L MONTUS KID Tablet

For relief of symptoms associated with seasonal allergic rhinitis, perennial allergic rhinitis, uncomplicated skin manifestations of chronic idiopathic urticaria.

Dosage and Directions for use

For paediatric patients 2-5 years of age: 1 tablet daily to be taken in the evening.

To be taken by mouth and should be taken at least 1 hour before or 2 hours after food.

Not recommended below 2 years of age.

Patients with known hypersensitivity: Patients who are hypersensitive to any component of this product or to montelukast sodium, levocetirizine or cetirizine.

Patients with end-stage renal disease (CLcr<10mL/min) and patients undergoing hemodialysis.

Pediatric patients with impaired renal function: Children 6 months to 11 years of age with impaired renal function.

Common side effects, which might be seen with the combination, are dyspepsia, abdominal pain, rash, dizziness, headache, fatigue and somnolence. Sometimes, hypersensitivity, irritability, restlessness, insomnia, vomiting and diarrhoea may occur. In rare cases, patients may present with systemic eosinophilia, sometimes presenting with clinical features of consistent with Churg-Strauss Syndrome.

The individual drugs are not known to have any interactions so far. Hence, no interactions would be expected with the combination.

Pregnancy

The combination should be used in pregnancy only if clearly needed but should not be continued.

Lactation

Since levocetirizine is excreted in breast-milk the combination is not recommended during breast-feeding.

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatics. Patients should be advised to have appropriate rescue medication available. Therapy with Montelukast can be continued during acute exacerbations of asthma. While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, Montelukast should not be abruptly substituted for inhaled or oral corticosteroids. Montelukast should not be used as monotherapy for the treatment and management of exercise-induced bronchospasm. Patients who have exacerbations of asthma after exercise should continue to use their usual regimen of inhaled (beta)-agonists as prophylaxis and have available for rescue a short-acting inhaled (beta)-agonist. Patients with known aspirin sensitivity should continue avoidance of aspirin or NSAIDs while taking Montelukast Eosinophilic Conditions: In rare cases, patients on therapy with Montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-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.

Levocetirizine: Precaution is recommended with intake of alcohol.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

The combination should be used with caution in patients with impaired hepatic and renal function. Patients on concurrent administration of CNS depressants should be administered with caution.

Combination of Antihistamine and leukotriene receptor antagonist

Montelukast sodium is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor. It causes inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD4 in asthmatics. Doses as low as 5mg cause substantial blockage of LTD4-induced bronchoconstriction.

Levocetirizine is the R-enantiomer of cetirizine. Levocetirizine is an orally active, potent, selective and long acting H1-histamine receptor antagonist with no anticholinergic activity. Levocetirizine, the (R) enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors.