Flovent HFA Drug Description

The active component of FLOVENT HFA 44 mcg Inhalation Femalefil Aerosol, FLOVENT HFA 110 mcg Inhalation Aerosol, and FLOVENT HFA 220 mcg Inhalation Aerosol is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17 dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:

Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C₂₅H₃₁F₃O₅S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.

FLOVENT HFA 44 mcg Inhalation Aerosol, FLOVENT HFA 110 mcg Inhalation Aerosol, and FLOVENT HFA 220 mcg Inhalation Aerosol are pressurized metered-dose aerosol units fitted with a counter. FLOVENT HFA is intended for oral inhalation only. Each unit contains a microcrystalline suspension of fluticasone propionate (micronized) in propellant HFA 134a (1,1,1,2-tetrafluoroethane). It contains no other excipients.

After priming, each actuation of the inhaler delivers 50, 125, or 250 mcg of fluticasone propionate in 60 mg of suspension (for the 44-mcg product) or in 75 mg of suspension (for the 110- and 220-mcg products) from the valve. Each actuation delivers 44, 110, or 220 mcg of fluticasone propionate from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the device and inspiration through the delivery system.

Each 10.6-g canister (44 mcg) and each 12-g canister (110 and 220 mcg) provides 120 inhalations.

FLOVENT HFA should be primed before using for the first time by releasing 4 test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds and releasing 1 test spray into the air away from the face.

This product does not contain any chlorofluorocarbon (CFC) as the propellant.

SIDE EFFECTS:Hoarseness or throat irritation may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: white patches in your mouth/on your tongue, signs of infection (such as fever, chills, cough, persistent sore throat), vision problems, increased thirst/urination, easy bruising/bleeding, mental/mood changes (such as depression, mood swings, agitation), bone pain.

Infrequently, this medication may cause sudden severe wheezing/trouble breathing immediately after you use it. If this occurs, use your quick-relief inhaler and get medical help right away.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS:Before using fluticasone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/past infections (such as tuberculosis, herpes), certain eye problems (cataracts, glaucoma, herpes infection of the eye), bone loss (osteoporosis), liver disease.

This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may slow down a child's growth if used for a long time, but poorly controlled asthma can also slow down growth. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

What Is FLOVENT HFA Inhalation Aerosol?

FLOVENT HFA contains a medicine called fluticasone propionate, which is a synthetic corticosteroid. Corticosteroids are natural substances found in the body that help fight inflammation. Corticosteroids are used to treat asthma because they reduce Cilafil airway inflammation.

FLOVENT HFA is used to treat asthma in patients 4 years of age and older. When inhaled regularly, FLOVENT HFA also helps to prevent symptoms of asthma.

The medicine is available in 3 different strengths, FLOVENT HFA 44 mcg, FLOVENT HFA 110 mcg, or FLOVENT HFA 220 mcg Inhalation Aerosol, and your doctor has prescribed the one most suitable for you.

1.	FLOVENT HFA is not a bronchodilator and should not be used to give you fast relief from your breathing problems during an asthma attack. You should use a short-acting bronchodilator, such as albuterol inhaler, during an acute asthma attack. You must take FLOVENT HFA at regular times as recommended by your doctor, and not as an emergency medicine.
2.	Tell your doctor before you start taking FLOVENT HFA if you are: pregnant or planning to become pregnant. breastfeeding a baby. allergic to FLOVENT HFA, either of its ingredients, or any other orally inhaled corticosteroids. taking a medicine containing ritonavir (commonly used to treat HIV infection or AIDS). The anti‑HIV medicines NORVIR® (ritonavir capsules) Soft Gelatin, NORVIR (ritonavir oral solution), and KALETRA® (lopinavir/ritonavir) Tablets contain ritonavir. taking other medicines, especially any other orally inhaled corticosteroid, over-the-counter medicines, and herbal products. There may be a time when FLOVENT HFA is not right for you, and your doctor may wish to give you a different medicine. Make sure that your doctor knows what other medicines you are taking.
3.	It is important that you inhale each dose as your doctor has advised. The prescription label provided by your pharmacist will usually tell you what dose to take and how often. If it doesn’t, or if you are not sure, ask your doctor or pharmacist. DO NOT inhale more doses or use your FLOVENT HFA more often than your doctor advises.
4.	It may take 1 to 2 weeks or longer for this medicine to work, and it is very important that you use it regularly. Do not stop taking FLOVENT HFA, even if you are feeling better, unless your doctor tells you to.
5.	If you miss a dose, just take your next scheduled dose when it is due. Do not double the dose.
6.	Your doctor may prescribe additional medicine (such as bronchodilators) for emergency relief if an acute asthma attack occurs. Contact your doctor if: an asthma attack does not respond to the additional medicine or you need more of the additional medicine than usual.
7.	If you also use another medicine by inhalation, you should ask your doctor for instructions on when to use it while you are also using FLOVENT HFA.
	NORVIR and KALETRA are registered trademarks of Abbott Laboratories. Important Information About FLOVENT HFA FLOVENT HFA is for patients with asthma 4 years of age and older. FLOVENT HFA is also for patients who are taking oral steroids, like prednisone, for asthma. Many of these patients may be able to reduce or eliminate their use of oral steroids over time. FLOVENT HFA does not replace fast-acting (rescue) inhalers for sudden symptoms. The use of FLOVENT HFA in children 4 to 11 years old is based in part on results of studies in patients 12 years and older and other FLOVENT products.