LEVOCETIRIZINE + MONTELUKAST

FIXED DOSE COMB

P. K. MITRA/EURODRUG

• 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

Allergic rhinitis co-morbidities

• Conjunctivitis

• Sinusitis

• Otitis Media

• Cough

• Asthma

ALLERGIC RHINITIS AND ITS IMPACT ON ASTHMA

ARIA

JACI 2001:56: 813-824

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

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

Allergy skin prick testing

Skin prick test / positive result

MANAGEMENT OF

ALLERGIC RHINITIS

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

Environmental control

• House dust mites• Pets• Cockroaches• Molds• Pollen

1. Allergens

2. Pollutants and Irritants

Oral antihistamines

• First generation

agents

Chlorpheniramine

Pheniramine

Diphenydramine

Promethazine

Tripolidine

Hydroxyzine

Azatadine

• Newer agents

Acrivastine

Azelastine

Cetirizine

Desloratadine/

FexofenadinLevocetir

izine/Loratadine

Mizolastine

• 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

Anti-leukotriene agents

CysLT1 Receptor

Antagonists

Montelukast *

Pranlukast *

Zafirlukast (Accolate-

Astra)

5-Lipoxygenase

Inhibitors

Zileuton (Zyflo-Abbott)

* Approved for allergic rhinitis

nucleus

cytosolicphospholipase A2

arachidonicacid

5-lipoxygenaseactivating

protein

leukotriene A4

5-lipoxygenase leukotriene C4

synthase

leukotriene C4

leukotriene C4

leukotriene D4

leukotriene E4

CysLT1receptor

mast cellsbasophilseosinophilsmacrophages

+

Cysteinyl-leukotriene production and the CysLT1 receptor

LEVOCETIRIZINE-5 MG +

MONTELUKAST-10MG FDC

MARKET

COMPETITORS AT A GLANCE

BRAND COMPANY PACKING

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

BRANDS COMPANYLAUNCH

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

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 !

THANQTHANQ

P. K. MITRAP. K. MITRA

MANAGER-MARKETING SERVICESMANAGER-MARKETING SERVICES

EURODRUG LABORATORIES -INDIAEURODRUG LABORATORIES -INDIA