Fluticasone

Name: Fluticasone

What Is Flonase (Fluticasone)?

Flonase is the brand name for fluticasone nasal spray, a prescription drug used to prevent and reduce nasal inflammation.

Doctors prescribe Flonase to treat symptoms of seasonal and year-round allergies.

Flonase is a corticosteroid, a class of drugs (also referred to as steroids) that's used to reduce inflammation in the nasal passages, lungs, and skin, and is sometimes given orally for more severe conditions.

In 2006, the Food and Drug Administration (FDA) approved the sale of fluticasone propionate nasal spray (the generic form of Flonase).

Flonase works by reducing inflammation and swelling in the nose, which can lead to a number of allergy symptoms, including:

  • Sneezing
  • Congested or stuffy nose
  • Runny nose
  • Itchy nose

Other nasal steroids are available over-the-counter, such as Rhinocort (budesonide).

Veramyst (fluticasone furoate) is a prescription steroid that's ideal for people who benefit from fluticasone yet do not tolerate the occasional dripping into the throat linked to Flonase.

Other Uses for Fluticasone

Fluticasone is also available (under other brand names) as an aerosol inhaled by mouth, and as a topical cream or ointment applied to the skin.

Flovent (fluticasone oral inhalation) helps people with asthma breathe more easily and reduces tightness in the chest. It can also treat asthma-related wheezing and coughing.

There is research suggesting that inhaled steroids such as fluticasone may benefit people with stable chronic obstructive pulmonary disease (COPD).

A study published in the International Journal of Chronic Obstructive Pulmonary Disease in 2014 found that a once-daily dry powder inhaler combination therapy could improve people's adherence to long-term inhaled therapy as well as their prognosis.

In the United States, GlaxoSmithKline markets fluticasone as Flovent for the treatment of asthma, as well as the combination of fluticasone and salmeterol as Advair for the treatment of asthma and COPD.

Additionally, doctors prescribe topical fluticasone to reduce inflammation and relieve symptoms associated with certain skin conditions, including:

  • Itching
  • Redness
  • Dryness
  • Scaling

PharmaDerm, a division of Fougera Pharmaceuticals, manufactures topical fluticasone and sells it under the brand name Cutivate.

Flonase Warnings

You may not experience the full benefits of Flonase for two weeks or more after starting treatment.

Fluticasone may also make it harder for your body to fight off infections. While taking the drug, your body may be less able to manage the stress of surgery, illness, severe asthma attack, or injury.

While taking fluticasone, you should avoid people who are sick, especially those with chickenpox or measles. If you get one of these infections or if you develop related symptoms, call your doctor right away.

Flonase could increase your risk for developing osteoporosis, a condition that causes the bones to become thin and break easily. If you're already at greater risk for osteoporosis, it's important to have your bone density assessed both before and during treatment.

Research shows that in rare cases, people taking fluticasone for a long period of time may develop glaucoma or cataracts.

Before taking fluticasone, be sure to let your doctor know if you've ever had any of the following:

  • Glaucoma
  • Cataracts
  • Other illnesses
  • Recurring infections (such as herpes)
  • Allergies
  • Tuberculosis
  • Liver disease

Also let your doctor know if you've never had chickenpox or measles and never got a vaccination against those diseases.

Although fluticasone can help prevent asthma attacks, it will not stop an attack that has already begun. Don't use fluticasone during an asthma attack.

You should also let your doctor know if you have any type of surgery planned, including dental procedures.

Flonase and Pregnancy

Be sure your doctor knows if you are pregnant, may become pregnant, or are breastfeeding.

There's not enough evidence to know whether Flonase is safe for pregnant women or breastfeeding infants.

Evidence also is lacking on whether nasal or inhaled fluticasone is safe or effective for treating kids younger than 4.

Children older than 4 who take the drug may grow more slowly, and it's unclear whether their final adult height will be shorter than it would have been had they not taken fluticasone.

Children 3 months and older can use topical fluticasone with caution. There's no evidence of safety or effectiveness of the drug when used on young children for longer than 4 weeks.

Flonase Interactions

Certain drugs may affect the way Flonase works, and the drug could also affect other medications.

It's very important to let your doctor know about everything you are taking, including recreational drugs as well as any over-the-counter medications, herbs, or supplements.

Types of drugs known to interact with Flonase or fluticasone include:

  • Drugs used to treat HIV, including ritonavir (Norvir), saquinavir (Fortovase, Invirase)
  • Antifungal medications, such as itraconazole (Sporanox), fluconazole (Diflucan), and ketoconazole (Nizoral)
  • Antidepressants, such as nefazodone (Serzone), fluoxetine (Prozac, Sarafem), and paroxetine (Paxil)
  • Certain antibiotics, including clarithromycin (Biaxin) and metronidazole (Flagyl)
  • Oral steroids, such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone)
  • Some drugs used to treat mental illness, such as fluvoxamine (Luvox)
  • The heartburn drug cimetidine (Tagamet)
  • Certain heart medications, such as amiodarone (Cordarone) and verapamil (Calan, Covera, Isoptin, Verelan)
  • Hormonal contraceptives, including birth control pills, patches, rings, injections, and implants
  • The asthma drug zafirlukast (Accolate)

Fluticasone Brand Names

Fluticasone may be found in some form under the following brand names:

  • Advair Diskus

  • Breo Ellipta

  • Cutivate

  • Dymista

  • Flonase

  • Flonase Sensimist

  • Flovent HFA

  • Veramyst

Side Effects of Fluticasone

Inhalational:

  • Common side effects of fluticasone inhalational include
    • upper airway infection or inflammation
    • throat irritation
    • sinus infection
    • hoarse voice
    • candidiasis
    • cough
    • headache

Topical:

  • Common side effects of fluticasone nasal spray include
    • headache
    • nosebleeds
    • irritated or burning nose
    • runny nose
    • cough
    • nausea
    • stomach pain
    • vomiting
    • diarrhea
    • dizziness

Stinging or sneezing may occur for a few seconds right after use of fluticasone nasal spray.

  • Common side effects of fluticasone lotion, ointment, and cream include
    • itching
    • burning
    • increased redness
    • hives
    • irritation
    • lightheadedness
    • an abnormal amount of hair growth over the body (hypertrichosis)

This is not a complete list of fluticasone side effects. Ask your doctor or pharmacist for more information.

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

Fluticasone Precautions

Inhalational:

  • 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 fluticasone 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 fluticasone.
  • slow growth in children. The growth of children using fluticasone should be checked regularly.
  • eye problems including glaucoma and cataracts. Tell your doctor about any vision changes while using fluticasone. Your doctor may tell you to have your eyes checked.
  • increased wheezing (bronchospasm). Increased wheezing can happen right away after using fluticasone. 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).

Topical:

  • Nasal Spray
    • nose problems. Nose problems may include:
      • nose bleeds
      • sores (ulcers) in your nose
      • a certain fungal infection in your nose, mouth, and/or throat (thrush)
      • hole in the cartilage of your nose (nasal septal perforation). Symptoms of nasal septal perforation may include:
    • crusting in the nose
    • nose bleeds
    • runny nose
    • whistling sound when you breathe
    • decrease in the activity of your immune system. This will make you more likely to get an infection. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your doctor if you are exposed to chickenpox or measles.
    • slow growth in children. A child using fluticasone nasal spray should have his/her growth checked regularly.
    • eye conditions including glaucoma and cataracts. Tell your doctor about any vision changes while using fluticasone nasal spray. Be sure to have regular eye exams while you are taking this medication.
    • slow the healing of wounds. Do not use fluticasone nasal spray until your nose has healed if you have a sore in your nose, if you have surgery on your nose, or if your nose has been injured.
    • hypersensitivity reaction:  An allergic reaction to fluticasone nasal spray can occur. Tell your doctor if you experience any of the following symptoms of an allergic reaction:
      • difficulty breathing or swallowing
      • hives or rash
      • swelling
      • hoarseness

Fluticasone nasal spray can cause dizziness. Do not drive or operate machinery until you know how fluticasone nasal spray affects you.

To avoid withdrawal side effects, do not stop using fluticasone nasal spray at once. Discuss with your doctor about slowly decreasing the dose before stopping use of this medication altogether.

Do not take fluticasone nasal spray if you:

  • are allergic to fluticasone nasal spray or any of its ingredients
  • are taking ritonavir (Norvir)
  • Lotion, ointment, or cream
    • 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.

Inform MD

Before using fluticasone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to fluticasone or any of its ingredients
  • are exposed to measles or chickenpox
  • have liver problems
  • take ritonavir (Norvir)
  • take any antifungal medication
  • have an immune system problem
  • have any type of viral, bacterial, or fungal infection
  • have a history of glaucoma or cataracts
  • have or have had nasal sores, nasal surgery, or nasal injury (fluticasone nasal spray)
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

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

Overdosage

Topically applied Fluticasone Propionate Cream can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

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Fluticasone PROPIONATE 
Fluticasone propionate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53217-164(NDC:0713-0631)
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fluticasone PROPIONATE (Fluticasone) Fluticasone PROPIONATE 0.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL  
MINERAL OIL  
CETOSTEARYL ALCOHOL  
CETETH-20  
ISOPROPYL MYRISTATE  
SODIUM PHOSPHATE, DIBASIC  
CITRIC ACID MONOHYDRATE  
WATER  
METHYLPARABEN  
Packaging
# Item Code Package Description
1 NDC:53217-164-01 1 TUBE in 1 CARTON
1 15 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077055 06/30/2006
Labeler - Aidarex Pharmaceuticals LLC (801503249)
Revised: 02/2017   Aidarex Pharmaceuticals LLC
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