Flonase eent

Synthetic trifluorinated corticosteroid.1 2 3 6 7 8 26 48 65 66

Seasonal and Perennial Rhinitis

Symptomatic treatment of seasonal or perennial rhinitis when conventional therapy with antihistamines or decongestants is ineffective or is not tolerated.1 2 7 16 19 27 33 34 46 51 54 55 57 71 73 74 76 78 110 113 122 123

Generally provides symptomatic relief of watery rhinorrhea, nasal congestion, sneezing, postnasal drip, and nasal itching;1 2 7 16 19 27 33 34 46 51 55 59 122 123 124 generally does not relieve signs and symptoms of conjunctivitis, although improvement in ophthalmic manifestations may occur.19 62 110 113

Relieves symptoms in both allergic1 2 7 16 19 27 33 34 46 51 54 55 71 73 74 76 78 110 113 122 123 and nonallergic1 57 113 rhinitis, although experience is more extensive with allergic rhinitis.1 2 7 16 19 27 33 34 46 51 54 55 57 71 73 74 76 78 110 113 122 123

Has been used successfully prior to the onset of the pollen season for the prophylaxis of symptoms of seasonal allergic rhinitis†.21

• Potent glucocorticoid and weak mineralocorticoid effects.48 110 113 117

• Local anti-inflammatory and vasoconstrictor effects17 22 55 58 63 result from local actions of the deposited inhaled dose on the nasal mucosa.1 13 22 56 67

• Reduces the number of mediator cells (basophils,2 5 7 13 17 27 35 46 51 55 57 58 eosinophils,2 4 5 7 9 13 17 27 35 46 50 51 55 57 58 60 61 63 116 helper-inducer [CD4+, T4+] T-cells,4 60 116 mast cells,7 50 60 61 116 and neutrophils)2 7 13 35 in the nasal mucosa. Also reduces nasal reactivity to allergens and release of inflammatory mediators63 and proteolytic enzymes.63

• May inhibit nasal postcapillary venule dilation and permeability.22 55 62

• May facilitate nasomucociliary clearance of nasal secretions.22 55 62

• May decrease nasal turbinate swelling, mucosal inflammation,22 55 and nasal hyperreactivity.2 4 5 9 10 49

• Proper techniques for assembly and priming of nasal spray pump and for administration and storage of the nasal solution.1

• Importance of not administering the entire dose (i.e., 2–4 sprays) into a single nostril.1

• Give patients a copy of the manufacturer’s patient instructions.1

• Advise patients to cleanse the nasal spray adapter and/or pump at least once weekly.6 110 b

• Importance of shaking containers of nasal spray gently prior to each use.b

• Importance of discarding the container after 120 actuations or once the expiration date on the label is reached.1 b

• Caution against spraying into eyes or directly on nasal septum.1 67 79

• Advise patients that effects are not immediate; full benefit requires regular use and usually can be achieved in several days.1 110

• Importance of taking as directed and not exceeding prescribed dosage.1

• Importance of informing clinician if symptoms fail to improve or if symptoms worsen.1

• Importance of not increasing dosage unless directed by a clinician.1

• Importance of advising clinician if sneezing or nasal irritation occurs.1

• Advise that concomitant nasal decongestants and/or oral antihistamines may be needed until effects of fluticasone are optimal.

• If receiving immunosuppressive doses of corticosteroids, importance of avoiding exposure to chickenpox or measles, and if exposed, to notify a clinician.1 89 98 99 100

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

You should not use Flonase if you are allergic to fluticasone.

Fluticasone can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

To make sure you can safely use Flonase, tell your doctor if you have any of these other conditions:

• tuberculosis or any other infection or illness;

• glaucoma or cataracts;

• liver disease;

• herpes simplex virus of your eyes;

• sores or ulcers inside your nose; or

• if you have recently had injury of or surgery on your nose.

If you use Flonase without a prescription and you have any medical conditions, ask a doctor or pharmacist if this medicine is safe for you.

Also tell your doctor if you have diabetes. Corticosteroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

It is not known whether Flonase will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant or plan to become pregnant.

It is not known whether fluticasone nasal passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Corticosteroid medicine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Use Flonase exactly as prescribed by your doctor or as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Do not share this medicine with another person, even if they have the same symptoms you have.

The usual dose of Flonase is 1 to 2 sprays into each nostril once per day. Your dose may change after your symptoms improve. Follow all dosing instructions very carefully.

Do not use Flonase in a child younger than 4 years old.

Any child using Flonase should be supervised by an adult while using the nasal spray.

This medication comes with patient instructions for safe and effective use, and directions for priming the inhaler device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Before your first use, prime the nasal spray pump by shaking the medicine well and spraying 6 test sprays into the air (away from your face), until a fine mist appears. Prime the Flonase spray pump any time you have not used it for 7 days or longer.

Using your Flonase Nasal Spray. Shake the inhaler device gently just before each use:

• Step 1. Blow your nose to clear your nostrils.

• Step 2. Close 1 nostril. Tilt your head forward slightly and, keeping the bottle upright, carefully insert the Flonase nasal applicator into the other nostril.

• Step 3. Start to breathe in through your nose, and while breathing in press firmly and quickly down 1 time on the applicator to release the spray. To get a full dose, use your forefinger and middle finger to spray while supporting the base of the bottle with your thumb. Avoid spraying in eyes. Breathe gently inwards through the nostril.

• Step 4. Breathe out through your mouth.

• Step 5. If a second spray of Flonase is required in that nostril, repeat steps 2 through 4.

• Step 6. Repeat steps 2 through 5 in the other nostril.

• Step 7. Wipe the nasal applicator with a clean tissue and replace the dust cover).

If you switched to fluticasone from another corticosteroid medicine, do not stop using the other corticosteroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about tapering your corticosteroid dose before stopping completely.

To be sure Flonase is not causing harmful effects on your nose or sinuses, your doctor may need to check your progress on a regular basis.

It may take up to several days before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after a week of treatment.

Store Flonase in an upright position at room temperature, away from moisture and heat. Throw the spray bottle away after you have used 120 sprays, even if there is still medicine left in the bottle.

• Flonase is a brand (trade) name for fluticasone nasal spray.
• Fluticasone is thought to work by controlling the release of prostaglandins and other substances that promote inflammation. Fluticasone reduces inflammation and relieves itching. It can also help constrict (narrow) blood vessels.
• Fluticasone belongs to the group of medicines known as corticosteroids.

AU, UK: Benefit should outweigh risk. US: Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.