Azelastine Hydrochloride And Fluticasone Propionate (Dymista)

Trade Name : DYMISTA

Meda Pharmaceuticals

SPRAY, METERED

Strength 13750 ug/1ug/1

Storage and handling for DYMISTA

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Azelastine Hydrochloride And Fluticasone Propionate (Dymista) which is also known as DYMISTA and Manufactured by Meda Pharmaceuticals. It is available in strength of 137; 50 ug/1; ug/1 per ml. Read more

Azelastine Hydrochloride And Fluticasone Propionate (Dymista) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

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DYMISTA nasal spray is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 6 years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief.
DYMISTA contains an H-receptor antagonist and a corticosteroid, and is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 6 years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief. ()

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DYMISTA is a nasal spray suspension.
DYMISTA: Nasal spray suspension delivers 137 mcg of azelastine hydrochloride and 50 mcg of fluticasone propionate (137 mcg/50 mcg) in each 0.137 mL spray. ()

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Candida albicans
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Systemic and local corticosteroid use may result in the following:
The most common adverse reactions (u22652% incidence) are: dysgeusia, epistaxis, and headache. (n n

No formal drug interaction studies have been performed with DYMISTA. The drug interactions of the combination are expected to reflect those of the individual components.

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Arrayn- DYMISTA:
Azelastine Hydrochloride:
Fluticasone Propionate:n- see n

Dymista (azelastine hydrochloride and fluticasone propionate) nasal spray is formulated as a white, uniform metered-spray suspension for intranasal administration. It is a fixed dose combination product containing an antihistamine (H receptor antagonist) and a corticosteroid as active ingredients.
Azelastine hydrochloride active ingredient occurs as a white, odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerin. It has a melting point of 225u00b0C and the pH of 5.2. Its chemical name is (u00b1)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is CHClNOu2022HCl with the following chemical structure:
Fluticasone propionate active ingredient is a white powder with a melting point of 273u00b0C, a molecular weight of 500.6, and the empirical formula is CHFOS. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Fluticasone propionate is a synthetic corticosteroid having the chemical name S-(fluoromethyl)-6u03b1,9-difluoro-11u03b2-17-dihydroxy-16u03b1-methyl-3-oxoandrosta-1,4-diene-17u03b2-carbothioate, 17-propionate, and the following chemical structure:
Dymista (azelastine hydrochloride and fluticasone propionate) nasal spray, 137 mcg/50 mcg contains 0.1% solution of azelastine hydrochloride and 0.037% suspension of micronized fluticasone propionate in an isotonic aqueous suspension containing glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, phenylethyl alcohol (2.5 mg/g), edetate disodium, benzalkonium chloride (0.1 mg/g), polysorbate 80, and purified water. It has a pH of approximately 6.0.
After priming [], each metered spray delivers a 0.137 mL mean volume of suspension containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base) and 50 mcg of fluticasone propionate. The 23 g bottle provides 120 metered sprays, after priming.

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Arrayn- Adults and Adolescents 12 Years of Age and Older
The efficacy and safety of DYMISTA in adults and adolescents 12 years of age and older with seasonal allergic rhinitis was evaluated in 3 randomized, multicenter, double-blind, placebo-controlled clinical trials in 853 patients. The population of the trials was 12 to 78 years of age (64% female, 36% male; 80% white, 16% black, 2% Asian, 1% other).
Patients were randomized to one of four treatment groups: one spray per nostril twice daily of DYMISTA, azelastine hydrochloride nasal spray, fluticasone propionate nasal spray, and vehicle placebo. The azelastine hydrochloride and fluticasone propionate comparators use the same device and vehicle as DYMISTA and are not commercially marketed. Assessment of efficacy was based on the reflective total nasal symptom score (rTNSS), in addition to the instantaneous total nasal symptom score (iTNSS) and other supportive secondary efficacy variables. TNSS is calculated as the sum of the patients' scoring of the 4 individual nasal symptoms (rhinorrhea, nasal congestion, sneezing, and nasal itching) on a 0 to 3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Patients were required to record symptom severity daily reflecting over the previous 12 hours (morning, AM, and evening, PM). For the primary efficacy endpoint, the combined AM+PM rTNSS (maximum score of 24) was assessed as a change from baseline for each day and then averaged over a 2-week treatment period. The primary efficacy endpoint was the mean change from baseline in combined AM+PM rTNSS over 2 weeks. The iTNSS was recorded immediately prior to the next dose.
In these trials, DYMISTA demonstrated statistically significant greater decreases in rTNSS as compared to azelastine hydrochloride and to fluticasone propionate, as well as to placebo. The differences between the monotherapies and placebo also were statistically significant. Representative results from one of the trials are shown below (Table 3).
In these trials, DYMISTA also demonstrated statistically significant, greater decreases in iTNSS as compared to placebo, as did the azelastine hydrochloride and fluticasone propionate comparators. Representative results from one of the trials are shown below (Table 4).
Onset of action, defined as the first timepoint at which DYMISTA was statistically superior to placebo in the mean change from baseline in iTNSS and which was sustained thereafter, was assessed in each of the three trials. Onset of action was observed as early as 30 minutes following the initial dose of DYMISTA.
The subjective impact of seasonal allergic rhinitis on patient's health-related quality of life was evaluated by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) (28 items in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional) evaluated on a 7-point scale where 0 = no impairment and 6 = maximum impairment), which was administered to patients 18 years of age and older. An overall RQLQ score is calculated from the mean of all items in the instrument. A change from baseline of at least 0.5 points is considered a clinically meaningful improvement. In each of these trials, DYMISTA demonstrated a statistically significant greater decrease from baseline in the overall RQLQ than placebo, which ranged from -0.55 (95% CI -0.72, -0.39) to -0.80 (95% CI -1.05, -0.55). In these trials, the treatment differences between DYMISTA and the monotherapies were less than the minimum important difference of 0.5 points.
Arrayn- Pediatric Patients 6-11 Years of Age
The efficacy and safety of DYMISTA was evaluated in one randomized, multi-center, double-blind, placebo-controlled trial in 304 children 6 to 11 years of age with seasonal allergic rhinitis. Patients were randomized 1:1 to receive either one spray per nostril twice daily of DYMISTA or placebo (vehicle control) for 14 days. The design of this trial was similar to that of the adult trials.
The primary efficacy endpoint was the mean change from baseline in combined AM+PM reflective total nasal symptom score (rTNSS) over 2 weeks. DYMISTA was not statistically significantly different than placebo, but the results were numerically supportive (Table 5).
CI = confidence intervalLS Mean, 95% CI, and p-value are obtained from the repeated-measures analysis of covariance model using observed data

DYMISTA nasal spray (NDC 0037-0245-23) 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 []. After priming [], 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.
DYMISTA should not be used after the expiration date u201cEXPu201d printed on the bottle label and carton.
Arrayn- Storage
Store upright with the dust cap in place at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Temperature] Protect from light. Do not store in the freezer or refrigerator.

See FDA-approved patient labeling ()
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Arrayn- Keep Spray Out of Eyes:u00a0
Arrayn- Keep Out of Children's Reach:u00a0
Arrayn- see n
U.S. Patents 8,163,723; 8,168,620; 9,259,428; and 9,901,585
Manufactured by:Cipla Ltd. Goa, IndiaM.L. No. 546
u00a92019 Mylan Specialty L.P.DYMISTA and ASTELIN are registered trademarks of Meda Pharmaceuticals Inc., a Mylan company.
Revised: 9/2018IN-023A6-06

DYMISTA ()
(azelastine hydrochloride and fluticasone
propionate) nasal spray
Important: For use in your nose only
What is DYMISTA?
It is not known if DYMISTA is safe or effective in children under 4 years of age.
What should I tell my healthcare provider before using DYMISTA?
Before using DYMISTA tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take
DYMISTA and other medicines may affect each other, causing side effects.
Especially tell your healthcare provider if you take:
Ask your healthcare provider or pharmacist for a list of these medications, 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 DYMISTA?
What should I avoid while using DYMISTA?
What are the possible side effects of DYMISTA?
DYMISTA may cause serious side effects including:
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 DYMISTA Nasal Spray include:
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 DYMISTA. For more information, ask your healthcare provider or pharmacist.
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 DYMISTA?
Keep DYMISTA and all medicines out of reach of children.
General information about the safe and effective use of DYMISTA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use DYMISTA for a condition for which it was not prescribed. Do not give DYMISTA to other people, even if they have the same symptoms that you have. It may harm them.
This Patient Information leaflet summarizes the most important information about DYMISTA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about DYMISTA that is written for health professionals.
For more information, go to www.DYMISTA.com or call Meda Pharmaceuticals Inc. at 1-888-939-6478.
What are the ingredients in DYMISTA?n- Active ingredients:
Inactive ingredients:
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Instructions for Usen n- Dy-Mist-A
For use in your nose only. Do not spray in your eyes.
Read the Instructions for Use before you start to use DYMISTA and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment. Before you use DYMISTA, make sure your healthcare provider shows you the right way to use it.
Shake the bottle gently before each use.
Your DYMISTA pump. (See Figure A)
Instructions for Using Your DYMISTA Pump.
Before you use DYMISTA for the first time, you will need to shake the bottle gently and prime the pump.
For use in young children:
Priming your DYMISTA pump
Step 1.
Remove the clear plastic dust cap from the spray pump tip of the bottle. n
Step 2.
Hold the bottle upright with two fingers on the shoulders of the spray pump unit and put your thumb on the bottom of the bottle. Press upward with your thumb and release for the pumping action.
Using your DYMISTA:
For use in young children:
Step 3.
Gently blow your nose to clear nostrils. n
Step 4.
Shake the bottle gently. Close 1 nostril with a finger. Tilt your head forward slightly. Keep the bottle upright and carefully place the spray pump tip u00bc to u00bd inch into your other nostril. n
Step 5.
For each spray firmly press the pump 1 time. Keep your head tilted down and at the same time, gently breathe in through your nostril. n
Do not
Step 6.
When you finish using DYMISTA, wipe the spray tip with a clean tissue or cloth. Put the dust cap back on the spray pump tip of the bottle. n
Each bottle of DYMISTA contains enough medicine for you to spray medicine from the bottle 120 times. You may not receive the right amount of medicine. Keep track of the number of sprays you use from your bottle of DYMISTA and throw away the bottle even if it has medicine left in it.
Do not count any sprays used for initially priming the bottle.
Cleaning the Spray Pump Tip:
Your DYMISTA should be cleaned at least 1 time each week. To do this:
Step 7.
Remove the dust cap and then gently pull upward on the spray pump unit to remove it from the bottle. n
Step 8.
Wash the spray pump unit and dust cap in warm tap water. n
Step 9.
Allow to dry completely. When dry, place the spray pump unit and dust cap back on the bottle. n
Step 10.
If the spray pump unit becomes blocked, it can be removed as instructed above in Step 7 and placed in warm water to soak.
Do not try to unblock the spray pump unit by inserting a pin or other sharp object. This will damage the spray pump unit and cause you not to get the right dose of medicine.
Step 11.
Step 12.
This Patient Package Insert and Instructions for Use has been approved by the U.S. Food and Drug Administration.
U.S. Patents 8,163,723; 8,168,620; 9,259,428; and 9,901,585
Manufactured by:Cipla Ltd. Goa, IndiaM.L. No. 546
Manufactured for:Meda Pharmaceuticals Inc.Somerset, New Jersey 08873-4120
u00a92019 Mylan Specialty L.P.DYMISTA is a registered trademark of Meda Pharmaceuticals Inc., a Mylan company.
Revised: 9/2018IN-023A6-06

NDC 0037-0245-23
Dymistan (azelastine hydrochlorideandfluticasone propionate)
Nasal Spray
137 mcg / 50 mcg per spray
120 Metered Sprays
FOR INTRANASALUSE ONLY
Rx Only
23 g net fill weight
Shake the bottle gentlybefore each use.
Each spray delivers 0.137 mL(137 mcg azelastine hydrochlorideand 50 mcg fluticasone propionate).
Contents:
Dosage:
Storage:
Protect from light. Do not storein the freezer or refrigerator.
Keep away from children.
Read PATIENT INSTRUCTIONS FOR USEfor additional information on howto use the product.
Dosing Instructions
CLEAR YOUR NOSE
LOOK AT YOUR TOES
SPRAY AND SNIFF GENTLY
Spray a fine mist, once per nostril.
Remember to sniff gently.
Discard after 120 actuations.
For assistance call n
DYMISTA is a registered trademark ofMeda Pharmaceuticals Inc., a Mylan company
Shake the bottle gentlybefore each use.
Initial Priming: 6 sprays oruntil a fine mist appears.
Repriming (only if you have notused Dymista for 14 or moredays): 1 spray or until a finemist appears.
FOR INTRANASAL USE ONLY
Manufactured by: Cipla Ltd.,Goa, India, M.L. No. 546
For: Meda Pharmaceuticals Inc.Somerset, NJ 08873-4120
u00a92018 Mylan Specialty L.P.
UC-023A6-06 Rev. 4/2018
U.S. Patents 8,163,723; 8,168,620;9,259,428; 9,901,585

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