Flovent Diskus

DRUG DESCRIPTION

The active component of FLOVENT DISKUS (fluticasone propionate) 50 mcg, FLOVENT DISKUS 100 mcg, and FLOVENT DISKUS 250 mcg is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6?,9-difluoro-11?,17-dihydroxy-16?-methyl-3-oxoandrosta-1,4-diene-17?-carbothioate, 17-propionate and the following chemical structure:

FLOVENT® DISKUS® (fluticasone propionate) Structural Formula Illustration

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 DISKUS (fluticasone propionate) 50 mcg, FLOVENT DISKUS (fluticasone propionate) 100 mcg, and FLOVENT DISKUS (fluticasone propionate) 250 mcg are specially designed plastic inhalation delivery systems containing a double-foil blister strip of a powder formulation of fluticasone propionate intended for oral inhalation only. The DISKUS® inhalation unit, which is the delivery component, is an integral part of the drug product. Each blister on the double-foil strip within the unit contains 50, 100, or 250 mcg of microfine fluticasone propionate in 12.5 mg of formulation containing lactose (which contains milk proteins). After a blister containing medication is opened by activating the DISKUS, the medication is dispersed into the airstream created by the patient inhaling through the mouthpiece.

Under standardized in vitro test conditions, FLOVENT DISKUS delivers 46, 94, or 229 mcg of fluticasone propionate from FLOVENT DISKUS (fluticasone propionate) 50 mcg, FLOVENT DISKUS 100 mcg, or FLOVENT DISKUS (fluticasone propionate) 250 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult patients with obstructive lung disease and severely compromised lung function (mean forced expiratory volume in 1 second [FEV1] 20% to 30% of predicted), mean peak inspiratory flow (PIF) through a DISKUS was 82.4 L/min (range, 46.1 to 115.3 L/min). In children with asthma 4 and 8 years old, mean PIF through FLOVENT DISKUS (fluticasone propionate) was 70 and 104 L/min, respectively (range, 48 to 123 L/min).

The actual amount of drug delivered to the lung may depend on patient factors, such as inspiratory flow profile.

What are the precautions when taking fluticasone propionate (Flovent Diskus)?

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 (such as lactose, milk proteins), 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...

Read All Potential Precautions of Flovent Diskus »


Flovent Diskus Consumer (continued)

SIDE EFFECTS: Hoarseness, throat irritation, or headache may occur. If any of these effects persist or worsen, 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 (such as lactose, milk proteins), 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.



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