Montiva 4 Tablet

Indications

Montelukast sodium is suitable for: 

• prevention and chronic treatment of asthma 
• acute prevention of exercise-induced bronchoconstriction (EIB) 
• relief of allergic rhinitis (RA) symptoms: seasonal and perennial allergic rhinitis

Pharmacology

Montelukast is a selective leukotriene receptor antagonist with oral activity that inhibits the cysteyl leukotriene receptor (CysLT1). Cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotriene and leukotriene receptor occupancy is related to the pathophysiology of asthma and allergic rhinitis, including airway edema, smooth muscle contraction, and changes in cell activity related to inflammatory processes, which all contribute to asthma Signs and symptoms.

Dosage & Administration

For adults and adolescents (15 years of age and older): 10 mg tablet once daily in the evening.

Children 6-14 years: 5 mg Oroflash tablet once daily in the evening.

Interactions

Montelukast has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma. In drug-interaction studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following medical products: theophylline, prednisolone, prednisone, oral contraceptives, terfenadine, digoxin and warfarin.

Contraindications

Montelukast is contraindicated to patients with hypersensitivity to any component of this product.

Side Effects

Generally, Montelukast is well-tolerated. Side effects include fever, headache, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, upper respiratory tract infection.

Pregnancy & Lactation

In Pregnancy: Montelukast is a pregnancy category B drug .There is no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed.

In Lactation: It is not known if Montelukast is excreted in human milk. Caution should be exercised when Montelukast is given to a nursing mother.

Precautions & Warnings

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Montelukast should not be abruptly substituted for inhaled or oral corticosteroids. Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking Montelukast. Patients should be alert for neuropsychiatric events. Physician should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications presenting in their patients.

Therapeutic Class

Leukotriene receptor antagonists

Storage Conditions

Keep in dry place away from light and heat. Keep out of the reach of children.

Pharmaceutical Name

NIPRO JMI Pharma Ltd.