MONTA PLUS Tablet

For relief and/or prevention of symptoms of allergic rhinitis (seasonal and perennial), Long term treatment of asthma and chronic urticaria.

Dosage and Administration

Adults (>15 years): 1 tablet once daily.

Oral route.

Patients who are hypersensitive to any component of this product or to Montelukast sodium, Levocetirizine or cetirizine and patients with completely impaired real function.

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 Churg-Strauss Syndrome.

Montelukast

Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma. In drug-interactions studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following medicinal products: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/ norethindrone 35/1), terfenadine, digoxin and warfarin.

Barbiturates & Primidone: Plasma concentration of Montelukast is reduced by phenobarbital.

Levocetirizine

Due to the pharmacokinetic, pharmacodynamic and tolerance profile of levocetirizine, no interactions are expected with his antihistamine. Actually, neither pharmacodynamic nor significant pharmacokinetic interaction was reported in drug-drug interactions studies performed, notably with pseudoephedrine or theophylline (400g/day).

The extent of absorption of levocetirizine is not reduced with food, although the rate of absorption is decreased.

See the package insert about the details below:

Pregnancy

This combination should not be used during pregnancy.

Lactation

The combination is not recommended.

Montelukast

Montelukast should not be substituted abruptly for inhaled or oral corticosteroids. Treatment with Montelukast does not alter the need for patients with aspirin-sensitive asthma to avoid taking aspirin and other NSAIDs.

Levocetirizine

At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0,5g/L). Nevertheless, precaution is recommended if alcohol is taken concomitantly.

Montelukast

Montelukast causes inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit broncho-constriction due to inhaled LTD 4 in asthmatics.

Levocetirizine

The (R) enantiomer of cetirizine is a potent and selective antagonist of peripheral H1-receptors.