Azelastine hydrochloride and fluticasone propionate

What is Azelastine hydrochloride and fluticasone propionate?

• Azelastine hydrochloride and fluticasone propionate (DYMISTA) contains an H1-receptor antagonist and a corticosteroid used for the relief of symptoms of seasonal allergic rhinitis.

What are the uses of this medicine?

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

How does this medicine work?

• DYMISTA contains both azelastine hydrochloride and fluticasone propionate. These drugs represent two different classes of medications (histamine H1-receptor antagonist and synthetic corticosteroid).

Azelastine Hydrochloride

• Azelastine hydrochloride, a phthalazinone derivative, exhibits histamine H1-receptor antagonist activity.

Fluticasone Propionate

• Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity.
• The precise mechanism through which fluticasone propionate affects allergic rhinitis symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Concurrent use of DYMISTA with alcohol or other central nervous system depressants should be avoided because somnolence and impairment of central nervous system performance may occur.
• Coadministration of fluticasone propionate and ritonavir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.
• Caution should be exercised when DYMISTA is coadministered with ketoconazole and other known strong CYP3A4 inhibitors.

Is this medicine FDA approved?

• Initial U.S. Approval: 2012

How should this medicine be used?

Recommended dosage:

• The recommended dosage of DYMISTA is 1 spray (137 mcg of azelastine hydrochloride and 50 mcg of fluticasone propionate) in each nostril twice daily.

Administration:

• Administer DYMISTA by the nasal route only.
• Shake the bottle gently before each use.
• Avoid spraying DYMISTA into the eyes. If sprayed in the eyes, flush eyes with water for at least 10 minutes.

Priming

• Prime DYMISTA before initial use by releasing 6 sprays or until a fine mist appears.

Repriming (as needed)

• When DYMISTA has not been used for 14 or more days, reprime with 1 spray or until a fine mist appears.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Nasal spray: 137 mcg of azelastine hydrochloride and 50 mcg of fluticasone propionate in each spray.

This medicine is available in fallowing brand namesː

• DYMISTA

What side effects can this medication cause?

The most common side effects of this medicine include:

• changes in taste
• nosebleeds
• headache

DYMISTA may cause serious side effects including:

• sleepiness or drowsiness
• nasal problems
• slow wound healing
• thrush (candida), a fungal infection in your nose and throat
• eye problems, such as glaucoma or cataracts
• immune system problems and increased risk of infections
• adrenal insufficiency
• slowed or delayed growth in children

What special precautions should I follow?

• Somnolence has been reported in some patients taking DYMISTA in placebo controlled trials. Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking DYMISTA.
• Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with DYMISTA because further decreased alertness and impairment of CNS performance may occur.
• Persons who are using drugs, such as corticosteroids, that suppress the immune system are more susceptible to infections than healthy individuals.
• Epistaxis, nasal ulcerations, nasal septal perforation, impaired wound healing, Candida albicans infection may occur. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma.
• Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
• Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections.
• Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue DYMISTA slowly.
• Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving DYMISTA.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• somnolence
• hypercorticism

Management of overdosage:

• General supportive measures should be employed if overdosage occurs. There is no known antidote to DYMISTA. Oral ingestion of antihistamines has the potential to cause serious adverse effects in children. Accordingly, DYMISTA should be kept out of the reach of children.

Can this medicine be used in pregnancy?

• Limited data from postmarketing experience with DYMISTA in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of DYMISTA for seasonal allergic rhinitis have been established in pediatric patients aged 6 years and older.
• Safety and effectiveness of DYMISTA have not been established in pediatric patients below the age of 4 years.

What are the active and inactive ingredients in this medicine?

• 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.

Who manufactures and distributes this medicine?

• Manufactured by:

Cipla Ltd. Goa, India

• Manufactured for:

Meda Pharmaceuticals Inc. Somerset, New Jersey

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

What should I know about storage and disposal of this medication?

• Store DYMISTA upright at 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 DYMISTA.
• Protect DYMISTA from light.
• Do not use DYMISTA after the expiration date “EXP” printed on the bottle label and carton.
• Throw away your DYMISTA 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.

• Dailymed label info on Azelastine hydrochloride and fluticasone propionate
• FDA Azelastine hydrochloride and fluticasone propionate

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