Monte+Levo

7/22/2019 Monte+Levo

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MONTE+LEVO

Montelukast 10 mg + Levocetirizine 5 mg

for

SEASONAL ALLERG! R"N#S


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Todays Discussion

Overvie$ of Allergic R%initis

&%armacot%era'( of Allergic R%initis

Nee) for t%e com*ination of MON#E+LEO

!linical Efficac( of MON#E+LEO

&lace in t%era'(


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DEFINITION OF AR

Allergic r%initis is clinicall( )efine) as a

s(m'tomatic )isor)er of t%e nose in)uce)

*( an gE,me)iate) inflammation after

allergen e-'osure.


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PROBLEM STATEMENT

Allergic r%initis is one of t%e most common allergic)iseases

Affects 15,/0 of t%e $orl)s 'o'ulation

n t%e last five )eca)es2 t%e 'revalence of allergic r%initis

%as tri'le) from 3 to 14 $orl)$i)e AR is t%e commonest allerg( encountere) in clinical

'ractice in n)ia

#%e 'revalence rate is estimate) to *e 0,/0 in n)ia

Priniples & practise of Tropical Allergy & Asthma 2006

Wiqar Shaikh


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CAUSES OF AR


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CLINICAL FEATURES

Nasal o*struction

Nasal )isc%arge

&ost,nasal )ri'

Sneezing

E'ista-is

6ater( e(es

Re) e(es

tc%ing aroun) e(es

"ea)ac%e or facial

'ain

S$elling or )eformit(

7istur*ances of smell Snoring

!%ange in voice 8%('er

or %('onasalit(9


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NASAL ANATOMY

&icture of nose $it%


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THE ALLERIC REACTION


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His!a"in#

C$#"o!ac!icFac!o%s

EARLYALLERICRESPONSE

&EAR'

Sneezing

tc%ing

R%inorr%oea

ALLERIC REACTION( EARLY PHASE

gE anti*o)(

Allergen


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ROLEOF HISTAMINE IN AR

&la(s a ke( role in t%e 'at%ogenesis or AR

Secrete) *( mast cells an) *aso'%ils

nfluences t%e activation of several ot%er me)iators of inflammation8inclu)ing neutro'%ils2 eosino'%ils2 macro'%ages9

Levels increase) in nasal secretions of 'atients of AR

!ontri*utes to nasal o*struction 2 sneezing an) r%inorr%oea in AR

#%us e-erts a )irect as $ell as in)irect effect

Ref: clinical therapeutics 200!2":#"#$##2


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ALLERIC REACTION( LATE PHASE

L#u)o!%i#n#s

LATE

ALLERIC

RESPONSE

&LAR'

Nasal congestion

nflammation

C$#"o!ac!ic

*ac!o%s


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INFLAMMATORY CASCADE

P$os$o,iids

P$os$o,ias# A-

A%ac$idonic acid

Cyc,oo.y/#nas#

P%os!a/,andins

LTB4 LTC40 LTD40 LTE4

C$#"o!a.is

o*

n#u!%o$i,s

12Lioo.y/#nas#

LTA4

Cysteinyl Leukotrienes


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Mast cells2 :aso'%ils2 Eosino'%ils

Cysteinyl leukotrienes

Effects t%e nasal vasculature

ascular 'ermea*ilit(

aso)ilation

Mucosal s$elling

Con/#s!ion3s!u**in#ss

Ann Pharmacother 2001;35:1274-7


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ROLE OF LEU4OTRIENES IN AR 7ilatation of nasal *loo) vessels2 increase

vascular 'ermea*ilit( $it% e)ema formationcongestion

ncrease mucus 'ro)uction

Recruitment of inflammator( cells into t%e tissue

&romote inflammation *( en%ancing t%e activit(of inflammator( cells

5000 times more 'otent t%an %istamine


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HO5 ARE THE SYMPTOMS CAUSED6

rritation of free

nerve en)ings,,,,,,,,,,,,,I!c$in/ and sn##7in/%histamine

ncrease)

mucus 'ro)uction,,,,,,,,R$ino%%$o#a

8histamine & leukotriene

aso)ilation ,,,,,,,,,,,,,,,Con/#s!ion

%leukotrienes

ncrease)vascular 'ermea*ilit(,,,O#d#"a

%leukotrienes


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CLASSIFICATION OF AR

S#asona, A,,#%/icR$ini!is &SAR'

S(m'toms increase)uring certain times of t%e

(ear an) cause) *( out)oorallergens 8e.g; trees2grasses < $ee)s9

P#%#nnia, A,,#%/icR$ini!is &PAR'

S(m'tom t%at occur(ear,roun)2 causes= )ust,mites an) animal )an)er8'ets9


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ARIA CLASSIFICATION

In!#%"i!!#n!

> ? )a(s 'er $eek

or > ? $eeks

Mi,d Normal slee' an)

No im'airment of )ail(

activities2 s'ort2 leisure

an)

Normal $ork an) sc%oolan)

No trou*lesome

s(m'toms

Mod#%a!#2S#8#%#One or more terms;

A*normal slee'

m'airment of )ail(

activities2 s'ort2 leisure

A*normal $ork an)sc%ool

#rou*lesome s(m'toms

P#%sis!#n!

@ ? )a(s 'er $eek

an) @ ? $eeks

ARIA report 2001


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UNTREATED AR CAN LEAD TO9

Ast%ma

Sinusitis

Otitis Me)ia Nasal 'ol('s

R#


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APPROACH TO TREATMENT OF AR

Avoi)ance of allergens Environmental control

&%armacot%era'(

mmunot%era'(


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TREATMENT OPTIONS FOR AR

An!i$is!a"in#sB #%e( *lock t%e action of %istamine an)

control sneezing2 itc%ing an) r%inorr%oea

D#con/#s!an!sB #%e( causevasoconstriction an) o'en

t%e *locke) nose

Mas! c#,, s!a:i,i7#%s ; #%e( 'revent t%e mast cells

from ru'turing2 %ence 'revent t%e me)iators from coming out


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Antic%olinergic agents B #%e( )ecrease t%e

nasal secretions %ence give relief from r%inorr%oea

ntranasal steroi)s B #%e( %ave anti

inflammator( activit(

Antileukotrienes B #%e( in%i*it t%e effects of

leukotrienes $%ic% are t%e un)erl(ing cause of

inflammation in AR


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FALACIES IN CURRENT TREATMENT

Anti%istamines control all s(m'toms

e-ce't congestion

Ol)er generation 8A"9 )rugs causese)ation

ntranasal steroi)s are currentl( 1st line

Not Cuick actingNot effective on ocular s(m'toms


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5HAT SHOULD BE THE IDEAL TREATMENT6

A d%u/


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HO5 CAN 5E ACHIEVE THAT6

COMBININ AN ANTIHISTAMINE 5ITH

AN ANTILEU4OTRIENE THAT 5ILL

TA4E CARE OF BOTH0 THE EARLY AS

5ELL AS THE LATE SYMPTOMS OF AR


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His!a"in#

C$#"o!ac!icFac!o%s

EARLYALLERICRESPONSE

&EAR'

Sneezing

tc%ing

R%inorr%oea

ASSAULT ON THE MEDIATORS OF AR

L#8oc#!i%i7in#

gE anti*o)(

Allergen

Nasal congestion

Inflammation

L#u)o!%#in#s

LATE

ALLERIC

RESPONSE

&LAR'

Mon!#,u)as!


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PHARMACOTHERAPY FOR AR

Nasa,P%#a%a!ion

Sn##7in/ I!c$in/ R$ino%%$o#a Con/#s!ion Ey#sy"!o"s

An!i$is!a"in#s +++++ ++++ +++ 0 ++

An!ic$o,in#%/ics 0 0 +++++ 0 0

Co%!icos!#%oids +++++ +++++ +++ +++ ++

D#con/#s!an!s 0 0 + +++++ 0

An!i,#u)o!%i#n#s ++ ++ ++ +++++ ++

ARIA report 2001


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't is thus reasona(le to consi)er that

com(ine) me)iator (locka)e may

re)uce the symptoms of allergic rhinitis

ARIA report 2001


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ROLE OF MONTELU4AST IN AR

t *elongs to t%at class of )rug $%ic% s'ecificall( *locks

leukotrienes2 an un)erl(ing cause of allerg( s(m'toms

:locks L#!? $%ic% is a''ro-imatel( 10 times as 'otent

as %istamine

:locks L#7? $%ic% $as s%o$n to *e 5000 times as

'otent as %istamine

Offers relief from congestion an) stuffiness

Gives )a(,time as $ell as nig%t,time s(m'tom relief


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ROLE OF LEVOCETRI=INE IN AR Levocetrizine acts *( *in)ing to t%e "1 rece'tors t%ere*( antagonising t%e

effects of %istamine in AR

Levocetirizine significantl( attenuate) t%e %istamine in)uce) increases in t%enasal air$a( resistance $it% almost 50 re)uction over 'lace*o

Levocetirizine also significantl( 8&>0.019 re)uce) %istamine in)uce)sneezes

Levocetirizine in%i*its eota-in,in)uce) eosino'%il migration t%roug% *ot%

)ermal an) lung microvascular en)ot%elial cells suggesting 'otential anti,

inflammator( effects

Allergy 200*+ 6: ,##$,-, .lin /p Allergy 2002+ ,2: **1"$**#2


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An!i$is!a"in#LEVOCETRI=INE

Sn##7in/

I!c$in/

R$ino%%$o#a

An!i,#u)o!%#in#MONTELU4AST

Nasa, con/#s!ion

In*,a""a!ion

Ea%,y $as# %#ac!ions

&Visi:,# sy"!o"s'

La!# $as# %#ac!ions

&Hidd#n in*,a""a!ion'

MONTE+LEVO( COMPREHESIVE TREATMENT OF AR


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CLINICAL EFFICACY

o*

UNIAIR L

COMBINATION OF MONTELU4AST AND LORATIDINE


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+

+

+

*

D

+

*

,0.F

,0.3

,0.5

,0.?

,0./

,0.

,0.1

0

7a(time Nasal

:aseline .1

Nig%ttimeS(m

8:aseline 1.59

!om'osite S(m

87a(Hnig%t nasal9IS


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IMPROVEMENT IN SYMPTOM SCORE 5ITH

COMBINATIONAS PROPHYLA>IS

D

DDD DDDDD

DD J

0

0.5

1

1.5

.5

!ongestio

n

R%ino

rr%ea

Snee

zing

Nose

itc%i

ng

E(eitc%i

ngS(m'to

mscore

&lace*o

Montelukast 10 mg

!etirizine 10

mgMontelukast 10

mgHcetirizine 10 mg

D

*P


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COMBINATION OF MONTELU4AST AND CETIRI=INE AS

EFFECTIVE AS INCS

00.5

1

1.5

.5

/

/.5

?

&lace*o Mometasone

furoate

Montelukast +

cetirizine

#otal

nasals(m'to

msscore

N"%%

)"% wee!s

&>0.05

* *

Bo!$ !$#%ai#s


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?35

?F4?40

?55

?30

?35

?F0

?F5

?40

?45

&lace*o :7 MON+!K

&eake-'irator

(flo$

8lHmin9

&lace*o

:7

MON+!K

**

P


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DOSAE AND ADMINISTRATION

Montelukast 10 mg + Levocetirizine 5 mg

One ta*let of MONTE+LEVO0once )ail(

in a)ults


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ADVERSE EVENTS REPORTED

Mon!#,u)as! P,ac#:o

"ea)ac%e 14.? 14.1

A*)ominal

'ain

. .5

7(s'e'cia .1 1.1

!oug% .F .?

7izziness 1. 1.?

PR 200"


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ADVERSE EVENTS con!d9

L#8oc#!i%i7in# P,ac#:oSe)ation 3

Naso'%ar(n

gitis

? /

Iatigue ?

7r( mout% 1

Prescri(ing 'nformation+ 3y4al


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COMMON SIDE2EFFECTS E>PECTED

7r( Mout%

Nausea

Se)ation


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PLACE IN THERAPY

In "od#%a!#2!o2s#8#%# sy"!o"s o* in!#%"i!!#n! %$ini!is

As "ono!$#%ay in "i,d #%sis!#n! AR

As "ono!$#%ay in "i,d in!#%"i!!#n! AR

P%o$y,ac!ic !$#%ay in SAR

In as!$"a co2#.is!in/


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HIHLIHTS OF MONTE+LEVO

n%i*its *ot% earl( an) late '%ase reactions Ra'i) onset of action Acts for longer )uration,gives com'lete control Once )ail( com're%ensive treatment Safe an) $ell tolerate)

Allergy an) Asthma Proc 200+ 26%*: --$-6 'nt 5 .lin Pract 200-+ 1%2: *0#$**1 5 Allergy .lin 'mmunol 2000+ *0: #*" 22 .lin /p Allergy 2000+ ,*: 6*$61


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THANK YOU

Monte+Levo

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