1. LEVOCETIRIZINE
+
MONTELUKAST
FIXED DOSE COMB
P. K. MITRA/EURODRUG

3. • Rhinitis: Symptomatic disorder of the nose characterized by
itching, nasal discharge, sneezing and nasal airway obstruction
• Allergic rhinitis: Induction of rhinitis symptoms after allergen
exposure by an IgE-mediated immune reaction; accompanied by
inflammation of the nasal mucosa and nasal airway
hyperreactivity.
• Seasonal rhinitis: Conjunctivitis, Hay fever
• Perennial rhinitis
• Idiopathic rhinitis
• Food induced rhinitis

4. Allergic rhinitis co-morbidities
• Conjunctivitis
• Sinusitis
• Otitis Media
• Cough
• Asthma

5. ALLERGIC RHINITIS AND ITS
IMPACT ON ASTHMA
ARIA
JACI 2001:56: 813-824

6. Perennial rhinitis: an independent risk
factor for asthma
(European Community Respiratory Health Survey)
Adapted from Leynaert B et al. J Allergy Clin Immunol 1999; 104:301
Asthma (%)
Atopic Non atopic
no rhinitis, N=5198
rhinitis, N=1412
OR=11
OR=17
0
5
10
15
20
25

7. Intermittent
Symptoms
• < 4 days / week
• or < 4 weeks
Persistent
Symptoms
• > 4 days / week
• or > 4 weeks
Mild
• Sleep: normal
• Daily activities (incl. sports):
normal
• Work-school activities: normal
• Severe symptoms: no
Moderate- severe
• Sleep: disturbed
• Daily activities: Restricted
• Work and school activities:
disrupted
• Severe symptoms: yes
Allergic rhinitis classification

10. Allergy skin prick testing
Skin prick test / positive result

11. MANAGEMENT OF
ALLERGIC RHINITIS

13. Leukotrienes – The major culprits
• Causes smooth muscle contraction,
• Increases vascular permeability,
• Helps in migration of leukocytes (eosinophiles) to areas
of inflammation,
• Causes airways obstructions
• Releases Histamines
• Triggers mucus secretions and accumulation of mucous
• Results in inflammation

14. Environmental control
• House dust mites
• Pets
• Cockroaches
• Molds
• Pollen
1. Allergens
2. Pollutants and Irritants

15. Oral antihistamines
• First generation agents
Chlorpheniramine
Pheniramine
Diphenydramine
Promethazine
Tripolidine
Hydroxyzine
Azatadine
• Newer agents
Acrivastine
Azelastine
Cetirizine
Desloratadine/Fexofenadin
Levocetirizine/Loratadine
Mizolastine

16. • First line treatment for mild allergic rhinitis
• Effective for
– Rhinorrhea
– Nasal pruritus
– Sneezing
• Possible additional anti-allergic and anti-inflammatory effect
• Minimal or no sedative effects
• Once daily administration
• Rapid onset and 24 hour duration of action
Newer generation oral antihistamines

17. Anti-leukotriene agents
CysLT1 Receptor
Antagonists
Montelukast *
Pranlukast *
Zafirlukast (Accolate-Astra)
5-Lipoxygenase
Inhibitors
Zileuton (Zyflo-Abbott)
* Approved for allergic rhinitis

18. nucleus
cytosolic
phospholipase A2
arachidonic
acid
5-lipoxygenase
activating
protein
leukotriene A4
5-lipoxygenase leukotriene C4
synthase
leukotriene C4
leukotriene C4
leukotriene D4
leukotriene E4
CysLT1
receptor
mast cells
basophils
eosinophils
macrophages
+
Cysteinyl-leukotriene production and the
CysLT1 receptor

19. LEVOCETIRIZINE-5 MG
+
MONTELUKAST-10MG FDC
MARKET

20. COMPETITORS AT A GLANCE
BRAND COMPANY PACKIN
G
MRP/10’s
MONTAIR- LC CIPLA 10’s 130.00
XARIA GLENMARK 10’s 86.00
NUKAST ZUVENTUS 10’s 119.00
XYZAL-M UCB 10’s 150.00
LEZYNCET-M UNICHEM 10’s 86.00
L-MONTUS FOURTS 10’s 119.00
MONTAS-L INTAS 10’s 138.00
ODIMONT-LC ZYDUS 10’s 122.00
MONTILAST CADILA 10’s 86.00
MONTEC-LC SUN PHARMA 10’s 86.00
ZENOM-M MARS 10’s 75.00

21. BRANDS COMPANY
LAUNCH
DATE
MAT MARCH
2011
VAL(Cr)
MAR CUM
UNITS
('000)
UNIT
GROWTH
LEVO+MONTE FDC – IMS ORG’2011 200510 106.97 5125.92 69.89
MONTAIR-LC CIPLA 200708 20.00 669.30 60.60
MONTEK-LC SUN* 200604 17.40 938.71 54.01
L MONTUS FOURTS INDIA 200603 15.62 582.52 22.88
MONTICOPE MANKIND 200905 10.93 830.24 126.07
MONTEMAC-L MACLEODS PHARMA 200808 8.97 495.11 37.83
ODIMONT-LC ZYDUS CADILA* 200707 6.95 230.09 36.15
LEVOKAST TTK HEALTHCARE LTD 200809 5.48 238.28 28.04
XYZAL-M UCB PHARMA 200908 3.62 112.39 200.22
LEVOCET-M HETERO HEALTHCARE* 200912 3.18 294.75 891.63
XARIA GLENMARK PHARMA 200912 2.91 132.64 2571.61

22. MARKET REALITY
• Major prescribers are Chest-Phy, Phys and ENT
specialists.
• Levo+Monte FDC Mkt is growing by 70 % ( units ) –
Phenomenal !
• As per 2011 ORG, Montair-LC (Cipla) was the largest
selling brand and growing by 60%
• As per 2011 ORG, major 30 brands were growing !

23. THANQTHANQ
P. K. MITRAP. K. MITRA
MANAGER-MARKETING SERVICESMANAGER-MARKETING SERVICES
EURODRUG LABORATORIES -INDIAEURODRUG LABORATORIES -INDIA