Kokast is indicated for :
- the prophylaxis & chronic treatment of asthma in children 12 months of age and older.
- Relief of symptoms of allergic rhinitis in children 2 years of age and older.
• The recommended daily dose is 1 tablet / day. N.B:
- For patients with asthma , dose should be taken in the evening .
- For patients with seasonal allergic rhinitis , dose may be taken at any time of the day,
which suits the patient.
- For patients with both asthma & seasonal allergic rhinitis , dose should be taken in the
Hypersensitivity to any of the product components.
Safety and efficacy of kokast have been established in adequate and well-controlled studies in pediatric patients with asthma, 6-14 years of age, safety and efficacy profiles in this age group are similar to those seen in adults.
* Kokast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus.
* Kokast can be continued besides the adequate medication for acute exacerbation of asthma.
* Kokast should NOT be taken concomitantly with aspirin or NSAIDs.
* Patients should be instructed not to decrease the dose or stop taking any other anti-asthma medications unless instructed by the physician.
* Kokast contains phenylalanine ( a component of aspartame ), so patients with phenylketonurea should be informed.
* Kokast should NOT be abrubtly substituted for inhaled or oral corticosteroids.
* Kokast should NOT be used as monotherapy for the treatment & management of exercise-induced bronchospasm.
* Physician should be alert to eosinophilia, vasculitis rash, worsening pulmonary symptoms, cardiac complications and/or neuropathy presenting in their patients with asthma on therapy with Kokast.
In general , Kokast with the recommended clinical dose did NOT have clinically important effects on a wide range of other drugs especially those used concomitantly in the prophylaxis & treatment of asthma. Phenobarbital or rifampin (potent cytochrome P450 enzyme inducers), which induces hepatic metabolism, decreases the AUC of montelukast approx. 40%, following a single 10 mg dose of montelukast.
In general adverse reactions of Kokast are rare and NOT common (about 1 % of patients only), even if compared to placebo. As an example of such rare adverse reactions: Asthenia, fatigue, abdominal pain, dyspepsia, dizziness, headache, skin rash, fever, trauma, infectious gastroenteritis, dental pain, nasal congestion, cough, influenza, ALT increased, AST increased, pyuria. Kokast administered once daily at bed time, is well tolerated, but the following events occurred with a frequency > 2% more frequently in patients receiving Kokast than in pediatric patients who received placebo:
• Pediatric patients 6-14 years of age with asthma: laryngitis, pharingitis, influenza, fever, sinusitis, nausea, diarrhea,
dyspepsia, otitis, viral infection.
• Pediatric patients 2-5 years of age with asthma: sinusitis, otitis, influenza, rash, ear pain, gastroenteritis, eczema,
urticaria, varicella, pneumonia, dermatitis & conjunctivitis.
• Pediatric patients 12-23 months of age with asthma: upper respiratory infection, wheezing, otitis media, pharyngitis,
tonsillitis, cough & rhinitis.
• Pediatric patients 2-14 years of age with seasonal allergic rhinitis: headache, otitis media, pharyngitis & upper
• Pregnancy: Kokast should be used during pregnancy if clearly needed.
• Nursing mothers: Because many drugs are excreted in human milk, caution should be exercised when Kokast is given to nursing mother.
• Pediatric use: The safety & effectiveness in pediatric patients below the age of 12 months have not been established.
Box of 7 chewable tablets in a blister.
Store below 25?oC, protect from light
Keep out of reach of children