Pronunciation:

floo-TIK-a-sone PROE-pee-oh-nate

Brand Names:

• Flonase

Dosage Forms:

• Spray

Classifications:

Therapeutic—

Corticosteroid, Intermediate

Pharmacologic—

Fluticasone

Uses of This Medicine:

Fluticasone belongs to the family of medicines known as corticosteroids (cortisone-like medicines). Corticosteroids belong to the family of medicines called steroids. Fluticasone is sprayed into the nose to help relieve the stuffy or runny nose, irritation, sneezing, and discomfort of hay fever, other nasal allergies, and these symptoms when not caused by allergies.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

There is no specific information comparing the use of nasal fluticasone in children up to 4 years of age with use in other age groups. Corticosteroids taken by mouth or injection have been shown to slow growth in children and cause reduced adrenal gland function. Before nasal fluticasone is given to a child, you and the child's doctor should talk about the good this medicine will do as well as the risks of using it.

Older adults—

Although there is no specific information comparing use of nasal corticosteroids in the elderly with use in other age groups, these medicines are not expected to cause different side effects or problems in older people than they do in younger adults.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir
• Boceprevir
• Bupropion
• Clarithromycin
• Cobicistat
• Conivaptan
• Dabrafenib
• Darunavir
• Eslicarbazepine Acetate
• Indinavir
• Itraconazole
• Ketoconazole
• Nefazodone
• Nelfinavir
• Piperaquine
• Pixantrone
• Posaconazole
• Primidone
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Tipranavir
• Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Glaucoma—Rare cases of glaucoma have been reported following use of nasal corticosteroids, including nasal fluticasone

• Herpes simplex (virus) infection of the eye or
• Infections (viral, bacterial, parasitic, or fungal)—Nasal corticosteroids may cover up the signs of these infections

• Injury to the nose (recent) or
• Nose surgery (recent) or
• Sores in the nose—Nasal corticosteroids may prevent proper healing of these conditions

• Tuberculosis (active or history of)—Nasal corticosteroids may cover up the signs of this infection or cause it to start up again

Proper Use of This Medicine:

This medicine usually comes with patient directions. Read them carefully before using the medicine.

Before using this medicine, prime the pump on the medicine bottle and clear the nasal passages by blowing your nose. Then, insert the nosepiece into the nostril, and with the head tilted slightly forward, spray while breathing in gently through the nostril.

Avoid spraying in the eyes.

In order for this medicine to help you, it must be used regularly as ordered by your doctor. This medicine usually begins to work in about 12 hours, but several days may pass before you feel its full effects.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of absorption through the lining of the nose and the chance of unwanted effects.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal spray dosage form:
  • For allergies:
    • Adults—2 sprays in each nostril once a day, or 1 spray in each nostril two times a day. Later, your doctor may decrease your dose to 1 spray in each nostril once a day.
    • Children 4 years of age and older (including teenagers)—1 spray in each nostril once a day. Your doctor may need to increase the dose in some children, up to 2 sprays in each nostril once a day, or 1 spray in each nostril twice a day.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

If you will be using this medicine for more than a few weeks, your doctor should check your progress at regular visits.

Check with your doctor:

• if signs of a nose, sinus, or throat infection occur.
• if your symptoms do not improve within 3 weeks.
• if your condition gets worse.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Bloody mucus or unexplained nosebleeds

cough

headache

nausea

shortness of breath

vomiting

Less common

Diarrhea

dizziness

excessive mucus

fever

general aches and pains

loss of appetite

stomach pain

weakness

runny nose

Rare

White patches inside nose or throat

Symptoms of overdose

Blindness

blurred vision

bone fractures

excess facial hair growth in females

fullness of face, neck, and trunk

high blood pressure

impotence in males

increased thirst or urination

lack of menstrual periods

muscle wasting

weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Burning, dryness, or other irritation inside the nose

sore throat

Less common

Runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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