Azelastine Hydrochloride and Fluticasone Propionate (Page 8 of 9)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied: Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray (NDC 0378-3458-23) is supplied as an amber glass bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump with a white nasal adapter and clear plastic dust cap. Each bottle contains a net fill weight of 23 g and will deliver 120 metered sprays after priming [see Dosage and Administration (2.2)]. After priming [see Dosage and Administration (2.2)] , each spray delivers a suspension volume of 0.137 mL as a fine mist, containing 137 mcg of azelastine hydrochloride and 50 mcg of fluticasone propionate (137 mcg/50 mcg). The correct amount of medication in each spray cannot be assured before the initial priming and after 120 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 120 sprays have been used.

Azelastine hydrochloride and fluticasone propionate nasal spray should not be used after the expiration date “EXP” printed on the bottle label and carton.

Storage: Store upright with the dust cap in place at controlled room temperature 20°C to 25°C (68°F to 77°F). [See USP Controlled Temperature] Protect from light. Do not store in the freezer or refrigerator.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use)

Somnolence:Somnolence has been reported in some patients (8 of 1,269 patients) taking azelastine hydrochloride and fluticasone propionate nasal spray in controlled clinical trials. Caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of azelastine hydrochloride and fluticasone propionate nasal spray [see Warnings and Precautions (5.1)].

Concurrent Use of Alcohol and other Central Nervous System Depressants:Advise patients to avoid concurrent use of azelastine hydrochloride and fluticasone propionate nasal spray with alcohol or other central nervous system depressants because additional reductions in alertness and additional impairment of central nervous system performance may occur [see Warnings and Precautions (5.1)].

Local Nasal Effects:Nasal corticosteroids are associated with epistaxis, nasal ulceration, nasal septal perforation, Candida albicans infection and impaired wound healing. Patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use azelastine hydrochloride and fluticasone propionate nasal spray until healing has occurred [see Warnings and Precautions (5.2)].

Glaucoma and Cataracts:Inform patients that glaucoma and cataracts are associated with nasal and inhaled corticosteroid use. Advise patients to inform his/her health care provider if a change in vision is noted while using azelastine hydrochloride and fluticasone propionate nasal spray [see Warnings and Precautions (5.3)].

Immunosuppression and Risk of Infections:Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physician 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)].

Effect on Growth:Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving azelastine hydrochloride and fluticasone propionate nasal spray [see Use in Specific Populations (8.4)].

Priming:Instruct patients to shake the bottle gently before each use and prime the pump before initial use and when azelastine hydrochloride and fluticasone propionate nasal spray has not been used for 14 or more days [see Dosage and Administration (2.2)].

Keep Spray Out of Eyes:Instruct patients to avoid spraying azelastine hydrochloride and fluticasone propionate nasal spray into their eyes.

Potential Drug Interactions:Advise patients that coadministration of azelastine hydrochloride and fluticasone propionate nasal spray and ritonavir is not recommended and to be cautious if azelastine hydrochloride and fluticasone propionate nasal spray is coadministered with ketoconazole [see Drug Interactions (7.2)].

U.S. Patents 8,163,723; 8,168,620; 9,259,428; and 9,901,585

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Cipla Ltd. Goa, India
M.L. No. 546

ASTELIN is a registered trademark of Meda Pharmaceuticals Inc., a Viatris Company.

© 2021 Viatris Inc.

21089209

Revised: 5/2021AFNS:R2p

Patient Information

Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray(ay″ ze las′ teen hye″ droe klor′ ide floo tik′ a sone proe′ pee oh nate)

Important: For use in your nose only

What is azelastine hydrochloride and fluticasone propionate nasal spray?

Azelastine hydrochloride and fluticasone propionate nasal spray is a prescription medicine used to treat symptoms of seasonal allergic rhinitis in people 6 years of age and older.
Azelastine hydrochloride and fluticasone propionate nasal spray may help to reduce your nasal symptoms including stuffy nose, runny nose, itching, and sneezing.

It is not known if azelastine hydrochloride and fluticasone propionate nasal spray is safe or effective in children under 4 years of age.

What should I tell my healthcare provider before using azelastine hydrochloride and fluticasone propionate nasal spray?

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

have had recent nasal sores, nasal surgery, or nasal injury.
have eye or vision problems, such as cataracts or glaucoma (increased pressure in your eye).
have tuberculosis or any untreated fungal, bacterial, viral infections or eye infections caused by herpes.
have been near someone who has chickenpox or measles.
are not feeling well or have any other symptoms that you do not understand.
are pregnant or plan to become pregnant.
are breastfeeding or plan to breastfeed. It is not known if azelastine hydrochloride and fluticasone propionate pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using azelastine hydrochloride and fluticasone propionate nasal spray.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Azelastine hydrochloride and fluticasone propionate nasal spray and other medicines may affect each other, causing side effects.

Especially tell your healthcare provider if you take:

antifungal or anti-HIV medicines

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

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

How should I use azelastine hydrochloride and fluticasone propionate nasal spray?

Read the Instructions for Use at the end of this leaflet for information about the right way to use azelastine hydrochloride and fluticasone propionate nasal spray.
An adult should help a young child use azelastine hydrochloride and fluticasone propionate nasal spray.
Azelastine hydrochloride and fluticasone propionate nasal spray is for use in your nose only. Do not spray it into your eyes or mouth. If you spray azelastine hydrochloride and fluticasone propionate nasal spray into your eyes, flush your eyes with large amounts of water for 10 minutes and then call your healthcare provider.
Use azelastine hydrochloride and fluticasone propionate nasal spray exactly as your healthcare provider tells you to use it. Your healthcare provider will tell you how much azelastine hydrochloride and fluticasone propionate nasal spray to use and when to use it.
If a child accidentally swallows azelastine hydrochloride and fluticasone propionate nasal spray or you use too much azelastine hydrochloride and fluticasone propionate nasal spray, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while using azelastine hydrochloride and fluticasone propionate nasal spray?

Azelastine hydrochloride and fluticasone propionate nasal spray can cause sleepiness or drowsiness. Do not drive, operate machinery, or do anything that needs you to be alert until you know how azelastine hydrochloride and fluticasone propionate nasal spray affects you.
Do not drink alcohol or take any other medicines that may cause you to feel sleepy while using azelastine hydrochloride and fluticasone propionate nasal spray. It can increase your chances of having serious side effects.

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

Azelastine hydrochloride and fluticasone propionate nasal spray may cause serious side effects including:

sleepiness or drowsiness.
nasal problems. Symptoms of nasal problems may include:
o
crusting in the nose
o
nosebleeds
o
runny nose
o
hole in the cartilage between your nose (nasal septal perforation). A whistling sound when you breathe may be a symptom of nasal septal perforation.
slow wound healing. You should not use azelastine hydrochloride and fluticasone propionate nasal spray until your nose has healed if you have a sore in your nose, if you have had surgery on your nose, or if your nose has been injured.
thrush (candida), a fungal infection in your nose and throat. Tell your healthcare provider if you have any redness or white colored patches in your nose or mouth.
eye problems, such as glaucoma or cataracts. Some people may have eye problems, including glaucoma and cataracts. You should have regular eye exams when using azelastine hydrochloride and fluticasone propionate nasal spray.
immune system problems and increased risk of infections. Azelastine hydrochloride and fluticasone propionate nasal spray may cause problems with the way your immune system protects your body against infection and increase your risk of infection. Avoid contact with people who have contagious diseases such as chickenpox or measles while you use azelastine hydrochloride and fluticasone propionate nasal spray. Symptoms of infection may include:
o
fever
o
aches or pains
o
chills
o
feeling tired
adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency may include:
o
tiredness
o
weakness
o
nausea
o
vomiting
o
low blood pressure
slowed or delayed growth in children. A child’s growth should be checked regularly while using azelastine hydrochloride and fluticasone propionate nasal spray.

Call your healthcare provider or get medical help right away if you have symptoms of any of the serious side effects listed above.

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

changes in taste
nosebleeds
headache

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of azelastine hydrochloride and 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 should I store azelastine hydrochloride and fluticasone propionate nasal spray?

Store azelastine hydrochloride and fluticasone propionate nasal spray upright with the dust cap in place at room temperature between 68°F to 77°F (20°C to 25°C).
Do not freeze or refrigerate azelastine hydrochloride and fluticasone propionate nasal spray.
Protect azelastine hydrochloride and fluticasone propionate nasal spray from light.
Do not use azelastine hydrochloride and fluticasone propionate nasal spray after the expiration date “EXP” printed on the bottle label and carton.
Throw away your azelastine hydrochloride and fluticasone propionate nasal spray bottle after using 120 sprays after initial priming. Even though the bottle may not be completely empty, you may not get the correct dose of medicine if you continue to use it.

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

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

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

You can ask your pharmacist or healthcare provider for information about azelastine hydrochloride and fluticasone propionate nasal spray that is written for health professionals.

What are the ingredients in azelastine hydrochloride and fluticasone propionate nasal spray? Active ingredients: azelastine hydrochloride and fluticasone propionate

Inactive ingredients: glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, phenylethyl alcohol, edetate disodium, benzalkonium chloride, polysorbate 80, and purified water.

For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

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