CETLOC Suspension

CETLOC Suspension
Levocetirizine 2.5 mg + Montelukast 4 mg

Allergic Rhinitis (AR) is one of the most commonly diagnosed health disorders among children with
prevalence reported to be as high as 40%. Commonly called hay fever, is defined as inflammation of the nasal
membranes that occurs when an allergic individual encounters an airborne allergen such as pollen, mold,
dust mites, animal dander etc. It is characterized by a symptom complex that consists of any combination of
the following: sneezing, nasal congestion, nasal itching, and rhinorrhea. The eyes, ears, sinuses, and throat can
also be involved. AR is not a life-threatening condition; however symptoms can have a profound effect on a
child’s health, behavior, sleep patterns, ability to learn, take part in physical activities/sports thereby
significantly impairing child’s quality of life and contributing to a number of indirect costs. Also, it is reported
that AR and asthma frequently coexist in children.

Levocetirizine:
Levocetirizine, the (R) enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-
receptors. Binding studies revealed that levocetirizine has high affinity for human H1 -receptors (Ki = 3.2
nmo1/1). Levocetirizine has an affinity 2-fold higher than that of cetirizine (Ki = 6.3 nmo1/1). Levocetirizine
dissociates from H1 -receptors with a half-life of 115 t_ 38 min. After single administration, levocetirizine
shows receptor occupancy of 90% at 4 hours and 57% at 24 hours.

The onset of action of levocetirizine 5 mg in controlling pollen-induced symptoms has been observed at 1
hour post drug intake in placebo controlled trials in the model of the allergen challenge chamber.
In vitro studies (Boyden chambers and cell layers techniques) show that levocetirizine inhibits eotaxin-
induced eosinophil transendothelial migration through both dermal and lung cells. A pharmacodynamic
experimental study in vivo (skin chamber technique) showed three main inhibitory effects of levocetirizine 5
mg in the first 6 hours of pollen-induced reaction, compared with placebo in 14 adult patients: Inhibition of
VCAM-1 release, modulation of vascular permeability, and a decrease in eosinophil recruitment.
Pharmacodynamic studies in healthy volunteers demonstrate that, at half the dose, levocetirizine has
comparable activity to cetirizine, both in the skin and in the nose.

Pharmacokinetic/pharmacodynamic relationship 5 mg levocetirizine provide a similar pattern of inhibition
of histamine-induced wheal and flare than 10 mg cetirizine. As for cetirizine, the action on histamine-induced
skin reactions was out of phase with the plasma concentrations. ECGs did not show relevant effects of
levocetirizine on QT interval.

INDICATIONS

CETLOC Tablets are indicated for relief of symptoms of allergic rhinitis (seasonal and perennial), as prophylaxis
in seasonal allergic rhinitis and treatment of comorbid asthma & allergic rhinitis in patients 15 years of age and
older.

CETLOC KID Tablets are indicated for relief of symptoms of allergic rhinitis (seasonal and perennial), as
prophylaxis in seasonal allergic rhinitis and treatment of comorbid asthma & allergic rhinitis in patients 2 to 5
years of age.

DOSAGE AND ADMINISTRATION

Adults (>15 years):
One tablet once daily
Children: (2-5 years)
One tablet once daily
Due to the lack of data, the administration of this product to infants and toddlers aged less than 2 years
is not recommended.

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