Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)

Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray), containing an H1-receptor antagonist and a corticosteroid, is used for the relief of symptoms of smoderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children who require treatment with both Azelastine Hydrochloride and Fluticasone Propionate for symptomatic relief.

1. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy

2. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Duonase Nasal Spray (Generic Azelastine and Fluticasone
Nasal Spray), containing an H1-receptor antagonist and a
corticosteroid, is used for the relief of symptoms of
smoderate to severe seasonal allergic rhinitis (SAR) and
associated ocular symptoms in adults, adolescents, and
children who require treatment with both Azelastine
Hydrochloride and Fluticasone Propionate for symptomatic
relief.

3. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy

4. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Duonase Nasal Spray is
manufactured by Cipla Limited,
India in the strength of 190 mcg
(Azelastine Hydrochloride 140 mcg
and Fluticasone Propionate 50
mcg).

5. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Chemical Structure -Azelastine Hydrochloride

6. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Chemical Structure - Fluticasone Propionate

7. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
The active ingredients contained in Duonase
Nasal Spray are Azelastine Hydrochloride and
Fluticasone Propionate.
Each spray delivers 140 mcg of Azelastine
Hydrochloride and 50 mcg of Fluticasone
Propionate.
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8. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Uses of Duonase Nasal Spray (Azelastine 140 mcg and Fluticasone 50 mcg):
Duonase Nasal Spray (Generic Azelastine Hydrochloride and
Fluticasone Propionate Nasal Spray) is used to treat an itchy or
runny nose, sneezing, or other symptoms caused by seasonal
hay fever (allergic rhinitis). Azelastine is an antihistamine.
It works by preventing the effects of a substance called
histamine, which is produced by the body. Histamine can cause
itching, sneezing, runny nose, and watery eyes.
Fluticasone is a steroid (cortisone-like medicine). It works by
preventing the inflammation that occurs with allergic reactions.
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9. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Recommended Adult Dosage
The recommended dose of Duonase Nasal Spray
(Generic Azelastine Hydrochloride and Fluticasone
Propionate Nasal Spray) in in adults and adolescents 6
years of age and older is 1 spray per nostril twice daily.
The recommended dosage should not be exceeded.
Prime before initial use and when it has not been used for
14 or more days.
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10. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
How Does Duonase Nasal Spray Work?
Azelastine/Fluticasone 140mcg/50mcg Nasal Spray relieves the
symptoms of allergies, for example:
symptoms relating to the nose - runny nose, post nasal drip,
sneezing, itchy or blocked nose
symptoms relating to the eyes - itchy, watery and red eyes.
Hayfever is an inflammation or swelling of the nose lining (which may
cause blockage, runny nose, itching and/ or sneezing).
You may have symptoms only during spring or summer. This type of
allergy is generally due to various pollens. Some people may
experience symptoms all year round. This is usually caused by house
dust mites, pets or moulds.
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11. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
How Does Duonase Nasal Spray Work?
Duonase Nasal Spray contains two active ingredients: Azelastine
Hydrochloride and Fluticasone Propionate.
Azelastine Hydrochloride belongs to a group of medicines called
antihistamines. Antihistamines work by preventing the effects of
substances such as histamine that the body produces as part of an
allergic reaction. This reduces symptoms of an allergic rhinitis.
Fluticasone Propionate belongs to a group of medicines called
corticosteroids which are used to help reduce inflammation.
Due to the fast relief and the anti-inflammatory effect,
Azelastine/Fluticasone 140mcg/50mcg Nasal Spray is more effective on
symptoms relating to the nose and eyes than either antihistamine or
corticosteroid therapy alone.
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12. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Contraindications
➔Duonase Nasal Spray is contraindicated in patients with a known
hypersensitivity to Azelastine Hydrochloride, Fluticasone
Propionate or any other component of the spray.
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13. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Storage Instructions
Duonase Nasal Spray (Generic Azelastine
Hydrochloride and Fluticasone Propionate Nasal
Spray) have to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F to 77°F) with
excursions permitted between 15° to 30°C (59° to
86°F).
Keep this as well as all other medicines away from
children and pets.
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14. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Warnings
Somnolence: Avoid engaging in hazardous occupations requiring
complete mental alertness such as driving or operating machinery
when taking Duonase Nasal Spray.
Avoid concurrent use of alcohol or other central nervous system (CNS)
depressants with Duonase Nasal Spray because further decreased
alertness and impairment of CNS performance may occur.
Epistaxis, nasal ulcerations, nasal septal perforation, impaired wound
healing, Candida albicans infection. 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.
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15. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Warnings
Development of glaucoma or posterior subcapsular 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 Duonase Nasal Spray slowly.
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16. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Warnings
Potential reduction in growth velocity in children.
Monitor growth routinely in pediatric patients receiving
Duonase Nasal Spray.
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17. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Effects On Ability To Drive And Use Machines
Duonase Nasal Spray (Generic Azelastine Hydrochloride
and Fluticasone Propionate Nasal Spray) has minor
influence on the ability to drive and use machines.
In isolated cases fatigue, weariness, exhaustion, dizziness or
weakness that may also be caused by the disease itself,
may occur when using Duonase Nasal Spray. In these
cases, the ability to drive and use machines may be
impaired. Alcohol may enhance this effect.
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18. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Possible Side Effects
Most common Azelastine Hydrochloride And Fluticasone
Propionate Nasal Spray (Duonase Nasal Spray) side effects
with an incidence rate of greater than or equal to 2% are
dysgeusia, epistaxis, and headache.
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19. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Possible Side Effects
The following side effects occurred in less than 1% of studies in adults
and adolescents, and from the placebo-controlled study in children 6-
11 years of age:
Ear and labyrinth disorders: Tinnitus
Eye disorders: Eye irritation
Gastrointestinal disorders: Dry mouth, Nausea, Abdominal discomfort,
Abdominal pain upper, Vomiting
General disorders and administration site conditions: Mucosal erosion,
Fatigue, Product taste abnormal, Mucosal ulceration
Infections and infestations: Upper respiratory tract infection, Acute
sinusitis, Laryngitis, Pharyngitis, Viral upper respiratory tract infection
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20. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Possible Side Effects
The following side effects occurred in less than 1% of studies in adults
and adolescents, and from the placebo-controlled study in children 6-11
years of age:
Metabolism and nutrition disorders: Polydipsia
Nervous systems disorders: Somnolence, Dizziness, Hypogeusia,
Lethargy, Parosmia
Psychiatric disorders: Disorientation
Respiratory, thoracic and mediastinal disorders: Nasal discomfort, Cough,
Oropharyngeal pain, Sneezing, Throat irritation, Nasal dryness, Rhinalgia,
Rhinorrhoea, Upper-airway cough syndrome, Dry throat, Nasal congestion,
Nasal mucosal disorder, Nasal septum ulceration
Skin and subcutaneous tissue disorders: Dry skin, Pruritus, Rash papular
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21. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Duonase Nasal Spray Overdosage
Duonase Nasal Spray contains both Azelastine Hydrochloride and Fluticasone
Propionate; therefore, the risks associated with overdosage for the individual
components described below apply to Duonase Nasal Spray.
Azelastine Hydrochloride: There have been no reported overdosages with
Azelastine Hydrochloride. Acute Azelastine Hydrochloride overdosage by
adults with this dosage form is unlikely to result in clinically significant adverse
events.
Clinical trials in adults with single doses of the oral formulation of Azelastine
Hydrochloride (up to 16 mg) have not resulted in increased incidence of serious
adverse events.
General supportive measures should be employed if overdosage occurs. There
is no known antidote to Duonase Nasal Spray. Oral ingestion of antihistamines
has the potential to cause serious adverse effects in children. Accordingly,
Duonase Nasal Spray should be kept out of the reach of children.

22. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Duonase Nasal Spray Overdosage
Fluticasone Propionate: Chronic Fluticasone Propionate overdosage may
result in signs/symptoms of hypercorticism. Intranasal administration of 2
mg (10 times the recommended dose) of Fluticasone Propionate twice daily
for 7 days to healthy human volunteers was well tolerated. Single oral
Fluticasone Propionate doses up to 16 mg have been studied in human
volunteers with no acute toxic effects reported.
Repeat oral doses up to 80 mg daily for 10 days in volunteers and repeat oral
doses up to 10 mg daily for 14 days in patients were well tolerated. Adverse
reactions were of mild or moderate severity, and incidences were similar in
active and placebo treatment groups. Acute overdosage with this dosage
form is unlikely.
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23. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Duonase Nasal Spray During Pregnancy
Azelastine Hydrochloride And Fluticasone Propionate Nasal Spray
(Duonase Nasal Spray) has been classified by the US FDA as Pregnancy
Category C.
There are no adequate and well-controlled clinical trials of Azelastine
Hydrochloride And Fluticasone Propionate Nasal Spray, Azelastine
Hydrochloride only, or Fluticasone Propionate only in pregnant women.
Animal reproductive studies of Azelastine Hydrochloride and Fluticasone
Propionate in mice, rats, and/or rabbits revealed evidence of
teratogenicity as well as other developmental toxic effects. Because
animal reproduction studies are not always predictive of human
response, Duonase Nasal Spray should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.
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24. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Duonase Nasal Spray During Nursing
It is not known whether Duonase Nasal Spray (Generic Azelastine
Hydrochloride and Fluticasone Propionate Nasal Spray) is excreted in human
breast milk. Because many drugs are excreted in human milk, caution should
be exercised when Duonase Nasal Spray is administered to a nursing woman.
Since there are no data from well controlled human studies on the use of
Duonase Nasal Spray by nursing mothers, based on data from the individual
components, a decision should be made whether to discontinue nursing or to
discontinue Dymista Nasal Spray, taking into account the importance of
Dymista Nasal Spray to the mother.
Azelastine Hydrochloride: It is not known if Azelastine Hydrochloride is
excreted in human milk.
Fluticasone Propionate: It is not known if Fluticasone Propionate is excreted in
human milk. However, other corticosteroids are excreted in human milk.
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25. Duonase Nasal Spray (Generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray)
© The Swiss Pharmacy
Duonase Nasal Spray (Generic Azelastine
Hydrochloride and Fluticasone Propionate Nasal
Spray) is manufactured by Cipla Limited, India.
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