Flovent HFA

DRUG DESCRIPTION

The active component of FLOVENT HFA 44 mcg Inhalation 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) 6?,9-difluoro-11?,17 dihydroxy-16?-methyl-3-oxoandrosta-1,4-diene-17?-carbothioate, 17-propionate and the following chemical structure:

FLOVENT HFA (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 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.

What are the possible side effects of fluticasone inhalation (Flovent Diskus, Flovent HFA)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • weakness, tired feeling, nausea, vomiting, feeling like you might pass out;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • blurred vision, eye pain, or seeing halos around lights;
  • signs of infection such as...

Read All Potential Side Effects and See Pictures of Flovent HFA

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

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...

Read All Potential Precautions of Flovent HFA


Flovent HFA Consumer (continued)

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.


Flovent HFA Patient Information Including Side Effects

Brand Names: Flovent Diskus, Flovent HFA

Generic Name: fluticasone inhalation (Pronunciation: floo TIK a zone)

  • What is fluticasone inhalation (Flovent HFA)?
  • What are the possible side effects of fluticasone inhalation (Flovent HFA)?
  • What is the most important information I should know about fluticasone inhalation (Flovent HFA)?
  • What should I discuss with my healthcare provider before using fluticasone inhalation (Flovent HFA)?
  • How should I use fluticasone inhalation (Flovent HFA)?
  • What happens if I miss a dose (Flovent HFA)?
  • What happens if I overdose (Flovent HFA)?
  • What should I avoid while using fluticasone inhalation (Flovent HFA)?
  • What other drugs will affect fluticasone inhalation (Flovent HFA)?
  • Where can I get more information?

What is fluticasone inhalation (Flovent HFA)?

Fluticasone is a steroid. It prevents the release of substances in the body that cause inflammation.

Fluticasone inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.

Fluticasone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fluticasone inhalation (Flovent HFA)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • weakness, tired feeling, nausea, vomiting, feeling like you might pass out;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • blurred vision, eye pain, or seeing halos around lights;
  • signs of infection such as fever, chills, sore throat, ear pain, flu symptoms;
  • wheezing or breathing problems after using this medication; or
  • worsening asthma symptoms.

Less serious side effects may include:

  • headache;
  • dryness in your mouth, nose, or throat;
  • white patches or sores inside your mouth or on your lips;
  • stuffy nose, sinus pain, cough; or
  • hoarseness or deepened voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fluticasone inhalation (Flovent HFA)?

Do not use fluticasone inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack.

Contact your doctor if your asthma symptoms do not improve after using fluticasone inhalation for 2 weeks.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

If you were switched from an oral (taken by mouth) steroid to fluticasone inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency.

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