This document discusses levocetirizine and montelukast fixed dose combination for the treatment of allergic rhinitis. It provides background on allergic rhinitis and the role of leukotrienes in causing inflammation. Newer generation oral antihistamines like levocetirizine are recommended as first-line treatment. Montelukast is an anti-leukotriene agent that acts on the cysteinyl leukotriene receptor. The document examines the market for fixed dose combinations of levocetirizine and montelukast in India, finding it is growing rapidly at 69% annually with Montair-LC as the current leading brand. Major prescribers of the fixed dose

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