Fluticasone Propionate (Page 5 of 6)

14 CLINICAL STUDIES

Perennial Nonallergic Rhinitis

Three randomized, double-blind, parallel-group, vehicle placebo-controlled trials were conducted in 1,191 subjects to investigate regular use of fluticasone propionate nasal spray in subjects with perennial nonallergic rhinitis. These trials evaluated subject-rated total nasal symptom scores (TNSS) that included nasal obstruction, postnasal drip, rhinorrhea in subjects treated for 28 days of double-blind therapy and in 1 of the 3 trials for 6 months of open-label treatment. Two of these trials demonstrated that subjects treated with fluticasone propionate nasal spray (100 mcg twice daily) exhibited statistically significant decreases in TNSS compared with subjects treated with vehicle.

16 HOW SUPPLIED/STORAGE AND HANDLING

Fluticasone Propionate Nasal Spray USP, 50 mcg, is supplied in an amber glass bottle fitted with a silver metering nasal pump, white plastic actuator, and translucent cap in a box of 1 (NDC 68788-9678-1) with a package insert (prescribing information and patient leaflet). Each bottle contains a net fill weight of 16 g and will provide 120 actuations. Each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. The correct amount of medication in each spray cannot be assured after 120 sprays even though the bottle is not completely empty. The bottle should be discarded when the labeled number of actuations has been used.

Store between 4°C to 30°C (39°F to 86°F).

Shake gently before each use.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Local Nasal Effects

Inform patients that treatment with fluticasone propionate nasal spray may lead to adverse reactions, which include epistaxis and nasal ulceration. Candida infection may also occur with treatment with fluticasone propionate nasal spray. In addition, fluticasone propionate nasal spray has been associated with nasal septal perforation and impaired wound healing. Patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use fluticasone propionate nasal spray until healing has occurred [see Warnings and Precautions (5.1)].

Glaucoma and Cataracts

Inform patients that glaucoma and cataracts are associated with nasal and inhaled corticosteroid use. Advise patients to notify their healthcare providers if a change in vision is noted while using fluticasone propionate nasal spray [see Warnings and Precautions (5.2)].

Hypersensitivity Reactions, including Anaphylaxis

Inform patients that hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, contact dermatitis, and rash, may occur after administration of fluticasone propionate nasal spray. If such reactions occur, patients should discontinue use of fluticasone propionate nasal spray [see Warnings and Precautions (5.3)].

Immunosuppression

Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and if they are exposed to consult their healthcare provider without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions (5.4)].

Reduced Growth Velocity

Advise parents that fluticasone propionate nasal spray may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route [see Warnings and Precautions (5.7), Pediatric Use (8.4)].

Use Daily for Best Effect

Inform patients that they should use fluticasone propionate nasal spray on a regular basis. Fluticasone propionate nasal spray, like other corticosteroids, does not have an immediate effect on rhinitis symptoms. Maximum benefit may not be reached for several days. Patients should not increase the prescribed dosage but should contact their healthcare providers if symptoms do not improve or if the condition worsens.

Keep Spray Out of Eyes and Mouth

Inform patients to avoid spraying fluticasone propionate nasal spray in their eyes and mouth.

APOTEX INC.

FLUTICASONE PROPIONATE NASAL SPRAY USP

50 mcg

Manufactured by

Manufactured for

Apotex Inc.

Apotex Corp.

Toronto, Ontario

Weston, FL

Canada M9L 1T9

33326

January 2021

Patient Information
Fluticasone Propionate Nasal Spray, USP

What is fluticasone propionate nasal spray?

Fluticasone propionate nasal spray is a prescription medicine used to treat non-allergy nasal symptoms such as runny nose, stuffy nose, sneezing, and nasal itching in adults and children aged 4 years and older.

It is not known if fluticasone propionate nasal spray is safe and effective in children younger than 4 years of age.

Do not use fluticasone propionate nasal spray if you are allergic to fluticasone propionate or any of the ingredients in fluticasone propionate nasal spray. See “What are the ingredients in fluticasone propionate nasal spray?” below for a complete list of ingredients.

Before using fluticasone propionate nasal spray, tell your healthcare provider about all of your medical conditions, including if you:

1.
have or have had nasal sores, nasal surgery, or nasal injury.
2.
have or have had eye problems, such as glaucoma or cataracts.
3.
have an immune system problem.
4.
have any type of viral, bacterial, or fungal infection.
5.
are exposed to chickenpox or measles.
6.
are pregnant or planning to become pregnant. It is not known if fluticasone propionate Nasal Spray may harm your unborn baby.
7.
are breastfeeding or plan to breastfeed. It is not known if fluticasone propionate Nasal Spray passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Fluticasone propionate nasal spray and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you take antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use fluticasone propionate nasal spray?

Read the step-by-step instructions for using fluticasone propionate nasal spray at the end of this Patient Information.

1.
Fluticasone propionate nasal spray is for use in your nose only. Do not spray it in your eyes or mouth.
2.
Children should use fluticasone propionate nasal spray with an adult’s help, as instructed by the child’s healthcare provider.
3.
Use fluticasone propionate nasal spray exactly as your healthcare provider tells you. Do not use fluticasone propionate nasal spray more often than prescribed.
4.
fluticasone propionate nasal spray may take several days of regular use for your rhinitis symptoms to get better. If your symptoms do not improve or get worse, call your healthcare provider.
5.
You will get the best results if you keep using fluticasone propionate nasal spray regularly each day without missing a dose. After you begin to feel better, your healthcare provider may decrease your dose. Do not stop using fluticasone propionate nasal spray unless your healthcare provider tells you to do so.

What are the possible side effects of fluticasone propionate nasal spray?

Fluticasone propionate nasal spray may cause serious side effects, including:

1.
nose problems. Nose problems may include:
1.2.
nose bleeds.
2.2.
sores (ulcers) in your nose.
3.2.
a certain fungal infection in your nose, mouth, or throat (thrush).
4.2.
hole in the cartilage of your nose (nasal septal perforation).
Symptoms of nasal septal perforation may include:
1.2.3.
crusting in the nose
2.2.3.
nose bleeds
3.2.3.
runny nose
4.2.3.
whistling sound when you breathe
5.2.
slow wound healing. You should not use fluticasone propionate nasal spray until your nose has healed if you have a sore in your nose, have had surgery on your nose, or if your nose has been injured.
2.
glaucoma and cataracts. Using nasal and inhaled corticosteroid medicines may result in you developing glaucoma and/or cataracts. Your healthcare provider may have you see an eye doctor (ophthalmologist) if you develop eye symptoms or use fluticasone propionate nasal spray for long periods of time. Tell your healthcare provider if you have any changes in your eye-sight while using fluticasone propionate nasal spray.
3.
serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following signs of a serious allergic reaction:
6.2.
rash
7.2.
hives
8.2.
swelling of your face, mouth, and tongue
9.2.
breathing problems
4.
weakened immune system and increased chance of getting infections (immunosuppression). Taking medicines that weaken your immune system makes you more likely to get infections and can make certain infections worse. These infections may include tuberculosis (TB), ocular herpes simplex infections, and infections caused by fungi, bacteria, viruses, and parasites. Avoid contact with people who have a contagious disease such as chickenpox or measles while using fluticasone propionate nasal spray. If you come in contact with someone who has chickenpox or measles call your healthcare provider right away. Symptoms of an infection may include:
10.2.
fever
11.2.
pain
12.2.
aches
13.2.
chills
14.2.
feeling tired
15.2.
nausea
16.2.
vomiting
5.
lowered steroid hormone levels (adrenal insufficiency). Adrenal insufficiency happens when your adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking medicine containing an inhaled steroid (such as fluticasone propionate nasal spray). Symptoms of adrenal insufficiency may include:
17.2.
feeling tired
18.2.
lack of energy
19.2.
weakness
20.2.
nausea and vomiting
21.2.
low blood pressure
6.
slowed growth in children. A child’s growth should be checked often.

The most common side effects of fluticasone propionate nasal spray include:

1.
headache
2.
sore throat
3.
nose bleeds
4.
nose burning or itching
1.
nausea and vomiting
2.
trouble breathing
3.
cough

These are not all the possible side effects with fluticasone propionate nasal spray.

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

How do I store fluticasone propionate nasal spray?

1.
Store fluticasone propionate nasal spray between 4ºC to 30ºC (39ºF and 86ºF).

Keep fluticasone propionate nasal spray and all medicines out of the reach of children.

General information about the safe and effective use of fluticasone propionate nasal spray.

Medicines are sometimes prescribed for purposes not mentioned in a Patient Information leaflet. Do not use fluticasone propionate nasal spray for a condition for which it was not prescribed. Do not give your fluticasone propionate nasal spray to other people, even if they have the same condition that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about fluticasone propionate nasal spray that was written for healthcare professionals.

What are the ingredients in fluticasone propionate nasal spray?

Active ingredient: fluticasone propionate.

Inactive ingredients: benzalkonium chloride, carboxymethylcellulose sodium, cellulose, dextrose microcrystalline polysorbate 80, 0.25% w/w phenylethyl alcohol and purified water.

For more information about fluticasone propionate nasal spray, call 1-800-706-5575.

Instructions for Use

Fluticasone Propionate Nasal Spray, USP

Fluticasone propionate nasal spray is for use in your nose only.

Read this information before you start using your fluticasone propionate nasal spray.

BEFORE USING

Parts of your Fluticasone Propionate Nasal Spray (See Fig 1)

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(click image for full-size original)

Shake the bottle gently and then remove the translucent cap (Fig. 2).

//medlibrary.org/lib/images-rx/fluticasone-propionate-16/figure-2-271x300.jpg
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It is necessary to prime the pump into the air the first time it is used, or when you have not used it for a week or more. To prime the pump, hold the bottle as shown with the nasal applicator pointing away from you and with your forefinger and middle finger on either side of the nasal applicator and your thumb underneath the bottle. When you prime the pump for the first time, press down and release the pump 6 times. (Fig. 3).

The pump is now ready for use. If the pump is not used for 7 days, prime until a fine spray appears.

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USING FLUTICASONE PROPIONATE NASAL SPRAY

Step 1. Blow your nose to clear your nostrils.

Step 2. Close one nostril. Tilt your head forward slightly and, keeping the bottle upright, carefully insert the nasal applicator into the other nostril (Fig. 4).

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(click image for full-size original)

Step 3. Start to breathe in through your nose, and WHILE BREATHING IN press firmly and quickly down once on the applicator to release the spray. To get a full actuation, 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 (Fig. 5).

//medlibrary.org/lib/images-rx/fluticasone-propionate-16/figure-5-261x300.jpg
(click image for full-size original)

Step 4. Breathe out through your mouth.

Step 5. If a second spray 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 translucent cap (Fig. 6).

//medlibrary.org/lib/images-rx/fluticasone-propionate-16/figure-6-267x300.jpg
(click image for full-size original)

Do not use this bottle for more than the labeled number of sprays even though the bottle is not completely empty. Before you throw the bottle away, you should talk to your healthcare provider to see if a refill is needed. Do not take extra doses or stop taking fluticasone propionate nasal spray without talking to your healthcare provider.

Cleaning your fluticasone propionate nasal spray

Your nasal spray should be cleaned at least once a week. To do this:

1. Remove the translucent cap and then gently pull upwards to free the nasal applicator.

2. Wash the applicator and translucent cap under warm tap water. Allow to dry at room temperature.

3. Place the applicator and translucent cap back on the bottle.

4. If the nasal applicator becomes blocked, it can be removed as above and left to soak in warm water. Rinse with cold tap water, dry, and refit. Do not try to unblock the nasal applicator by inserting a pin or other sharp object.

STORING YOUR NASAL SPRAY

1.
Keep your fluticasone propionate nasal spray out of the reach of children.
2.
Avoid spraying in eyes.
3.
Store between 4ºC to 30ºC (39ºF to 86ºF).
4.
Do not use your fluticasone propionate nasal spray after the expiry date shown on the label or box.

REMEMBER: This medicine has been prescribed for you by your doctor. DO NOT give this medicine to anyone else.

FURTHER INFORMATION

This patient leaflet does not contain the complete information about your medicine. If you have any questions, or are not sure about something, then you should ask your doctor or pharmacist.

You may want to read this patient leaflet again. Please DO NOT THROW IT AWAY until you have finished your medicine.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

APOTEX INC.

FLUTICASONE PROPIONATE NASAL SPRAY USP

50 mcg

Manufactured by

Manufactured for

Apotex Inc.

Apotex Corp.

Toronto, Ontario

Weston, FL

Canada M9L 1T9

33326

January 2021

Relabeled By: Preferred Pharmaceuticals Inc.

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