Dymista Nasal Spray 137mcg50mcg

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

FLUTICASONE PROPIONATE; AZELASTINE HYDROCHLORIDE

Tilgjengelig fra:

MYLAN HEALTHCARE SDN. BHD.

INN (International Name):

FLUTICASONE PROPIONATE; AZELASTINE HYDROCHLORIDE

Enheter i pakken:

17 ml; 4 ml

Produsert av:

Cipla Limited

Informasjon til brukeren

_Consumer Medication Information Leaflet (RIMUP) _
DYMISTA® NASAL SPRAY
137 micrograms/50 micrograms per actuation Nasal Spray, Suspension
_Azelastine hydrochloride/fluticasone propionate _
Page | 1
Dymista Nasal Spray
WHAT IS IN THIS LEAFLET?
1.
What DYMISTA Nasal Spray is
used for
2.
How DYMISTA Nasal Spray works
3.
B
efore you take DYMISTA Nasa
l
Sp
ray
4.
How to take DYMISTA Nasal Spray
5.
While you are using DYM
ISTA
Nasal
Spray
6.
Side effects
7.
Storage and disposal of DYMIS
TA
Nasal
Spray
8.
Product Description
9.
Manufactur
er
10.
P
roduct Registration Holder
11.
Date of Revision
WHAT DYMISTA NASAL SPRAY IS
USEDFOR?
Dymista Nasal Spray is used for
symptomatic treatment of moderate to
severe allergic rhinitis and rhino
conjunctivitis in adults and children 6
years and older where use of a
combination (intranasal antihistamine
and glucocorticoid) is appropriate, for
example: runny nose, post nasal drip,
sneezing, itchy or blockednose and itchy,
watery and red eyes. These are allergic
reactions to substances such as pollen
(hayfever), house mites, moulds, dust or
pets.
HOW DYMISTA NASAL SPRAY WORKS
Dymista Nasal Spray contains two active
substances: azelastine hydrochloride and
fluticasone propionate.
•
Azelastine hydrochloride
belongs to a group of medicines called
antihistamines. Antihistamines work by
preventing the effects of substances
that the body produces as part of an
allergic reaction – thus reducing
symptoms of allergic rhinitis.
•
Fluticasone propionate belongs
to a group of medicines called
corticosteroids which reduces
inflammation.
BEFORE YOU TAKE DYMISTA NASAL
SPRAY
•
_Do not use Dymista Nasal Spray:_
If you are allergic to azelastine
hydrochloride or fluticasone
propionate or any of the other
ingredients of this medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist
before using Dymista Nasal Spray if:
You had a recent operation on your nose.
•
You have an infection in your nose.
Infections of the nasal airways should
be treated with antibacter

Preparatomtale

Dymista
®
Nasal Spray
137 micrograms / 50 micrograms per actuation Nasal Spray,
Suspension
PRODUCT INFORMATION
NAME OF THE MEDICINE
Azelastine hydrochloride and fluticasone propionate
The
chemical
name
for
azelastine
hydrochloride
is
(
_R,S_
)-4[(4-Chlorophenyl)methyl]-2-
(hexahydro-1-methyl-1
_H_
-azepin-4-yl)-phthalazin-1(2
_H_
)-one
hydrochloride.
Azelastine
hydrochloride has the following chemical structure:
C
22
H
24
ClN
3
O
.
HCl
Molecular weight: 418.37 g mol
-1
CAS Registry No: 79307-93-0
The chemical name for fluticasone propionate is
6α,9-Difluoro-17-[[(fluoromethyl) sulphanyl]-
carbonyl]-11β-hydroxy-16α-methyl-3-oxoandrosta-1,4-dien-17α-yl
propanoate.
Fluticasone propionate has the following chemical structure:
C
25
H
31
F
3
O
5
S
Molecular weight: 500.6 g mol
-1
CAS Registry No: 80474-14-2
DESCRIPTION
DYMISTA is formulated as a white, homogeneous and redispersible
suspension. It is available as a
metered-spray suspension for intranasal administration.
DYMISTA nasal spray is a fixed combination product containing the
following active ingredients:
azelastine hydrochloride and fluticasone propionate. Each g of
suspension contains 1 mg azelastine
hydrochloride and 0.365 mg fluticasone propionate. One spray (137 mg)
contains 125 µg of azelastine
(as the base) and 50 µg of fluticasone propionate.
DYMISTA nasal spray contains the following inactive ingredients:
disodium edetate, glycerol,
microcrystalline cellulose, carmellose sodium, polysorbate 80,
benzalkonium chloride, phenethyl
alcohol and purified water.
PHYSICAL AND CHEMICAL PROPERTIES
Azelastine hydrochloride occurs as a white, odourless, crystalline
powder with a bitter taste. It is
sparingly soluble in water, and soluble in ethanol and
dichloromethane. Azelastine hydrochloride is
slightly hygroscopic.
Fluticasone propionate is a white or almost white powder. It is
practically insoluble in water, sparingly
soluble in dichloromethane and slightly soluble in alcohol.
PHARMACOLOGY
PHARMACODYNAMICS
Pharmacotherapeutic group: Decongestants and oth