Lejet-M / Lejet-M Jr

Lejet-M / Lejet-M Jr

Product Description

Composition: Levocetirizine 5mg, Montelukast 10mg tablet, Levocetirizine 2.5mg, Montelukast 4mg junior tablet

 

Levocetirizine:

 

Introduction: Levocetirizine (as levocetirizinedihydrochloride) is a thirdgenerationnon-sedative antihistamine, developed from the second-generation antihistamine cetirizine. Chemically, levocetirizine is the active enantiomer of cetirizine. It is the R-enantiomer of the cetirizine racemate.

 

Mechanism of action: Levocetirizine, the (R) enantiomer of cetirizine, is a

potent and selective antagonist of peripheral H1-receptors. Binding studies revealedthat levocetirizine has high affinity for human H1 -receptors. Levocetirizine has anaffinity 2-fold higher than that of cetirizine .Levocetirizine dissociates from H1 -receptors with a half-life of 115 ± 38 min. After single administration, levocetirizineshows receptor occupancy of 90% at 4 hours and 57% at 24 hours. The onset ofaction of levocetirizine 5 mg in controlling pollen-induced symptoms has beenobserved at 1 hour post drug intake in placebo controlled trials in the model of theallergen challenge chamber.In vitro studies (Boyden chambers and cell layerstechniques) show that levocetirizine inhibits eotaxin-induced eosinophiltransendothelial migration through both dermal and lung cells.

 

Montelukast:

 

Introduction: Montelukast is a leukotriene receptor antagonist (LTRA) used for

the maintenance treatment of asthma and to relieve symptoms of seasonal allergies.It is usually administered orally. Montelukast is a CysLT1 antagonist.

 

Mechanism of action:

The cysteinylleukotrienes (LTC4, LTD4, LTE4) arepotent inflammatory eicosanoids released from various cells including mast cells andeosinophils.These important pro-asthmatic mediators bind to cysteinyl leukotriene(CysLT) receptors. The CysLT type-1 (CysLT1) receptor is found in the human

airway (including airway smooth muscle cells and airway macrophages) and on otherpro-inflammatory cells (including eosinophils and certain myeloid stem cells).CysLTshave been correlated with the pathophysiology of asthma and allergic rhinitis. Inallergic rhinitis, CysLTs are released from the nasal mucosa after allergen exposureduring both early- and late-phase reactions and are associated with symptoms ofallergic rhinitis. Intranasal challenge with CysLTs has been shown to increase nasalairway resistance and symptoms of nasal obstruction. Montelukast is an orally activecompound that binds with high affinity and selectivity to the CysLT1 receptor.Montelukast inhibits physiologic actions ofLTD4 at the CysLT1 receptor without anyagonist activity.

 

Dosage and Administration Lejet-M:

Adults: One tablet should be administered daily orally

Dosage and Administration of Lejet-M Junior:

Children 2 to 6 years of age: One tablet should be administered daily orally

Children below 2 years of age: Not recommended

 

Indications of Lejet-M:

Seasonal /Perennial allergic rhinitis, Rhinoconjuctivitis, Asthama with allergic rhinitis,chronic bronchitis

 

Indications of Lejet-M Jr:

In pediatric patients with recurrent allergic rhinitis

 

Pregnancy: There are no well controlled studies available. It is used when

Potential benefit justifies.

Lactation: It is not known if montelukast is excreted in human milk. Cetirizine has been reported to be excreted in human breast milk. Because levocetirizine is alsoexpected to be excreted in human milk this combination is not recommended duringlactation.

 

Contraindications: This combination is contraindicated in patients with known

hypersensitivity to Montelukast, levocetirizine, to other piperazine derivatives, or toany of the excipients. Patients with rare hereditary problems of galactose

intolerance, the Lapp lactase deficiency or glucose-galactosemalabsorption shouldnot take this medicine. Aso contradicted in patients with severe renal impairment atless than 10 ml/min creatinine clearance.

 

Warning and Precaution:

Montelukast:

Eosinophilic Conditions:

In rare cases, patients on therapy with montelukast may present with systemic

eosinophilia, sometimes presenting with clinical features of vasculitis consistent withChurg-Strauss syndrome, a condition, which is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between Montelukast and these underlying conditions has not been established. Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal antiinflammatory agents while taking Montelukast.

Levocetirizine: Avoid engaging in hazardous occupations requiring complete

mental alertness such as driving or operating machinery when taking levocetirizine.Avoid concurrent use of alcohol or other central nervous system depressants with

levocetirizine.

 

Side Effects: There is no data available on undesirable effects of this

combination. However, side effects have been reported with individual molecules.

Montelukast: Common side effects include dyspepsia, abdominal pain, rash,

dizziness, headache, fatigue, fever, trauma, cough, nasal congestion.

Levocetirizine: Use of levocetirizine has been associated with somnolence,

fatigue, nasopharyngitis, dry mouth, and pharyngitis, very rarely visual

disturbances and palpitation also occurred.

 

 

Storage Condition:Store below 25 0 C (77CF) & to protect from light.

 

Pack:

 

·        Lejet-M: one strip contains 10 tablets

·        Lejet-M Jr: one strip contains 10 tablet


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