu-like signs.
• Runny nose.
• Nose stuffiness.
• Upset stomach or throwing up.
• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Initial doses should be based upon previous therapy and asthma severity:

Fluticasone propionate INHALATION AEROSOL:
-For patients previously receiving bronchodilators alone:
Initial dose: 88 mcg via oral inhalation twice a day
Maximum dose: 440 mcg twice a day
-For patients previously receiving inhaled corticosteroids:
Initial dose: 88 to 220 mcg via oral inhalation twice a day
Maximum dose: 440 mcg twice a day
-For patients previously receiving oral corticosteroids:
Initial dose: 440 mcg via oral inhalation twice a day
Maximum dose: 880 mcg twice a day

Fluticasone propionate INHALATION POWDER:
-For patients previously receiving bronchodilators alone:
Initial dose: 100 mcg via oral inhalation twice a day
Maximum dose: 500 mcg twice a day
-For patients previously receiving inhaled corticosteroids:
Initial dose: 100 to 250 mcg via oral inhalation twice a day
Maximum dose: 500 mcg twice a day
-For patients previously receiving oral corticosteroids:
Initial dose: 500 to 1000 mcg via oral inhalation twice a day
Maximum dose: 1000 mcg twice a day

Fluticasone furoate INHALATION POWDER:
-For patients not previously receiving inhaled corticosteroids:
Initial dose: 100 mcg via oral inhalation once a day
-For patients with prior use of inhaled corticosteroids:
Initial dose 100 to 200 mcg via oral inhalation once a day
Maximum dose: 200 mcg once a day

Comments:
-Inhalation aerosol doses are generally intended to be given by a minimum of 2 inhalations twice a day.
-Higher initial doses may be considered in patients with poorer asthma control or those who have previously required higher doses of other inhaled corticosteroids.
-If asthma stability has not been achieved in 2 weeks, may increase dose without exceeding maximum dose; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects.
-For patients receiving oral corticosteroids,taper oral corticosteroids no more than once weekly beginning after the first week of inhaled therapy; patients should be carefully monitored for asthma instability during transition; once oral corticosteroid taper is complete, inhalation dose should be reduced to the lowest effective dose.
-Not indicated for the relief of acute bronchospasm.

Uses: As prophylactic therapy for the maintenance treatment of asthma and for those patients requiring oral corticosteroids for asthma who may be able to reduce or eliminate their requirement for oral corticosteroids over time.

Safety and efficacy of fluticasone propionate have not been established in patients younger than 4 years.

Safety and efficacy of fluticasone furoate have not been established in patients younger than 12 years

Consult WARNINGS section for additional precautions.

Administration advice:
-For oral inhalation only
-Patients should rinse mouth with water (without swallowing) after each use
-Patients should receive instruction on proper use; children may need assistance to ensure proper use

Storage requirements:
INHALATION AEROSOL:
-Store with mouthpiece down. Contents under pressure; do not puncture or store near heat or open flame
-Discard when counter reads "000" even though the canister is not completely empty
INHALATION POWDER:
-Prior to use: Store in dry place away from direct heat or sunlight
-In use (fluticasone propionate): Remove from pouch immediately before use: Discard 6 weeks (50 mcg) or 2 months (100 and 250 mcg) after opening foil pouch or when counter reads "0"; whichever comes first; the inhaler is not reusable.
-In use (fluticasone furoate): Remove from pouch immediately before use: Discard 6 weeks after opening foil pouch or when counter reads "0"; whichever comes first; the inhaler is not reusable.

Preparation techniques: The manufacturer product information should be consulted for complete instructions.
Fluticasone propionate: INHALATION AEROSOL: Shake well before each spray
Fluticasone propionate INHALATION POWDER: Do no use with a spacer device

General:
-This drug is not intended for acute asthma exacerbations; patients should treat acute asthma symptoms with an inhaled, short-acting beta 2-agonist, such as albuterol.
-Use with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex.
-Patients switching from oral corticosteroid treatment should do so gradually while monitoring HPA axis functions regularly; oral corticosteroid supplementation may be needed during periods of stress.

Monitoring:
-Monitor asthma signs and symptoms including serial objective measures of airflow
-Monitor bone mineral content in patients at high risk of decreased bone mineral density
-Monitor growth regularly in pediatric patients
-Regular eye examinations should be considered, especially in patients with a history of ocular changes or those experiencing visual changes
-Periodically assess oral cavity for signs and symptoms of Candida albicans infection
-Monitor for signs and symptoms of adrenal insufficiency
-Monitor adrenocortical function in patients transferring from corticosteroids with higher systemic effects.

Patient advice:
-Patients should understand that this drug is a corticosteroid; they should know the signs and symptoms of hypercorticism and adrenal suppression.
-Patients should understand that during times of stress, such as surgery or infection, additional oral supplementation may be necessary; they should discuss with their healthcare professional whether they need to carry a medical identification card identifying their corticosteroid use.
-Patients on immunosuppressant doses of corticosteroids should understand that a greater risk of infection exists; they should avoid exposure to chickenpox or measles and if exposed, they should consult their healthcare professional promptly.
-Patients should check with their healthcare provider before taking any new medications, including herbal supplements and over the counter products.
-Patients should be instructed on proper inhaler technique and the importance of regular use.
-Patients should understand this drug is not intended to relieve acute asthma symptoms and a short acting bronchodilator should be used for that; if asthma symptoms do not respond to a short acting bronchodilator, or require higher or more frequent dosing, they should contact their healthcare professional for reevaluation of therapy.
-Patients should be instructed to rinse and spit after oral inhalation use to avoid infection; if infection develops, they should contact their healthcare professional.